DRUG RESOURCE MATERIALS - AIDAN
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RF_DR_10_SUDHA
This is taken from a book with very strict copy right instructions.
THIS IS FOR PRIVATE CTROILATION ONLY.
CONTROVERSIES IN CONTRACEPTION
Edited by
S. Moghissi, MD.
i
STEROIDAL CONTRACEPTIVES AND CONGENITAL ANOMALIES
Excerpts from
"Controversies in Contraception"
Chapter 4,
pages 49 to 59
By Gloria E. Sarto, M.D., PhD.
Pregnant women are exposed to exogenous sex hormones (i.e. Androgens,
Oestrogens and Progestogens) as a result of one of the following:
1.
Hormones usually progestogens; prescribed with intent of
preventing a spontaneous abortion
2. Oestrogen and progestogen combination prescribed as a tfest
for pregnancy
3* The continued use of oral contraceptives through the early
stages of an undiagnosed pregnancy.
Teratogenesis depends upon several factors:
1.
2.
3.
4.
5-
i
Specificity of the drug or ".infectious agent
Dosage
Time of exposure of the developing embryo
Genotype of the mother and embryo
Other confounding factors - for example, other drugs and
certain disease states.
Some environmental agents acting alone are capable of initiating a .process
of dysmorphogenesis; however, malformation most commonly is dependent upon
a combination of teratogenic agent and the genotype of the individual,
Each alone is innocuous but in combination an upset of the dynamics
normal development results in anomalies.
It is evident that our capability - to detect a teratogen in man is strongly
dependent upon a competent surveillance system. In order to have incidence
rates that are reliable, several factors have to be clearly defined. The
periods of gestation to be included must be established. Obvious malformatre
tions such as-anencephaly and cleft lip are easily recognised; internal
malformations, however, may go undiagnosed. Transmission of the information
both within the hospital and within the system for collecting the data have
potential difficulties.
Recognizing the difficulties in determining teratogenicity in man and the
inadequacies of the surveillance system, one can understand why reports
in the literature linking a certain drug with an anomaly can vary.
Steroid Hormones and Exftragenital Anomalies
$
&
o
A
co
-o
o’
< o
Neural Tube Defect®:
In 1967, Gal et al reviewed the drug histories of one hundred women who
?
had babies born with meningomyelocele or hydrocephalus and of the same^> £- <r'r
number of control women who had delivered healthy babies. The surv^ £
women were on an average some two years older than the controls. As peSrt-'
0
2/^
D-1O.341(a)
S:pt:12.2.>82
:
2
SLiXrZnT T
611 were aSked
°W the
women
asked h
how
the Prog^oy
pregnancy was
was diagnosed.
diagnosed.
h“T re“i T
y group
Sr°UP and four
fOUr of
°f the
the control
Contro1 "omen reported
—j+Z7
survey
presumably hormones, for the diagnosis
"> significant (P> 0.01).
contain 10 mg
0.05 mg of ethinylestradiol.
mairo^at^ 3 „
SXXXpXXr “
as a mechanism to determine
W Xm (lX'S »y ajolta rotr<,^6ctlve
°f “nS“,ital
Ba<le
“ 433 Atlanta
"iwonen who had elveS ilrth
„S? 7 5 t’’ .lnX
thls’ “
rtW,
months
J””'1'® ”C're
three
There were
<^ire family history, socio economic status,etc.
3 those'” » iSS’S,?’,?/ oM1,a ”lth *
“e defect
»ith
postzve hiSo“t ln tUXip™“» S“ ttsrt i>».r”rt“n
fr« the proportion ob^ed ■ to tho’tith^
Liinb defects:
di2ts a^CniCh 6t a1*’
10S caees of congenital limb-reduct.-on
I'”
frequency among the cases was significant (P>0 02'
^Tn
“creassd
S’reduSioSnm:eSSrS’ThSine ST reCords'looked at -cular tJeSsTr
Heart defects with or without associated malformations
and family histories were obtained
with transposition of great vessels (TGV) born
r™
of-sreat
^8elto
’ (TG
’) >»■ J-h TCJ were latched
according
birth
dates
*ita control cases who had various
■. „
Mendelian disorde:irs. Ten of the ?6
babies with TGV had been treated
--- 1 with some hormone,
of threatened abortion and
t__ 1 one
w was given a hormonal Six were treated because
pregnancy test. The
other 3 included 2 women who
r—
. 2.j w
®re on insulin and 1 woman who was on thyroid
dedication. .So in 7 of these 76 cases
there was no other factor that night
cause malformations; this was c
76 controls in which there were
no malformation. The difference between't'ke^
- -------* two is significant(P = 0.00?).
frS T^women
3/
y
D-lO.341(a)
S:pt:12.2.'82
:
3
& N°ra
reported on 19 patients with multiple congenital
™^xes from a group of women who had been exposed to est^SpZEeJ
<^“?6
sxr13
®e^ogen/estrogen exposure in the VACTERL group during a period
of oxS^roi’?thZ1a?f31Sar eXp0SUre any tLne durinS Pre£ancy, the frequency
exposure, in the affected group was significantly higher (P> 0.001). 4
7
cohort^tud^^S 282m tI1h 0°llaborative Perinatal Project, a prospective
cohort study of 50,282 mother-child pairs, Heinonen et al (1977) reported:
births)
^thucardiovascular defects born to 1,042 women who
female hormones during early pregnancy ( a rate of 18.2/1000
Among the 49,420.children not exposed in utero to these agents,
here were 385 with cardiovascular malformations, a rate of 7.8/1000
011?L XIS •
'
This study alleviates some of the biases seen in earlier studies. The drue
use was recorded before the birth of the child and the diagnosis of congenital
^^ut knowledge of whether or not the individSl wL
os®?;
P°tentiaW -'confounding factors such as diabetes mellitus
ZeS^inf^SaS! in a P^°r siblin8> maternal age more than forty
'
bacterial infections and many others were controlled. In spite of this relative
weS ~f congenital heart defect remained appreciably elevated for those’whQ1
were exposed. Again,the question is whether the hormonal treatment freouentlv
given to women with threatened abortion is the causative agent, or wither
pregnancy had an inherent risk factor that increased the likelihood of
nomalies and caused the individuals to threaten to abort. Subtle- and
unrecognized biases enter at many levels. In spite of this, it would seem
prudent to cease pregnancy testing with hormonal agents and discontinue un
necessary use of steroid sex hormones anytime in the pregnancy.
D->10.341(b)
S:pt: l6.2.!82
REFERENCES ON
OESTROGEN-PROGESTERONE TESTS FOR PREGNANCY
D. V eng ad a Salam et al
International Journal of Gynaecology & Obstetrics
14: 34^-352,
1976.
Synopsis;
This study was designed to’evaluate, the efficacy of an exogenous oestrogen
progesterone preparation for inducing "withdrawal- bleeding" in non-pregnant
women for diagnosing early pregnancy.
Three hundred patients not -desiring
to be pregnant and- with no signs of pregnancy other than menses delayed by
14 days or less were randomly assigned to treatment or control groups.
The treatment group received an I/Nl injection of $0 mg progesterone and 3 mg
of oestrogen benaoate in oil. The control group received no hormonal
injection. There was no significant difference between the two groups in
the incidence of uterine bleeding with?1?days.. Thus the hormonal preparation
was ineffective in induaing "withdrawal bleeding".
Its use as a diagnostic
test for pregnancy is not recommended.
"Women who received no hormones were more likely to begin uterine bleeding
within 1-3 days after their initial visit, while uterine flow among the
treated women was most likely to occur 4-6 days after the injection.
Thus
not only was there no evidence that administration of the oestrogen-progester-one combination made "withdrawal" or menstrual bleeding more likely, but the
treatment regimen also appeared to delay the onset of bleeding". .
"Complaints reported by patients at the 7“day follow up - 52.6$ of the patients
treated with hoimones had, one or more complaints compared with 36.4$
bhe
women not treated. Although most symptoms were reported more frequently by
the treatment group, the only significant differences between the two groups
for specific complaints were for vomiting and headache."
"The proportion of women undergoing menstrual regulation (MR) because ammenorrh
hoea persisted 7 days after the initial clinic visit who Were found to be not
pregnant by microscopic examination of uterine contents was 21
in the
control group and 18.9$ in the treatment group.”
Since failure of the hormonal injection to induce uterine bleeding has been
previously alleged to indicate pregnancy, theTfalse~positive! rate associated
with the use of EP combination as a clinical pregnancy test was 18.3%. This
is higher than the false positive rates associated with pr^gnosticon Dri-Dot
test.
Not only does there appear to be no benefit demonstrated from the present use
of this oestrogen-progestin combination, but there may be added risks,
especially when it is used as a pregnancy test for the women who do not desire
pregnancy termination. As. a result of this investigation the authors suggest
that the use of this oestrogen-progestin combination for diagnosis of early
pregnancy be discontinued.
2/
^lth cell ;
COMMUNITY
, ivurks Hoad
47/1»(First Floor) - bangalore -560 001
too 099 - BHO-iVONVa
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*—
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P-10.341(b)
S:pt; 16.2. ’82
2
:
Isabel Gal
Nature
Vol. 240, November 24, 1972.
elhninate^ias.
infection) Were excluded to
A hilhfr
the pri?Mmcy test S
in, producing the malformation in one in eight of the cases.
°fIa
&^Xt”
findings may be only of
<HTn-?T^X;+
i i
1
i
,
Ch^nistered ^earl>' Pregnancy. Some of these
borderline statistical significance but th^
tTSSrof the tre,,d t,“e
th.
S
r
changes produced
the tablets
disturb a non-prefXit
uteXs by
4^
\S‘eP“1
=•«< tee...
effective to
non-pregnant uterus, there is “
a !strong
the
pr.gnan.y oaX
“r°”S ■possibility'that
x,3sihl“* “»t th.
"g coi0£g„?pr“■«>'i»-
into the outcome of pregnancy found a lO^b r.+^er'‘3raJ’ petitioners survey
administration and BrotheS and Gr^t Z aboPlon rate
-Primodesspontaneous abortion folloXU^sTof
bhe5elatively
hoi^ne^Se pS^nSc^testSets
dose of
unit, by upsetting the hormonal balane^f^^P Wlt,h the foeto~Placental
interaction netween mem. ms w
foetal development.
rflJ-
e
Xt
Ll.w»
| 1 .
1. •,
1..
i..
........
.
i
.. t «. 1
..+
r--'-nor
studies?)
Excerpt from a letter written in the British Medical-Journal, 26th April 9
1975*
Page 192.
By G. Green Benz & $0 Committee on Safety of
W,H.W. Inman
Medicines, London.
and
Josephine A.C.
Weatherall
A.M. Ad el st ein
0
0
0
Office of population
Census and Survey.
London.
In a study with 149 abnormal babies (?0 with malformations of the CNS,
9 with reduction deformities of the limbs, 13 with congenital disease,
11 with Downs Syndrome, and 46 with other malformation) with 149 controls.
Of this a total of 23 mothers of abnormal babies had been exposed during the
first trimester of pregnancy to drugs containing hormones compared with
only eight of the control mothers. One of the 23 had also taken an oral
contraceptive and tablets of nor-ethisterone. This evidence supports the
recommendation that ’’there is little justification for the continued use of
withdrawal type of pregnancy tests when alternative methods are availablec
3/
-
1
D-lQ.34l(b)
S:pt:l6.2. ’82
3
!
Editorial ’The New England Journal of Medicine’
Page 731•
Vol. 29b No.14-
Suspicions regarding a potentially teratogenic role for progestogen/
oestrogen have been voiced for several years, But reports have been
conflicting.
The unique features that first attracted our attention to the potential
teratogenicity of progestogen/ estrogen were the associated anomalies
now covered by the acronysm VACTERL. These anomalies of simultaneously
developing and simultaneously vulnerable structures recapitulated the systems
involved in the thalidomide syndrome but presented a somewhat different
pattern. One may speculate that a number of factors may influence whether
or not an anomaly will occur as a discrete malformation or in association
with other anomalies - among these are hereditary predisposition, dose
response and precise timing of the insult.
A unique feature of the data
of Janerich et al is that all patients who had limb - reduction anomalies
associated with maternal oral contraceptives exposure were male.
Available data suggest that if progestogen/oestrogen produces malforelations,
it is at a low frequency rate probably acting on predisposed, persons.
The epidemiologic impact of these hormonal agents would thus not be related
to high risk for each individual exposure but to
the high number of
exposures from wide use.
In any case as we have earlier stated, and as Janerich and his co-workers
have concluded, it is prudent to discontinue the use of hormonal pregnancy
tests.
Integrated Obstetrics and Gynaecology for Post Graduates
By Dewhurst.
In a series of 50 habitual abortion patients, Sherman and Garret found
as good results in the placebo group. This paper proved turning point.
Further studies (e.g. Gold-Zeiher’'1964, Klopper and Macnaughton 1965)
produced similar findings. Ever since, critical-gynaecologists have been
hesitant to accept that hormone treatment is specifically important in
prevention of abortion.
(Page 234)
The use of hormone wMhdrawl regimen tests for pregnancy based on the work
of Zendele (1942) was until recent years popular. Contrary to previous
assumptions new data suggest that the administration of hormone will not
hasten and may even delay the onset of menstrual bleeding. This lack of
efficacy together with some evidence of ’’Increased incidence of congenital
malformations ” associated with the administration of hormones in early
pregnancy suggests that hormonal withdrawl test should be abandoned.
Quoted from - Post graduate Obstetrics & Gynaecology by Krishna Monan,
D evi, B haskar Rao, 1930. Ghapt er I.
Williams Obstetrics^ 16th Edition 1930.
Moreover, currently there is the fear that progestons are potential teratogens.
While the evidence to support such a conclusion is not yet definitive,
nonethless considering the lack of utility of this procedure, progestin
induced withdrawl menses as a test of pregnancy cannot be recommended.
Page - 268.
V
D-10,341(b)
S :pt: 16.2. ’82
:
4
Progesterone on Threatened Abortion
(Goodman Gilman^ 1980
‘Pages 1439 - 1440)
Pregnant patients should not be given estrogens, particularly during uhe
firtt trimester - a time when the foetal reproductive tract is.developing
and may be influenced by exogenous estrogens. For the diagnosis of
nreanancv immune - assay of urinary chorionic gonadotropin, which is .
increased’very early during the first trimester of pregnancy is a relatively
simple technique and is preferred.
Of course there are reports which suggest the opposite i.e. the sex tormones
linkage with foetal abnormalities is statistically not (or margi
y)
significant.
Editorial ’Lancet1
December 1974.,
Page 1489-
Most new drugs offer only fringe benefits, if any, incomparison to their
nearest rivals; and serious side effects, or even well- founded suspicions,
should normally result in such a drug being witndrawn from the, market,.
Tn case of oral contraceptives, anxieties, whether about teratagenesis, n
well founded, should lead to modification rather than withdrawl of he
product. (My comment: What cheek;)•
As regards pregnancy test drugs, there are prospective studies which so far
have revealed no suggestion of teratogenic action. (Smithells, 3.W.
’Practioner’ 1965?
194, 104)
Furthermore, it seems likely that mothers who undergo, such tests form a
selected (possibly self selected) group when compared with mothers whoj>e
pXg^y te“ is eSl«l out on I Ttoo speotaon, or with those who do not
have any kind of test.
The observation in the study done by Levy Cohen & .^aser apd from the
study of Nora and Nora raise two important problem. The first is that four
apparently unrelated anomalies or groups of anomalies - limb reduction,
defSs, congenital defects of the great vessels, the VACTERL association
and DiGeorge syndrome (thymus, parathyroid aplasia).have been linked with
hormone ingefttion in early pregnancy. If the link is due to
teratogenic effect of hormones, the effect is remarkably non-.pecific and
could be compared only with the effects of antimitd&ic drugs. It is
certainly Se unliL the effect of thalidomide which although capable of
dSgiS maS different organs, did so in. a remarkably constant and recogmsabll way. The second problem, arises from regarding as a single group
mothers who have taken widely differing hormonal preparations for widely
differing reasons.
The evidence of linking hormone ingestion in early pregnancy with malforma
tions (other thanvirmsing effects) i> so.far ^remely tenuous^ Further^
nrnsnective' studies are needed. Moreover since the question has been raised,
an op^rtuno ttae to . ovl„ th. ourront us.s of horwnal prepara
tions in the llasnosls of pregnancy. In post coital
manarernent of habitual abortion. The association of maternal oestrogen
thXy ^h va?inal ^cinoma in female offspring should sharpen our
critical faculties.
"
D-10.341(b)
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5
Kenneth J. Rothman, Donald C. Fyler, Allan Goldblatt and Marshall B. Kreidberg.American Journal of Epidemiology:
Vol. 109 No.4, Pago 433
Rothman, K.J. (Harvard School of Public Health, Boston, MA 0211 5)>
D.C. Fyler,A. Goldblatt andM.B. Kreidberg, Exogenous hormones and
other durg exposures of children with congenital heart disease.
Am J Epidemiol 109: 433-439, 1979 *
A history of oral contraceptive use, hormonal pregnancy tests,
prescribed hormones and other drugs was obtained from 390 mothers of
infants with congenital heart disease and 1254 mothers of normal
infants in Masschusetts. The data show a small positive associa
tion between estrogen/progesterone exposure and cardiac malformation,
the prevalence ratio estimate of exposed to non-exposed being 1.5
(90 per cent confidence limits are 1.0, 2.1). No association was
evident, however,between hormones and trunco-conal or any other class
of defect among the cases, an observation which casts doubt on a
causal relationship between hormones and cardiovascular malformations.
Dear Friend,
1 have already sent to you copy of the letter E P combination
and one set of reference material, This is the second bit of information
taken from the different articles.
If your article on the E P drugs gets published, please send us
a copy of the article to VHAI’s address.
Best of Luck.
/
Sathyamala.
Voluntary Health Association of India
C-14, Community Centre
%
Safdarjung Development Area.
~Ao\
New Delhi-110016
/o
/ til
P-9/331(c)
S:pt:5.8.r82
Telegrams : VOLHEALTH
New Delhi-110016
Phone : 652007, 652008
COMMuwn, HMtrH
(First F|c^GA4ORE.660007
1LEVIEW OF SUPPORTIVE HORMONE THERAPY IN
OBSTETRICS
Hormone treatments have been used for the following indications during
pregnancy: threatened abortion, recurrent abortion and premature or delayed
labour.
According to the report of a WH) Scientific Group on "The effect
of female sex hormones on foetal development and infant health" (Technical
report series 657) ;
’’The benefits of progesterone therapies (and of oestrogens) need
to be proven before any of these drugs can be recommended for
supportive treatment in pregnancy... There is a suspicion that
progesterons may be weakly teratogenic or f etc toxic” •
This report
A.
■
B.
the medical literature on these two points;
Efficacy of supportive hormone treatment in
threatened and habitual abortion
The teratogenic effoots of these hormones on
the foetus.
viability. The
Abortion means the expulsion of a foetus before it reaches viability.
WHO has recommended that a foetus shall be considered viable when the gestation
poriod is more than 20 conpleted weeks or the foetus weighs 400 gm or more.
About 15% of all pregnancies terminate as a spontaneous abortion. The peak
time of spontaneous abortion is between the 6th and 10th week of pregnancy
when 65% of abortions occur. This has been connected with a reduced progest*^
erone secretion, as at this time the activity of the corpus ^Leteum is
waning and the placental production of the hormone has not reached ’adequate1
levels.
The rationale for hormone treatment is based upon observations first made in
1930’s that abnormal pregnancies are often accompanied by a relative deficiency
of female sex hormones. It was observed that the natural production of oestroand progesterone in pathological pregnancy did not increase at the
same rate as in normal pregnancy and exogenous female hormones were given in
order to supplement the low endogenous hormone secret ion. Correspondingly
some of the therapeutic regimens involved progressively increasing doses of
hormone supplement during pregnancy. In certain cases large doses of
oestrogen and/or progesterone were used for short periods in critical
situations such as threatened abortions. (A list of common brand names of
drugs prescribed for threatened and habitual abortion is attached.)
k
Efficacy of supportive hormone treatment iniJiabitiial abortion;
Evaluation of any treatment requires a comparison with the spontaneous cure
rate. This fact has always been a major stumbling block in the assessment of
regimens used to treat recurrent abortion, since the prognosis of this condi
tion has never been satisfactorily established. The first statistical attempt
at evaluation was that of Malpas in 1938. He based his calculations on the
assumption that the overall abortion rate consisted of the sum of two inde
pendent rates, one due to a non-recurrent (i.e. random) factor, and the other
to a recurrent cause. He selected several reasonable combinations of
1
f
I
I
4
P-9/331(c)
.S:pt:5.3.’82
2
incidence rates for these two factors and calculated the expected abortion
rates.
At a later date, Eastman and Hellman used the same formula to calculate
the prognosis from incidence rates which they felt were more realistic.
These theoretical calculations are summarized in Table I.
If one assumes,
for example, that the recurrent abortilaclent factor has an incidence of 8%,
and the random frequency of abortions has one of 10$, and if there has been
one previous abortion, then the formula predicts a 50:50 chance of there
being an abortion in the next pregnancy. Unfortunately, it has often been
forgotten that these are simply theoretical predictions which require sub
stantiation by careful, well-designed experiments. Instead, if some regimen
yielded a pregnancy salvage rate better than the predicted one, this has
been taken to constitute ’’evidence” of therapeutic effectiveness. The
fallacy of such thinking was emphasized in a review of the problem by
<iiu3/iv5nher and BenignoFrom the inadequate and highly variable data
which coula Vo collected, it appeared that the incidence of abortion after
two previous abortions
23g (not 12.6% or 13*2% as predicted). After
three consecutive abortion it did not
+o 3g jg as expected, but
remained at about 24%; and after four consecutive
not
rise to 73 to #4% as predicted, but remained just under 4^5• finally
the observed abortion frequency remained at this figure even in pat lent o
although the Malpas fornula predicted that the abortion rate should approach
100%. When one considered other cases, in which there had been term
pregnancies prior to the series of abortions, the discrepancy between
theory and observation was even greater. No tendency whatever for the
abortion rate to rise with increasing numbers of previous abortions was
observed. Unfortunately, the published data on abortion incidences in
untreated patients were so variable that no statistically valid prognosis
could be estimated, Goldzieher and Benigno pointed out that the only
way to evaluate therapeutic effectiveness would be by double-blind placebo
techniques, with the reservation that a high spontaneous salvage rate might
make such a comparison impractical because o^the large numbers of patients
required to enable the investigators to distinguish between spontaneous
salvage and therapeutic benefit.
Table IPredicted abortion incidence after one to four successive
abortions as calculated from assumptions.
Assumed abortion incidence, %
^Due to Recurrent
Due to Non- ’
cause
recurrent
cause
8
2
10
16
Previous
successive
abortions.
No.
r1
0 2
0 3
L4
? 1
V 2
0 3
1
17
L4
ri
(2
3
L4
0.4
9.6
Fl
2
3
L4
Predicted
Abortion
Incidence, %
50
91
93
99.7
25
53
85
97
13
38
73
94
13
37
84
88
3/
D-9/33l(c)
S:pt:5.S.!S2
3
Misinterpretations of the Malpas calculation continue to appear, as1 in the
studies of Goldfarb and Gongsaki with norethynodrel. Some i nvest5gator3
have lumped- threatened and habitual abortion together in their evaluations
— a procedure of doubtful merit - or have reported the superiority of one
progestin over another from data not even subjected to
simple statistical
test such as chisquare analysis, which, in fact, shows that the differences
observed can be explained equally well by pure coincidence. Seidl et al,
instead of using a placebo, compared oral progesterone with 19-norsteroid
administration. The former group showed a 21$ abortion rate am the latter
a 71$ abortion rate - a significant difference. They concluded that
progesterone was of therapeutic benefit.
Another equally valid conclusion
might be drawn from these data, namely, that progesterone treatment has no
value at all, and that 19-norsteroids are harmful.
Data presented below indicate that the latter inference is probably the
correct’ one.
I.
The first investigation to approach the problem of recurrent abortion
in a statistically sound fashion was the double blind study of Sherman
and Garrotte.
■
The purpose of this study was to present the result of a double blind
study of treatment with a. progestogen in 50 patients selected for
treatment on those individuals showing evidence of a low or declining
progesterone production. ■. If progesterone treatment is of material
assistance to these individuals then there should be a significant
difference in the. salvage rate from those receiving an adequate dose
of the active preparation compared with those receiving placebo. 50
patients with two or more consecutive previous abortions with a
persistent low or declining pregnanediol excretion in the current
pregnancy were selected (patients showing uterine reduplication or
persistent t normal levels of pregndnediol excretion were eliminated
from the study).
All 50 patients received injections of either solution A or B, one of
which contained hydroxy progesterone caproate .and the other only the
injection medium. Of those receiving solution A, 18.5$ aborted. Of
those receiving solution B, 21.7$ aborted. They concluded that
"The overaill incidence of foetal wastage is 20$ whichever of
these solutions contain the progestogen. These results do
not so far support the claims that progestational therapy
is of specific value in the prevention of abortion. Of the
six aborters examined, four were grossly abnomal.”
II. The second double blind trial was conducted by Joseph W•4 Goldjueher.
54 habitual aborters (those with 2 or wre previous abortions
rtions) with low
or normal pregnanediol excretion were selected,
The drug used in this
study was medroxy progesterone acetate.
’’The habitual aborters with a low pregnanediol excretion have a
spontaneous salvage rate of about 80$. This favourable prognosis
places the gravity of the problem of habitual abortion in an entirely
different light. It may also explain the curious coincidence that a
great variety of gynaecological, endoerine, or psycho-therapeutic
treatments have all achieved the same, level of therapeutic benefit
- a salvage rate approximating 80$. This high spontaneous salvage
rate makes it virtually impossible to prove the therapeutic efficacy
of a drug used to treat habitual abortion. The data of our study
provide no evidence for a difference in the prognosis of habitual
aborters with low pregnanediol excretion as contrasted to those in
whom pregnanediol excretion is normal” •
4/
D-9/33l(c)
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4
The study concluded with a conmunt that nIf one excludes well-defined
causes of recurrent abortion such as cervical incompetencej the scarcity
of "idiopathic1’ habitual aborters becomes noteworthy. It may be timely
to raise once again the question whether there is any such disorder as
habitual abortion at all or whether it is merely the unfortunate result
of chance coincidence”.
III. The third double blirkl study was conducted by Arnold Klopper and Malcolm
MacN aught on.
Two groups of patients were studied. The first, consisting of 33 individuals
were the subject of the therapeutic trial; the second consisting of 41
individuals did not have any hormone therapy but, like the first, had
urinary steroid assays done. Both groups were .subject to recurrent
abortion having had 2 or more abortions and never having carried any
pregnancy beyond 28 weeks. A point of cardinal importance was that they
should come under surveillance very early in pregnancy. In a previous
publication, MacNaughton (l?6l) had shown that in their hospital population
more than half the patients who abort do so before the 12th week. Any
group of patients of whom a considerable proportion are more than 10 weeks
advanced in pregnancy when they first come under study is a group heavily
biased toward spontaneous success. In this series nobody was accepted
for trial who was more than 10 weeks pregnant.
The drug chosen for administration was cyclopentyl enol ether of progesterone
as it is the only artificial gestagen which is like progesterone metaboli
zes to pregnanediol in the body.
The study concluded that:"It is unlikely that the wrong compound has been
chosen for trial. It is more probable that the element in abortion which
can be corrected by exogenous progesterone is a very small one and that
very few pregnancies will be salvaged by this means. Much of the apparent
success of progesterone therapy in the past may be due to the fact that
proper blind therapeutic trials were not done and that the steroid admini
stration was begun at 10 to 14 weeks of pregnancy; a stage when the
danger of abortion is largely past. It is possible that foetal chromosomal^
abnormality, rat her than excessive myometrial contractility due to hormone
deficiency, is the most frequent cause of abortion in early pregnancy.
Too much emphasis has been placed on the prognostic value of hormone
estimations. It seems more probably that a reduction in hormone production
is an effect rather than the cause of abortion and that in the majority
of cases, when a lowered pregnanediol occurs the pregnancy is already beyond
‘salvage" •
IV. Study by R.R. Macdonald et al. Cervical mucus ferning indicating^some
degree of hormone deficiency was observed in 40 of 56 patients with
recurrent abortion. These 40 patients were treated with oral dyhydroge st erone on a double blird basis. S5^ of the patients delivered healthy
babies, but no direct effect or improved result could be seen when the
active drug was used.
»
They recommerd a clinical plan for specific treatment of women with a
history of recurrent abortions.
5/
D-9/33l(c)
S:pt:5.8,'B2
5 :
At the first visit, as early in pregnancy as possible, a mens
sample is taken from tho lower endocervical canal and a cytology
soear from the lateral vaginal wall (the cervical mucus and
vagannal cytology smears are simple to collect, aost less and give
an assessment more quickly. They are of greater clinical value in
demonstrating for more deficiency and in assessing progress).
- Urine is collected for a gonadotrophin pregnancy test.
The results of the metis test for ferning and of the pregnancy test
are available before the patient leaves the clinic the sane day.
- Specific assurance is given that regular attendance at the clinic
with correction of any detected abnormalities will give the patient
at least an SCjS chance of a live child in that pregnancy regardless
of her history.
-
t
An oral tablet to be taken twice a day is prescribed and the patient
is told that it will help her naintain the pregnancy : regular
psychologic reinforcenent is>we believe, of specific benefit —
at present folic acid tablets are prescribed.
- This is repeated every week to 14 weeks and then every 2 weeks
to tern.
B. The teratogenic effects of these hormones on the foetus:
(Excerpt from report of a WHO Scientific Group, No. 657)
Concern about possible, hazards tojthe fetus
Risks to offspring:
exposed to various sex hormones provided as supplements during,pregnancy
dates back to a report of masculinization of a female fetus as a.result
of exposure to i7-a-ethinyl-l9-nortestosterone.
These observations
have not been reported froin studies designed specifically to identify
adverse fetal effects. Other adverse effects of this exposure have
been recognized in both female and male offspring following recognition
of the occurrence of clear cell adenocarcinoma among young women with.a
history of in utero exposure to diethylstilbestrol. In female offspring
other adverse effects are adenosis of the vagina and cervix, which
occurs in a high proportion of the exposed and an increased risk of
prematurity in their pregnancies. Also observed have been alterations
in the shape of the uterine cavity as documented by hysterosalpingography.
Among the male offspring, there have been reports of epididymal cysts
and abnormal it.les of sparm number, morphology, and motility.
Possible'risks to the fetus of exposure to steroidal sex hormones are
difficult to study, and published studies are difficult to evaluate.
Some have ^wargued that the question of the safety of progesterone is
distinct from that concerning other progestogens since the oocyte and
anbryo are exposed to physiologically high concentrations of endogenous
progesterone during pregnancy. There is an "intuitive belief
.
progesterone must be safe". However, some researchers have questioned
"whether exogenous progesterone has an effect on the body
and biochemically different from the effect of endogenously produced
progesterone"•
6/
D-9/33l(c)
S:pt:5.8.'S2
:
6
The effects on the health of the fetus of the underlying conditions
for which exogenous homones are given need to be separated from the
effects of the hormone itself. Case series without adequate controls
have been reported, some showing no increase in malformations and others
an increase.
In respect of several studies it is not readily possible to separate sex
hormone support therapy from other hormone exposure such as hormonal
pregnancy testing or inadvertent use of contraceptive steroids. Moreover,
in- many of the.reports information on exposure is insufficient to allow 9
the reader to distinguish between progestogens, progesterone, estrogens,
or combination preparations.
Studies that report mainly on hormonal support therapy are summarized in
Tables 17 and 18. Table 17 lists several case-control studies in which
the use of supportive hormones during pregnancy has been compared for
mothers of_ malformed children and those of normal children; In some studies
the control mothers had infants with certain abnormalities, such as gastric
disorders, which were thought to be unrelated to hormone use. Recall bias
is not excluded in several of the studies and in many the selection of
controls can^be criticized. In some, inadequate attention is paid to
confounding in the analysis. None of the research groups attempted to
identify the underlying condition that led to the choice of hormonal therapy
or its possibly independent effect on the pregnancy outcome.
Three of the 7 studies reported a significant increase in the relative
risk of various malformations associated with hormonal support therapy.
In 2 of these studies the malformations investigated were congenital heart
disease and the other considered limb-reduction defomit ies.
The results of 5 cohort studies are suu^iged in Table 18. In these the
investigators compared the rates of congenially malformed children among
mothers with a history of exposure to suppoiA^ve sex hormones during
pregnancy with rates among unexposed mothers. & small increase in
risk of congenital malformations was observed in tv.-© exposed group in 3
of the 5 reports.
The findings from these various studies do not rule out the possibility of
a small increased risk of congenital malformations, especially
the heart,
among children exposed to supportive sex hormone therapy during pregnancy.
Since the risks observed in these studies were small it is impossible i;0
determine whether they could be explained by the donfouniing effects of
demographic variables or by the health effects of'the underlying condition
for which the woman received hormones. Moreover, the effectiveness of
sex hormone therapy during pregnancy is still unproven.
■• ■
7/
D-9/33l(c)
S:pt:5.8.'82
7
Table 1?:
Author
Case-control studios on possible association between
supportive sex hormone therapy and congenital abnormalities
Typo of
abnormality
Normal
Abnormal
controls
cases
(and %
(and %
exposed to
exposed
to hormone hormone
therapy)
therapy)
Odds
ratio
Coments
Includes corti
coids and
thyroid
Nelson &
. Forfar
Various congeni^tal malformations
453
(4.1%)
911
(2.9%)
Levy et al.
Transposition of
great vessels
76
76
(13.2%)
(0.0%)
Janerich et al. Limb-reduction
defects
108
(8.3%)
108
(2.8%)
3.0
Recall bias
possible
Yasuda & Millex-.Transposition
of great vessels
’58
(1.7%)
93
0.8
(2.2%)
Control series
of limb-reduction deformities
collected at
a different .
time from case
series
Hellstron et al. Limb-reduction
defects
32
(12.5%)
30
(3.3%)
3.3
Control series
of spina bifida
Jenerich et al. Heart defects
104
5.3
(5-8%)
104
(1.0%)
Recall bias
possible
390
(3.7%)
1254
(2.4%)
1.5
Recall bias
possible
1.4
Control series
of Mendelian
disorders
matched for
date
-f
Rothman et al.
Heart defects
i
D-9/331(c)
4‘S'jpt:5.8. »82
3 :
•T ■
Table 18:
Cohort studies on possible association between supportive
sex hormone therapy and congenital abnormalities
Type of
abnormality
Exposed
Not
to hormonos exposed
(and rate/1000 (aid
abnormal)
rate/1000
abnormal)
Rela
tive Comments
risk
Harlap et al.
Various congenital
malformat ions
432
(108.8%')
11036
(77.6%)
1.4
Ku Hand er &
Kallen
Various congenital
malformations
112
(125.0%)
4904
(129.7%)
1.0
Goujard &
Various congenital
Rumeau Rougette
malformations
830
(13.1%)
10157
(16.3%)
1.1
Heinonen et al. Various congenital
malformat ions
866
(86.6%)
49416
(64.2%)
1.3
Exposure to
progesterones
614
(71-7%)
49668
(64.5%)
1.1
Exposure to
estrogens•
About 20% of
exposed were
only to oral
contracept iv-es.
1042
(13.2%)
49240
(7>8%)
2.3
About 20% of
exposed were
exposed only
to oral contra-ceptives.
Author
Heinonen et al. Heart defects
A few cases
with abortifacients
included
ANNEXJRE
Brand Name
Manufacturer
Compound
1
DUPHASTON
Duphar Interfran
Dyhydrogesterone
5.0 ng tab.
2.
FARLUTAL
Walter Bushnell
Medroy progesterone
acetate 5*0 ng tab.
30-60 ng daily
20-40 mg daily
3. GESTANIN
Organon
Allylestrenol 5 og
tab.
5 ng t.ied. for
7 days
5 mg once or
b.i.d. as soon as
pregnancy is esta
blished.
''•Treatment to be
continued at least
a month after the
critical period.
4. LUT ESTRON FORTE
Mac.
Progesterone 25 ng
oestradiol dipropicnate
3 ng.
per ml; anp.
5.
FROLUTON DEPOT
German remedies
(Schering)
Hydroxy progesterone
caproate 125 ng &
250 mg/ml. & 500 mg
in 2 ml amp.
6e
OSTERONE
Iyka
Progesterone 25 mg
oostrikdiol benzoate
2.5 mg, per ml.
Threatened
abortion
Habitual
abortion
4
1 amp* weekly until
a few weeks before
delivery.
>
Source:
CIMS,
May 1932.
i
r
D-9/33l(c)
S:pt:5.S.’S2
REFERENCES
1.
WHO Scientific Group on”the effect of foaale sex hormones on
foetal development and infant health” Technical report series 657*
2.
’’Double blind trial of a progesterone in habitual abortion”
W. Goldzieher, JM Vol.
No.?, 651-654, 1964.
3.
” Hormones in recurrent abortion” Arnold Klopper and Maecolm MacNaughton. Journal of Obstetrics & Gynaecology. 72; 1022, 1965.
4.
’’Double blind study of effect of 1? hydroxy progesterone caproate on
abortion rate”
Sherman & Garrett. British Medical Journal
2 Feb. 1965, 292-295.
5.
’’Cervical mucus, vagainal cytology and steroid excretion in recurrent
abortion”
Macdonald et al. Obstetrics and Gynaecology Vol. 40,
No. 3, Sept. 1972. 394 - 402
Joseph
1
a.
V
lCO 099 -9VOW9NV9
VOLUNTARY HEALTH ASSOCIATION OF INDIA
TOO HnV3H WNOmiOO
-10/341(d-i)
ID:a/5.10.84
Sept emb er 24 , 1 984
Dear Friends,
As you must be aware that last June the Drug Controller of
India gave■directions by DO No. XI 9013/8/81-D to ban manufacture
of the E P drug from 31st December 1982 and sales from June 1983
(On basis of this extention of license for manufacture for 2 years
has been issued). You must have gathered from the last Drug Action
network newsletter that a stay order was obtained by Unichem,
Nicholas and Organon against the ban of E P drugs from Bombay and
Calcutta High Courts.
Since the matter is in the court where it may stay for eternir/
production and sales of the drug will continue. Approximately
160,000 00 women undergo Hormonal pregnancy tests annually. These
drugs recommended for withdrawal by ICMR and banned by the Drug
Controller of India should not be in t he market. By the very number
of the users involved tho problem takes on a graver significance
known about the chances of foetal malformation. There are various
ways in which you can help the people in demaming oa-fer an& rat
ional drugs and drug policies and help in the campaign.
You are requested
1. Not to use these drugs and inform others about their potential
hazards about the ban issued by Drug Controller Of India, the
stand of ICMR expert Committee, WHO and peoples organizations,
2. Document evidence of continued use of these of these drugs
for pregnancy testing and induction of abortion. Find out which
are the commonest uses of these banned drugs - pregnancy
testing, inducing abortion, secondary amenorrhea (missed period)
heavy periods etc.
J. Find out how many gynaecologists, health centres, hospitals use
as an alternative urine pregnancy test and are aware of the
Nancy Kit test which costs about Rs 7 per test.
4. If you are aware of any child born within last few years with'
malformation, specifically check for use of any hormonal preg
nancy tests and hormones during pregnancy. Confrim document
and inform us. Get details of brand, drug house and mother^
correct address. These would be required for their fight for
compensation.
5. Check out the management practice^ in your area of secondary
amenorrhea, drug induced abortion, pregnancy testing, menstrual
irregularities specially heavy bleeding.
6. Obtain letters from the gynacologists and endocrinologists
regarding hazardous nature of the IB P drugs and that you support
the ban, send to the Drug Controller of India with a copy to
me for follow up letters requesting the sources from medical
people have been compiled by dozens by the drug companies*
7. Plan to make the issue of E P drugs and its non implemented ban
one of the focal points of the National Drug Campaign in
November.
8. Use earlier handouts prepared by us in VHAI on E P drugs - Are hommonal pregnancy tests safe?
- References on E P testing
- Review of the E P Campaign
- The case against E P Forte
and poster on danger of hormonal pregnancy testing prepared by
Saheli and VHAI which are available with us. For preparing
material added information can be obtained from CED-Counterfact,
Arogya Dakshtata Mandal, MFC.
.
.2...
Contact the Consumer groups and the women in your area to j ?i
in the protest against unsafe drugs since the case of E P
not merely an issue of a particular unsafe drug but indicative
of grave lacunae in our drug control mechanism.
10. Based on the material available with us and with other Drug
Action networkers write in local papers in regional, languager
and send letters to the editor aboutihis issue giving names
of the drugs and drug companies involved.
11. An alternative to Hormonal pregnancy test Nancy Kit - urine
pregnancy testing. Kit is available from HAL at Rs62 for 10
tests, approximately Rs? per test. Try it, propagate it high
lighting hazards of hormonal pregnancy test and recommending
its non use by your local medical colleagues and people.
12. For those who are more academically inclined, review fehe medica.
literature regarding latest medical opinions about management
of secondary amenorrhea, about other gynaecological disorders.
Document specially alternative treatments suggested and share
with us and others.
13. Contact doctors in your area, request them not to prescribe
these drugs giving reasons why. Heguestskhemists not to stock
these drugs, given the reason why?
14. Write to Drug Controller of India, bvciuc
State Drug Controllers,Health.
^11^0,11
Ministry, National tfrug Development Council representatives
to ask about information on action taken to curb misuse and
sales of banned and hazardous drugs specially about efforts,
made towards increasing drug and health awareness. This is to
demand greater public accountability.
15. Write to the Medical Directors and public relations Officers
of the Drug companies concerned about your views and those of
your people demanding cessation of their continued sales of
banned drugs. Semd copies to us, to local newspapers.
16. Prominently display the Black list constituting of drugs banned
or worth banning with reasons for banning.
17. Threaten to boycott drug companies that insist on selling
banned bannable drugs. Communicate this to the’ medical repre
sentatives of the drug company concerned. If alternatives of
the drug products are available refuse to buy the products of
the offending companies. Give your rational and the reason for
your stand, make it well known.
18. Write to us for any other material on this subject to help
you in your drug action.
19. Indicate the E P issue in your efforts 'toward national drug
9.
campon.
20. Keep us and each other informed.
With warm regards,
In solidarity,
Yours sincerely,
Dr Mira Shiva
Coordinator
Low Cost Drugs & Rational Therapeutic
V H A I.
-10/541(d-i)
LCD: a/5/10.84
THE UNFINISHED E F CAMPAIGN
E P UPDATE
Dr Mira Shiva
Coordinator
Low Cost Drugs & Ration..:.
Therapeutics,VHA1.
The Story Uptill now:
February 1975
On finding a close relationship between the use of hormonal
preparations for pregnancy testing and congenital malformationAustrale. Department of Health on recommendations from Australian
Drug Committee decided to withdraw these hormonal preparations fro
the market. WHO issued a warning to all the member countries.
DG-HS on consulting the experts in India decided to allow the produc
to be marketed but curtail its use in pregnancy testing. The oblige
tory warning was as follows:
Warning: There is some evidence to show that hormonal
preparation when used drnzing prpgua:uoy'nay lead to f oetaD.
to foetal abnormalities and as such these should
not be used during pregnancy or for pregnancy
diagnosis unless a decision has been taken to
terminate the pregancy after its confirmation.
No. 12-1O/74-DC, New Delhi, dated 15.12.75 Drug Controller prohibits
the use of E P drugs for pregnancy testing.
Indian Chemical Manufacture Association also issued copies of
this letter to therr members.
February 1979
Dr Palaniappan,Prof. Obstetrics and Gynacologist, Kilpauk- Medicral
College, Madras presented a paper at Bombay, Association Congress on
Induced Abortion and voluntary sterilization showing 31% of 52-moth--,
who gave birth to congenitally malformed babies with hare lip cleft
palate and limb anomalies had taken hormonal preparations in early
pregnancy.
April 1979, Onlooker published ’Pregnancy Test Drugs can deform
babies’ and controversy resurfaced.
January 11, 1982 at VHAl’g Drug Workshop, Pune ’Drug Issue
and choosing feasible Alternatives’ decision to launch an E P
Campaign was taken. It was decided to tunn.our efforts for the
Women's day ie. Sth March 1982 to highlight the issue. March 8,1982
E P Campaign was launched spearheaded by VHAl but with close involve
ment of Dr Mathur, PGI,Chandigarh; Arogya Dakshata Mandal; SaheliRs
MFC, and CED.
Numerous articles, letters to editor were written and memoranda
sent to health authorities by numerous groups.
March 18
Issue of E P drugs reopened at government level and directive
were issued to add the following warning 1 Not to be used for
pregnancy test and in suspected cases of pregnancy! These were, to
be displayed prominantly on cartoons of injectables and catch coverof tablet preparations in indebtable ink. It was added that these
products should be indicated only for secondary amenohrrea.
J.
....2....
April 17, 1982
Letter sent from Drug Controller of India to Managing Directa:'
n-p Companies
(Pmrsn-iflfi producing
nrodnninff B
E P drugs
drua-s to print
nrint warning prominantly
prominantlv evt: ’
of
on existing cartoons and catch covers with indebtab 1 e ink.
May 10, 1882
Drug Controller of India(DCI) informed Drug Companies that fl
consistency's sake warning statement indicated in package insert
promotional literature and the following words be deleted from tl.
earlier warning written earlier. The deletion was to be 'UNLESS
DECISION HAS BEEN TAKEN TO TEP11INATB THE6PREGNANCY AFTER ITS COKlk... •ATI ON'
June 21/22, 1982
Ministry of Health & Family Welfare reviewed the situation am
recommended a total ban of its production and its sales by its leta. r
No. 12-48/79-DO, New Delhi, dated the 21/22/June 1982. Out of date
for manufacture by JI st December 1982 and cut off sales JOth June
198 J.
July 24, 1982
Unichem informed DOI that various endocrinologists and gynaeco
logists felt that high dose E P drugs were essential and that requ
ired for gynaecological disorders.
August 4,1982 .
OPPI made representations to the government against the ban.
Main arguements were as follows:
1 • Any 'drug can be misused, prescribing doctors and consumers are
responsible not producers.
2.
tJo Aiithnrit^tivA
Avi
cl Ari^epppfi.
avI d
of risk.
3 • No sub st 11 ufrfi s Aval 1 able <
August,30
All Ini la Medical Organization made representation against the
b a nl
Writ petition filed by Unichem Labs, producers of E P Forte
against the Lrug Contirol Authorities, and also by Nicholas writ
No. 2098 of 1982 in Bombay High, Court and by Organon in Calcutta
High Court.
The stay was granted. Not merely was the stay granted but extention of production license given for 2 years on its basis. Review
of the main arguments offered by Petitioners ie. Unichem in their
petition No.2977 in Bombay High Court.
1982 Writ petition filed by Vincent Panikulangara of Public
Interest group Cochin for continued sales of banned drugs. Writ
petition in Supreme Court for some E P drugs included.
E P Forte produced by Unichem was licensed for production in 9.4.66.
Its contents are
E P Injection
E P Tablet
Progesterone
50mg.
Hydroxy Progesterone Acetate 30mg.
Estradiol Benzoate Jmg.
Ethnylestradiol
O.Obmg
Hydroxyzine Hcl
10mg.
Mode of Action
Due to the hormonal nature of the product stoppage of its
administration results in withdrawal bleeding in non pregnant pec;.
It was therefore, earlier used for pregnancy testing and with its
use cyclically for restoring the regular cyclical periods.
Arguments put forward by Unichem to justify withdrawal of the dr•
ban against high dose E P drugs in their writ petition.
used
for 20 yeA.rs and there have been no, comy.
1. The drug___
has
been
laints and since there no published reports of hazardous and
therefore it is safe.
(in absence of any mechanism to screen adverse Drug reactions C‘
doesn’t expect to see it. This does not mean adverse reactions
don’t exist and some drugs are hazardous. Regarding publications
the following articles have indicating the hazardous have public
DR Palaniappan - Journal ocf jrhe Indian Medical Association
Venkat
Australia
VHAI( hand outs - Are hormonal pregnancy Tests Safe?, The case
against E P Forte, Review of the Estrogoneprogesterone Drug Campaign, References on
E P drug for pregnancy test etc )
2. There is no substitute for E P drugs, which are based for varicgynaecological disorders.
(This is not true. See Appendix for W^O recommendations)
3. Under Section 18 of Drugs & Cosmetics Act of 1940 only a State
Government after issuing official gazette notification can bai
a product and therefore ban is illegal,unconstitutional and
contrary to principles of .social justice.
4. Under section 18 of the Act only substandard and adulterated
drugs of those manufactured which are sold in contravention of
the drug act can be banned,since E P drugs are none of these ba
is illegal,null and void.
(See actual text of the Act pg.17t19 of the writ petition and
also Deputy Drug Controller’s response to the above).
5. All drugs can be misused eg. Adrenalian Hydrathazone,Guanethedi —
Sulphonamides, Oxyphenbutazone if they are used in excess not i.
keeping with the directions in the package. Picking on E P drug
is irrational, arbitary and discriminatory.
(Anabolic steroids have been banned due to their scope for misu ,
-for use in children, See UR list of hazardous drugs for stand
on anabolic steroids).
6. The E P drugs are manufactured and marketed in various countries
and the use has never been banned for treatment of secondary
amenorhea and other gynaecological disorders. In.India too bein
used Qj&ly for secondary amenorhea which is also indicated m
medical literature.
.
(See list of countries where it is banned- -drug Bulletin & Uh
list - Appendix).
7. There a re no non hormonal substitutes available for menstrual
disorders such as dysfunctional uterine bleeding, menorrhagia~
metorrhagia endometriosis polymenorrhea, aligomenorehia,amenorrhea
and menopausal syndrome. Use of all hormones in Pregnancy io
associated with foetal malformations.- reprint and handout IJ
Gynaecology Obstestrics 14:548-552,1976. Since E P is associat
with developing bleeding in early pregnancy and since safer
alternaatives for pregnancy testing and secondary amenorrhea
exist.
(Only recognised indication is secondary amenorrhea WHO’s rec.
mmendation for it is use of esterogen and Then progesterone
separately cyclically).
8. The decision to ban the drug 'adversely affects the proprietor.^
rights of the petitioners complaining and is fought with grave
civil consequences and the decision is in contravention of the
principles of natural justice and fair play*.
(If a company was allowed to. market Thalidemide for nausea in
pregnant women, would they be allowed to continue to produce
and sell it unchecked? ¥ill their proprietary rights continue
to be respected when the drugs have known potential risk).
9. Not only have the disadvantages of such a fixed dose combinatihave not been indicated to the petitioners by the respondents
but the petitioners have also not had any opportunity whatsoevo
of showing that the disadvantages could have been effectively
baen dealt with issuing suitable directions or imposing- warning:
and the imposition of a total and absolute ban on the manufact
ure and sale of the said formulation, was unjustified and
unwarranted.( What has been the impact of the written warnings
on the drug misused? The reports from the newspapers and healt
groups indicate that the impact was far from it).
10. There is no ban on consuming estrogen-progestron separately
and hence the ban is on combined on irrational and self defea
ting. The formulation of E P drugs is highly recommended by
the medical world and the person affiliated to the medical
world and the person affiliated to the medical world that use
of progesterone with estrogen reduces possibility of End emetricil cancer. BMJ dated 5th June 1982.
11. AU India Association of Obstretics and Gynaecology are not
in favour of the ban and the ban is to the opinion of the
Federation of Obstretics and Gynaecology Society of India.
(ICMR Expert Committee met in 1982 and felt that besides mere
warning the drug be withdrawn because of the associat ed misuses)
12. The Drug Technical Advisory Board and the Drug Consultative
Committee appointed under section 5 and 7 of the Drugs and
Cosmetics Act 1940 and has not been consulted and decision
taken contrary to the mandatory provision of the act.
(Besides ICMR Expert Committee various leading gynaecologists
from India and abroad who shared the concern about misuse of
high dose E P drugs and majority saw no role for them and they
recommended ban.
15. Under Article 19(1) (g) of the constitution, the pet it ioners
have a right to carry on trade can be restricted only in a
. r
reasonable manner and in public interest.
Petitioners: Sales of Rs2 crores will be affected and many
employees engaged in manufacture of the formulations will be
rendered jobless. (Will women risk the normally of their new
borns to pay for continuation of this trade and will compen
sation Be paid to them if in case of foetal abnormality?)
14. Drug & Cosmetics Act 1940 and Drug Cosmetics Rules 1945 ensuj
that no spurious and substandard or misbranded drug is sold.
’Under the guide of protecting public interest the
impugned decision (to ban) the drug arbitarily interfer.
with the well established trade of the petitioner and
directly impairs the guarantee contained in Article
19(c)(g) of the constitution’.
(Any rule or regulation that is against the interest of
the majority needs to be changed, specially if it was
made to favour our excolonial masters at the cost of th.,
people. Quoting such a rule against public interest is
adding insult to injury. More so. facts ar elating to haz
ardous xiexture of the drug are withheld from the women.
, Use of this potentially hazardous drug without providing
the women unbiased drug information and then calling
their passive acceptance., their active choice, public
interest is absolutely ridiculous and insulting).
15. Under provision of Article 301 of the Constitution, the freed
of trader commerce and is declared and this includes both
interstate and intrastate trade and this can be restricted
only in public interest.
(No one has ever stopped anyone in trade of essential and life
saving drugs, we encourage it. Trade of hazardous drugs shoul
be and will be curtailed and changes in legislation demanded
and needed).
16.
’There are numerous equally capable of misuse picking on E P
drugs is discriminatory and without basis and is violative
of petitioners right to equality guaranteed under provisions
of Article 14 of the constitution requiring to be stated with
E P and the 23 combination drugs!
(This should be taken seriously and all hazardous and irrat
ional drugs recommended for being weeded out by Drug Consult
ative Committee(DCC) be banned and no discrimination should
be shown in allowing them to be manufactured and sold.Being
indiscriminate wouldn’t mean allowing E P drugs to be continue’
t o b e s old).
17.
’The decision is in contravention of principles of natural
justice and fair play, and violative of petitioner fundamental
rights guaranteed under Articles 14 and 19(1) (8) of the
constitution’ .
(NO ONE HAS THE FUNDAMENTAL RIGHT TO DEFORM OTHER PEOPLES
BABIES AND MAKE PROFITS OUT OF A HAZARDOUS DRUG WHOSE VERY
PRESENCE IN THE MaiRKET MEANS MISUSE.)'
18. Since the decision to ban was dated 21st June by which manu
facture of the formulation was to be banned from 31 December
1982 and of sales from June 1983 shows that there was NO
GRAVE URGENCY- IlbBAN.’ .
{This was unfortunately conscious act of charity on part of
the Drug Control Authorities to phase out the withdrawal.
VHAl and other organizations had demanded a^ immediate ban
at that time. It is a lesson for the future show ’ Consideratica
to those who need it and in case of such decision taken in
public interest, all del^y should be avoided).
19. In the regainder of the writ association of oral contracept
ives and estrogens with cancer have been shown in an attempt
to show that all these hormonal preparations have side effects
and problems, hence they are all alike where their hazardous
potential is concerned. (This is not true. High dose E P Drugs
1
have more danger pot ent ial»
they- have safer effective alt ema
tives they are not essentially needed. Oral contraceptives if nio
used and associated with health problems will also come under
ality).
attack if found as hazardous as E P drugs in today’s reality).
Our Prayer
1. To take an early judgement to ban these drugs and stick to the
decision and ensure its implementation.
2. Court should brder a retrospective and prospective study with
the sole aim of identifying children malformed due to the use
of E P drugs and ensure their compensation to be paid by the
drug companies and state.
3. Immediately.withdraw manufacturing liceses issued to the drug
companies to extend to production of these drugs for another.
2 years.
4. Order the Erug companies involved in sales of drugs banned by
the PCI initiative as well as central and State health authori
ties to publish the list of brands and drug companies involved
in various news media aatperiodicals,journals,to inform womens
groups,consumer organizations to ensure the implementation
of the ban of these drugs.
5. Direct State and Central Drug Authorities to keep organizations
openly supportive of their stand informed, and seek information
from other ogganisations eg. Health Action International,Social
.
,,
,
.
Audit eto.
iray er by the p etitioner
1. declare the ban illegal?null and void.
2. Issue writ of memorandums under Act 22 respond. ent s not t o act
directly or indirectly in any manner act in furthgrence or
implementation of impugned decision ie. the ban.
3. Issue write of ceriotony under act 226 to guash the inplighted
decision.
4 . I ssue writ of prohibition under act 226 to prevent imp 1 erne nt at 1 o
of the ban.
Till
final disposal of case restrain respondents by order and
5.
injunction with from taking any action to implement the ban.
6. Take care of costs of petition.
7.
Such other and further reliefs.
Voluntary Health Association of India
C-14, Community Centre
Safdarjung Development Area.
New Delhi-110016
^7
c
cl\
M
\
w
/Jov
Telegrams : VOLHEALTH
New Delhi-110016
Phone : 652007, 652008
&
^9/551(a)
25rd February,1982
Ms-cb/HCA-18/
ARE HORMONAL PREGNANCY TESTS SAFE?
Widespread indiscriminate misuse of Oestrogen-Progesterone combination
drue-s
drugs in -pregnant
pregnant women is cause for grave concern.
■ ; -•
) of the WHO on ’’THE
This is inspite of the fact that the scientific
DEVELOPTOT
AND
INFANT HEALTH” , in
EFFECT OF FEMALE SEX HORMONES ON FOETAL -------its report ’WHO TECHNICAL REPORT SERIES 657, 1981 have recommended that
these tests should no longer be done.
TNp annroved pharmacology text book for medical schools, Goodman and Gilman
says "PREGNANT PATIENTS SHOULD NOT BE GIVEN OESTROGENS, PARTICULARLY DURING
THE FIRST TRIMESTER - a time when the foetal reproductive tract is develo
ping and may be influenced by exogenous oestrogens. For the diagnosis oi
simple technique and is preferred •
are not
not reiiaoie.
reliable. THE TEST IS FALSE POSITIVE
’’Hormonal tests for pregnancy
_ --- THEre is ALSO AN INCREASED RISK OF FOETAL
IN ONE OUT OF FIVE
WOMEN:
(D.Vengada
Salam et al: International Journal of
ABNORMALITIES". (
Gynaecology and Obstetrics). 14:348-555, 1976.
In a study with 149 abnormal babies,(70 with malformations of the
,
9 with reduction deformities of the limbs, 15
13 with congenital disease, 11
with Downs Syndrome, and 46 with other malformation) with 149 controls.
Of this a total of 23 mothers of abnormal babies had been exposed during
triSster -r pr.gn«oy
containing ho^onoo oonpnn.a
only eight of the control mothers. One of the 23 had also taken an oral
Vs OP
“nt”Zruo„Xtte“^0is”°LS“SSmh™™1
WITHDRAWAL TYPE 0? PBBOSAHCY TESTS WHEN ALTERNATIVE WH0DS ARB AVAILABLE".
(Excerpt from a letter written in the British Medical Journal.,April
1975 Dage 192, by G. Green Benz and W H H Inman of Committee on oa e y
Medicines, London and Josephine A C Weatherall and A M Adelstein on
e
Office of Population and Census and Survey, London).
/
♦
have earlier stated, and as Janerich and his co-workers
In any case,, as we
have concluded, IT IS PRUDENT "'O
TO DISCONTINUE THE USE OF HORMONAL PREGNANCY
Vol.291,
TESTS• (Editorial: ’’The New England Journal of Medicine”
No 1.4, page 751)Contrary to previous assumptions new data suggest that the administration
of hormone will not hasten and may even delay the onset of menstrual
••’l some evidence of “Increased
bleeding. This lack of efficacy together with
associated
with the administration
incidence of congenital malformations"
of hormones in early pregnancy suggests that hormonal withdrawal tes|
should be abmdonei. (integrated Obstetrics and Gynaecology for Post
Graduates by Dewhurst)
D-9/551(a)
2
tfe-cb/HCA-18/
Moreover, currently there is the fear that progestons are potential
teratogens. While the evidence to support such a conclusion is not yet
definitive, nonetheless considering the lack of utility of this procedure,
PROGESTIN INDUCED WITHDRAWAL MENSES AS A TEST OF PREGNANCY CANNOT BE
RECOMMENDED. (Williams Obstetrics, 16th Edition, 1980)
PRBGiUSW PATIENTS SHOULD NOT BE GIVEN ESTROGENS, PARTICULARLY DURING THE
FIRST TRIMESTER - a time when the foetal reproductive tract is developing
and maybe influenced by exogenous estrogens. (Progesterone on Thryatened
Abortions Goodman Gilman, 19-80, pages 1459-1440)
The above extract from medica„ literature are just to give added evidence
to the fact that these pregnancy frests are no longer* considered safe; In
view of the dangers associated with their use, prescribing them is not
merely UNETHICAL: IT IS ALMOST CRIMINAL.
Even where RELIABILITY AS A PREGNANCY TEST is concerned hormonal preparations
like EP Forte have been found to have 18.91% FALSE POSITIVES according to
a study conducted by I) Vengada Salam at al (international Journal of
Gynaecology & Obstetrics 14:548-352, 1976)
The FOETAL ABNORMALITIES linked with the use of hormones during early
pregnancy are limb reduction defects, congenital defects of the great vessels,
the VACTERAL association and di George Syndrome (Thymus parathyroid aplasia)
according to observations in the study done bh Levy Cohen & Frazer and the
study done by Nora and Nora*
According to Isabel Gel in Nature: Vol 240, Nov 24 1972, "The pregnancy
test works by altering the maternal equilibrium and because the hormonal
changes produced by the tablets are sufficiently effective to disturb a non
pregnancy uterus, there is a strong possibility that the pregnancy case be
affected as well.”
Probably on this consideration hormonal pregnancy tests are frequently used
with the very intention of inducing abortion apparently successfully in
susceptible individuals. The Royal College of General Practitioners Survey
into the outcome of pregnancy found a 10% ABORTION RATE after Primodes
administration & Brotherton & Graft reported an incidence of 7.6%
_SP1NTANE0US ABORTION following the use of hormonal pregnancy test. What
about • women who do not wish to risk such a thing - is exposing them to
it justified
”It is possible that in less sensitive cases the relatively large dose of
hormone in pregnancy test tablets may interfere with"the foeto-placental
unit, by upsetting the hormonal balance of the mother, the foetus or the
interaction between them. This may not interrupt pregnancy but may affect
’FOETAL DEVELOPMENT.’
3
O-9/351(a)
MS-cb/HCA-18/
Another cause of concern is the ^EXPOSURE OF WOMEN TO HORMONAL PREPARATIONS
FOR VARIOUS REASONS, from contraception to pregnancy tests, for alleged
maintaining pregnancy in cases of threatened and habitual abortion, for
irregular period®,for functional uterine haemorrhage, etc.
This t takes on a serious magnitude since such preparations can be prescribed
by the qualified as well as the unqualified health personnel.
An adequately
trained and supervised, knowledgeable and concerned health personnel not
holding a degree is not half as dangerous as"a smooth-talking, profit
oriented medical person even if he or she has a string of qualifications
attached.. This is so because no one dares to question the latter s wisdom
and worse still is the fact that the latter set the trends - Efficiency
and concern for the patients are not always associated with popularity of
the medical professionals.
These preparations can be bought over the counter EVEN WITHOUT PRESCRIPTION
as was our experience, there is no warning with these preparations (E.P.Forte
tablets and injections)* Even ‘on specifically asking for the literature
we were told that 'the Literature is given only to the prescribing doctors
This of course leads one to believe that the prescribing doctors would
READ THIS LITERATURE and communicate this information to the woman being
prescribed this diagnostic test* One would expect t^e CHEMIST selling the
drug specially when it is without a prescription to communicate this
information. Very obviously THIS LITERATURE IS EITHER NOT READ OR TOTALLY
IGNORED* So ’even if the drug companies swear by this literature - ITS
VALUE AS AN EFFECTIVE MODE OF COMMUNI CATIONS IS VERY DOUBTFUL. Even if this
often microscopically written drug related information is made available,
it is often in a LANGUAGE NOT EASILY UNDERSTOOD BY THE CONSUMER^ eg* any
relationship of ’secondary amenorhea’ with pregnancy is not at all clear.
The most important fact still remains HOW MANY WOMEN BEING PRESCRIBED THIS
DRUG CAN READ AND THAT TOO IN ENGLISH AND IN A PRINT-SIZE WHICH OFTEN
REQUIRES EITHER PERFECT EYESIGHT OR THE USE OF A MAGNIFYING GLASS.
The THALIDOMIDE DISASTER has not yet been forgotten where this popular drug
given to pregnant women caused abnormalities of the limbs in more than 60,00
children in West Germany alone. This drug was sold under 90 brands, and
even if information n^out the dangersus of Thalidomide were made knows, how
many women would realise that the brand drug they were taking contained
Thalidomide? How many even know that the tablets and injections they are
taking are hormones?
How many more allegedly statistically significant tragedies do we need to
avoid dangerous preparations and opt for less toxic alternatives?
In India" where women are relegated by society to second class citizenship,
where even bearing a normal female child by her is looked upon as her
failure - knowingly exposing her to the dangers of bringing an abnormal
malformed child into the world is CRIMINAL.
.^4/-
4 -
D-9/351(a)
Ms-cb/HUA-18/
Today the evidence about the dangers of pregnancy tests are well documented
and the earlier agreement of ’statistically not significant’ does not hold
good.
The recent issues of commonly used reverral sources of information by
prescribers, the MIMS (Monthly Index of Monthly Specialities) and the
CIMS (Current Index of Monthly Specialities) have added pregnancy in the
contra-indications. This is not so for all the preparations. For some
preparations it is written - ’see literature’. How many prescribers
take the trouble to dig out this literature and read it is anybody’s guess.
SOME PREPARATIONS ARE STILL INDICATED FOR PREGNANCY IN THE MIMS.
Since this wqming about not using it in pregnancy has been added in only
the most recent issues of MIMS and CIMS, one wonders, in how many reader’s
minds has this change registered. Do the drug companies supplying these
preparations to the chemists and the prescribers h^ve a responsibility of
categorically warning them of this CHANGE? If it is their responsibility
who ensures that UNBIASED INFORMATION is given to the chemist, the doctor
and the consumer?
Who ensures that some form of'regulatory measures for the prescribers are
formulated to prescribe and control malpractice. This
single action may
do a lot in ensuring ethical madical practice, but it may also become
soemthing of an eye-wash, leading to undue harassment of the innocent and
allowing the guilty to tip their way out. Any worthwhile control has to
come from the AWARE PUBLIC whick keeps itself well
formed to avoid
exploitation of any form, done knowingly or unknowingly;
IT IS THE UNDENIABLE RIGHT OF A CONSUMER TO BE TOLD
ABOUT THE HAZARDS OF SOME OF THE KI'TOLH PROBLEI/i DRUGS
MORE SO' IT IS THE RIGHT OF A PREGNANT WOMAN TO KNOW
THE SIDE EFFECTS OF ANY DRUG- PRESCRIBED FOR HER.
For this, what w<? recoinniend is§
PRINTING OF THE CAUTION AND WARNING ON THE DRUG PACKET ITSELF, warning
against its use as a PREGNANCY TEST OR IN PREGNANCY.
There is a need to develop-alternative CHEAP NON-HAZARDQUS DIAGNOSTIC TEST
FOR EARLY PREGNANCY as a tfollosal amount is spent on contraceptive research,
some amouzHi could be definitely allotted for simple early pregnancy tests-
5
D-9/551(a)
MS-cb/HCA-18/
Since delay in detection of pretnancy leads to problems as in the case of
a woman wanting termination of pregnancy - the fact that six lakh Indian
women die due to criminal abortion has its ovm tragic story to tell. Early
detection is associated with simple and safer termination procedures.
This diagnostic pregnancy test is BECOifflWDED FOE ONLY THOSE WOMEN WHO ’HSH
TO TERMINATE THEIR PREGNANCY, if found pregnant according to medical litera
ture. This, of course, is not to be misinterpreted as a recommendation for
MTP (Medical terminationof pregnancy), With adequate precautionary measure
an unwanted pregnancy should not occur
if it does, it is the woman’s right
to choose how to progress with it. 7But, it is the responsibility of the
physician and the pharmaceuticals to give all the appropriate information
about the danger of all drugs prescribed
It is the role of wo-wn1 s groups, (consumer associations and socially
conscious individuals to disseminate and share relevant information, If the
health personnel could have done this, so many of the problems would have
probably not existed in the first place.
The idea of our involvement with all this is because of our concern for
women who are passive recipents of many potentially hazardous drugs, when
low cost, less hazardous alternatives may exist. All those concerned have
no choice but to join in any additional information can be obtained from
VHAI. If we dont have it we would ^i dig it up for thofee imVclved in '
issues of. women and health.
'
-'
'
- .
Dr Sathyamala
Dr Mra Shiva
Voluntary Health Association of India
B 1Q/pjrl4dponimunity Centre,
^^SgttteTTfffig-pBVBlopmenl Area,
""" "New Delhi-110016
/r/ I
/V /
'V / V'-4Ai V'v p
>1
cl M
Itif
lA \ 7
Telegrams : VOLHEALTH
New Delhi-110016
668071
Telephones * 668072
CT^
CASE AGA HIST m P
of the Controversy.
FOHTE s -
The issue of Estrogen-Progesterone GOLtbination dxugs was raised
seriously for the first time in India in 1975» after a number of countries
had already banned such high dosage combinations completely or had banned
their use m preghaHcj? testing. At that time the controversy had centred
around their association with congenital malformations of foetus in women
who had used them during the ,early stages of pregnancy. The torld Health
Organisation had informed all governments regarding the action taken by the
Australian Department of Healtii to withdraw from the market a number of HPT
(hormone pregnancy test) preparations
on the basis of their Questionable
■safety and the availability of adequate and reliable alternatives,
Consequently, the government of India after consultations with experts decided to bar
the use of these drugs as pregnancy tests, making it obligatory for the
manufacturers to print a caution on the packaging -Lri 197^J»
In April, 1979 the controversy surfaced again with the publication of
a cover story in the Bombay magazine "Onlooker" under the caption "Pregnancy
lest Drugs can Deform Babies- Ban tnem" prompted by a study conducted in
U’"d'1 ""J by J1 B' i,:ilaniaPPan» Prof, of Obstetrics and gynaecology at ’filp.iLk
Medical College, the story highlighted the fact that these drugs were being
taken by a number of women in the mistaken belief that they could terminate
an unwanted pregnancy. Of 52 mothers who had given birth to babies with
congenital defects, Jl^, had taken hormonal preparations during early
<3
-J
2
•J SC
Ui
o
X
(A
r«.
«3
O
o
i~ 2
pregnancy, often with a view to terminating it. The furore caused by the
< .
L4 V)
article made the government once again re-examine the whole issue. However X
UJ
■
m
H°
on this occassion too the government did not decide to ban the drugs
s £
altogether. The Indian Council of Itodical .Besearch, Department of Family
Welfare, Government of India,9 and the Federation of Obstetrics and Cynacco- 2
S »•.t’•» <
CO
o
logical'Societies of India were
wore consulted
consulted, and all three agreed to let the 6
r£
drugs remain on the market,? albai'twith
a ,strong caution on the packaging.
albeit with a
In practice, for the next few years, u03t rcanufacturers ignored this
directive. In fact CIMS and MIMS carried -Pregnancy diagnosis' as an
indication for the use of these drugs for quite a few of the manufacturers.
Moreover, they were sold readily by most chemists as over-tSe--counter(OTC)
drugs for pregnancy tests and also as abortificants.
Such
scale mis
use of the drugs led a number of women and health groups to ruSpen this
issue as one directly affecting women and a campaign spearheaded by THAI
was launched on &rch 8th 1982. Various groups placed forward number of
demands ranging from rigid implementation of the "warning" rule to a complete
i
D-lO/jaifd)
1.11.85
ban of such drugs.
-0.2.
As a result of trie campaign, the issue was also reopened at the govern
mental level and the Drugs Controller first. issues a directive on 18th
March 1982 for strengthening the warning on the packages and later directed
that all 2/P formulations (other than Oral 1Contraceptives in low doses)
would be banned for manufacture with effect from JIst December 1982 and for
sale from JOth June 198J.
Of Pi, chc lobby of the multinational drug companies in India, set
forth the case of the manufactures in at letter tc the Drugs Controller of
India (dated Aug 4, 1982). This case, :in □ summary form is as follows?
(a) Any drug can be misuseds no drug is totally safe,
Since there are
dangers connected with the uses during pregnancy , a warning to the
consumer would suffice the needs of caution, Since these are prescription drugs, doctors who misuse it should be better inferred- but one
cannot penalise the companies for their defaults.
(o)
Even for H.P.T. there is no authoritative evidence as to the magnitude
of the risk,
in their words 1’we.• are by no means defending the use of
such drugs for pregnancy tests, ‘but reiterating that if, ... a few
uninformed individuals do use them for this purpose, the risk involved
does not call for a total ban on these drugs”.
(c)
are no substitutes available for the treatment of a lot of
menstrual disorders, such as dysfunctional uterine bleeding, endometri osis, polymc-norrhoea, oligomenorrhoea, amenorrhoea and pest menstrual
syndrome.
Subsequently, Onichen and Nicholas in Bombay and Organon in Calcutta
moved the respective High Courts in an attempt to get the. order of the
Drug Controller rescinded. They have obtained an interim stay against the
order.
Thus the Drug Controller’s directive remains ineffective till the
case is finally decided or at least till a higher court vacates the stay
order of the respective High Courts.
We have tried
examine and reexamine the above arguenenfs 2
With regard to point (a) Misuse- education of doctors-warning etc.,
we attempted once again to. purchase these drugs over-the-counter, without
prescription, with a request to the chemist for a ’’pregnancy test”.
Considering the- case with which we collected a variety of high-dose E/P
combinations from shops in New Delhi, one can imagine the extent of misuse*
*
when prescription drugs can be so easily available OTC, it is clearly
glib argumentation to say that a warning can stop the misuse. Especially
wnc-n the largo masses of consumers, naiiely women in this case,
case are
illiterate. As for informing and educating the doctors, the drug companion
for their own marketing and profit reasons, have a far better and smoother
* Over the counter.
D-10/341(d)
network, for reaching individual doctors.
In fact it is well established
that irrational therapy and dangerous prescribing are a consequence of
deliberate niseducation of doctors, by drug company representatives and
nismfcreation broenures innocently called 'literature'. The Drug Controller
of India in a discussion with us(our meeting with bin on 6 July 198j)has
stated that there is no aichingiy to monitor such aisinfomation stemming !
from the companies. He hiiiself is in touch.only with the I.M.A. and states’
that it is 'impossible' for him to inforri health personnel, groups(like
VHAI, hffi'C, etc) or the consuning public at large.
•io examine one such source of information to doctors more closely, we
have compiled the table below from CIMS and IvlIMS, with regard to E.P. drugs.
\"nile perusing the table to see what sort cf data the doctors get from tliese
publications the following points must be borne in mind?
(i;
CIMS and Mllib are the most commonly used ready references for prescribj ■
ng by doctors, especially by the large majority who are deprived of
most other costlier sourcess
(ii) CIMS and MIMS are also supported by advertising from the drug companies
in iViiMS, product names in bold type; indicate that the manufacturer is
supporting MIMSj
(jii) I1 or the same drug of the sane manufacturer there are discrepancies
between CIMS and HIMS5
(iv) These discrepancies- extend even to the strength .of.the ingredients in
(v)
the combination (sec h0P. Porte and Piseeron Forte). Moreover, these
errors continue from month to month.
.. •■
i
Yfjiile there is aa colum highlighting the addition of "new
products" to
"
CIMS and IvKIvlSy as well as a list of ’’deleted products” in each issue 9
there is no ’’errata1’ page.
Moreover if there is a change in product
composition or in the- instructions under c/l and s/Pr. these- are not
highlighted. So undessthe doctor refers to the latest issue of CIMS/
LUMS each time he prescribes a fcrmulaticn which he is already accust
omed to prescribing for years, he is unlikely to be aware of such
changes.
(vi) The September 1983 issue of MIMS which we have used for compiling the
table, contain a detailed note on C/l and s/P with respect to ’’Hormones
at the beginiiing>f the section, through this infomation does not app
ear alongside the individual product details.
* /
C/I - Contra indication
S/P - Special precaution
'■
i =
The
information in
CIMS’ ro«
1Q83 is^un
The informticn
in the
the ’'LUUS'
row is
is from
fren the
the Aiay
Sept.i^J
issue
Nano
Formulation
I
Dosage
s/p= Special precautions
P = Pregnancy
P Information in CIMS/MIMS on C/l and S/P
See
lit.
J
i_
i
i
CI&S r Hy
d r oxyj roge
sterone
HydrOxyi
rogc-stercne
| acetate 30 mg
[ otninylestradiol 0.06mg
1. 2.P.Forto
(unichan)
*
Uk ■* v J — -x
!
_
?_ _ n
-i r\
i hydroxyzine
hcl 10,z rig :
/
also in
j)
j tab ((also
inj)
see literat
ure
; mis ! Hydre^progesterone
. Secondary
: amenorrhoea:
Ethinylc-stradiol 10.06 . 1 tab daily
mg.Hydrczyzine hcl
lOmgy tab
j for J days
k-Is inj )
__ T
5. .Secrodyl
(Allenbury’s)j
co
4. Lut-Estron
Forte
(liac)
^2
I ClilSj
I
• MIMS
Progesterone 25 mg
Oestradiol dipropicn3 mg per nl, amp. ate
! c/i
J C/l for
j for P
i other
r indications.
j
i
1
»
1I V
I
1
J
•
'
Not C/l
for P
!
i
i
i
i
Not mentioned in CIMS
Not mentioned in MIMS
!
I
Not mentioned in iS’lvlS
'
------------------
Indication
for
Sccondaiy
anenorrhooa
Primary
anencrrhoea
I
I1
j See. anen,
I
L
j Pri. amen.
i
1
■ Net mentioned in CIMS
’ Not mentioned in MIMS
» one amp.daily •
!
' for 1 or 2
»days for HPT
V
.,
Indica
tion
for Dreg.
!
| ace'Gate 30 mg
2. Cunorit
~ CoJt^indicSlns
•
i
!
!
\z
Recurrent
abortion
Araenorrhoea
oligGiiencrrhoea
• early ding, of
! preg.
f
feu a
|
Fc n.-uls ticn
Dosage
Infomaticn in CIWMIMS cn C/I
(
._
and s/p
c/l for Net b/l
for
Indica
jlit.
other
for P
tion
i
indicafor Preg.
iSee
>
5* Men st it gon
Forte
(organon)
!
______
CII.iS
Estradic1 benzoate 5 mg
i'rogesit rtone 50 ^g/nl,
inj.
I
UMS !
-do|-----6- Gostapion
CIMS J
(Khandelv/al) j iilMS j Progesterone 25 ug
» Cestradiol benzoate
| 2.? ng(jnj)
■also tats.
7*^Orasecrcn
'CUIS I Fthisteionc 50 ug
* • Fo^teP h.’
i ^.9 Ethinyl estradiol
(Nichol^ 5-..)
• O.C5”hg (tab) ...
1
;
i
j
j
j
'■
ff
-do-
in
•—1
o'
i
A
Gj
a
8. Disecron
Forte(Nicholas,.)
CIMS . Progesterone 50 ng
■ULiS
’
i
Indication for
tions
inj cnl>;
Repeat course of ;
tab for 5-4 cpl-
Sec. auen.
-do-
1
v
J Sec.
aiJon.
j Net in CI11S
■
1 nl. i. g . on t wo
successive days
1 tab on three I
successive days ’
Sec. aiaenorrhcea j
1 daily for 5con.
day s. Repea ted
at intervals of
28 days for a
total period of
four or nore
cycles
-dO-
*
j Sec. auen. of
j short duration
----I
I
i
•I
i
i
V
t
--------- J--
Oestradiol benzoate
0.5 'ng, inj.
one aup. i.m
!
repeated at 28
day intervals fc-r
»
4 cycles or rjore
Progesterone 50 ug
Oestradiol benzoate
25 ug irj.
i
1
-do-
Sec « anen. where,
prog, has been
excluded5
postpen e£tent
? of mens.
I
i
I
-do-
j Sec. teen o wh en
prog- is excluded
t
i
Sec. amen.
i
}
D-10/541(d)
kkha 1.11785
•«0•60.
Having examined in some detail the kind of information that is accessi
ble to doctors through the drug companies, we can move to the second drgue-
nent of OPPI that ’’there is no authoritative evidence as to the oiagnitude g
the risk”.
i
1 <
At the very cutset it nay be stated that the kind of' "proqf” or
n
•
authoritative evidence” that would satisfy OPPI would entail a prospective
randc’Liiscd S'tudy which would be quite unethical to perfori'i.
Wat is irmort
ant is that the magnitude of the risk is large enough for authoritative
sources all over the world to categorically condei..n the use of these drugs
for HPT.
’
"These tests should no longer be done”
-WO Technical Report Series 657 , 1981
’’Pregnant patients should not be given, oestrogens , particularly
during the first trimester”
-Goodijan and Gilman.
’’The test is false positive in one out of five womens There is also
an increased risk of foetal abnormalities”.
-I).' Vengada Salam et al.
International Journal of Gyn. and Ob. 14:546-555^
1976. •
ti
It is prudent to discontinue the use of HPT”.
-The. New England Journal of Medicine
Vol: 291, Nol4, Pg 751.
”. 0.. .hormonal withdrawal test should be
abandoned”.
-Integrated Obstetrics and Gynaecology ’
. for graduates by Denhufst.
It is indeed difficult to imagine ’which particular authoritative sourc
would satisfy OPPI’s definition, for one can add endlessly to the few
example quoted above. Old attitudes die hard.
should carry an ’’expiry date”.
Perhaps such arguements
What about the claim of the drug companies that there are no substi
tutes for the treatment of a number of menstrual disorders such as
dysfunctional uterine bleeding, endometriosis, polymenorrhcaa,' oligomehorrhoea, ancnorrhc^a, and post menstrual syndrome?
In fey 198-9 the Ministry of Health and Family Welfare consulted the
Indian Council of Medical Research again in Jibe natter. The DirectorGeneral, ICMR informed the Ministry that he fed convened a meeting of
exports and also invited comments from EndocAnologists and Gynaecologists ;
in the country. The exports unanimously expix-ssed the opinion that those
preparations have no- place in the confirmation of prognancics. The Council
D-10/j41(d)
inSsa 1.11.83
ob.7...
niade the following recoi^endations
’’Fixed dose combinations of oestrogens and progesterone may
oc totally banned in the country, even for the treatment
of secondary anonorrho.e as other substitutes are available
in the market for nanagOLient of secondary amenorrhoea”.
Dr. B. Palaniappan’s study referred to earlier, besides proving the dangers
and ineffectiveness for pregnancy tests also suggested that these drags are
totally useless and ineffective for secondary amenorrhcea also.
In fact hi.r
conclusion was that the menstrual periods which would have otherwise set in
were delayed due to the use of hormones.
This was also the view of the vVHO’s expert scientific group which net
in 1981s ’’substantial proportion of worien who are not pregnant will have their menses delayed by the admnistration of hormones”.
-WHO Technical Report Series No. 65'7,1931 (Pgs^2)
,7e -also posed the sane question to a number of exports in other
countries. We quote below sone of the replies, almost in full, as they
touch upon a number of interesting points, besides confirming the views of
the other experts quoted above;
Froai
M.D
Rawlins,
I-'rof. of Clinical Pharmacology,
Wolfson Unit of Clinical Pharmacology,
University of Mewcast upon lyno.
”It is i^y view, and that of Professor Dunlop, that there is no place
for high dose 00strogon-<progcsterone combinations in gynaecological
practice either as therapeutic agents or as diagnostic tests. To
the best of my knowledge no such preparations are currently markeded
in the- United Kingdom.
\Vhilst the Organisation of Pharmaceutical
Producers of India may be correct in saying that these preparations
wore not ’’banned”, in Britain, they have certainly lapsed from conven
tional usage and I know of no manufacturer who is currently marketing
such preparations. Indeed,y in the United Kingdom drugs are rarely
’’banned” and the medical profession and the Department of Health and
Social Security persuade manufacturers tc withdraw their products
in most instances.
On the generality of the issues raised by the Organisation of Phuriua*
ceutical Producers of India, I believe that-the burden of proof about
risk? benefit lies with the manufacturer of the drug rather than
■i'
with a governmental regulatory agency.
In this instance, for example
I would cxect the- companies concerned to demonstrate the safety and
efficacy in their products 5 it should not be the responsibility of
7 1'
C ----- 1 ' - 1 j
D-10/341(d)
"iViSsa 1.118 J
the Indian Government to do so.
In ny view the opidrj33i.ological evidence
demonstrating the risks of cestrogen-progosterone preparations in pregnancj
are substantial 5 "Proof" would require a prospective randonisod study which
would, be quite unethical to peTfcm”.
Pre li s
Dr. Stephen Franks
Senior Lecturer in Roprcductive Endocrinology
dept, of Obstetrics and Gynaucclogy
St. fery’s Hospital Medical Schdcl
London W” IPG.
I feel strongly that there is nc .justification for tho uso of these
drugs in auenorrhoca, menstrual irregularities ..and other "gynaecolo
gical disorders". Gonorrhoea and loonstrual irregularities require
investigation and specific causes indentifiod and, if necessary,
treated. If menstrual regulation is required in patients who have no
Periods cr who nave irregular(and perhaps heavy and painful) periods
then the treatment of choice is either the conventional low dose
oestregen-progesterone oral contraceptive pill, or progestogens alone..
1 think it vzould be irresponsible and dangerous tc encourage the use
of high dose ocstrogen-progestogen combinations in nanagGLiont of these
gynaecological symptoms”.
I *.iight odd that there is very little literature in tho most reputabl
journals of gynaecology on the use cf the high-dose ’'pill” for aiaen-
orrhuea or other gynaecological problems. The reason is obvious5
there seems little point in conducting trials on preparations, conta
ining higij doses cf steroids (with well recognised spectrum of side
effects) when low doses cf the same' drugs or alternative agents are
effective and widely available”.
From s
Dr. H.S. Jacobs BA ifl) FRCP, Pref, cf Obstetrics& Gynaecology
The Kiddlesox Hospital Kedical School, Cobbolf
Laboratories, Thorn Institute of Clinical Science,
London ?,IN 8AZu
”1 know c-f no indication whatsoever for the use of an injectable
preparation containing the combination cf oestrogen with progesterone
in the diagnosis ur management of secondary anenorrhoea. Thus the
drugs that you indicate- Bisecturn Forte, II?Forte, Gestapion s
Menstrogen, Oesterone have no indication whatsoever that I can
determine.
The preparation, Buolu.tjn, contains an amount of Norgestrel which is
unacceptable these days- there are plenty of tablet formulations
containing Ethinyl Oestradiol and Norgestrel, but the modern approach
is to reduce the dose of Norgestrel radically and certainly 0.5 mg is
■ nunacceptable amount these- days.
B-10/541(li)
MS:a 1.11.83
Orasccron is an extraordinaiy preparation which is not in use in this
country and I can soo little point in using 50 ng- of Ethisterone »hc-n there
are so nany norc powerful progestogens-rocomond that drug is discontinued.
If cy raenory serves ne correctly, Dinothisterone, which is present in
Socrodyl, is such a weak progestogen that it was associated with carcincua
of the cndonetriui.1 when in use.as contraceptive•
1 note it has been
recoixiended here in an extraordinary/ schedule of one tablet twice ?. day for
t-wo days- I can’t see the point in that whatsoever as that would give the
patient far too r.iuch Ethinyl Oestradiol 9 particularly in the presence of
such a weak proges togc-n.
I think that drug should be discontinued.
Sistranetril contains an unacceptably largo amount of Mestranol which
nobody would ever use in this country and I cannot think there is .r;
any use
whatsoever for that drug, particularly, for the indications given here, The
combination of this huge amount of liestranol with the substantial dose of
Lynestrol, which is a fairly oestrogenic progestogen , is again a bad one”.
My previous prevarication to you was that I didn’t know what drugs you were
talking about. Now you have listed them for ne I see that they are a
dreadful bunch of drugs and I would strongly support the removal of these
injectables for the diagnosis
and management of secondary amenorrhoeaH.
Thus medical opinion appears to be unequivocally against the use of
these drugs for any purpose whatsoever, and the decision of the governnent
of India one which is correct and worthy of support.
For the- more technically minded amongst our drug network wo are preparing
a separate paper on the profored treatment for secondary anunorrhoea and the
correct laanagenent of menstrual disorders for which the drug companies
claim there is no alternative approach.
In the Neantine we would be grateful for feedback and news from your
end , so that together we can successfully clinch the case against EPForto
9
once and for all.
Dr. Mira Shiva
Aspi B. IvtLstry
Low Cost Drugs & Rational Therapeutics 'Cell.
Phones 1r 668071
668072
C-14, COMMUNITY CENTRE
S.D.A., NEW DELHI 110 016
VOLUNTARY HEALTH ASSOCIATION OF INDIA
ALL
INDIA
DRUG
ACTION
NETWORK
RATIONAL DRUG POLICY
CAMPAIGN
January 22, 1986
Dear Friend,
Several organizations deeply concerned about the drugs issue have been
making a concerted effort for several years towards ensuring the formulation
of a Rational Drug Policy.
In view of the new Drug Policy coming up in the Parliament in the coming
session, it is imperative that socially conscious individuals, health pro
fessionals and organizations make a clear statement regarding the kind of
National Drug Policy that we want for our nation.
We want a rational people-oriented Drug Policy, which ensures :
1.
Easy availablity of essential and life saving drugs at all levels.
This is the basic aim of the Rational Drug Policy.
Today shortages of anti-TB, anti-leprosy, several other drugs and
even iodized salt exist. Production of Vitamin ‘A’ is steadily declining while
over 40,000 children are becoming blind each year for lack of Vitamin ‘A’.
Adequate production and streamlined distribution of essential drugs must
be ensured.
2.
Withdrawal of hazardous and irrational drugs.
Over 43,000 formulations are sold in India. This large number of for
mulationsnot only creates confusion in the minds of consumers, doctors,
and chemists but also confuses the licensing and drug control authorities.
Several thousands of these formulations are known to be irrational, hazardous
and are banned in other countries. Drugs not allowed to be produced in the
parent countries of the manufacturing multinational companies are being
made and sold here.
(
2
)
It is critical that we throw out irrational and hazardous drugs; that we do
not clutter and clog the drug control mechanism.
3. Need for Drug Legislative Reforms—so that legalistic loopholes
are not used against the people repeatedly and systematically.
The EP case is the cruellest of such examples. In 1976 a warning against
use of High Dose Estrogen-Progersterone combinations for pregnancy testing
had been issued, as these drugs were found to be aosociated with foetal
malformation.
In 1982, the Drug Controller of India banned high dose EP combinations
vide DO No. X19013/8/81-D.
Organon, Nicholas and Unichem went to court and managed to get a stay
order against the ban—A stay order which has to date not been challen
ged. The sales of these banned drugs still countinue.
I
A point to note is that Organon now calling itself Infar) is notallowed
to market high dose Estrogen-Progesterone combination in its home country
Netherlands.
4. Availability of unbiased drug information to health personnel
and consumers. This is basic to Rational Drug use.
Today health personnel depend heavily on drug companies and their
representatives for drug information. The drug information given to doctors
for the same product of the same company differs in developing countries
like India and the developed countries—which clearly shows existence of
double standards.
5.
Effective Drug Quality Control
Every fifth drug in the Indian market is substandard. Allowing produc
tion and sales of substandard, essential and life-saving drugs is a crime
against the consumers. Quality control mechanisms need to be overhauled
There is a need for more quality control laboratories.
We need more qualified, and trained and competent drug inspectors for
drug quality control. Co-option of consumer bodies is also needed to ensure
drug control. Use can also be made of quality testing facilities of teaching
institutions.
You are requested to join the Rational Drug Policy Campaign and
do the following :
Health Ministry
1.
Write to:
Mrs. Mohsina Kidwai, Minister for Health and Family
Welfare, Nirman Bhawan, New Delhi-110001.
(
i)
ii)
2.
3
)
asking for the stand of the Health Ministry regarding the drug
policy.
asking the Health Ministry to take a leadership role in formula
ting a Rational Drug Policy and not absolve itself of its
responsibility.
Dr. Harcharan Singh
Advisor, Health and Family Welfare Planning Commission, Yojana
Bhavan, Parliament Street, New Delhi-110001.
for the same.
3.
Director General Health Services
Nirman Bhavan, New Delhi-110001
for the same.
Ministry of Chemicals and Indus/ry
4.
Mr. R. K. Jaichandra Singh
Minister of State for Chemicals and Petrochemicals,
Shastri Bhawan, New Delhi-110001.
—asking him to clarify to the nation why the drug policy is looking
only at the pricing and production aspects totally ignoring other
aspects needed to rationalize the nation’s drug policy.
5.
Mr. N. □. Tiwari
Minister for Industries, Udyog Bhawan, New Delhi-110001.
B.
Boycott all Banned and Bannable products and all the products
of companies like Organon (Infar), Nicholas and Unichem which
are flouting our laws.
C.
Approach the Parliamentarians in your state about safeguarding
people’s interest when the policy comes in the House.
(For list of Parliamentary Drug Consultative Committee and a note
on how to use the Parliamentary procedures, please contact me).
D.
Find out more about the drug and health issue and share the
information with others, help in distribution of the drug campaign
material produced by All India Drug Action Network comprising of :
(1)
(2)
(3)
(4)
/(5)
J6)
<t7)
/(8)
(9)
ztro)
411)
Arogya Dakshata Mandal, Pune.
Catholic Hospital Association of India, Delhi.
Consumer Education & Research Centre, Ahmedabad.
Consumer Guidance Society of India, Bombay.
Drug Action Forum West Bengal, Calcutta.
Delhi Science Forum, Delhi.
Kerala Sashtra Sahitya Parishad, Kerala.
Locost, Baroda.
Lok Vigyan Sangathana, Bombay.
Medico Friends Circle, Pune.
Voluntary Health Association of India, Delhi.
4
(
E.
)
Ensure effective drug distribution of essential drug and vaccines,
iodized salt to the peripheral areas.
While vaccines are unavailable or available with the cold chain not
being maintained. It is criminal to allow children to be crippled and
maimed for life because as a nation we are unable to ensure an
effective drug distribution system even 38 years after we have had
the total freedom to revamp our health and drug policies.
I
The new Drug Policy is coming in March. It is mainly looking at drug
pricing and production and will safeguard the interest of the greatest in
fluencers of our drug policy i.e. the drug industry.
We want the following to be considered in the formulation of the
National Drug Policy :
—WHO’s recommendation and criteria for a Rational Drug Policy.
—Conclusions
of two Summits
of
Heads of State of
Non-aligned
nations — Havana snd Colombo.
—The recommendations of ICMR — ICSSR report 'Health for all
by
2000 AD.
AIDAN’s and VHAI’s stand is along the lines of the above national and
internationally accepted conclusions.
Drugs cannot become a substitute for basic health needs for food, water
and safe hygenic living and working conditions.
Hazardous, irrational and substandard drugs cannot become substitutes
for life saving essential and quality controlled drugs.
DRUGS POLICIES SHOULD HAVE MORE TO DO WITH
HEALTH AND LIVES OF PEOPLE, THAN PROFITS FOR
THE DRUG INDUSTRY.
People have the right to reject irrational and hazardous drugs and
policies.
PLEASE EXERT YOUR RIGHT ’ ACT FAST NOW, WE URGENTLY
NEED YOUR SUPPORT!
— Dr. Mira Shiva
Coordinator
All India Drug Action Network
and
Low Cost Drugs & Rational Therapeutics
n
KWHAlWm
We, the health personnel and citizens of India recognize health as a
fundamental right of the people in this, our* welfare state. We recognize
and strongly believe that the health status of our people is more dependent
on their access to adequate food, safe and adequate water, proper sanitation
and clean environment.
While we support the overall perspective and approach of the new
National Health Policy Statement and demand its proper implementation, we
believe that a 1 Rational Drug Policy1 is an integral part of a good National
Health Policy.
1.
I
2.
3.
We therefore, demand the following:
We have a right to safe, essential, quality drugs which are in keeping
with the health needs of the people, at costs which the majority can
afford.
We urge our government to accept and implement the Hathi Ccmmittee
Recommendations which are also in keeping w-i f.h
a Rational Drug Policy.
,
Further the national drug formulary should be revised ejid canpileo. ty.
an export multi dixiplina^ ccmmittee keeping the following criteria in
mi nd;
Es s e nti ali ty
T^P-P^ n
Safety
Cost
Ease of administration
Availability
Potential for misuse.
Such evaluation of the drugs in the market and revision of the lists
should bo done periodically.
4. The Essential Drugs Policy should be adopted for all health services,
government and private, and priority in production, distribution and
dispensing should be given to these essential drugs.
5- The public . sector should pr^xluce essential and life saving drugs on a
priority basis at the national level.
6. Drug production by multinationals and private manufacturers in India
should also be aligned with national health priorities.
7. Bulk procurement of essential and needed drugs should be through world
wide competitive tenders and rationalization of drug purchases should
govern both the public sector as well as private health sector.
3. Imports and production of non essential, specially hazardous drugs,
should be strictly curtailed.
9. Drugs which have been banned from, sale otter being marketed for some
time in one country may net be submitted for clinical trial or marketing
in India. The onus of proving why a non-essential drug should be intro
duced or allowed to continue on the market should be with the manufact
urer and such introduction should be preceded by adequate trials and
evaluation by Drug Control Authorities.
10. Comprehensive drug legislation which covers areas such as price control
at different levels, patents, and marketing practices should be incor
porated to serve the objectives of the nati nal drug policy and there
should be no levies, sales tax or excise duty on any pharmaceutical pro
duct in the essential drugs list by the Central or State governments.
11. No technology transfer agreement shall be legal and binding which cont
ains restrictive practices, disproportionate and unnecessary use of
imported intermediary. os or obsolete technologies or unfair arrangements
with respect to prices, payments or repat risti' n of profits.
12. The National Drug Policy should state clearly the steps towards a
coupletc abolition of brand names and as a first step use of generic
names should bo made conpulsory in medical education, prescribing and
labelling of drugs. Generic names should appear more prominently on all
packagings
•„ .
•f
-.2.,
13* It shall be the primary responsibility of the manufacturer to ensure the
quality of drug products. However, it shall be the statutory responsibi
lity of the Drug Control Authorities to monitor the standards and ensure
a minimum uniform1 level of government control. Consequently, the govern
ment shall take all necessary raeasuros to enable the Drug Control Autho
rities to function in an effective manner and discharge the statutory
duties .cast upon them.
14. It shall bo the statutory duty of the drug control authorities to inform
health personnel and ^consumers of the essential drugs lists, policies,
catcgori.es or brands0 drugs banned for manufacture or sale, through pub
lication in the national newspe,pers, magazines, medical journals with
adequate explanations and details.
1 rth-i li hv. of drugs required in the Governments National Programmes
sh'-'uld be' ensured on a priority basis to the government as well as
voluntary and private health institutions. Quotas for anti TB, anti
leprosy, anti malarial drugs, iodized salt etc should be made easily
available with regularity of supply t<> t»he voluntary health institutions
whercevcr possible, specially when their performance, in health care
delivery is known to be effective.
16. In all review ccmmitteos, statutory bodies and ether such bodies, there
should be adequate representation of consumer groups and voluntary health
sector.
17. Drug companies should follow, ethical marketing practices, and this should,
be ensured by their own organizations like OPPI,1DMA, IFFMA. We deplore
the tendency of those companies and associations to get around every
progressive measure of the government through re ccursetQbechni call ties of
the law and through the courts.
18. The marketing code drawn up by HAI(Health Action International) should
form the basis for a National Code for Marketing Practices, This should
be accepted ty our government and should be suitable implemented through
legislation.
19. Ihe government ■ of India should take a lead and endeavour to influence
the bHA and WHO to adopt ti.o Code in the interests of the other develo
ping countries and their peoples.
7
(IFPMA and HAT Cede attached).
t
- Voluntary Health Association of India
- Centre for Science and Environment
- Centre of Social Medicine and Ccrnmunity Health-Jav/airarlai Nehru Univer- Kerala Sahitya Shastra Parishad
sity.
- Medico Friends Circle
- Arogya Dakshata Mandal
- Lok Vigyan Sanghatana
- Consumer Guidance Health Services
- Consumer Education Research Centre
- Federation of Medical Representatives Association of India*
/
D-10/341(d)
MSsa.22.11.85
Wat,..is^ rational drug therapy?
■Vhat is Rational Drug Therapy?
^a^^ona'^ drug therapy is the art and science of prescribing the best
suited drugs to individuals who need them , not to those who merely want them.
The drugs used will be
efficient
safe (with low incidence of side effects)
low cost
easy to administer
The person
who
will, have
-- rprescribes
--- cilia concern
lor knowledge skill and concern for
the patient. Rational drug therapy requires firstly accurate diagnosis.
Are a number of tests necessary for accurate diagnosis?
No, not always. Tests are ?
‘
time
consuming. They also add to the cost of
treatment. Ordering many tests is a poor substitute for accurate history
taking and physical examination.
What prevents accurate diagnosis?
Situations like an over crowded 0 P D. Accurate diagnosis is only poss
ible "-here
where doctors can spend enough time with the patient.
In choosing a drug what are the points one should consider?
For most illnesses use the cheaper preparations as the drug of first x ’
choice.
Use more expensive ones for those who do not respond to the first drug
cr those who develop adverse reactions to it.
Consider all aspects together
Some times a poor patient can afford only a less powerful drug, in a
life threatening situation cost will not be the1 main consideration.
Remember these
Most potent drugs are not necessarily tne best.
The most rational drug therapy in a given situation is not always the
• ideal.
V/hen do doctors become irrational in their use of drugs?
According to TOO, there are 75 ways doctors misuse drugs. The commonest O
is overuse of drugs.
They prescribes
'
too large quantities
for too long duration
entirely unnecessary drugs
too many drugs at tne same time for the same problems.
’TOat happens when patients overuse drugs?
ft
O
§1§
The following are the results of overuse of drugss
wastage of drugs
wastage of money
increased chances of adverse reaction due to toxicity and drug
interaction
confusion in the minds of patients.
Why do some doctors over prescribe?
Doctors over prescribe when they do not have enough time and facilities
to do a proper diagnosis. They try to make the patients happy by overpres
cribing.
Sometimes doctors do not have enough knowledge of drugs and their prescribing principles, due to lack of continuing education.
At other times it is the patients who.pressurize doctors into overpres
cribing. Because many patients believe that a good doctor gives heavy
prescriptions.
iH
D-10/341(d)
MS:a.22.11.85
5
therefore very irrational. Since1 most doctors do not have time to open the
pharmacology books, they accept what the drug representative or the accomp
anying literature has to say about the drugs. Bven information regarding the
combination drugs banned by the- government is not known to many.
What steps are needed to rationalise the use of drugs in the market?
Initially the following three steps need to be taken.
1. Elimination of imitative drugs for which adequate therapies already exist
in the market which are cheap as well as effective.
2. Elimination of ineffective drugs-those having irrational combinations
and drugs of unproven efficacy.
5. Elimination of drugs for which the toxic effects are unacceptably high
and the use of which needs to be more severly limited than is actually
the case.
Such an approach called a rationalized rather than an essential drug . list allocates different priorities to different kinds of drugs based on
therapeutic need, efficacy, cost and available resources. The drugs easily
obtainable within the country should be grouped into three categories accor
ding to priority.
What are these three categories?
1. First line main drugs needed by primary health care units of the country.
These products would be relevant to tae diseases of wide prevalence and
would include pharmaceutical cire. Such drugs should number 50 to 60
.and meet 80 to 90% of the total health needs of the developing country.
Second line drugs would be available at district and regional hospitals
2.
and would be needed for cases not responding to first line drugs, or
that are so severe that second line drugs should be used immediately.
They would also be needed for less prevalent conditions. This list may
be longer than the first but quantities needed would be much less.
3. Finally the third line drugs would be available only for specialised
tertiary care. Vi/hat is meant by basic drugs refers to first line drugs
while all the drugs taken together may be called the rationalised list
of drugs.
How do patients use tneir drugs?
f
AWHO working group report on Rational Drug Therapy, 1975, lists follow
ing reasons for patients failing to take drugs properly.
failure to obtain prescribed drugs
failure to take prescribed drugs sufficiently long or at all
failure to follow physician’s instructions
seeking treatment from more than one doctor
^elf medication with potent drugs.
Wat can a doctor do in such situations?
Lxind the drug-taking behaviour of the
The prescriber needs to keep in mind
population; their attitude towards prescription of drugs; their simplicity;
illiteracy and gullibility to believe anything the doctor says.
The doctor in turn has by force of habit come to believe everything
the smooth taking drug representatives and drug firms claim. This too is
irrational. Merely writing a prescription even if it is medically sound is
not rational drug therapy. 'The dcctor's responsibility does not end there.
The patient has to be given clear instructions and explanations as ^uired.
The patient needs motivation, reassurance and follow up if need be. The role
of non drug therapies also needs to be learnt by the doctor, and their use
conveyed to the people. The doctor's role is of an educator and liberate .
The doctor needs to liberate the patient from drugs and disease and not
encourage slavish dependency on eitner the drugs or the doctor.
Dr Mira Shiva
Coordinator
Low Cost Drugs & Rational Therapeutics
Cell.
Reprint from ’’Medicines as if people mattered"-Health for the Millians AprilJune 1981.
Voluntary Health Association of India
C-14, Community Centre
Telegrams : VOLHEALTH
Safdarjung Development Area
New Delhi-110016
New Delhi-110016
I><1\
\
/V
Telephones : |68071
D-344
L/23.9.85
PRIORITY DRUG LIST AS SELECTED BY NATIONAL
DRUGS AND PHARMACEUTICALS DEVELOPMENT COUNCIL
THE STEERING COMMITTEE
MINISTRY OF CHEMICALS AND FERTILIZERS
GOVERNMENT OF INDIA
AUGUST, 1984
ANAESTHETICS
1)
2)
3)
4)
5)
Ether Anaesthetic
Halothane
Thiopental
Lidocaine/Procaine
Nitrous Oxide
ANALGESTICS; ANTIPYRETICS ETC
6)
71
8)
Aspirin
Ibuprofon *
Paracetamol *
ANTI-ALLERGICS
9)
10)
Chlorpheneramine
s
Epinephrine
o
2 ®
ANTI-INFECTIVES
11)
12)
13)
Ci?
■ -
Anthelmintic
(a)
Mebendazole
Piperazine
Behphenium Hydroxy Naphthoate
(b)
Chloroquine
Metronidazole
Ampicillin
17)
18)
19)
20)
Benzathine Bonzyl Pencillin
Benzyl Pencillin
Procaine Benzyl Pencillin
Chloramphenicol
21)
22)
Sulphadimidine
Sulphamethoxazole
n
•»
Antiomoebic
14)
15)
16)
cC
cont’d .. 2
s
2
23.
24.
25.
Trims thoprim
Tetracyclines
Oxytetracyline
26.
E ryth romyc i n
Anti-Leprosy
27.
28.
29.
Chlofazimino
Dapsone
Rifampicin
ANTI-TB
30.
Ethambutol
31.
32.
Isoniazide
Pyrazinamide
33.
34.
St reptomyci n
Thi acetazone
ANTI-FILARIAL
35.
Diethylcarbamazine
ANTI-FUNGAL
36. Griseofulvin
ANTI -HALARI AL
37.
Primaquine
38. Amodiaquine
IMMUNO-SUPPRESSIVE
39.
Busulphan
40.
41
42.
Ch1o rambuci1
Cyc1opho shamide
Flurouracil
ANTIANAEMIC
43.
44.
45.
Ferrous Salts *
Acid
Folic
Hydroxocobalamine/Cyanocobalamine
cont’d .. 3
-344
s
3
s
PLASMA SUBSTITUTE
46 o
Dextran
CARDIO VASCULAR
47 a
48.
49.
50.
51.
52.
53.
54.
Glyceryl trinitrate
Isosorbide dinitrate
Propranolol
Verapanil
Hydrailazine
Hyd rochlorothiazide
Methyl dopa
Digozin
DERMATOLOGICAL
55. Neomycin
56. Bacitracin
57.
58.
Bethanethasone
Benzl Benzoato
OPTHALMIC DRUGS
59. Sulphacetamide
60.
61.
Pilocarpine
Homo t roph i ne
DISINFECTANTS
62. Chlorohexidine
63. Cetrimide
64
Dettol (Xylenole)
DIURETICS
65.
Fruesamide
GASTRO-INTENTINAL
66. Premethazine
67. Oral Rehydration Salts (deleted in the
meeting of Steering Committee)
cont’d .. 4
— 3 Z:i- 4
s
4
HORMONES
68,
Dexamethasone
69.
Prednisolone
ORAL CONTRACEPTIVES
70. Ethinyl Oestradrol
71. Levenogrgestrol
72. Nerethisterone
ANTI-DIABETICS
73, Insulins
74. Glybenelamide
75.
76.
Chloropropamide
Tolbutamide
MUSCLE
77.
78.
RELAXANTS
Neostigmine
Suxamethomium
OXYTOCICS
79,
80.
Ergometrine/methyl orgomotrino
Oxytocin
PSYCHOTHERAPY DRUGS
81.
82
Amitriotyline/lmipyramine
Chlorpromazinol (substituted)
83,
Trifluperazine
RESPIRATORY
84. Ami nophy11i n/theophy11i n
85.
86.
Hydroxy Ethyl Theophyllin
Salbutamol *
87.
Ephedrine
cont'd.. 5
5
s
VITAMINS
88.
Vitamin A
89.
Vitamin D
90.
Vitamin C
91.
B Vitamins Nicotinamide
92.
Pyridoxide
93.
94.
Pantothenetes
Riboflavin
95.
Thiamine
★ decided as
requiring special attention
for encouraging production.
* *
*
*
*
*
*
*
a
Voluntary Health Association of India
C-14, Community Centre
/V
Safdarjung Development Area.
c
New Delhi-110016
%
Telegrams ; VOLHEALTH
New Delhi-110016
/v
Telephones :
..-344
“-23.9.85
September 23, 1985
Dear
As you are aware the “NATIONAL DRUG POLICY”
of India is being formulated at present.
Voluntary Health Association of India (VHAI)
has been deeply concerned about the
- non-availability of essential and life saving
drugs in the field
- flooding of the market with costly irrational
and hazardous drugs
non-availability of unbiased drug information
— poor quality control and drug control (so that
one in every five drugs is substandard)
With 30,000 formulation in the market, it
is becoming impossible for the doctors, chemists and
the consumers to differentiate the good from the bad.
In countries like Sweden, with a very efficient drug
control mechanism, adverse drug reaction monitoring
and strict prescription monitoring, merely 2,000
formulations are permitted in the country.
As a nation we can not afford to squander
the scarce resources of the nation and of the
individual consumers on irrational and useless drugs.
•*
This letter is being sent to you to obtain
your expert views on
(1)
what should be our essential drug list ?
(2)
if graded according to level of expertise and
size of health institutions, what kind of graded
essential drug list would you recommend ?
(3)
your comments on the essential drug list as
drawn up by National Drugs & Pharmaceutical
Council Steering Committee
cont’d .. 2
*•
□7
w _■
:O9O85
s
2
2
Alongwith this letter the following is being sent
to you s
(1)
vVHO Essential Drug List as reprinted in CONTACT
(2)
List of 115 drugs selected as essential by the
National Drugs & Pharmaceutical Council Working
Group (NDPDC) (Trying to obtain this list)
(3)
List of 95 drugs selected by the NDPDC Steering
Committee which was compiled with the aim of
"decreasing the number of drugs under price
control"
(4)
A cyclostyled Graded Essential Drug List dravzn up
by us last year is also being sent, which compares
the essential drug lists recommended by various
Governments and organizations.
Before I end, I wish to quote two statements
(1) From ICSSR-ICMR Report, "Health For All - An
Alternative Strategy" 1981
"There is always a dangerous turning point at which
the overproduction of drugs and doctors creates a
vested interest in the continuance or expansion of ill
’•' health. It is not generally recognized that we
are dangerously close to this explosive point".
(2) Quoting Dr Halfden Mahler, Director General, W.H.O.
"I am saddened that by and large the (medical)
profession has not grasped the seriousness of the
world health situation in spite of heroic medical
efforts, nor has it realized how inappropriate
society’s response to this situation is, no
matter at what level of social and economic
development. 1 can only appeal to it again to
assume its leadership role in health befo-re it is
taken away from it irretrievably’’.
Reference s Eighteen Years to go to Health for All
in WHO Chronicle 1982 s Code of Practice
for the Pharmaceutical Industry.
We would like to see this selection process
being a part of your medical college or institution's
important activity, you could discuss it in s
a medical conference
journal or club
staff meeting, or whatever you think is best
cont’d o. 3
-344
3
s
Needless to say that prices of drugs
outside this essential drug list will be decontrolled
and shoot up, while availability of essential and
life saving drugs will still probably not be ensured.
I would very deeply appreciate at least
some response from you at the earliest.
A week ago in Gorakhpur for the first time
one of the Medical Professional bodies deliberated on
drawing up their stand regarding the National Drug
Policy. VHAI and other organizations constituting
the All India Drug Action Network (AIDAN) have been
urging for a Rational Drug Policy for our country for
s eve ral ye ars.
An irrational drug policy would not merely be
anti-people and anti-health, it would irrevocably alter
the very concept of health care and wipe out self
reliant low cost effective alternatives that may
exist in the field. A policy made by politicians
and bureaucrats-and with half the members on the
NDPDC being from the drug industry - could do great
harm if allowed to be finalized without a public
debate, at least amongst key health institutions
and medical colleges and the academic bodies.
Your response would be deeply valued.
Kindly consider this a personal as well as
a collective appeal for your help.
With sincere regards.
Yours sincerely,
//•
Dr Mira Sniva, MoD.
Coordinator
Low Cost Drugs & Rational Therapeutics
ends s as above
^Indian Academy of Paediatrics, Gorakhpur, UP
.4
OUR DEM,aND FOR A •’PEOPLE ORIENTED RATIONzaL
NATIONAL .DRUG POLICY" - JDRAFT OF ALL INDIA DRUG
NETWORK'S (AIDAN) MANIFESTO.
COMMUNITY HEALTH
CEIL
Floor)St. M3r!<3 ;ioac?
£’ANG.^tO7ig - 5CQ 007
InProducti on
We, the health personnel and citizens of India recognize
health as a fundamental right of the people in this our welfare
state. We recognise and strongly believe that the health stat
of our people is more dependant on their access to adequate foe
safe & adequate water, proper sanitation and environmental pro
tection and primary health care services.
We stron gLy endorse the WHO action programme for Essential Drugs
and Rational Drug use, and we support the overall perspective
and approach of the new National Health Policy statement. We
demand its -immediate and effective implementation - (specially
in view of our being signatories to the Alma Ata Charter) and
our official acceptance of the GOal Health for All by 2000 A.D.
A rational drag policy is an integral part of a National He a It I
Policy — which in turn is strongly effected by the countrv’s
agriculture, educational, industrial policy etc., but if health
for all is really meant to be a goal — the action towards its
realization shou'.d atleast to bogiin now.
Our demand for a rational drug policy is made with full recogni
tion of the limited r;°le of drugs in ensuring' good health. We
recognise that Provision of "food, ■-’Water, shelte r, physical and
cultural environment are essential and much more crucially need,
in attending any improvement of the, health of the majority of
our people. A rational drug policy would' tremendously• help as
adjuvant part of this broader social process.
Today with the increasing dependance on drugs, which are being
projected as panacea for all ills — the 'drug culture', 'drug
colonialism', 'drug pollution' is beginning to dominate, our
society - (this includes policy makers, health personnel and
consumers). Health is still regarded as an individual or p-.rsoi
responsibility and it is believed that freedom from disease cou
only be obtained by greater and greater variety of greater and
greater number of patent drugs.
We are not merely questioning
the existing pattern of dru^ production, its distribution, its
quality control, but we are questioning the health care delivery
system which has failed to provide even basic health care to the
majority wore questioning the existence of social injustices
which lead to diseases of deprivi^tion.
Not that there has been dirth of recommendations from Shore
Committeez Hathi, Mudaliar Committee and Srivastava report etc.
about health care services and from Hathi Committee, Alternative
strategy. Health for All, ICSSR, ICMR report about Priority
Drug needs.
We demand that atleast rec ommend at i on s made by the Govts, own
essential Drugs Action Programme.
intoetechnh^?ChhY1 ■USt hU<? policy' which ioo^s not merely
into technic 3! and clinical aspects but also economic, social anfor hea?ih TnShnS Qf the drug P°licy- Allocation if resource"
latlons, 1, pollcS’hSe^o
1“alth legispr-ofit interest of the 'drug makers' and the of the people before
revenue interest of
policy, makers ' .
VHAT
________
: k: 2 2/11/ 84
2 :
While the drug industry has been very vocal about the cohstr-i*”
of the drug policy - The voice of the consumer and that' of the
health personnel believing in consumer's rights has not been
heard.
Where drugs are concerned the main objections have' been becaus
of
1.
Unavailability of ______
essential
__ / life saving drugs of accept •
able safety/ at affordable price to those who need them
the most.
2.
Flooding of the Drug market with non^essentisit often
irrational canbinations and even medically unapproved
hazardous drugs.
3.
Unacceptably dysfunctional system of provision of unbias co
drug information to
- to. doctors and health personnel
- to retail pharmacists (qualified & unqualified)
- to the consumers (liberate and' illiterate)
- drug policy & decision makers.
4<
Weak,drug legislation and (probably) ineffective adminis
trative machinery/ which leads to non-implementation of
any progressive decision.
5.
Increasing drug prices- ( arid health care costs) .
6.
Grossly inadeequate quality control mechanism (which allows
substandard and spurious drugs to be profitably marketed.
Obigctives of the Rational Drug Policy *
1.
Ensuring availability of safe essential and quality drugs
in keeping with the health needs of the majority/ at costs
majority can afford — in keeping with WHO & H'athi Com
mittee recommendations.
2.
To eliminate useless irrational and hazardous drugs from
the market.
3.
To provide comprehensive drug legislation and administra
tive support by effectively dealing with areas related to
price control, patents, marketing practices which should
ensure implementation of rational drug policy - with modif?
cation and updating of health legislations ensured wheneve:
required.
4.
To ensure workable drug monitoring and drug information
system for health personnel as well as consumers.
5.
To keep drug prices at the lowest possible level by purch-us
ing raw material through world wide competitive tenders
through effectively functioning bulk purchase system. Thic
being alongside attempts to indigenously produce the pharm
ceutical products with improved technologies from basic st;
6.
To ensure adequate training/ monitoring and functioning of
profession‘al health personnel and pharmacists in principles
of rational drug use and rational pharmacy management.
*The objectives of the 1974 drug policy cert dn aspects havebeen emmitted which we feel strongly about*
7^.4/37 7______________
V HA I; MS :k: 22/11/84
3 :
7
To ensure efficient quality control mechanism for all drug
in the market whether brand or genericz whether from a
multinational or from
Small scale sector).
8.
^:O ensure finalisation of graded Essential or Priority dr
list in keeping with the concept of Rational drug policy.
This being applicable to Govt, as well as private sector f
prioritization in production, distribution and dispensing.
9.
To promote national self-reliance on priority drugs in
production of raw materials as well as formulation. Ensur
ing that technology transfer agreements containing restric
tive practices involving unnecessary use of inter-mediaries
or absolete technologies or unfair arrangement with respect
to prices, payments or repatriation of profits are not
binding.
Drug imports and drug production whether public or private
(foreign as well as national sector to be guided by drug
and health needs of the people)•
10.
Ensure smooth centre state and interdepartmental coordina
tion ensuring effective & relevant drug production drug
control and drug supply.
11.
To give priority to preventive measures eg. vaccine, and
to drugs needed for community medicine over others.
12.
To ensure that professional bodies of drug manufacturers
retail pharmacists, druggists, medical professionals are
accountable and responsible for seeingto ethical production
marketing ^nd use of drugs.
Meeting Drug Needs' ■
The greatest need of the ■ mo merit is .greater public accountabilit
and a greater social control over pharmaceutical industry which
is an essential need area.
xMIrTEE .
2J 4 ■ .GS
HARMA""■/JT1CALS
For this an independent machinery such as a National Drug Agency
with a special Drugs '& Therapeutics Committee needs to be s -t up
which can scrutinize all the drugs currently marketed in India,
on ongoing basis and be held responsible for the nature of drugs
in the market..
This permanent body should have representatives with medical,
pharmacy, management, producers, experts and from
- drug £4 health authorities from states
- trade union representatives
- from medical profession
- chemists & druggists
- consumer groups and NGOs involved in health work
This committee should not be a mere recommendatory and powerless
body but be provided with powars to oppose or grant issuing of
new license and registeration. This Committee should meet
regularly . and proceedings df the .meetings made available to healpersonnel for feedback and for providing additional information.
Under no circumstances should adhoc committees be formed only to
be dissolved after their submitting their recommendations — as
this interferes with the committee ensuring that its decisions
are implemented and secondly it leads to lack of public
accountability.
?
--4/377___________ __
VHaI :MS : k: 22/11/84
4
be t te r
Itwould b a .tuncti^nensure increasing powers of tfe
Conyoller of India and state Drug Controllers
It is
if,, eSSn b °lyVe "
‘ Powerless committee or authority whose
advice like that of Drug Consultative Committee will never by
acted upon promptly and adequately.
Relationship of NDA with <centre
'
_..d state drug and health
and
authorities should be clearly defined^ I.o
Its constitution func
tioning and powers should be such that its decisions are not
routinely challenged in the court.
Drugs should be dealt with by health ministry rather than
chemicals and fertilizers, to give greater emphasis to the
therapeutic re levmce rather than industrial profits and
Govt.'s revenue.
Identification of Drug needs and drawing up of priority on
Essential Drug list.
Priority for production has to be given to thef prevailing dise-3se pattern and incidence of diseases, which are mainly communicable as well as nutritional
in our country.
o s c ie nt i f ic j us t i fi c at i on should act as a primary
crieterion.
Production and import of drugs should be carefully planned accomg to the pattern and incidence of diseases in our country and
reliance9 tO
requirements of economic and technological sei
For this, it is essential to produce a priority drug list.
These being -
- Drugs required for Community Medicine.
Drugs required for diseases causing greater mortablitv
(death greater morbidity (illness), severe sequelae (after
effects) should get greater priority.Drugs used in Nation
programmes, eg. TB leprosy, malaria, blindness, goitre con
trol, and immunisation programmes should get priority.
“*
T-cacy: Drugs selected should have a measureable role
to play in protecting maintaining or restoring health.
- J_hgrapeutic Index should be high i.e. high efficacy and
safety. Assessing benefit to risks of side effects and
.oxicity involved has to be a guiding principle for the
introduction or continuance of a substance as drug pharma
cokinetics, toxicity and side effects. Their incidence and
seriousness of side effects have to be considered serious 1\ .
Drugs.with excessively low benefit risk ratio should be
immediately and severely restricted.
Seif-ii^e^md storage requirements: Climatic conditions
availabiiity of refrigeration and storage facilities avail
ability of uninterrupted power supply have to guide selec
tion of drugs and those considered essential need closer
monitoring.
— when there is no qualitative difference between
therapeutic? rationality and quality of 2 drugs, priority
shoul d be given to the cheaper one.
'-4/377______________
d. :MS:k: 22/11/84
: 5
Self-reliance:
Everything else being same, locally and
indigenous 1 ' produced drugs should get prigrity ensuring
national self-reliance.
Keeping the reality of inadequate
h e a 1th in fra -st rue t u re as well as cost factor (of form of
drug) drugs that are easily administered should get
priority-
- Ease of administration:
- Potential for misuse
Certain drugs may have a limited therapeutic role but their
gross misuse makes them hazardous to the community, egs•
being anabolic steroids, fixed dose steroid combination,ever.
for asthma,~-'high-dose estrogen-progesterone combination
.
.streptomycin combinations.
Some patent essential drugs af(also widely-misused eg. antibiotics and steroids, their
sales have to- be severely restricted.and consumer cnutron
provided in regional languages.
- B
Bioavailability:
This is important for some drugs with- ....
i o av aiLabi1ity:
efficiently functioning drug control mechanism,quality and
bioavaiLability of the products in the market should be
ensured.
With’new information on older drugs...
. withdrawn
of some of the absolete drugs may be required.
ihe above
criteria for selection of-drugs is applicable not merely
to the drugs already in the market but those being intro
duced for the first time.
Both this activities should be
done at the earliest without unnecessary delays and red
tapism.
0
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The second step after selection of the essential and priority
drugs would be preparing of graded essential drug , list, for dif
ferent. categories of health personnel and health institutions.
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These lists should form the basic guidelines' for bulk purchase
procurement and requisition, stocking, and dispensing.
Ensuring Rational Drug Therapy
National Drug Formulary should be reviewed immediatelyby
"& R.T. Committee should be recompiled based on the lines of
British National Formulary.
It should provide adequate relevant
Up-to-date information and form the Therapeutic prescription
guide for doctors in the public as well as private sector.
Drugs & Rational-Therapeutics Committee should also assess drug
needs and drug production and capacity utilisation for their
production — monitor drug utilisation patterns-,, hfeal-th needs,
changing pattern of diseases, drug requirementnew information
on old drugs, introduction of new drugs, efficacy of the exist
ing policy of production, distribution and use of drugs in the
light of principles of Rational Drug Policy should be.monitored
by a committee with representatives from drug industry.
O)
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The Rational Drug Therapeutics Committee, (such as the CTT1- 'the
Mozambiques "Technical Committee for Therapeutics & Pharmacy
should be responsible for "procurement" for drawing up of the
National Drug Formulary" .
■
The graded essential drugs'list for drawing up and maintaining^
therapeutics guidelines and recommend withdrawal of pharmaceu»ticals and their production licences of those drugs "lacking
proven therapeutic value"; "those representting the worstexam
ples of 'Olypharmacy" and "those with .an unreasonable profit
margin".
(Drugs & the Third World, The Mozambique Pharr.mo
/377___________
•.k: 2 2/11/84
: 6 :
Withdrawal of hazardous-irrational and unsafe drugs
Drugs recommended for weeding out by the Drug Consu11ative
Committee (see Appendix 1) should be immediately withdrawn.
Drugs banned by the Drug Controller of India under the Gazeute
Notification of 23rd July 1983-should be cleaned up from the
market and destroyed (an incomplete brand banned drugs and
changes in the DCC, DTAB and gazette notification (Appendix 2)
list being attached). The brand banned list should be made
public immediately upon issuing of bans.
Further to this the criteria of Drug ban drawn by the Expert
Committee of Bangladesh for its campaign and rationale drug
policy be used to withdraw the unneeded, useless and unsafe
drugs from the market.
For criteria see -Appendix 3) .
Provision of Drug Information
It should be the statutory duty of the drug control authorities
to inform health personnel and consumers of the WHO’s concept
of essential drugs, India’s graded essential drug lists, drug
policies and their rationale regarding banning drugs. Names
of the.brands banned for manufacture and sales should be widely
publicized in medical journals, magazines, national newspapers
giving briefly the explanation and rationale of the ban. Moni
toring sales promotion and promotional literature.
All sales promotion material including package inserts enterics
in CIMS & MIMS by the drug units should be screened by a Perma
nent National Drug Information body, which could be a part of
the Rational Drugs and Therapeutics Committee. This subccmmitte.
should be responsible for screening as well as ensuring avail
ability of unbiased drug information to the health personnel and
consumers.
All drug promotional literature should contain balanced information about indication, contra indications, side effects and drug
interaction and antidates.
Qpfy verified scientific information should be allowed to be
made available in sales promotion material.
Inadequate and inaccurate information in promotional literature
or package insert or worse still the total ommission of the
package insert (as is the trend at present) should be considered
a permishable offence.
Seminars, scientific sessions held by Drug Companies to present
mainly industry sponsored research studies should be closely
monitored.and if need be restricted as it is associated with
presentation usually only of favourable results and tends to
create a sense of obligation in the minds of certain medical
personnel towards Drug Companies for sponsoring their research.
Sponsoring of National Conventions, Professional, Medical and
Academic societies by drug industry should be discouraged since
consumers have to ultimately indirectly foot th3 bill and such
sponsorship inevitably introduces bias in favour of the company
and its products.
'-4/377"_____________
i .1 :MS:k: 22/11/84
: 7
CTC Sales advertisements should be banned^spec tally those
making false or inaccurate claims. Authorities should ensure
that adequate consumer caution is provided to the consumer in
regional languages, this should also be done for potentially
serious prescribed drugs too.
Labe11inq should be clear. International non-propritory names
generic names should appear more prominently. Consumer cautio.
should be in regional languages. Eg. for diarrhoea - anti
diarrhoeals are not enough the main treatment of dierrhoe is
oral rehydration therapy and this is how to make it (to be .qiV'pictorially).
Eg. for food supplements, nutrients, tonics — consumer caution
in regional languages should be added "This is not a substitute
for normal food”, and messages given pictorially where possible
eg. making ORT — on all anti diarrhoeal package inserts.
Free samples to doctors and pharmacists should be discouraged
as they tend to- create unhealthy greed for samples for selling,
and an unhealthy sense of obligation causing bleeding of
therapeutic rationale gifts. Medical professionals and retail
ers should be curtailed from accepting gifts and favours to
avoid bias in prescribing bonus md incentive system on sales
of the products by distributers or retailers should be curtail?
as the consumers have ultimately to pay for these ex 'enses and
it encourages biases often not in the interest of the consumera
Monitoring of Ph 3rmac<?utical shares in Drug Companies as bought
by Medical professionals and individuals in responsible posi
tion in health services is required, to prevent unhealthy bias
in their drug purchases and drug prescription.
__________________
Marketing
Code
As drawn up by Health Action International
should form the basis of a national code for ethical marketing
practices. This should be accepted by our Govt, and suitably
implemented through legislation.
India should also take the
leadership role in the World Health Assembly to get WHO Code
for ethical marketing practices passed.
Inclusion of Rational Drug Po1icy in ^edical Education
Their should be compulsory continuing education of doctors and
other medical personnel (like paramedics chemists in the princi
ples and latest trends in rational low cost pharmaco therapeu
tics specially as related to the commoner medical problems of
the majority.
Medical Audit System should be introduced to review the medical
costs, the prescription practices, patient complaints of negli
gence or financial exploitation and drug misuse. Atleast mini
mal medical/clinical record keeping should be made mandatory.
Physicians and Pharmacists should be answerable to Rational
Therapeutics Committee of Experts. This could be appointed by
Indian Medical Council or any.other academic neutral body.
Medical experts involved in primary, secondary and tertiary
medical care, chemists and consumer organisations should be
represented.
M. Finpowe r de ve 1 opment
Not merely medical and pharmacology related manpower development
is required but also development of drug managers, drug inspector
quality control technicians, researchers and scientists willing
to do R & D in areas of greater concern to the health of our
people.
-4/377
1.1 :MS:k: 22/11/84
: 8 :
The training and development should include training of legal
personnel who will be—dealing with Food & Drug courts»
Exposure and training of policy makers to the other dimensions
of the drug issues as experienced by consumers and health per
sonnel in the field is also relevant. Drug control machinery
has to be as developed as our drug industry and be proportion at
to our drug production and sales.
Dgugs and Health Deg is 1 at ions should be established and admin i:
trtative mechanism to implement them should be developed. The
legislation should be reviewed, regularly modified and updated
in the interest of the public, they should not become bottle
necks for implementation of the national drug policy.
Drug Legislation should provide for the following:
a system of registeration of all medical products
(including traditional medicines)
- enforcement of good manufacturing practices
- full control of labelling and advertisement
- control of prices of finished drugs and therapeutic
raw materials
- prescription control of toxic/poisonous and habit forming
drugs
...
- summary trial for violations against the drug policy by
manufacturers and traders in special drug courts
- heavy penalties including oonfiscation of equipment and
properties for the manufacture and/or selling of spurious
and substandard drugs
~ regulation of technology transfer and licensing agreement
with foreign MNC's.
- .Restriction-of ownership of retail pharmacies to profes
sional pharmacists only
- the patent laws in respect to pharmaceutical substances
should be revised
(As based on Memorandum for a National
Policy on Pharmaceutical drugs in
Maiasia, 2nd February 19 83 by Consume!
Association of Penang.)
Quality Control
It should be the primary responsibility of the manufacturers
to ensure the quality of drug products. However it should ?oe
the statutory responsibility of the Drug Control Authorities
to monitor the standards and ensure availability of good qualify
safe and effective drugs. The Govt, should take all necessary
measures to enable the Drug Control authorities to function in
an effective manner and discharge the statutory duties cast upon
them.
7
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9 :
WHO's scheme of certification should be used to build up mecha-nism of .quality assurance into the procurement, system. Adeg—p;
number of drug testing labs in different parts of the country
should be established and adequate number of efficiently trained
drug inspectors be taken on in stipulated numbers i.e. 1 for 25
drug premises/ 1 for 10Q drug outlets.
Regular sample survey of drugs in the market should be done by
Drug Control authorities. Names of brands, batch number, name
of pharmaceutical unit concerned in producing substandard or
spurious drugs (if caught) should be published widely to te
a deteriant to others.
Food and Drug Courts should be established for expedious trials
with deterring punishments being melted out. Consumer complair.i
should be confronted quickly and action taken against the errir ‘
producers as would be taken on complaint lodged by a drug inspec
tor or someone from drug control authority.
Action taken by Drug Control Authorities against erring produce ■. ■
and traders should be made public.
Drug, legislation to check sales of harmful and substandard dru
s h ouId be en forc ed.
Be s ides punishment, payment of fines and
compensation to patients should be enforced — to be paid by
erring and convicted producers and collaborating chemists and
pharmacist.
1%. surcharge on drugs could generate adequate finances for
generating adequate no. of quality control labs .-and drug contrc 1
mechanisms.
Drug Distribution
Drug supply management:
This is aimed at ensuring the /best us
of finances allocated for the most essential pharmaceuticals.
Drugs and Therapeutics Committee (or its subcommittee) should
look in depth into the drug needs of the peripheral health unit,;
identify the battle necks and deal with them as a priority.
It.should look into — requirement estimation•of various drugs
and their dosage forms.
- purchasing effective/ safe and quality drugs at most
reasonable costs through bulk purchase and other
purch as e proc edure s.
- operating an efficient inventory and stock control system
- developing an efficient workable system, where drug needs
of the peripheral institutions can be gaged and timely
drug supplies ensured.
(Dr. S, BalasubramanianzUnctac.
National Corporation for distribution of drugs and pharmaceutics,
to retailers drug outlets, hospitals and dispensaries should be
established.
Adequate drug distribution through the Govt.'s health services
infrastructure should be ensured.
E,4/377______________
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10 :
Quality essential drugs should be made available from Govt.
puice pharmacy shops to decrease costs for consumers oy
avoiding chain of middlemen constituting of wholesale stockist •
distributors, etc.
These could be handled by PHC£ and sub
centres .
Education & relevant material con good pharmacy management as
produced by WHO should be male available
- --------------- i to those who need th*
information to prevent wasteful ------------------inefficient
j pharmacy managemt r.t
systems.
v
S t re am 1 in ing Drug Pr ic ing
Modification of the Drug Price Control order of 1979 may be
needed to c
-------- reasOnabl
' " ? Profitability of essential and life
!2
SU5L
saving drugs, non-essential and irrational drugs shouldt be taxci
highly and production made• economically unprofitable-.
Prices should be reviewed r^gularly and efficiently without
unnecessary delays that leads
----- to problems for the drug industry.
ievies on essential and olife saving drugs should
essenti3iCdru&s1n-'Adtrt°^1k removed'- units producing 100%
ntial dru^s need to be given tax
tax and
and duty
duty reliefs
’ v
recommended for export oriented units.
Y reliefs,
relle£s' as bein7
units.
Leader Price s; / _... _ 1 __
drugs should te calculated on the basis of BICP data?
and ail BICP data about drugs and pharma.ee .
ticaIs sh ouId he t re ated
-d as a public.document. Which can be
made available to <organisations and groups involved in Drug iss
to ensure support and trust.
---------(Bureau of Industrial Cost and
. ../Pricing) .
Stricter controls over the loan licensing'
systern should :oc
enforced.
Drug Nomenclature
Use of International non-proprietory names
— and generic names
This should be .so as INN or generic nam.es are used in under
graduate, post-graduate medical and pharmacology education th-^
- - - penflni »f more i-atimal
a"d dls-
With a well functioning
f
drug control imechanism,difference betweoi
quality
of
brands
and
-3 . ,
,
—-1 generics should not exist
-- and
—d standard
gu lity be ensured to. the public.. The recently
passed
US Bill
in favour of generics and reasons given for proves our point.
Qualified pharmacists ^ff^^of_Ueneric equivalents < :
of a lower
cost could play an important
role
- — if
— rational choice- of drug not
based on commission <alongbeing
the guiding factor* Use of Bran a
corrupts the medical profession.
- ----- *
(Hathi Committee).
For a start generic n:iT.__
•'
ernes of the
products should be put more
prominently on the lable~
-4/377______________
Al A :MS:k:22/11/84
11
of generic prescribing and the dangers -and irraThe advantages
i___ ______ _
tionality of brand names prescribing have been well documented
whether it should be brand or generic is no ?longer a matter of
debate or discussion.
Ref. :
Dr. Balasubramanian/ UNCTAD
Quoting Brand names vs. generic names
Editorial 1973 - The Prescriber
Brand name protection should be withdrawn and only generic: na"i€
quality
control and drug control
allowed to be used - once our q
’‘
mechanism is strengthened. This being not merely for decresing
in drug price (little though it may be) but to avoid confusion.
Trade marks allowing identity of the original product.should be
allowed to be retrieved.
Ng drug 1 abeHing or its advertisement should be permitted unlet..
the generic name is also clearly stated.
Patents
Pruxluct Patonfs only for those products fulfilling essential
health needs/ and Produced from indigenous Research h Develop
ment (R & D) should be given to ensure returns -and act as
incentives for R & D for in priority areas. All other patents
should.be gradually withdrawn as is being done U.S. <1 U.K.
"Safe guards prescribed for ensuring satisfactory.working of
patented invention would be —
a)
to specify that importation does, not constitute
working of the patent,
b)
to provide for an expeditiousness system of compulsory
1icons ing,
c)
to provide for forfeitive or revocation of the patent
on specific grounds,
d)
to shorten the duration of patentsj as an incentives to
speed up the working of the patented invention.
NDP for countries in the
Caribean Region
Dr. K# Balasubramanianz
Tech. Div. , UNCTAD
Licensing & Registeration Machinery
Needs to better streamlined with greater public accountability.
Licensing and re licensing of drugs should take into considera
tion the nations quantitative and qualitative drug needs.
Priority and essential ;drugs should take precedence over nonessentials.
License for known hazardous drugs license and drugs
for which Drug Controller has issued a ban should be withdrawn
at the earliest in the interest of the public.
Drug Registeration — Refer HAIfeHandbook page No.32 to ’35,
Article 4: Drug registration; Article 5: Registration of new dru
Article 6: Pre-registeration clinical trials of new drugs.
-4/377______________
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:
12
:
Central Drug Control authorj-ties should have an up-to-datei
information about the various drug formulations in.,the mfirKet,
their combinations, their date of licensing, drug information
being given with them by* the producers and the latest in
national medical views on the products*
Drugs which have been banned from sale after being marketed f .a.
sometime in one country may not be submitted f or cUncial tri ;
or marketing in India. The onus of proving why a non—assent Lal
drug should be introduced or allowed to continue on the market
should be with the manufacturer such introduction should be
pr ceded by adequate trials and evaluations by Drug Control
.Authorities •
Self Reliance
Hathi Committee recommendations towards a self reliant drug
industry should be implemented.
Dilution of fore ign equity shares to 2 6% should be ensured as
recommended by Hathi Co.unittee.
It should be brought down to
10% within next 3-5 years and no company having any amount of
foreign equity should be considered as Indian Company unless
the plant and machinaries are installed on turn key basis and
no stipulation is put for import of raw material from the
parent company.-
Transfer of technology should be guided under UNIDO recommenda
tions. Only latest technology can be imported on the basis of
global tender from all the developed countries.
Preference
should be given to the countries who accept "Rupee” as the
transfer currency and indigenous pl^nt and machinery are
accepted.
Petrochemical industry oriented mainly towards chemicals,
detergents, paints and synthetic fibres, should lay adequate
stress on production of raw materials for fine chemicals and
petrochemicals.
Production capacity of the plants producing basic drugs of
essential nature should be increased import of intermediarjes
speci illy of essential drugs should be discouraged.
Multinationals (even those with 40% foreign shares) should not
be allowed to manufacturer household remedies cosmetics food
products.(
20% of all drug oroduction should constitute of essential drugs,
(I think we can make it 50%)
(I
No import of machinaries if similar machines are indigenously
availab.e. Import of machines for filling, sealing, labelling,
capping and packaging should be discouraged through high taxa
tion, in view of the ensuring unemployment. Standards for
packing of fixed dosage forms should be set, for bottle sifce
strips, etc. Needlessly expensive packaging should be con
trolled .
All taxes from priority essential drugs should be abolished to
decrease its un prof it ability to the producers as well as prices
to the consumers.
Subsidy should be provided for tr ins-port of essential drugs anc
raw material into rural remote and interior areas.
- Full utilization of existing capacities for essential dm n should be ensured — whether it is in public, foreign
small scale sector.
-4/377<_______
N .1
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13
_
Range of products and production capacity has to be deter
mined by the Drug Review Committee and distributed to tr a
manufacturers for essential drugs which should form the
baseline for capacity utilization.
~
No c^rrv on Business license or production over the license
cap icity should be allowed for non-essential drugs.
Open General License system is to be abolished. There
should be raw' material pool in each state for informal •
pricing of raw materials.
R & D
T h e rec omme nd a t i on s of NISTADS & MDI as presented
with their pilot study on R & D for production
‘_
of essential
as ide red.
drugs in India - '84. needs to be considered
R d D should be in keeping with the countr Y
pre sent d is e as e
patterns md present and future drug requirements.
Amount spent on R & D should be related and equal to the amount
spent on sales promotion. Drug Units involved in basic rose arcv,
of essential drugs should be encouraged by providing them with
appropriate subsidies andz tax rebates and a relatively higher
mark up on this products and longer process patent?
R & D in phytochemicals should be given extra encouragement as
for in public and private sector as well as national research
labs .
List of Background papers and related reading:
1.
Alternative drug policy some criteria — Amitava Guha/FMRAI
2.
Essential of a Rational Drug Policy &
Towards A rational Drug Policy/ Anant Phadke, M.F.C.
3.
Criteria of Rational Drug Policy/ Dr. Sujit Das/(HSA & DAE)
4.
Memorandum — Our demand for a rational drug policy
(VHAI/ ADM, KSSP etc.)
5 .
Other documents consulted:
- Bangladesh Drug Policy - Economic use of drugs HAI
document)
- Memorandum ^f Rational Drug Policy for Malaysia
(CAP Document)
- Mozambique Drug Policy (V,1AI handout
- Drug Policies for Developing Countries - Caribbean
— HAI Code Pg. No. 32—5 2
51?’
*
- Pharmaceutical Policies - Andrew HerxhAner
Bitter Pills Ch. 9, Pg. 246 - Pgz 161
- Healthy Solutions
3rd World National & Region b! Policies
Chapter 11/ Health Now Action for Change Pg.194-199.
*
Pharmaceutic Is and Health Policy International
Perspectives on Provision and Control of m'-dicines
Edited by Richard Blum/Andrew Harxheimer/ C -therinc?.
th ria
Stenzl and Jasper Woodcock.
-4/377______________
<iAI :MS :k: 22/11/84
: 14
:
(This draft is being circulated for feed back
before it is finalized. The purpose/doing so
is twofold :
/of
Note:
1.
To go through the exercise of under
standing the drug policy as it exists
and as we want it.
2.
Prepare our recommendations in response
to the steering committees recommenda
tions before the National Drug Policy
is finalised.
The above draft is based on the above friate-rial 1
discussion at the
z
*
? as well as our
q;
r
at
Wirdhi 30-31st h:
coordinating Committ *.• meeting
A further modified draft w as submitted to the Expert Comr
meeting on 29th Novemb er which met to review the
National Drug Development Council Steering Committee
rec onmme nd at i ons.
I had c lied an urgent consul t-tion prior to the above
meeting in VHAI to prep re ourselves and our stand.
Mr Mazumdar FMRRI, Dr Rane Arog yi Dakshata Mand lz Dines.
Abrol and Prabir of Delhi Science Forum and myself
constituted the working te im .
Our conclusions have "b'een un nimous on most things excep
for some differences in a few areas eg. drug pricing
ie. need for uniform pricing vs continued grided pricing
for different c itegories of drugs.
2nd
The /document is being sent to some of you and will be se
to others’on hearing from you as there are very few copie,
Your feed back is expected so that we are un mimous about
our reaction to National Drug Development Council Recommc
ations and about our demand for added modifications in
the National Drug Policy.
Matters concerning health and drugs should become a matte
of public debate. An informed public opinion and public
pressure can make all the difference between 'a people
oriented. Rational drug policy' or a 'P rofit and growth
oriented drug policy'. It can also make the difference
between implimentation of a ration il drug policy anda non
implementation of a theoritically good drug policy.
The recommendatjons of the Ste 'ring Committee of the
National Drug Development Council in some form or the otb
are expected to reach the Parliament in its next session
as the new Drug Policy.
We strongly be ieve in the democr tizition of the decision
making process. If views of the people are not invited,
they should be presented never the less.
J
...15...
•
er
The question today is not of a ev7/,dn 1 g£-their prices md
safety, it is a question of cre“Ttinc fals_e_dmat th
cost of not fulfilling genuine health needs, its a questi.r?
ch anging~dramatic illy the very concept' o£~~he al th - the repurcussTons will Sf ar re aching . The process “of margin alizati
of many due to warped po..icies will continue if not worsen.
Besides continuing the valuable work at micro level in which
many of you are so deeply involved it is crucial to keep the
nation -31 perspective in mind.
Appealing for your help *nd awaiting your feed back.
In solidarity.
Dr Mira Shiva
Coordinator
All India Drug Action Network.
Please Note: WE WILL MEET FOR 2 DAYS AT B ANGALORE FROM
30-31st J;\NU/aRY AFTER THE MFC MEET.
A
CHAPTER 8
„ summary of recommendations/comments
OF THE STEERING COMMITTEE
1.
There should be a smaller span of price control on the
drugs than now.
2.
There was need for an economic study (App.X) to provide
to study
the data base for changes in policy as also
the impact of the present proposals.
3.
A priority list of drugs as amended (Appendix VI) was
approved# as essential from the Health angle by the
steering Committee.
4.
The Comittee recognised the need to match essentiality
with keeping the price control basket as minimum as
possible and left further consideration to the NDPDCand
Government.
5.
The Committee felt that the priority list would require
updating periodically# at least once in five years.
6.
The production of these drugs should be monitored and
any shortfall in production be immediately attended to
after assessing the causes therefore.
7.
The minimum economic scale of production should be
permitted. •
8.
The drugs in the priority list and the formulations
3
based on them are to be under price control. The
rest of the drugs and their formulations may be price
9.
decontrolled.
The essential formulations based on the priority list
listed in (i) the ^0 publication/ "The use of
Essential Drugs:" (ii) Hath! Committee.Report
(iii) National Formulary and (iv) Indian pharmacopoea
will be the leader compositions. The leaders, among
those who make formulations.
With the listed compositions will be identified and
their price fixed.
The prices will apply to these who
make the same compositions in the same dosages and
packs.
10.
-u O
H if
ui
For single ingredient formulations suitable'plus minus
formulas for changes in dosage or packs oc packing
materials will be worked out to enable the leader price
to be adopted without actual costing to the non-confor
ming multiple or sub-multiple dosages and packs of
formulation.
O
5
i
X
>
r—
o 9
o
2 iX <
D
£ □
11.
For multi-ingredient formulations individual price fixi
ng will have to be resorted to. There was a majority vi
ew that for multi-ingredient industry should be allowed
to fix and revise the price themselves subject to review
by Government.
>
The export members contended that this
was not consistent with price control and needed to be
looked into from the point of view of administrative
feasibility.
12.
It was felt that the feasibility of adopting normative
costing of the leaders deserves examination and
consideration.
13.
(A) There were four views on mark-up on priority list:
A common mark up of 75%/
i.
Two mark-ups (a) 65% for those formulations based on
ii.
priority drugs which are listed in the categories
I & II DPCO 79 and (b) 100% for formulations based
on the rest of the priority drugs:
iii. 65% for the cat. I&II list as mentioned above and
125% for the rest of the priority list; and a common
mark up of 80%.
The technical members and the public sector representative
were for a common mark up of 75%. The private industry
and trade representative were strongly for two mark ups.
One technical member agreed with the private industry
view.
(B)
14.
The mark up on imported formulations should
continue to be 50%.
On trade commission there were two views:
a total commission of 20% for the retailer and
ii.
wholesaler together; and
a total commission of 26% as recommended by the
working Group.
There w®s no consensus,
15.
A decision may be taken by Govt.
after suitable study.
On over-all profitability limit on the turnover of
formillations, again there were two views:
Civen the frame work of recommendations the
1.
predominant view was that in view of the insistance
on. each producer marking 20% of the priority drutjs
and formulations this being a self limiting parameter,
there was no necessity for an overall profitability
limit.
2.
There was another view which desired continuance of
the overall profitability limit on formulations, and
supporting the working Group recommendation of a
limit of 10% on turnover of formulations for whose
companies not engaged in research and development and
12% for those companies engaged in R & D.
3.
16.
17.
All agreed that there should be no overall profitabi
lity limit on bulk drugs.
The "
”independent" small scale sector should be outside
price control for formulations irrespective of the turnover.
On bulk drugs made by both small and large units, without
formally pricing the small scale secotr, the price fixed
would operate as a ceiling for the small scale sector.
It was recognised that large units who buy bulk drugs from
the small scale sector and formulate and where the bulk
drugs.is produced only by the small scale sector would be
rare but the large units in such cases, would have to be
18.
price controlled.
Many members felt that there should be liberalised licen
sing procedure, without capacity and demand should projec
tion restrictions for priority bulk drugs, proposed ffom
basic stages and involving no import of technology, where
technology was available in the country. Where technology
is not available, import of technology should also be under
liberalised procedure for priority drugs.
Import however,
needed scrutiny and should be allowed in needed areas only.
19.
The Steering Committee had earlier felt that there should
be no free licensing of formulations.
At the VIth meeting
four views were expressed.
Formulations can be dealt with thrnc.h ordinary lice
ii.
2 0.
nsing hence no change in the earlter consensus
free licensing of formulations is necessary to react
20% target insisted.
iii. Having permitted liberalised licensing] of bulk drugs
at least related formulations should be permitted.
One member felt that no compulsion to produce 20%
iv.
should be there and no free licensing^.
The OPPI representative . favoured free li ce*.r*sl.ng of bulk
drugs in the non-pr.itwtfc^ area. The IOMA representative
was against free licensing in any area, as l^elng harmful
to National Industry.
21.
20% of the total value of production of each producer
every year should be in the form of priority bulk drugs and
formulations based on priority bulk drugs and combinations
of the priority drugs.
Fuflfilment of these obligations
will be monitored as and when industrial licence application
is received from a manufacturer.
22.
The committee recognised the desirability of all sectors
contetibuting to the production of priority drugs.
23.
There should be incentives to those producing more than
20% of their total value of own legitimate production in
terms of priority bulk drugs only.
The return for such bulk
drug production would be higher than the normal rate.
24.
Duties on intermediates should be much less than those on
bulk drugs.
25.
In the priority list for those bulk drugs under basic
production, there should be no customs duty on imported
26.
inputs or domestic duties on production.
There should be exemptions from duty on formulations based
on priority drugs.
(a)
One member felt that increase of import duties should
not be resorted to during the middle of the financial
year.
27.
On brand/generic formulations there were two views:
1,
Since gradual removal of brand names was a conscious
ii.
decision and the matter is sub-judic, it would not
be proper to promote brand products.
Others supported the view of the working Group for
industrial Approvals which had recommended
permitting brand names.
latter.
The predominant view was the
iii. For encouraging generic production a much lower
corporate (income) tax on profits from generic
production and marketing as compared to normal rate
of cotroorate
28.
tax was proposed.
Details of imports should be computerised to enable watch
and scrutiny at senior levels in Government.
29.
It was not<?d that the drugs sector should not be a drag
on foreign exchange and that tljere were complaints of
transfer pricing, in intended benefits through imports etc.
i
. i
30.
There were two views on whether individual foreign
exchange balance for each company should be insisted
or not.
on the view was that export production should
be promoted and made competitive.
The other view was
that the individual producer should justify outgo of
foreign exchange through advantageous import substitu
tion/ failing w^ich he has submit a scheme to Government
to reach a favourable balance as quickly as possible.
There were again two views whether individual insistance
should be made on all sectors or not.
According to one
view view export obligation to correct adverse balance
should be made on all foreign share holding companies.
The other view was that the •-•>» suggestion of individual
balance should be applied to all manufacturers who were
spending foreign exchange.
There was no consensus. At the
Vlth meeting it was felt that application of the concept
of DRC to the drug sector required examination.
31.
If this policy is to be implemented effectively there
have to be a statutory National Body to ensure quality
Control and ethical practices, and all producers and
dealers will have to be registered.
Registration of
all dealers and manufactuers with some National Agency
32.
was considered possible.
A Code of conduct inciliuding GMP (for manufacturers)
33.
can be drawn up to be observed voluntarily by all
manufacturers and dealers.
Any beach of the code of conduct if proved will entail
de—registration from the
34.
National Body and the fact
will be given due publicuty.
Consumers associations and voluntarily Health Organis
ation have been active role in informing the public and
35.
educating them.
Adequate funds for strengthening the Drug Control machinery
36.
in the States and the Centre must be ensured.
Special fiscal and other measures such as easy bank loans
at concessional rates of interest/ import of equipment
under O.G.L./ procurement of equipment under H.P.
system and exemption of customs duty on imported equip
ment/ may be provided to the small scale sector for
37.
installing quality control equipment.
One member was of the view that insisting on each manu
facturers setting up a chemical testing laboratory is
not practicable.
38.
More drug testing laboratories set up jointly by indu
stries themselves in the co-operative sector by the
National Body should be■encouraged and recognised as
39e
per rules.
The recommendation 2.9 of the working Group on Pricing
& Procedure was accepted deleting the word ‘'Permanently”.
4 0.
41.
The recommendations 2.10 of the same Working Group was
accepted deleting the words “along with their formula
tions"..
Regarding DPEZ^/ there were two views:
DPEA should be abolished.
1.
It should be retained. There was no concensus.
2.
At the VI meeting this was rediscussed.
It was
felt tljiat Govt, should substitute and arrive at a more
dynamic and workable scheme to solve the problems asso
42c
ciated with multiple costs and prices.
All the recommendations of the Working Group on Pricing
Policy & Procedure# not covered in the list above were
accepted by the Steering Committee.
43.
All the recommendations by the Working Group on
Planning & Development were accepted.
44n
On recommendations 1 and 2 of the Working Gropp on
approvals.
1. ‘ It was agreed in principle that wholly Indian
Companies deserve a more concessional treatment,
concessions to be left to Government.
However,
this does not mean that the existing facilities
for diluted FERA Companies should be reduced.
2.
According to one view, foreign share holding com
panies should be given restrictive treatment for
licensing, registration, ratio parameters and
sectoral reservation as compared to wholly Indian
3.
45e
Companies.
,
The other views were for following the present
policy or for accepting the Working Group
recommendation^
On recommendation No. 3 of the Working Group on Industrial Approvals, there were two views:
that the Working Group recommendations should apply
1.
only to non-priority sector.
minant view.
This was the predo
2.
4 6.
One view was for accepting the recommendation with
the IDMA view.
On recommendation No. 4 of the same Working Group, there
were three views*
1.
One view was for drawing up new reservation lists
for. both priority and non-priority ..sectors.
(App„XIIl)
2,
Having reservations in non-priority sector in
addition to insistence of 20% production of the
3.
priority drugs was an undue restriction was a
second view.
The third view was that because of the 20% stip
ulation reservation was not justificable in the
priority sector/ Reservation lists might be drawn
up for the non-priority area.
This was the predo-
47.
minant view.
Recommendation No.6 of the same working Group was
deleted being redundant.
48.,
On recommendation No, 12 of the Working Group on
Industrial Approvals there were three views:
lo
Parties to apply for registrati-on or licences and
the applications should be disposed of on a' case
to case basis as per new policy being framed.
This was the predominant view.
2.
The second view was to follow working Groqi
rec omme nd at i o n s.
3.
The third was to go by decisions of Government
on the recommendation of the Task Force Consti■
tuted to study this problem.
4 9.
On loan licences there were two views, equally
divided
1.
2.
Loan licensing should continue.
Loan licensing should be progressively stopeed as
suggested by the Task Force on substandard drugs
constituted by the Ministry of Health.
There was no concensus:
5 0o
All other recommendations of the Working Group on
Industrial Approvals not referred to in the list
above were accepted by the Steering Committee.
«
51.
The comments of the Steering Committee on the recomm
endations of the three Working Groups are indicated in
Appendix II.
52.
The existing patent law should continue.
53.
The recommendations as per additional note (Appendix IX)
given by Dr. Namjoshi were accepted by the Steering
Committee.
54.
Interim revision in prices based bn increase in prices
of inputs should be considered by Government.
We are grateful to the Hon'ble Minister Shri. Vasant
Sathe and Shri B.B. Singh, Secretary for their guidance
and advice. Thanks are due to the officers of the
Ministry and in particular to Dr. R.V.V. Ayyar, Dr. O.K.
Roy , Shri E.N. Murthy, Shri Mehta, Shri K.C. Kohli,
Shri. B.R. Verma and Shri K.L. Kakkar for constant
assistance.
This report was discussed in the V and the VI meetings
of Steering Committee held on 14th Augustiji 1984 and on
18. 8. 84 and appoved a mendments.
1.
2.
3.
4.
Shri Mahendra Prasad, M.P. Chairman
Shri Krishna Mohan, M.P.
Dr. B.B. Gaitonde
5.
Dr. Nitya Nand
Dr. Gothoskar
6.
Dr. Nam Joshi
7.
Shri Khorakiwala, President, IDMA
8.
9.
Shri Danial, President, OPPI
10.
11.
12.
Shri J.B. Kochhar, President AISDMA
Shri Gharpure, MD, HAL.
Shri H. Grover, Secretary IMA.
Shri. V. Shah, President AIOCD.
13.
14.
Dr.
(Mrs.) Satyawati, Deputy Director General ICMR,
Dr.
lagh. Chairman BICP
15.
16.
Shri S.L. Kapoor, JS Ministry of Ind. Development
Shri Mahta, CCIE
17.
18.
19.
2 0.
Shri Keltar, Economic Adviser.
Representative of M/0 Finance/Rev.
Shri. Chaturvedi, Planning Commission.
Shri, Keayla. A/O Commerce.
21.
Dr. V. Vankitanarayan. Member Secre -ary.
13.
11.
President,
Indian Council of Medical Research
.. Member.
Dr. V. Venkita Narayanan,
Joint Secretary and Development
Commissioner (Drugs)
.. Member
Secretary.
The f: Committee would also have the following Special
Invitees to its Meetings: -
1.
Representative of Department of Industrial
2.
Development.
Controller of Capital Issues (®CCE)
3.
Representative of Ministry of Finance/
4.
Department of Revenue,
Chairman, Bureau of Industrial Costs and Prices.
5.
Representative of Ministry of Planning.
Representative of Ministry of Commerce.
7.
Shri Vijay Kelkar, Economic Adviser,
3.
Ministry of Chemicals and Fertilizers.
The terms of reference of the Committee will be as
follows:
a.
b.
4.
to evolve a consolidated Report based on the recomm
endations of the respective Working Groups;
to formulate a re-conciled perspective between the
different sectors concerned;
to finalise recommendations to the National Drugs
and Pharmaceutical Development Council keeping in view
the main obrjiectives of the Drug Policy, namely, to produce
medicines for the masses particularly of life saving nature
and those required for the National Health Programme
ensuring quality and fair prices.
The first Meeting of the Committee would be held on 16th
April 1984 at 11.30 A.M. in Room No. 353 ’A' Wing.
(E.N. MURTHY)
DEPUTY SECRETARY TO THE GOVT. OF
INDIA.
Note:- The above is the summary of the recommendations of the
steering committee set up by National - Drugs & Pharmace
utical Development Council Aug. 84 Ministry of Chemic
als & Fertilizers.
Please go through it carefully & give your comments
preferably in writing to me.
Dr. MiraShiva
Coordinator
All India Drug Action
Net Work.
.
Area,
MEMORAIWIM
We, the health personnel and citizens of India recognize health as a
fundamental right of the people in this, our welfare state. We recognize
and strongly believe that the health status of our people is more dependent
on their access to adequate food, safe and adequate water, proper sanitation
and clean environment.
While we support the overall perspective and approach of the nw
National Health Policy Statement and demand its proper implementation, we
believe that a 1 Rational Drug Policy1 is an integral part of a good National
health Policy.
1.
z?.
3.
We therefore/demand the following:
Vfe have a right to safe, essential, quality drugs which are in keeping
with the health needs of the people, at costs which the majority can
afford.
We urge our govcrment to accept and implement the Hath! Canmittec
Recommendations which are also in. knopi ng wi f.h
TJITn
■
a Rational Drug Policy.
Further the national drug formulary should be revised and cemptied by.
an export multi disciplinary canmittee keeping the following criteria in
mi nd;
Esse ntia.li ty
TT’P-p^
Safety
Cost
Ease of administration
Availability
Potential for misuse.
Such evaluation of the drugs in the market and revision of the lists
should be done periodically.
4. The Essential Drugs Policy should be adopted for all health services,
government and private, and priority in production, distribution and
dispensing should be given to these essential drugs.
5- The public sector should produce essential and life saving drugs on a
priority basis at the national level.
6. Drug production by multinationals and private manufacturers in India
should also be aligned with national health priorities.
7. Bulk procurement of essential and needed drugs should be through worldwide competitive tenders and rationalization of drug purchases should
govern both the public sector as well as private health sector.
8. Imports and production of non essential, specially hazardous drugs,
should be strictly curtailed.
9. Drugs, which have been banned from sa.lc after being marketed for some
time in one country may net be submitted for clinical trial or marketing
in India* The onus of proving why a non-essential drug should be intro
duced or allowed to continue on the market should be with the manufact
urer and such introduction should be procedcd by adequate trials and
evaluation by Drug Control Authorities.
10. Ccmprchcnsivo drug legislation which, covers areas such as price control
at different levels, patents, and marketing practices should be incor
porated to serve the objectives of the nati -nal drug policy raid there
should be n^ levies, sales tax or excise duty on any pharmaceutical pro
duct in the essential drugs list by the Central or State governments.
11. No technology transfer agreement shall be legal and binding which cont
ains restrictive practices, disproportionate and unnecessary use of
imported intermediaries ' r obsclote technologies or unfair arrangements
with respect to prices, • payments or repatriation of profits.
12. The National Drug Policy should state clearly the steps towards a
complete abolition of brand names and as a first step use of generic
names should bo made ccmpulsory in medical education, prescribing and
labelling of drugs. Gei eric names should appear more preminently :-n all
packagings
•„ .
•f
..2..
13. It shall be the primary responsibility of the manufacturer to ensure the
quality of drug products. However, it shall be the statutelar responsibi
lity of the Drug Control Authorities to monitor the standards and ensure
a minimum uniform level of government control. Consequently, the govern
ment shall take all necessary measures to enable the Drug Control Autho
rities to function in an effective manner and discharge the statutory
duties cast.upon them.
14. It shall bo the statutory duty of the drug control authorities to inform
health personnel and ^consumers of the.essential drugs lists, policies,
categories or brands orugs banned for manufacture or sale, through pub
lication in the national'newspapers, magazines, medical journals with
adequate explanations and details.
f
A-tra-i 1
B fy of drugs required in the Governments National Programmes
sh-'uld be ensured on a priority basis to the government as well as
voluntary and private health institutions. Quotas for anti TB, anti
leprosy, anti malarial drugs, iodized salt etc should be made easily
available with regularity of supply -bo the voluntary health institutions
whereevor possible, specially when their performance, in health care
delivery is known tc be effective.
16. In all review committees, statutory bodies and other such bodies, there
should be adequate representation of consumer groups and voluntary health
sector.
17. Drug companies should follow ethical marketing practices, and this should
be ensured by their own organizations like OPPI,1H4A, IFPMA. We deplore
the tendency of these companies and associations to get around every
progressive measure of the government through rec curs ctQtechni call ties of
the law and through the courts.
18. The marketing code drawn up by HAl(Hcalth Action International) should
form the basis for a National Code for Marketing Practices. This should
bo accepted by our government and should be suitable implemented through
legislation.
19. The government of India should take a lead and endeavour tc influence
the iVKA and WHO to adopt the Code in the interests of the other develo
ping countries and their peoples.
(IFB1A and HAI C<?dc attached).
- Voluntary Health Association of India
- Centre for Science and Environment
- Centre of Social Medicine and Community Health-Jawairarlal Nehru Univer
sity.
- Kerala Sahitya Shastra Parishad
- Medico Friends Circle
- Arogya Dakshata Mancini
- Lok Vigynn Sanghatana
- Consumer Guidance Health Services
- Consumer Education Research Centre
- Federation of Medical Representatives Association of Iridia*
I
■ v
4
B-4/378
k/17/7/84
Voluntrv We;,jth ASSOCiation G<Of India,
C-14, Community Centre,
Safdarjung Development Area
New Delhi*] 16016
CRITERIA OF A RATIONAL DRUG POLICY
(Background paper prepared by Dr.,Suiit K. Dass Sm
others z Calcutta for DRUG ACTION NETWORK (DAN)
Core Group meet, Wardha - July 30-31/ 1984.)
Drugs may be defined as substances used in the exercise to
alleviate physical and mental ailments of living body as well as
to prevent illness. Hence, the use of drugs is a part of the
health care service for the individual .and the community,
India
has no .precise or comprehensive policy on health care service.
A drug policy cannot but be an integral part of the health care
policy. The basic elements of -desirable health care policy for
the country should, therefore, be, identified before we discuss
the criteria of a rational drug policy.
i
T
Majority of the Indians suffer from the diseases of poverty and
ignorance i.e. Communicable diseases/ diseases due to undernutri
tion/ etc. These are preventable and curable.
Industrialisation
and urbanisation have also led to spread of consequential diseases.
What we need then/ is adequate nutrition/ safe water/ universal
sanitation/ environmental protection and a primary medical care
service available to all. Obviously/ this is a tall order at
present. Keeping therefore/ all socio-economic-polltical-cultural
constraints in mind/ the following should constitute the prio
rities of our health policy:
'
1.
Universal immunisation programme.
2.
Free clinical service to all indigent people (people living
below a pre-determined level of income).
3.
Provision of adequate Calorie for the indigent people..
4.
Planned extension of sanitation and water supply.
5 ■
A rational drug policy.
These priorities may appear to be inadequate and imperfect.
.v
-
But
these have been, set up with a view to confine within achievable
goals o
Role of drugs
To the people/ doctors and non-doctors alike/ drugs appear as.
panacea for all ills. Health is still regarded as an individual
or personal responsibility and it is believed that freedom from
diseases could only be obtained by better and better and more and
more drugs. Such a belief/ among educated and illiterate alike/
h--is led to a universal craze for drugs and the DRUG CULTURE has
come to dominate the society. On. the other hand another school/
comprised of obscurantist and progressives/ point out the harmful
consequences of the drug culture and prescribe a journey back to
nature. We are u^lcl to reject this dependence on drugs and con
centrate on attacking the soci-^concxnic causes of illness.
It is not disputed 'that without being free from inequality and
exploitation/
society cannot achieve freedom from avoidable ill
ness. On the usthej* hand/ one cannot allow people to suffer and
die till that rctal^ freedom arrives.. Hence, in our society/ medical
care service has ail immediate/ q»®sential and priority role to play
and the-, drugs occupy a pivotal position in the medical care service.
Besides/ there a^u p^ver|jtive dx%igs too e.g,/ vaccines etc.
a’
. - 2/-
£-4/378
k/17.7.84
«
:
2
ro3X“‘ltt polloy- “oouia L aShgdieo—scientific as pect
bJentf£?iZrevSft^ ■ °^hrUg Pr^UCxiOn (inclPdd-ng import) have
Zi? ; y-rtvtded
the report of the Hath! Conroittee ( 197s)
shoZZhd Z
feV subsequent works. It has been conclusively
.that drug promotion does not bear a parallel or rZJprZal
’leithZ ZT W1Z
disease pattern or need of the count/.
tioJ
MaL aiways governed by the medico-scientific justifiesion. Medico-scicntific justification should act as a orimarv
sideritlori? °n thlS b^iS the folj10wing issues come up?for'cJnE fficacy:
a drug must be a <drug
”
according to its accepted
definition. it must have
----- j a tractable or measur
able role to play in protecting or maintaining
er
restoring health^
In
various substances rare consumed
as drugs in the prevai1ing different systems of therapy or
even belonging to no system at
< In or-der to obtain license, as a drug, a substance must fulfil
all the universal o.. .
critGria - no system of therapy
could claim any special criterion
for itself.
sr;icaBioavailability: The issue of Bioavailability does not
pose
a practical problem and
— should therefore, be ignored.at
present.
Socio-political as pc-ct
aSOiese^hns^lSd1Stiov -°£
necessit/S. sSce tS
** Producti<*n, distribution
S0^o-P°Htical realities £d
the TNCs and regulated 'bv
3re dominated by
economy, a peopLe-ori
a v
ofnthe international capitalist
conflict with the prevailin/tlend
necess^ily come into
' drug policy hardly appearto
he
rddical change in the
appears todwell
be r nZS- ^object.
in -Chis reg-.rt
thcreZre
The criteria
- — -—
dwe 11
five feasibility.
..
on
considerations of operaPriority drugs: f
ft&edr °niph*s*3 that we have to set up
priorities for the
\
P
2
2 Of dru9s uqdbrding to the prevailing
disease pattern, i.e
diseases'shouid claim Priority CO^bat comtriinicnble and nutritional
’essential drugs 1 ‘ aoDears
rprevailing much used term
has its distinct efficaciouLflirtoZlav^r^h^* SlnCS every drug
better- served by using'^^dZ^Sit^gS!
-4/378__
/V17.7.84
:
3
:
ca^e, priority drugs ought to be made available to all And
F i X XX X ^^3°S
e
mt
take the Govt, to task for its dereliction of dutv
poseful andn?ot?f Xe®lanka and Bangladesh has show that by pur£5 ^gnlfianj"t“ierve“lon/ t!1? ««• COOK
sffeJtive
oartichlLb 2
9 1 the chaotic dtug situation and this -:s
exeroifinl ?; ?
f pri°rit/ drugs, an effective mechanism for
- ercismg state control should be formulated and implemented.
?hrSlO1Udir,'J dlS’
free re er 1 „
y^Jr?j;DniC!lly the whole country and be delivered
level)
Like heVthb^^^mAliving bel°w a predetermined income
buy drt'gs?
Lth Care' °ther catagories of population will have
Legislation: A National Drug Authority as recommended by the
Hathi Committee bd established alongwith the inclusion of representatives of the social
___
action groups on Drug. The powers and
functions of Drug Control
Authority should be subordinated to the
NDA. NDA
should
.
^A4-^
OI1^.be
be,empo
Vered to impose control
-------------- over prescribing
nonns of the medical profession and - should
time to time issue
guidelines in this regard. 1NDA should <■'
1
ensure
that allJ7scientific
and legislative informations
’profession, NDA should also on drugs are circulated to the medical
» recommended to the Govt. on the leqislation in the' matter of promotion
t packaging# public education
regarding drugs.
name of old glorious Indian
objectively and
promotion of indigenous
— —----- ; 3n cl
^v.iluated
- —
jJil^^grch & DeveloCffTlAnt* Prinri+-v nn n f n 1
? ,
u<r~ pattern and economic
v shou}<a be guided by the
accorded to thosA diseases wbteb * - oremost priority should be
but h„e no gS aSg ue.
°£ In‘W'" f»OPle
indigenous druqs on 1 v for tC
I i ® f ' cheaP etc - R & D of
claim on priority unlels it is eL^i?n9 indigenous have little
in comparison to^^avaiXble drugs?
ly
COsteffective
Le a1th Bducat ion: F
"
Education
of the pubiic on all aspects partlcular_
Education! 3nd C°St °f drUgS Sh°uld
be an integral part of Health
-----------Medical Education: The conversion of
GENERIC education of the
med ic a1 s tudents to the BRAND educationthe
<after graduation should be
a
resisted. Informations
7 ~__
on all aspects of drugs should'be
- —
made avail
able to students. nda should undertake
the responsibility
of con—
tinning education of medical practitioners
of drugs.
on advanced information
Drug Culture: Priority of health education should be
towards an attack on the
prevailing drug culture.
pointed
Ceneric name (l.N.N ) : Should be compulsorily introduced with
suitabl e legislation,
thA
devised to introduce nonproprietory names for the
combination drugs.
«
D-4/378
k/17.7.84
: 4
Economic aspect
ll^Nnology: Technological reality should be assessed and
necessary import of technology should be vigorously pressed
is*“
Production: P
‘
Definite
production quota for priority druos shouId
be imposed on individual producer?.
In respect of priority drugs, j.prices
1
should be uniform7'^
any mark
up.
marknY
p'
taxes should"be abolished.
— ___4 All import
should be channelised through state agency.
£rice:
Non-priority drugs: , should be licensed in a
r separate
---- category and
so designated in the packaging. High taxation is desirable^
Oth^r Issues
jjruqs banned in other, countries: .should
'
"’ 'be banned in India till
its fulfilling the above
.j criteria is reevaluated
- ----------- 1 and reestablished.
Implemen tat ion : should be initiated in
the state sector to begin
with.
Nationalisation: If other methods failz
Drug industry and wholesale
trade should be’ nation a Used •
** ********
L
VOLUNTARY HEALTH ASSOCIATION OF INDIA
C-14, COMMUNITY CENTRE,
PHONES : 668071, 668072
S.D.A.
NEW DELHI 110 016
GRAMS : “VOLHEALTH" New Delhi 110 016
DRUGGING OF ASIA—PHARMACEUTICALS
AND THE POOR
Workshop organized by IOCU, VHAI and ACHAN
Madras 6th—9th December 1 985
Summary of Workshop Conclusions on National Drug
Policy prepared by Dr. K. Balasubramaniam, Pharma
ceutical Advisor, Caribbean Community Secretariat
IL
The Heads of States or Governments of Non-aligned and other developing
countries had at two of their summit conferences recommended unanimously
that each developing country should formulate and implement an integrated
national drug policy in order to ensure access of the entire population to
essential drugs at reasonable cost.
At the request of the developing countries, the United Nations Action
Programme for Economic Cooperation among Non-aligned and other deve
loping countries (UN-APEC) convened a meeting of a group of experts on
Pharmaceuticals in July 1976 in Georgetown, Guyana. This Expert Group was
mandated to prepare an Action Programme on Pharmaceuticals and present
it to the Fifth Non-Aligned Summit Conference held in August 1976 in Colombo.
The Summit Conference endorsed the recommendations of the Expert Group
in Resolution No. 25 on pharmaceuticals. In this Resolution, the Heads gave
an outline of an integrated pharmaceutical policy and also requested the
relevant UN agencies to assist developing countries by examining in depth
the pharmaceutical sector in developing countries and preparing a detailed
drug policy and programme suitable for these countries. Accordingly in 1978,
four UN agencies-UN APEC, UNCTAD, UNIDO and WHO constituted a Joint
Task Force on Pharmaceuticals and fielded an inter-agency mission to several
countries in Asia, Africa and Latin America to study the pharmaceutical
sector in these countries. The Mission had discussion with relevant govern
ment officials involved in the public sector pharmaceutical supply system and
with the private pharmaceutical industry and reported its findings to the Joint
Task Force which then prepared a comprehensive report entitled, “Pharma
ceuticals for the Third World : Policy for Health, Trade and Production.”
The conclusions and recommendations of their report contained a detailed
description of an integrated national drug policy This report was
submitted to the Sixth Non-aligned Summit Conference held in Havana in
September 1979. The Conference endorsed the conclusion and recommen
dations of the Task Force Redort in their Resolution No, 8 on Pharmaceuticals.
X3
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X «5 °
H S
J
5
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LJ
X
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u rc
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H
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-J
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ca
o
o
k?
(
2
)
From the foregoing it is clear that the developing countries have, at the
highest political level, underscored the imperative need for each developing
country to formulate and implement an
integrated national drug policy to
ensure access of the entire population to essential drugs at reasonable cost.
The policy recommended by the Heads was based on a limited list of
essential drugs.
Of the countries represented at the Asian Seminar on Pharmaceuticals
Bangladesh alone had in 1982 formulated and implemented a rational drug
policy based on the guidelines recommended by the Non-aligned Summit
Conference. Within a period of three years the pharmaceutical supply system
in Bangladesh has improved tremendously. Essential drugs are increasingly
available to larger sections of the population at reduced costs. On the other
hand countries which had not formulated and implemented a national policy
based on essential drugs are paying very high prices for their lapse. For
example the Workshop was informed that in India. A child was going totally
blind every 13 minutes due to the unavailability of Vitamin ‘A’—a cheap and
essential drug. Some participants believed that it would be amounting to
criminal neglect if health authorities in other countries continued to delay the
formulation and implementation of a national drug policy based on essential
drugs, particularly when our Heads have on two occasions, given clear direc
tives to this effect. The participants therefore, appeal to the Prime Minister
of India, Mr. Rajiv Gandhi, as the Current Chairman of the Non-aligned
Movement to use his good offices to force health authorities of the member
countries of the Non-aligned Movement, particularly those in South Asia, to
formulate and implement national drug policies based on essential drugs
and suited to their needs without any further delay.
The workshop also took the opportunity to identify the major components
of a model drug policy suitable to countries in South Asia, using as guide
lines the directives given by Non-aligned Summit Conference, Countries in the
region may wish to use their model drug policy as a basis to formulate their
own national drug policies.
A MODEL NATIONAL DRUG POLICY
A national drug policy should be linked to the health needs of a country
and designed to ensure access of the entire population to essential drugs
at reasonable cost.
The supply of essential drugs involves the active participation of many
sectors including health, industry, trade, finance etc. It is, therefore, essen
tial that an intersectional drug committee with representatives from all
relevant sectors be established prior to the formulation of a national drug
policy. Failing to observe this vital point and formulating a drug policy
(
3
)
without participation of all the relevant sectors would result in floundering
at midstream at some point in the implementation stage leading to an inter
ruption in the drug supply system. In formulating the national drug policy
care should be taken to avoid undue influence of the private drug industry,
particularly the multinationals.
The following would be the major components of a model national
drug policy :
Drug Needs : National lists of essential drugs selected on the basis of
the health needs of a country should be established. Evidence from some
developing countries and the reports of the WHO Expert Committee on
Essential Drugs indicate clearly that a limited number of essential drugs of
about 250-300 would be sufficient to meet the major needs of the people.
Drug Names :
International Non-Proprietory names (generic names)
should be used whenever possible.
Quality Assurance : Appropriate steps should be taken to assure the
quality of all marketed drugs. The success of a generic drug policy is
critically dependent on assuring the quality of drugs.
Objective Information on Drugs and Therapeutics: Health Authorities
should provide objective information to health persons.
Drug Legislation : A country should enact appropriate legislation
covering registration, control of drug information including therapeutic
indication, mention of adverse reactions, contra-indication, drug interaction
price regulation and post market survey.
Price controls or monitoring should be introduced at the import, whole
sale and retail levels.
Any introduction, amendment, alteration, variation, deletion of any drug
legislation or releated laws shall be made available to ail organization,
association and individuals.
Procurement : At present drug imports are fragmented not only bet
ween the public and private sectors but also within each of these sectors.
Foreign exchange savings could be effected by pooling these purchases by
means of a centralised buying agency, some of the countries in the region
have a centralised buying agency for the purchase of the public sector
requirements but their bargaining power is limited since they do not have
the vital market intelligence.
Production : All countries in the region have already established drug
manufacturing units. In the majority of the countries, local production is
dominated by the private sector. The commercial practices of the private
(
4
)
sector with emphasis on creating a demand and generating profits are counter
productive to the large scale production of socially useful essential drugs.
A national drug policy based on essential drugs cannot be implemented with
the uncontrolled practices of the private sector. Countries in the region
should therefore give a leading role to the public sector and to socially
conscious manufacturers like GK Pharmaceuticals of Bangaladesh.
Transfer of Technology : The uncontrolled transfer of pharmaceutical
technology into the countries of the region has resulted in the manufacture
of a large number of non-essential expensive drugs. Production facilities
brought into the country at high costs are not being used for the manufacture
of essential drugs.
Priority technological needs of the country should be identified when the
decision to acquire technology has been made. Explore all possible sources
of technology and select the most suitable technology, if necessary with
assistance from relevant international agencies. The terms and conditions
of the technology transfer agreement should be carefully examined and all
restrictive clauses controlled and reduced. Priority should
acquiring technology from another developing country.
be given to
Promotion : Drug promotion by the drug industry must be controlled
by the drug regulatory authority.
Patents : All countries in South Asia except India grant patent protec
tion to pharmaceutical products and processes. India grants protection to
processes only. Product patents enable the patent holder to gaida monopoly
of the market. The host country will be prevented by its own national patent
legislation from buying the same drug from a cheaper source.
The Non-aligned Summit Conference has recommended that pharma
ceutical products and processes should be excluded from patentability. If
process patents are granted, compulsory licensing should be used for ex
ploiting the patent locally. Other alternatives relate to shortening of the
duration of patents.
Regional Cooperation : Some of the components of the drug policy
would be difficult to implement at the national level by some of the smaller
countries of the region. These would include quality assurance, collecting
market intelligence and local production. Taking these constraints into
consideration, the Non-aligned Movement recommended the formation of
regional pharmaceutical centres by developing countries so that member
countries belonging to a regional centre could take joint action to implement
some of the components at a regional level.
(
5
)
Several years of multinational negotiation would be required before a
South Asian Regional Pharmaceutical Centre could be established. However
Health authorities in the region could initiate some joint activities.
1. Market intelligence is totally lacking in the region. Countries could
exchange information on manufactures, price trends, quality of products
etc. among themselves.
2. Drug regulatory authorities in the region may wish to establish drug
quality norms and explore the possibilities of enacting
uniform drug
legislations. This would enable the smaller countries in the region with their
drug registration and quality assurance.
3. Objective information on drugs and therapeutics is another compo
nent which could be provided regionally.
The crux of the matter still remains that the cheif responsibility
for the formulation of Rational Drug Policies lies with the
National Governments.
In the view of the availability of well defined WHO criteria for
such formulation - it is possible for Asian countries to have
such rational policies provided they have the political will to do so.
For more information on Rational Drug Policy contact : Co-ordinator, low Cost Drugs &
Rational Theraputics VHAI
*
VOLUNTARY HEALTH ASSOCIATION OF INDIA
C - 14 Community Centre,
S. D. A.
Nev Delhi 110 016
D-9/334-(a.:l.)
19.8.1982s a.
BACKGROUND PAPER PREPARED BY VHAI FOR DRUG-INF0.RMATI0N4SHARING
TO PREPARE FOR ACTION
THE CLIOQUINOL CONTROVERSY
D eman ding its ban. A Just Demand. Or, Just a Demand?
We are grateful to our friends in IOCU,Penang, Social Audit,UK?
for some valuable information they sent to us.
Historical Background
Hydroxy quinolines were introduced into the Swiss Pharmacopea in
1900 as a topical and antiseptic agent. In the SO’s it became a focus
of interest when its potential as an intestinal amoebicide was invest
igated.
It was around 1932 that classical animal studies established the
‘’therapeutic potential of the halogenated hydroxyquinolines as lumen al
amoebicides
’g
j
i) Ref: Leake, C.D. (1932) Chemotherapy-of Amoebiasis*
of American Medical Association - 98. 195-199..
J oumal
The initial clinical trial of clioquinol was conducted in the
U.S.A, in 19^3.
o
q-o
Data cited in this report suggested ’’the compound might have a
useful spectrum of action against other enteropathogenic.protozoa and
bacteria”.
Since then ’’halogenated oxyquinoline derivatives H0Q”-have been
popularly used for prophylaxis and treatment ’of gastroenteritis, amoebiasis,
travellers* diarrhoea (hoQ include a todochlorhydroxyquinoline? proxy
quinoline, halquinol, diiodohydroxyquiholine, chlorquihaldol,chiniofon)•
In 1934 the first proprietary prep ar at ion was promoted''to the
public for treatment of amoebic dysentery and. simple diarrhoea.'
As a result of a chance clinical observation, hydroxyquinclines
became established for twenty years for the treatment of acrodermatitis
enteropathica (a rare skin disorder) until “it was shown that it acted by
rectifying the underlying selective malabsorption of zinc by forming an
absorbable chelate and it was replaced by zinc»
According to Dr. Ole Hansen, in 1935, the very first year after
CIBA (of Switzerland) had started marketing the drug - ”a report from
doctors in Argentina describing exactly the same side effects as the
Japanese cases in the 60*s and 70* s was. received by-CIBA".
"From internal documents in 1939, frOm Switzerland and documents
''released in the Courts in Japan, it was discovered that experiments of
the drugs with c^ts and dogs had proved fatal".
.. 2>
to
■d
:
WHEN WERE THE INITIAL OBSERVATIONS ABOUT CLIOQUINOL RELATED
PROBLEMS NOTICED?
O
X « °
h k o
ii) Dhvid, N.A., Johnstone? H.G., Reed, A.C., Leake, C.D.,1933.
The Treatment of Amo'ebiasis with t o do oh lorhy droxy-quinoline
(vioform N.N.N). Journal of American Medical Association.
IQU. 1658 - 1661.
®
j
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o O
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o <
!
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"In the early GO’s, a Swiss and a Swedish veterinarian reported to
CIBA GEIGY that they had found dogfl- with diarrhoea treated with Entero
vioform had died, in seizures".
According to Dr*01e Hansen ’’attempts to hide facts, deny factsi"
(e.g. denial that the drug is absorbed) and attempts to convince doctors
not'to publish their negative experimental findings have been made'
throughout by CIBA GEIGY, the producers of Mexaform and Enterovioform.
EVeh before or during epidemics of SMON in Japan, several reports
regarding systemic toxicity following partial absorption with oral
administration was recorded.
Cases of optic atrophy were observed in a small proportion of
children receiving the treatment for acrodermatitis enteropathica - this
was prolonged fn' hi$i dosage treatment* Since earlier, children never
survived without treatment, optic atrophy as a late manifestation of the
disease could not be excluded.
In 1964, reversible and. unusual gait changes were noted in 20
out of 4000 institutionalized patients on long term treatment.
(Refs Cholz, L.M., Arons> W.L*(1964).: Prophylaxis and Therapy of
Amoebiasis and Shigellosis with lodochlorhydroxyquin*
American Journal of Tropical Medicine and Hygiene* 13*396-401).
Convulsions in laboratory mice on high dosages was reported in
1969 and in "domestic dogs and cats treated for diarrhoea in veterinaiy
practice".
A reversible confusional state had been described following acute
dosage in man*
Five personal observations of "transient global amnesia after
'clioquinol" have been reported in the Journal of Neurology, Neurosurgery
and Psychiatry 1979: 42, 1084-1090 by M.Mumenthaler, H.E.Kaiser,
A. Meyer and T-Hess from the Department oi* Neurology, University of Berne
and Basel, the State Hospital, Lucerne and the Department of Internal
Medicinej Berne, Switzerland.
According to WHO’s Drug Information: Jan-March 1978, though sporadic
cases for about 6-7 years were reported, it was only after three decades
of use of ’’clioquinol in the treatment end prophylaxis of diarrhoea in
Japan that SMON was recognized as a distinct clinical entity in 1964
(Tsubaki, T*, Toyokura, Y., TSU Kagoshi, H. (1965). Sub-acute Myelo
Optic Neuropathy following abdominal symptoms - A clinical and pathological
Study1, JapanI Journal of Medicine: 4, . 181-184).
HOW USEFUL IS CLIOQUINOL?
There is no evidence to sugges that clioquinol is effective in the
prophylaxis of travellers’ diarrhoea*
British National Formulary, 1981
The claim for the value of clioquinol in the prevention and
treatment of that nebulous ragbag ’’travellers* diarrhoea" do not withstand
critical examination*
The Lancet (1977)
The Committee (on Safety of Medicines,UK) has reviewed the data
relating to the efficacy of clioquinol in the treatment of diarrhoea and
considers "that there is inadequate evidence to support the claim"*
Pharmaceutical Journal (30.7.77)
page 597.
D-9/334 (a.l)
a: 19.8.82
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The drug was excluded from consideration by a WHO expert committee
convened in 1977 to prepare a model list of "essential drugs" on the
grounds that the risks of treatment out-weighed the potential benefits*
(Ref: WHO 1975: Selection of Essential Drugs. Techn.Ref.Series
615, page 14).
-
The editorial in ihe Journal of American Medical Association
10th April 1972, page 273 stated:
in the 40 years that clioquinol has been available
only one study which is not entirely convincing, has shown
it to be effective in preventing travellers’ diarrhoea
whereas one other prospective study has shown it to be nd
more effective than a placebo.••••"
"Hydroxyquinclines are active only on organisms present
within the intestinal lumen. Used alone, therefore, they
are active only in the absence of significant tissue invasion a development that cannot be excluded with certainty even in
patients with asymptomatic amoebiasis".
PDT/Dl/78.1 WHO:Drug Information.
Jan-March 1978
Anti-diarrhoeal drug blinds and damages brain - M.V.Kamath,
Times of India, 20th June 1977.
"The scientific evidence for the value of clioquinol in the
treatment Of prevention of traveller’s diarrhoea is scanty".
According to Dr. P. 0. P-andiya of Jaipur, then President cf.
the Pharmacy Council of India. "The Indian brand of Mexaform contains
2 more'drugs (besides Iodo chloro hydroxyquinoline the basic drug phanquone and oxyphenonuiia - and has come to be used not only for
travellers1 diarrhoea but diarrhoea of all descriptions including that
due to indigestion”.
"The dramatic relief is due to oxyphenonuim which reduces the
spasm of the intestines and bowel movements and thus markedly reduces
abdominal pain and discomfort".
The Hathi Committee had included clioquinol'in the analogous list
of essential drugs, "Due to its low cost in relationship to alternative
treatment and having regard to the paucity of documented evidence of
SMON within the country”.
But in India Hydsroxyquiholines are supposed to be obtained only
under prescription (like many other drugs). How much this restricts the
vigorous selling of the drugs over the counter is well known to all of us.
WHAT IS SMON?
SMON stands for Subacute Myelo Optic Neuropathy*
"In its classical form the'condition was characterized by the
prodermal gastro-intestinal symptoms considered to be of neurogenic origin.
- an ascending numbness of both legs associated with severe and
persistent dyaesthesiae*
- frank myelopathy revealed by exaggeration of reflexes extensor
plantar responses a sensory level nn the trunk and sphincter
disturbances could also occur and the combination of exaggerated
patellar reflexes and absent ankle jerks was considered to be
a characteristic finding.
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Disturbances in visual acuity developed but they were not usually
an early manifestation.
The increase in the number cf SMON cases reported annually was
substantial. In 1965 451 cases were reported and in 1969 the number
went up to 2340.
- . .
(pDT/d1/77.4 page 10): WHO Drug Information. 1977
nFemales and elderly were particularly vulnerable and formed a
high proportion of patients who also suffered from serious chronic
diseases”.
(Ref: Sobur, I., Ando, K., (1969) - Review and Comment on Myelo Neuropathy Accompanied by Abdominal Symptoms, Paisnin Igakn
24, 2390 - 2397.
More reports were received in summer "A correlation "between the use of clioquinol and the occurrence
of SMON in a series of 171 patients was first reported in 1971”.
(Ref: ■^aubaki T. Honmaj Hoshi, M«(1971)s Neurological Syndrome
Associated with Clioquinol* Lancet 19 696 - 697.
This was following the discovery pf a green compound - later
identified as an iron chelate of clioquinol on the tongue of some patients
and in the urine and faeces of others by Professor Tsubaki of Sigata,Japan.
Regarding the effects of SMON which, according to some clioquinol
sympathisers-, have allegedly been due to ididsyncrotic causes the relation
ship between SMON and Clioquinol has unequivocally.been shown*.
According to the WHO report the fact that some 15$ of the victims
hada apparently never taken clioquinol may merely reflect the difficulty
in obtaining precise drug histories from patients;''alternatively, it may
indicate the existence of other factors in the etiology "'of the disease,
or that SMON may not always be readily distinguishable on clinical
grounds from other neuropathies.
Pharmaceutical" Journal
30.7.77* page 597
Similarly, the reasons for having detected less number of cases
before-1955 could be attributed.
‘
- to a low detection rate
• "
- the absence of an unidentified aetiological co-factor
- relatively low volume of sales
- relatively low dosage and duration of treatment
- or to the existence of poorly absorbed formulations
The effect of particle size and presence of emulsifying agents
on the absorption of clioquinol, could have a bearing on the discrepant
results of long term toxicity test on animals.
Social Audit’s leaflet on Cliquinol*
SMON:
I
’’Bad infoimation means bad medicine” has this to say about
’’Clioquinol has caused thousands of cases of SMON a condition
involving continuous pain, paralysis, blindness and, in
extreme cases, death. In Japan, cases of SMON reached epidemic
proportions — affecting an estimated 10,000 — 30,000 people before
the drug was banned there in 1970”.
The casual relationship between clioquinol and SMON has even been
accepted by the Japanese courts.
..54
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WHAT IS THE INCIDENCE OF SMON OUTSIDE JAP/IN?
According to a Lancet editorial of the 28th May 1977, page 596,
’’the companies deny that the neurological damage from clioquinol is a
serious risk outside Japan and identical abnormalities of the nervous
system have been reproduced in animals”.
According to the Journal of the American Medical Association:
’’The d)sence'of epidemics in other countries does not invalidate the
conclusion that clioquinol is neurotoxic. Clinicians from England,
Australia, Switzerland, Sweden, Denmark, the Netherlands, and the USA,
have described patiente who developed neurological symptoms while taking
these compounds.
The clinical symptoms'of these patients were like the one that
characterized SMON”.
Journal of the American Medical Association
23rd July? 1973s Page 296
. According to an international survey on recent reports concerning
intoxications with halogenated oxyquinolines derivatives - "A survey
off the literature has proved that 86 cases were reported as SMON or
intoxication of halogenated oxyquinoline derivatives (including duspected
cases in 47 articles published outside Japan from January 1970 to
February 1^77).
According to Dr. N. H. Wadia in his article: ’’Some Observations
on SMON” from Bombay in the Journal of Neurology, Neurosurgery and
Psychiatry 1977: 40, 268-275 where he reported 9 cases of SMON by
retrospective study of their hospital records from 1967-71 and prospective
search from March 1972 till 1977.
"In 1977 it would be imprudent totally to ignore the Japanese
experience. If the factor which makes for the reported
difference in SMON prevalence' is genetic, SMON may never
appear in India in epidemic form- But, if the factor is
environmental or infective then the change in the Indian
environment may result in the appearance of SMON”.
(-The above study was funded by CI BA. GEIGY) • -
CIBA GEIGY one of the two main "manufacturing companies of hydroxy
quinolines has collated' details of about 200 possible cases - published
as well as unpublished.
The total number of cases of SMON reported from outside Japan
is less than 100, of these a high proportion are from Australia..
- CLIOQUINOL - RESTRICTIONS,BANS?BOYCOTTS
Hydroxyquinolines are sold in more than 100 countries.: In some,
there is a han on its sale while in others sale is restricted to
prescriptions.
Some of the countries which have imposed restrictions are Australia,
Denmark, Venezuela and Norway* In the Federal Republic of Germany, Finland,
France, ’’Traveller’s Diarrhoea” has been deleted from recommended indicat
ions and'the compound has been placed on prescription.
- •.MORE SPECIFICALLY:
SWEDEN:
At first, HOQ was accepted, for treatment of acrodermatitis
..6/-
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6
enteropathica. Later, however, Sweden totally withdrew it and replaced
it by zinc ;alts, which is considered safer and more efficacious.
In the summer of 1976, Dr* Ole Hansen proposed that all CIBA GEIGY
.products should be boycotted in Sweden as the company continued to market
or promote their products of Enterovioform and Mexaform in spite of
conclusive evidence showing their relationship with SMON.
In 1977, the boycott started with doctors writing to the Swedish
medical journals protesting against the continued sales of clioquinol.
Thanks to the information obtained by a Swedish free-lance journalist
from the CIBA GEIGY’s internal documents.
On September 27, 1981 the Swedish newspapers published that for
each individual drug, CIBA GEIGY lost 25% of their market in Sweden.
CIBA GEIGY is said to have lost 75 million Swedish Kroner during the
boycott years. In 1980, this was equivalent to the total turnover of
CIBA GEIGY (Sweden).
The boycott by the Swedish doctors and the public was their way
of contributing to the developing countries, fulfilling their responsib
ility towards all peoples in preventing drug suffering.
38 individuals afflicted with serious side effects by taking
Mexafo.riji, sued CIBA GEIGY for damages in Sweden. CIBA GEIGY and Eraco
agreed to pay 1.8.million Swedish Kroner as damages in an put of aourt
settlement according to the Economic Times of the 14th April 1982.
JAP AM
About 10,000 persons are reported to be suffering from
5/1 ON in J ap an • The number of suits in various parts of the countiy in
September 1979, a ccording to the Japan Times, was 5200.
It took more than 8 years and 4 months after the first SMON
damage suit was brought against the State and three pharmaceutical
companies (CIBA GEIGY - Japan -Takeda Chemicals and Tanabe Selyakulo)
for the Tokyo district court to reach two.decisions
1
2
Clioquinol causes SMON
CIBA GEIGY et al* were liable in failing to pass on information
about the dangers of clioquinol*
Regarding the demand for appropriate instructions and a warning
for doctors and patients, the company has argued:
"It is however not possible to achieve complete uniformity of
the information for the doctors and patients, because in
different countries there are different rules which are usually
laid down by the local health authorities".
(br-J• Sobotkiewicz: Statement at Geneva press Conference on SMON).
Proc, of 28th April 1980: p.34.
(if there were no rules, more such drugs would be let loose
on the'public; and, in countries where'the’rules are lax,
the people are obviously at the mercy of some unscrupulous
drug industries who knowingly take full advantage of these
rules).
Some of the SMON victims who have won their cases are using part
of their money to fight against needless drug induced suffering*
According to Michiko Kinoshita? a SMON victim from Japan, in an interview
’ wibh the New Internationalist, Januaiy 1981:
"We want our .fight against clioquinol in Japan to help secure
assistance for SMON victims in other countries, just as thalidomide
litigation in Europe and the USA helped £p±n assistance for
thalidomide victims in Japan".
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U,.S.A*
According to the National Drug Regulations, 1961, the use
of clioquinol for amoebic dysentery is restricted. The maximum dose
recommended is : 22*5 gm. for 10 days.
BANGLADESH
The Bangladesh Government on June 12, 1982j acting on the
advice of an Expert Committee, banned the manufacture, import, distribution
and sale of 1707 drugs, which were considered irrational and harmful.
Mexaform and Enteroviofoim and all products containing hydroxy quinolines
have also been banned.
. (A lesson India can follow from its small neighbour!)
ENGLAND
In 1973, the UK saw no reason i;o restrict the sale of HOQ.
However, in 1977, it was felt that oral clioquinol should be/vailable
only on prescription.
(Ref: Pharmaceutical Journal 1977s 106,219)
? •
In 1'977, the Lancet had said:
- .
- .
’’The time has come to halt free sales of clioquinol (i.e.enterovioform) and similar drugs for vague intestinal ailments and to
demand good evidence before their use for other purposes is
allowed to continue”•
In London, in May 1978, the Sunday Times and BBC television covered
in a programme’the clioquinol dangers. This was following the briefing
of a medical journalist and a TV producer by Dr^ Ole Hansen.
Questions were raised in the parliament a few weeks later and just
two months after the press and TV coverage, the Ministry of Health demanded
that all bottles from pharmacies be withdrawn and the texts on the bottles
and leaflets be altered. Even though these drugs are formally on prescriptrion only, they have just disappeared frotfi the market in England.
(The role of the press and Government Health .Ministry needs to
be^noted and appreciated).
A point to note:
The Medical authorities in Britain had said:
’’This (SMON) is no
problem in Britain”. Fortunately, in spite of them, these drugs have
disappeared from the market in Britain.
INDIA
According to the Hathi Committee, HOQ are supposed to be
prescription drugs, but- they can be obtained in any amount over the counter
without prescription, without adequate warning. Even if the details of the
warning were not written in such small print the English-knowing population
being so small, the caution hardly succeeds in warning most of i;he consumers.
Therefore, banning of dangerous drugs is the only solution in the absence of
adequate control.
DUR
PLAN
OF
ACTION .
1. Distribution of this briefing document amongst our drug core
groups and discussion at the Drug Workshop*
2* Sending its summary to the Central and State Drug Controllers and
Health Ministers.
3. Sending it to various medical
discussion and feedback.
and pharmacology heads for
<
J
- 8 D- 9/534 (a.l)
23.8.82: a
4.
Dissemination of this information via Health For The Millions,
to our members, asking them not to prescribe this drug.
5.
Dissemination to our journalists friends and consumer
activists.
6.
Demand for a warning which can be understood by consumers.
Caution
I
- The use of this drug may lead to blindness,loss
of the function of your legs, loss of bladder
control or constant pain in the legs.
(Myelopathy, optic neuritis are meaningless for
a consumer - as long as we can- hot ensure sales
of potentially toxic drugs without a prescript
ion, it becomes our responsibility to ensure
adequate warning) •
7.
8.
Demand that a cheaper alternative be made available.
Letters to MIMS, CIMS, IMA.JOURNAL.
9.
Try to get figures of SMON or suspected SMON cases from our
colleagues in neurology or eye departments in the larger
teaching colleges, PGI, NIMHANS, Al IMS.
10.
Keep pressure on the Drug Controller to get Clioquinol
banned and make alternatives easily available at low cost.
.
References?
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
*An international Survey on Recent Reports concerning
Intoxication with Halogenated. Oxy quinoline derivatives
and regulations against their use and supplement1’
Kiyohiko Kalthaira, Ph.B, Tokyo Medical and Dental
University. Medical Research Institute.
Supplement of the above.
Bad Information means Bad Medicines Clioquinol Pamphlet by
Social Audit, LondonTransient Global Amnesia after Clioquinol* Fiver personal
observations from outside Japan.
M. Mumlenthaler et al. Dept.of Neurology, University of
Berne and Basel, Switzerland. Journal of Neurology,Neuro
WHO Drug Information:
urgery
Psychiatry, log'll
Jan-March, 1978. PDT/Dl/78.1 Page 9-11.
WHO Drug Information' PDT/DI.77.4 Page 10-15
The SMON Syndrome:
Utusan Konsumer5 March 1982
Some Observations on SMON from Bombay:
N.H.Wadia, Department of Neurology, J.J^Hospital,Byculla.
SMON Victims Plaintiffs Make Compromise Accordi
Japan Times'Sunday (Sept. 16. 1979)
Journal of Neurology, Neurosurgery and Psychiatry, 1977,
40 - 268-275
Goodman Gillman
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ALTERNATIVES
: Nitjonidazoles : like. Metronidazole ,(lNN)
Finidazole (iNN) ...
PROS
—r
I-
11 ?
have amoebicidal action in the tissues as well as
in the. intestinal contents.
they are fairly well tolerated by the majority,
therefore Metronidazole czn
- can be ied
used fy
forA amoebic
dysentery as well as hepatic amoebiasis’.
\
CONS
‘ J
•r
■
■
Occasional reports of neuropathy and mutogenic ar
carcinogenic potential in animal models (of ur^e^ain
relevance to man), has led to statutory requi-^Ats
for warning labelling in the USA and India.
- Metronidazole is relatively costly,
/Since
'
'■
/ Metronidazole is extensively absorbed in the 35:8-1
intestines and hence for greater and adqirate ei^ion
m addition a lumenal amoebicide/should be roVtineslyv /it
prescribed.
:
Diloxanide furoate
PROS
is highly effective against nonsymptomatic carriers.
in 95j£ cases eradication of organisms ?iaF been, reported
i.
X
- regarding its use in acute amoebic d/sen«eiy divergent
‘ results-have been obtained - concurrent use of tissue.
amoebicide whenever possible , is reoommended.
P aromnmycine
S
Aminoglycoside.
Antibiotic - Is effective both for symptom less causes and
acute amoebic dysentery.’
CONS
High cost
Troublesome diarrhoea
. .... . .
Carbasone arsenical and Glycobia»sol gave unimpressive '
per ormance - isolated fatalities attributed to carbasone.
"" ^^^ionally - evidence of cumulative toxicity.
^©choice of lumenal amoebecide should be 'based on its
effectiveness.
—..
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References continued!
Ashworth,B. (1975) Neuro-ophthalmology, In recent Advances in" Clinical
Neurology, ~p. 101. Edited'by W.B.Mathews, Churchill Livingstone,London.
Tsubaki,T«Honma,Y., and Hoshi,M. (1971) Neurological syndrome associated
with clioquinol, Lancet,!, 696-697
Wadia, N.H. (1973) Is there SMON in India? Necrology India,21,95-105
Kean, B.H., (1972), Subacute myelo-optic neuropathy! Journal of the
AMA, 220, 243-244.
'
' " 1
Kono, R.(1971) Subacute myelo-optico-neufopathy, a new neurological
disease prevailing in Japan, Japanese Journal of Medical Science and
Biology, 24, 195-216.
Le Quesne, P.M. (1975) Neurotoxic substances. In Modem Trends in
Neurology - 6,pp.91-93.Edited by B.Williams, Butterworths; London.
Meade, T.W.(1975). Subacute myelo-dptip neuropathy and clioquinol.
An epidemiological case history fordiagnonis. British Journal of
Peventive and Social Medicine, 29, 157-169.
Osterman, P.O. (1971), Myelopathy after clioquinol treatment;Lancet
2,544.
Pallis,C.A.(1976) Proceedings Honolulu Symposium on 1 Epidemiological
issues in reported drug-induced illness. SMON and other examples1 ,
McMaster University Press, Hamilton (Ontario).
Pallis,C.A. and Lewis, P.B.(1974). Neurological comppications of
clioquinol therapy. In The Neurology of Gastrointestinal Disease,
pp. 179-188, Saunders: London.
,
Report of the Committee on Drugs and Pharmaceutical Industzy (.1975),
Ministry of Petroleum & Chemicals, Govt.of India, Chapter X pp.251-261
Selby, G. (1972) Subacute myelo-optic neuropathy in Australia; Lancet
1,123-125.
Selby,G. (1973) Subacute myelo-optic neuropathy (SMON),Neurotoxicity of
clioquinols, Proceedings of the Australian Association of Neurologists,
9, 23-30.
Shiraki, H (1973), Neuropathology of subacute myelo-optic-neuropathy,
SMON, Neurology India, 20, Supplement, 3, 395-419*
Sobue, I| Ando,Ki Lida M: Takayanagi,Ts Yamamyra,Yi and Matsuoka^Y:
(1971), Myelo-neuropathy with abdominal disorders in Jap an, Neuro logy
(Minneapolis) 21, 168-173.
Sobue, I? Ando,Ks Lida,M: Takayanagi,T: Mukoyama M: and.Matusoka,Y:
(1973) Subacute myelo-optica-neuropathy in Japan: Neurology India 20,
Supplement 3, 420-425.
i
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VOLUNTARY HEALTH ASSOCIATION OF INDIA
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,
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h
n
G-14 Community Contre,
Safdarjung Development Area,
NEW DELHI - 110 016 .
I
s
i
i
TOY NOT TO PRESCRIBE ANABOLIC STEROIDS
iiiaioritve0fnuqi’StTnfl?’1:>le’-Un!hskeable faith in tonics and vitamins of the
stra^X^ J 4 ^dians is due primarily to the excellent marketing
nS£sSoL?=
^Ug companies, and the compliance of the health
pro!essionals and the consumers.
!
j
I.
doubl^blLk 1
as h*Zards associated with, its intake make it a
uoubiy black-listed product.
j
Anabolic Hormones -"most of them are weak versions of male sex
^rmones and were synthesised and introduced into medicine as agents
to speed the transformation of foodstuffs into body tissues. They were"^
orrgxnally promoted- and some still are - as drugs^hat could stSuIS
Silitv cent
P UP
3trenSthen hones, increase athletic
contro1 a variety of emaciating diseases and in the recovery
m urgery, infections, burns, fractures and severe traumatic injuries"
Ref: Prescriptions for Death" p.67
Milton Silverman*
I
f
Accepted Indications
Based on objective evidence anabolic hormones are
accepted for use in:
I
- certain kinds of (aplastic) anaemias.
- inoperable breast cancer*
- prevention and treatment of osteoporosis
- bone sofetning as seen in post-menopause of women
- senile patients.
But used as an adjucnt and not as
l__
primary therapy - diet, calcium balance
physiotherapy and good general health
’
promoting measures need equal or
greater consideration.
Toxicity
’4
U jd o
— i ®
r5 o
H
<3
In large quantities, they may cause:
In Women
- masculinization
- baldness
- deepening of the voice
- hirsutism
- menstrual irregularities
- 1X>
y
2?
□ •4
In young children
virilization
2
rff-4— ■Ji£- <x
2 U. a
o
□c
S
- Early closure of epiphyses in the bones resulting, in
stunted growth.
.
/
- precocious sexual development.
I
- they can produce enlargementofof the
theclitoris
clitorisor( jihe
development of false penis.
}
Alteration in glucose tolerance test, thyroid function
test*
test. Electrolytes
T.ectrolytes -- sodium chloride water phosphates,
calcium*
y
Liver Function Test :Serum cholesterol,suppression of
clotting factors, II,V, VII & X
"7
(Editorial: Pune Journal of Ongoing Education)^
How adequately these warnings are given to the prescribing docl^r
■
‘
c’
I
>•
£
irreversible
Adverse effect on liver - jaundice, liver tumors.
Can n S CaU^f sodium retention -leading to edemia and heart failure.
ln Cardiac’ renal or hepatic diseases and increased or
uureasea udiclo.
Boys
Young girls
i
\
r
7
I
- 2 D-9/334 (a)
a:2S.6.83
i
i
by the drug company or to the consumer by the doctor - is well known!!
1
I
When the actual problem is lack of food, the solution is not tonics
or anabolic steroids. When the desired action should be to look deeply
into the causes of malnutrition-our major health problem -' a prescription
of anabolic/steroids (tonics, etc) displays our ignorance or irresponsib
ility | apathy and indifference towards such medically irrational
practices.
i
!
Different anabolic steroids are promoted in various parts of the
third world (including India) for vague indications like overcoming of
loss of weight, poor general health, wasting illnesses, to aid mal
nourished children (drug experts have emphasised that these products
can help transform food to body protein only if the patient is getting
enough food, patricularly enou^i protein and total calories).
for treatment of debility and emaciation.
- .senility, muscular dystrophy
for eppetite improvement
- for pernicious anaemia, lack of energy
- poor weight gain
- reduced resistance to infection
t
h
...
tiredness and debility, lack of stamina and list-l^ssriegs---- -—
____
According to the British National ^oraularynthe use of anabolic.,
steroids as body builders or tonics is quite unjustified.,r
.
According to AMA Drug Evaluations, the use of anabolic hormones to
improve athletic performance is unanimously condemned. Besides the fact
that there is ’’no increase in the size and. strength and in the muscle size,
there is an added risk of liver damage and interference with the testicular
function”.
7
What is more objectionable is that the ’’indications for use” and
the ^warnings, about the drug” very in different countries depending .
on the effectiveness of the countiy’s controlling authorities and the
general awareness of the medical community and the public”.
1
r
The three most popular brands of anabolic steroids are:
-
Winstrol - a form of stanozolby Winthrop, USA
.
Durabolin - a form
foiro of nandrolone phenpropdinate by Organon
Bianabol - .a form of methandrostenolone by CIBA GEIGY
Some of the other brands available in India, the drug houses are:
OROBOLIN BBOPS - By Organon, which promoted Orbalin drops in Bangladesh
for paddiatric use in conditions like marcismus, malnutrition,
poor weight gain, retarded growth - krashiorkoi," etc
^According to Bi ana Melrose in her working paper ’Medicines and the
Poor in Bangladesh”.
r a
Becadurobolin’’stimulate the appetite,ensures adequate
food intake..checks protein depletion...resistance against infections
diseases and improves general constitution and'restores a sense of well
being” They also cause ”no fluid retention and free from harmful effects
on the river”.
In the UK doctors are. told ’’not recommended for children”. Warnings
include"anabolic steroids may cause fluid retention". Tumours of the liver
have been reported occasionally.
'
Relative costs are- given in the.Appendix* Numerous tonics contain
anabolic steroids-an exhaustive list heeds to be prepared. The Pune Journal
of Continuing Medical Education of June 1982 gives and editorial-on CIBA
GEIGY withdrawing Dianobol.
We can make■sure this is-really done and that
others follow suit.
7
i
■5
1
■'''
t
s
p
V
-4/3.79(a)
;
7.84
0 0
$ 6
■0
Phenyl ^utazone-Oxyphenbutazone
HAZARDOUS DRUGS.
(Prepared for Drug Action Network Core Group
meeting at Wardha 30-31 July 1984)
Dr Mira Shiva, VHAI.
U. K.:
On 6th March 1984, U K banned Phenylbutazone.On 3rd April 1984
Ciba Geigy withdrew Oxyphenbutazone, a breakdown product of phenylbutazone from U K Market.
Germany 65 such drugs have been banned, and use of another 206
severely restricted.
In Finland, manufacturers have been asked to withdraw these drugs.
In U S, the Public Citizen Health Research Group has asked the depa
rtment of Health and Human Services for an imminent danger ban.
Japan
has severely restricted the use of these drugs.
____
I0CU has sent world wide consumer alerts. Norway, Federal Republic
of Germany, Italy, Australia, Sweden, Finland and Bangladesh have
severely restricted their sales.
It is not that, we have not been concerned about the misuse of
these antiinflammatory agents and their irrational combinations,
prior to the knowledge of these bans. We feel that after receiving
unbiased authentic information about the extent of the adverse
effects related to these drugs, it is our responsibility to alert
others. The public needs to be informed of their dangers realizing
that a significant number of patients to buy the drug oVer the coun
ter unwarned and uninformed.
We are using this as yet another case where, double standards
have existed in the drug information given to doctors in the West
ang to our own doctors.
The total annual turn-over of the two products of phenylbutazon
and Oxyphenbutazone (BUT AZOLID IN & TANDRIL of Ciba Geigy’s) fetch
200 million Swiss-France ie. £ 65 million ie. Rs 1170 million and
these drugs have been in the market since 1952 and 1960 respectively
and are well known). It is very unlikely that, Ciba Geigy will
withdraw these products from the third world, specially after having
already stated their decision to withdraw Mexaform(Clioquinol) and
Dianabol(Anabolic steroid) from the world market. Withdrawing
Butazolidin and Tandril at this point would lead to a financial set
back. It is unlikely that Ciba Geigy will give in very easily to
consumer pressure - a stand already made clear by the makers of
Butazolidin and Tandril.
What are these drugs used for?
Phenylbutazone and Oxyphenbutazone are non steroidal antiinfla
mmatory drugs which also have mild antipyretic and analgesic pro
perties. They give only SYMPTOMATIC RELIEF and in no way ALTER the
course of the illness. In the U.S. the labelling indicates the drug
for ’acute gouty arthritis’, ’active rheumatoid arthritis’, ’active
ankylosing spondylitis’, ’short term treatment of acute attacks of
degenerative, joint disease of the hips and knees, and not responsive
to other treatment and painful shoulders’. Ciba Geigy warns that
Tandril should not be given to children below 14 years(The Physician
Desk Reference, U S A).
/
i
i
Similarly, warning for elderly patients is given, that every
effort to discontinue the use of these drugs after a period of 7
days should be made as there is ^xeedingly high risk of severe
fatal toxic reactions!
..
In Malaysia, dose packages for children as small as 12 months
carry inserts. Ciba Geigy states, that in elderly patients as also
in long term therapy, smaller maintenance doses are indicated.
to :
in West Germany, the use of the 2 drugs is severely restricted
1) ankylosing spondylitis and
2) gout for the maximum of 7 days.
(In a personal communication from Dr 01le Hanssen,January6,84)
In the third world it is indicated for minor ailments including
joint stiffness of muscles and joints lumbago, headache, viral
infection and fever and for long term treatment.
Phenylbutazone was introduced into India in 1$49 strictly for
treatment of rheumatoid arthritis and allied disorders. The drug is
more of an CTO product in India being freely consumed by public
often without prescription, for aches,pains and fever.
Phenylbutazone with its equally potent relative oxyp^enbutazono
needs to be taken more seriously. IT IS A BAD BET TO GAMBLE WITH IT
IN NON-RHEUM AT 10 DISORDERS.
1 in India, oxyphenbutazone is being used for treatment of
fractures, post operatively, in dental practice: ordinary common
joint pains: bodyaches and backaches’according to Pune Journal of
Continuing Health Education, June 1981.
Dr W V Pane of Arogya Dakshata Mandal talking about oxyphen
butazone has pointed out that it is being promoted for quicker post
operative healing.. Not only is this unethical but it is also unscie itific and irrational. More painful is the fact according to him thfet
a study was conducted by Professor of an Orthopaedic Department
for bone healing and that too on Paediatric patientl.The paper
was presented to an August gathering and most probably, received
its quota of applause and mutual back scratching from the Conferenc.
sponsors. No one in that scientific gathering questioned the ration
ale and ethics of conducting the study on children, when in the U S
in the Medical Pharmacology books the use of these drugs in those
below 14 is contraindicated. Probably the drug company sponsoring
the study preferred not to give this dismissable bit of information.
’Phenylbutazone and oxyphenbutazone should not be used unless
the urine had been examined for protein and a blood examination and
had shown that white cells and platelet counts were within the
normal range. B M Ansell, Prescribers Journal, 1969, 8, 120 in
Martin dale - the extrapharmac opia, 28th edit ion, 1982. A routine
urine and blood test prior to usage of the drug is recommended. In
view of the additional costs this may not always be possible f(jr the
poorer patients. An extra caution and restrain in the utilization
of these drugs is therefore, indicated.
In India the drugs have been recommended by certain manufact
urers for minor problems and feeble conditions. Gifford 1975 has
been quoted in MIMS editorial, November 1982 that according to
Pharmacology books ’Phenylbutazone as an antipyretic and an analgesic
is relatively inferior to aspirin.’ Phenylbutazone as an antiinfla
aamatory agents is effective, but serious toxicity limits its use
in long term therapy. In rheumatoid arthritis, phenylbutazone has
a limited role and should be used primarily for acute exacuebations
not relieved by other measures.
WHAT ARE THS DAHERS ASSOCIATED WITH THE USE OB PHENYLBUTAZONE
OXYPHENB UT AZ ONE? .
Bone Marrow Toxicity:
Aplastic anaemia or pancytopenia ie. total bone marrow shut
down which is fatal in over 50% cases. Agranulocytosis, which is a
severe depression of white blood (granulocyte cell product ion-fatal
in about 35% cases). Leukaemia which is a cancer of bone marrow;
Gastro intestinal bleeding or peptic ulceration-fatal in about 20%
cases.
L
Other risks are liver damage Hepatitis in less than .1% cases
access to liver. It is mainly hepato-cellular necrosis. Hepatitis
usually starts within 4 weeks of starting treatment but in 20% cases
can be started upto or even after 1 year. Cholestatic Jaundice occurs
in less than 3% cases. Serum sickness type of hyper sensitivity,
ulcerative stomatitis, nephritis(kidney failure) thrombocytopenia
(depletion of platelet count) are other serious side effects, though
some of these are ijuch rarer. (Ref: Phenylbutazone and hepatitisFowler P D Woolfe D, Alexander S Rheum Rehabilitation, 14,17, 1975).
MIMS editorial adds that ’’because of its sodium and chloride
retention properties, phenylbutazone can increase plasma volume by
as much as 50$, thus straining cardiac functions and occassionally
causing acute pulmonary edema. Since, toxic effects are more pronou
nced in the senior citizens, the drug is contraindicated for use in
geriatic patients.
The seriousness of the .Problem:
A STUDY IN SWEDEN OF DRUG INDUCED BLOOD DYSCRASIAS ATTRIBUTED
PHENYLBUTAZONE AS THE DOMINANT CAUSE.(Drug induced dyscrasias in
Sweden Battinger L E & Westerholm N, British Medical Journal,3 339 ’73
Incidence of bone marrow'aplasi due to phenylbutazone and oxy
phenbutazone is assessed as 1 in 33000 to 1 in 99000. Aplasie. anaemia
or agranulocytosis were quoted as underlying or contributing causes
of death. In 376 death certificated in the year October 1974 to
September 1975, the mortality rate was estimated as 2.2 per 100,000
cases.
The study of fatal bone marrow depression with special reference
to phenylbutazone and oxyphenbutazone-Inman W H W, British Medical
Journal 1-1500(1977). The effect of bone marrow depression is seriou...
Drug induced agranulocytocis- phenylbutazone. Pisciotta A V Drugs
15 132 (1978) Drug induced bone marrow depression by phenylbutazone,
British Medical Journal 4, 490(1973).
Ciba Geigy’s adverse effects department at its head office Xn
Basic in one its internal memos in February 1983, gave its findings,
of 1182 reported deaths from these drugs, 2724 detailed patient repbr- j
Of other adverse effects. Well, over 1/2 of these deaths were from
bone marrow toxicity including leukemia, gastro-intestinal bleeding
or perforated ulcers. Of the 6716 cases of undesirable side effects
reported on the drug, 777 persons have known to have died with
Butazolidin between 1952 and 1981. Of 4165 cases of side effects
reported fcith Tandril, 405 persons are reported to have died. 199
cases of serious undesirable effects and 18 deaths have been reports
in Japan.
A *
...4...
After 12 years, the receipt of the first report of adverse
reaction to Butazolidin from Great Britain, came from West Germany
indicating that identification of adverse reactions come along only
with experience and a high degree of alertness and suspicion about
possible adverse reactions. In third world countries, adverse react.ln
reporting is depressingly inefficient, as are the controls on poten
tially hazardous drugs. Double standards in giving the drug infor
mation to the health personnel makes matters worse.
Phenylbutazone and oxyphenbutazone is poorly tolerated by many
patients. Even if diarrhoea^ nausea, nervousness, insomnia are
associated with the drug, it is ignored that the potential fatality
cannot be overlooked. Some type of side effect is noted in 10 to 45:
of patients and medication may have to be discontinued in their
cases. Its use should be limited to short term therapy of not more
than a week during any one treatment period. Even then, the incidence,
of disturbing the side effects is about 10%. Phenylbutazone has a
limited role in the therapy of rheumatoid arthritis. It is primarily
used for relief of acute exacubatiOns of the disorder that are not
relieved by the other measures.
4
Goodman Gillman;5th Edition, Chapter 17.
■
According to Martindale :’’Although phenylbutazone is effective
in almost all rheumatic disorders including ankylosing spondylitis,
osteo arthritis, rheumatoid arthritis and reit usd eseas, it is
GENEIULLY RESERVED FOR USE IN THE TREATMENT OF RHEUMATIC DISORDERS
where less toxic drugs have failed.
- Martindale; 28th Edition.
In 1975, a study was done in U K to determine the true incidence
as opposed to the reported incidence of deaths due to aplastic
anaemia, and agranulocytosis in people using phenylbutazone or oxy
phenbutazone. In U K even where all death certificates mentioning a
drug have to be reported to the Government Drug Authority, only
one out of 4 deaths due to drugs were found to have been reported.
It was only because of■ the study, that the relationship of the drug;
and death could be found. According to Oldver Gillie, medical corfe pondent, Sunday Times, states "In Britain where the 2 drugs have be a
used comparitively cautiously, 512 deaths associated with them hav<
been recorded between 1964 and 1980. But the real total is probably
at least double that world wide as reported in the Ciba Geigy interi -1
report (Ref: Dr Hanasen) which records 1182 deaths associated with
the drug upto 1982.
Since it is impossible that almost half of thesd deaths occured- j
in Britain alone, many deaths must have gone unrecorded in other
countries and the actual figures would certainly run into many
thousands, giving Butazolidin and Tandril amongst the highest death
total for any drug".
Scrip. No.854; December 12, 1983, pg 18.
In U K the death rates were found to be 22 deaths per million
users of phenylbutazone, and 38 deaths per million users of Oxyphen
butazone. Dr Sidney Wolfe uses the companies own estimates of patie/ ,
exposure world wide ie. 75 millions users of phenylbutazone, 66
million users of oxyphenbutazone to estimate the number of patients
that must have been affected. Using the U K study result and their
mortality rate due to these drugs as the basis, he estimates the
following:
with phenylbutazone, about 75 million people exposed by
22 deaths per million ie. about 1650 deaths.
3
with oxyphehbutazone, about 60 million people exposed
by 38 deaths per million ie.2280 deaths. Total= 3980
deaths (ie 1650+2280)
World wide from aplastic anaemia and agranulocytisis; 3930
deaths must have occured many of which went unreported. The interna.document shows that aplastic anaemia and agranulocylosis constitute
37.8% of the deaths. If 3930 deaths constitutes only 37.8% of total
deaths, then the total number of the deaths due to these d rugs woul'
be approximately 10,400 ie. 10,400 deaths world wide merely due to
use of 2 drugs. If we try to extend this to other brands that are
available in the market, then there would definetely be more deaths.
By mid 1982, 311 deaths in U S were reported. It is known that only
one in ten deaths due to these drugs got reported. In other words
total deaths would be over 3100.
According to Dr Olle Hanssen another Ciba Geigy’s internal men
has stated inlight of the dangers of the drug and the ’’presence of
many newer equally effective non-steroidal anti inflammatory drugs
now available in the market with comparatively less toxicity, that
it is reasonable and necessary that the risk and benefit ratio of
Butazolidin and Tandril should be carefully reassessed for the indi
cations of all forms of inflammatory and degenerative arthritis as
promoted, to see if such promotions are justified”.
Malaysia:
Consumer association of Penang report based on discussions with
University Hospitals, Pharmacologists reports that phenylbutazone
and oxyphehbutazone are amongst the 5 drugs accounting for the
majority of the adverse drug reactions suffered by patients, admitt
into the hospital. Consumer Association of Penang has demanded an
immediate recall of the d rug from the market for the safety and
health of the Malaysian Consumer.
Japan:
Mainichi Daily News which is a Japanese newspaper dedicated to
Interaational understanding covered the news in its headlines on
9th February,1984. Ciba Geigy’s antiinflammatory pain killing drugs
killed 1182 in the world.
INTERNAL DOCUMENTS OBTAINED; BAN IS CALLED FOR.
The newspaper covered the issue daily in its morning as well a.'
in the evening issue, including a strong editorial. The headlines o .
February 11, stated that the Government ignored findings of courts
in drug poisonings. Apparently, two litigations took place about
15 deaths in Japan due to these drugs have so far been recorded. Phar
maceutical company stocking preparations of Ciba Geigy’s declared
withdrawal according to Mainichi, February 10. February 12th Mainici.i:
’’Documents of side effects ordered severe restrictions being decidec
and it is possible for all drugs containing these drug”.
India:
Pune Journal of on going education: In this issue no.37 June 8 '
in a letter to the Managing Director of Ciba Geigy, the journal had
raised strong objection against their new product parazoladin (para~
^olandin being a combination of paracetamol and phenylbutazone) for
conditions like fever.
.O.6.o.
0 E R C:
CERC prepared a document on irrational and hazardous anti
inflammatory agents including phenlybutazone and oxyphenbutazone
combination with amidopyrines. They had submitted this to the Drug
Control Authorities and demanded their ban. It is important for us
to be constantly aware that the situation in India is more serious
than the countries mentioned earlier.
1.
We have these drugs available over the counters in any dosage
for any duration of time with Us (falsely continuing to
believe in the sanctity and magic of western medicine.
2.
Patients are rarely given any warnings by their doctors and if
they buy the drugs over the counter they can rarely make head or
tail of the medical literature inserts.
Phenylbutazone and oxyphenbutazone have been availaVle often
in deadly combinations with amidopyrine, analgin, paracetamol., ■
diazepan, Vitamin B, d extraprop oxyphene acet ominophen which
makes the combination.
3,
Phenylbutazone and Oxyphenbutazone are dangerous drugs.
Do not prescribe these when safer and effective alternatives are
available.
If you want more information about misuse of these and other
hazardous drugs please write to us.
Low Cost Drugs & Rational Therapeutics
Voluntary Health Association of India
G-14, Community Centre, S D A
New Delhi 110016.
I
£
0.0
is
h
Phenyl butazone -o
~ < xyphenbut g zone
‘"hazardous' dhw
K .
Prepared for:
Drug Action Network core
group meeting at Sevagram
30 •— 31 July 1984
On 6th March 1984 , UU K
K banned
Phenylbutfaonef9 Shiva» 1/HAI
banned Phenylbutazone.
On 3rd April. 1984 Ciba G-eigy withdrew Ox5rphenbutazone 9 a
breakdown product cf phenylbutazone from U K market.
In Genriany 65 such drugs have been banned. and. use of another
206 severely restricted.
In FjnJ..and -2- manufacturers have been asked to withdraw these
drugs.
?ri —Publ.ic Citi^en Health Research Group has asked the
d ep art m ent ofHea It h and Turn an S e rvi c e s ' f or an imminent danger
ban.
iapaJL. has severely restricted the use of these drugs.
lOCU^ has sent world wide consumer alerts. Norway 9 Federal
Republic of Germany, Italy, Australia, Sweden, Finland and
Bangladesh have severely restricted their sales.
It is not that, We have'not been concerned about the misuse of
these antiinflammatory agents and their irrational combinat
ions, prior to the knowledge of these bans. We feel that after
receiviiig unbiased authentic information about the extent of
the.adverse effects related to these dru^gs, it Is cur respon
sibility to alert others. The public needs to be informed of
their dangers realizing that a significant number of patients
to ouy .the drug*'over the counter' unwarned and uninf oirnied.
We are using this as yet another case where, double standards
have existed in the drug- information given to doctors in the
West and to our own doctors.
The total annual turn-over of the two products of phenyls
butazone and Oxyphenbutazone (BbTAZOLIDIIT & TA1DR1L of Oiba
Geigy ’ s) fetch 200 million Swiss-Francs ie. £ 65. miJ.lion ie.
Rs 1170 million and these drugs have been in the market since
1952 and I960 respectively and are well known).. It is very
unlikely that, Oiba Geigy will withdraw these products from
the third world, specially after having already stated their
decision to withdraw Mexaform(Clioquinol) and Dianabol(Anabolic
Steroid) from the world market. Withdrawing Butazolidin and
Tandiij. at this point would lead io a financial set-back. It is
unlikely that Ciba Geigy will give in very easily t©consumer
pressure- a stand already made clear by the makers of Butazo
lidin and Tandril.
What are these drugs -usod for?
. Phenylbutazone' and Oxyphenbutazone are non-steroidal
ariwiinflammatory drugs which also have mild anti—pyretic and
analgesic properties. They give only SYMPTOMATIC RELIST and
.A
in no way ALTER the course of the illness. In the U.S. the
labelling indicates the drug for ”acute gouty arthritis",
"active rheumatoid arthritis", "active ankylosing spondylitis H y
"short term treatment of acute attacks of degenerative, joint
disease of the hips and knees, and not responsive to other
treatment and painful shoulders". Ciba Geigy warns that Tqndril
should not be given to children below 14 years(The Physician
Desk Reference, U S a) .
Similarly, v/arning for elderly patients is given, that
every effort to discontinue the use of these drugs after a
P6of 7 days should be made as there is nexceedingly high
risk of severe fatal toxic reactionsn.
In Malaysia, dose packages for children as small as 12
months carry inserts, Ciba Geigy states, that in elderly pat
ients as also in long tern- therapy, smaller maintenance doses
are indicated.
West. Germany. the use of the 2 drugs is severely restrioted to:
1) ankylosing spondylitis; and
2) gout for the maximum of 7 days.
(In a’ personal communication from Dr OUe Hannsen , January
6, 1984).
n
third world it is indicated for minor ailments
including joint stiffness of muscles and joints lumbago,9 headache, viral infection and fever'and for long term treatment.
Phenylbutazone was introduced into India in 1949 strictly
for treatment of rheumatoid arthritis and allied disorders.
The drug is more of an OTC product in India being freely
consumed by-public, often without proscription,
prescription for aches 9
pains and fever.
4
Phenylbutazone with its equally potent relative oxyr-henbutazone needs to be taken more seriously. IT IS A BAD BBT TO
G;Aj[E5LE WITH IT IN NON-RHELT4ATIC DISORDERS.
” In India, oxynhenbutazons is being used for treatment of
fractures, post operativelyy "in dental practice; ordinary
cormaon joint pains; bodyaches and backaches” according to Pune
Journnl of Cont inuing Health Educat ion,'June 1981.
/in the
t
. , • Dr V,r / Rane of xlrogya Dakshata Ifendal talking about oxyphenbutazone has pointed out that it is being promoted for
q.Hi^kox:__pQst._operative healing< Hot only is this unethical but
±t is also unscientific and irrational. More painful is the
fact according to him that a study was conducted by + ’
Professor of an Orthopaedic Department for bone healing and
that too on ■ Paediatric patient. The paper was presented to
an August gathering and most probably, received its quota of
applause and mutual back scratching from the Conference
sponsors. No one in that scientific gathering questioned the
rationale and ethics of conducting the study on children, when 4in
the N.sy Medical Pharmacology books the use of these drugs in ~
those btQow ,14 is contraindicntod.Probably the drug company'
sponsoring the study preferred not to give tnis dismissable
bit of information*
....
...3...
'
uma8„ theXlnXS^'
*ta> tai, is
in a^in
^p^«^s<,ae««•
,urna<*’
not always be possible forthe poors?
r;«‘“ngg.£StraB 10 tte “«“»»««> pAaes^^n-^..
foc+u;“ ?the druSs have been recouuaended by certain -onu_
?07^
for fflinor Prot>lenis and feeble conditions Gif“o^
1973 has been quoted in MIMS editorial, Novesbe? 1932 ?h°t
xS^^nT^Ti001-87•bC°ks ,,i>hWlbutazone as an anti-
j^one.Marrow Toxicity;
shut Si?swhiC?n!rfitoi t?n^Xwa ie- tot-ai bone
which is a severe denr^sh/nf1 -^C+ e^ees. Agranulocytosis,
production - fatal in ^bS? 33/ ^xte blood (granulocyte ceil
cancer of bone e™. n J 35<° ?3Sff3)‘ leukaemia which is a
uioerati“y:y“^o,S^r?0%,^Si?'J-bleeai* «p»p-<=
oaBes0aooo83itoSJj:rUi:\^S°11fepllils i» iUsa than .U
Hepatitis usually start- withTn'1^1’7
but in 20% 2 sc J
t"±d
necrosis,
°f starting treatment
CholsalatioUlliSJ ooouS’lriX ttonew7after
year-
sickness type of hvrpr-qrn^if-ivi"+kS t n
Case8* SilTum
nopnritisdddnsy failure) tteoabSyt^sStdoplet^S1’! t
a»ool
1: fe B,
sx:iaa
D
Chlorid j rSortlo? p?on rtSt b£C*u^ °f
sodium and
plasma volume by Js^uch a~ 50^ fhnlbuJaaone ^n increase
ions and occassioJally ca?sii2
sbralninS cardiac functtoxic effects are more n?™?X
edema. Since,
drug is contraindicated"^
The_s,eri us ness of t he Prob lea;
BUT ED
AMRI-
V
o
0 O 4 0 O 6
Incidence of bone narrow aplasi due to phenylbutazone
and oxyphenbutazone is assessed as 1 in 35000 to 1 in ^QOOO.
Aplasie anaei^ia or agranulocytosis were quoted as underlying
or contributing causes of death. In 376 death certificates
in the year October 1974 to September 1975, the mortality rate
was estimated as 2.2 per 100,000 cases.
The study of fatal bone marrow depression with special
reference to phenylbutazone and oxyphenbutazone- Inman W H W 9
British.Medical Journal 1-1500 (1977)- The effect of bone
marrow depression is s'erious. Drug induced agranulocvtocis—
phenylbutazone. Pisciotta A V Drugs 15 132 (1978) Drug induced
bone marrow depression by phenylbutazone, British Medical
Journal 4, 490 (1973).
e.
Ciba Geigy’s adverse effects department at its head office
in Basle in one its internal memos in February 1983, gave its
findings of 1182 reported deaths from these drugs :
2724
detailed patient reports of other adverse effects. Well
over /2 of these deaths were from bone marrow toxicity inclu
ding leukemia, gastro-intestinal bleeding or perforated izlccro.
Of the 6716 cases of undesirable side effects reported on the
drug, 777 persons have known to have died with Butazolidin
between 1952 and 1981. Of 4165 cases of side effects reported
with Tandril, 405 persons are'reported to have died. 199 cases
of serious undesirable effects and 18 deaths have been reported
in Japan.
After 12 years, the receipt of the first report of adverse
3?eaction to Butazolidin from Great Britain, came from West
Germany indicating that identification of adverse reactions
come along only with experience and a high degree of alertness
and suspicion about possible adverse reactions. In third
world countries, adverse reaction reporting is depressingly
inefficient, as are the controls on potentially hazardous drugs.
Double standards in giving the drug information to tie health
personnel makes matters worse.
Phenylbutazone and oxyp ho nt ub az one is poorly tolerated by
many patients. Even if diarrhowa, nausea, nervousness, insomnia
are associated with the drug, it is ignored that the potential
natality cannot be overlooked. Some type of side effect is
noted, in 10 to 45 % of patients and medication may have to be
aiscontinued in their cases. Its use should be limited to
short term therapy of not more than a week during any one trea
tment period. Even then, the incidence of disturbing the cLfde
effects is about 10%. Phenylbutazone has a limited role in the
therapy of rheumatoid arthritis. It is primarily used for
relief of acute exacubations of the disorder that are not
relieved by the other measures.
Goldman Gillman; 5th Eiditicn
Chapter- 17.
Recording to Martindale : #Although phenylbutazone is
effective m almost all rheumatic disorders including ankylo
sing spondylitis, osteo arthritis, rheumatoid arthritis -'’nd
reitusdeseas, it is GENER/oLLY RESERVED FOR USE IN THE TREAT-!.
MEND OF RHEUMATIC DISORDERS where less toxic drugs have failed
- Martindale’; 28th Edition
►
3
...5...
In 1975, a study was done in U.K. to determine the true
incidence as opposed to the reported incidence of deaths due
to aplastic anaemia, and agranulocytosis in people using
phenylbutazone or oxyphenbutazone. In U.K. even where all death
certificated mentioning a drug have to be reported to the
Government Drug Authority, only 1 out of 4 deaths duo to.drugs
were found to have been reported. It was only because of the
study, that the relationship of the drugs and death could be
found. According to Oliver Gillie, medical correspondent,
Sunday Times, states ”In Britain whore the 2 drugs have been
used ccmparitivcly cautiously, 512 deaths associated with ihera
have been recorded between 1964 and 1980. But, the- real total
is probably at least double that world-wide $ as reported in
the Oiba Geigy internal report (Ref: Dr Hanssen) which records
1182 deaths associated with the drug upto 1982.
Since it is impossible that almost half of these deaths
occured in Britain alone, many deaths must have gone unrecorded
in other countries and the actual figures would certainly run
into many thousands, giving Butazolidin and Tandril amongst the
highest death total for any drug*.
Scrip. Uo. 854; December 12, 1983;
pg.18.
In U.K. the death rates were found to be 22 deaths per
million users of phenylbutazone, and 38 deaths per million
users of oxyphenbutazon. Dr Sidney Wolfe uses the companies
own estimates of patient exposure world-wide ie.75 million
users of phenylbutazone, 66 million users of oxyphenbutazon to
estimate the number of patients that must have boon affected.
Using the U.K. study result and their mortality rate due to
these drugs as the basis, he estimates the following;
with phenylbutazone, about 75 million people exposed
by 22 deaths per million ie. about 1650 deaths."
with oxyphehcatazone, about 60 million people expo
sed by
deaths per million ie. 2280 deaths,, Total=
3930 deaths(ie«, 16504-2230)
World widbe from aplastic anaemia and agranulucytisis; 3930
deaths muslh have occured many of which went unreported. The
internal document shows that aplastic anaemia and agranulocylosis constituted 37.8'% of the deaths. If 3930 deaths consti
tutes only 37.8$ of total deaths, then the total number of the
deaths due to these drugs would be approximately 10,400 ie.
10,400 deaths world-wide merely due to ’use of 2 drugs. If we
try to extend this to other brands
are’ J available in the
market, then there would definitely be~ more deaths. By mid
1982, 31 1 deaths in U.S. were reported. It is known that only
one in ten deaths due to these drugs got* reported. In other
words total deaths would be over 3100.
According to Dr Olio Hansson another Oiba G-eigy’s internal
memo has stat ed in light of the 'd^nqers of the''dtira--“'"o and "the
presence of many newer equally effective non-steroidal antiinflllammatory drugs now available in the market with comparati
vely less toxicity, that it is reasonable and necessary that
the risk and benefit ratio i of Butazolidin and Tandril should
be carefully reassessed for the indications of all forms of
inflammatory and degenerative arthritis as promoted, to see if
such promotions are justified”.
*
I^layasia:
i
P e na ng r ep o rt
by ^at.l^£t^^dmittgd into the hospiTal^^onJb-'o• ^sswc±ation of Penang has demanded an’’immedi-at^ recoil
for tha
o
Japan:
Mainichi Daily News which is: a
a Japanese newspaper deu.ica
to International understanding
1
covered the news in its
headlines on 9th EeVruary, 1984o
Ciba Geigy’s antiinflamnator
pain killing drugs killed 1182 in the world.
IMPERIL POCUMEiVJS OBTAIW) ;
BAN IS CALLED for
won Tho.ney®PaPor covered the issue daily in its mornirrfell as m the evening iseju^ ,•
i ,— ,• _,7 J t
s 1Jyt n r“ a
The headlines on Feb™
’ f +1
2 ?tro«g editorial,
findi nrro ^-p o— p
•
’ stated that the Government ic-
ttS
...
bec-n done, /bout 15 d-othc.''i n t
?Inv®stigations should ha/e
so far been recorded
--h
J«-Pan due to these drugs have z.
preparations of Giba’s^ivy's denlorff f mS C°i s^ooki:'L^
Moinichi, February 10.'tebrlf y'th
wnl according to
of
J-S possible for all drugs containing these drug”.
India:
Junbhf0Urnal ?f ongoing
on-going* Education : In this issue
n81?- 11 a letter to the Managing Director ■. ~ 'y no„ t-i‘
of Ciba
Geigy
5 thei r
(parasolandin being
of
it for condition
n-xx.
37, "
C- E. R O;
prepared a document
tasartous arts,
.Jf1, oyphentazc-e
combination with
with amidopyrines.
amidopyrine^
ant for us to'be“e"de’"larited their“ban
IS nore
1.
20
countries mentioned
°i?y,rt'3ra ir no»-
iwS'f'oJUJ!/
5 .p +l_a
'
aal' “SI?
, -^1^1./ given a ny warnings
bv their docto-c/
3.
»i-.iihB^^-X SS^io°!’rtraE,ro^iy-’>ho“
Phenyl butazone and oxyphenbutazone
are dangerous drugs.
Do r ■-f o s -‘•7 b
nor
-
3-9/334 (g)
a:24.8.82
WLUNT^RY. i« HEALTH
ASSOCIATION OF INDIA
'uBrss«»r2ga..ffnTr^=^-^MMri., ------------ ------------ ---------
J——
WHY AMIDOPYRINES MUST GO
C-14 Community Centre?
SDA - New Delhi 110016
Drugs have come to form the 1 isis (most emphasised part) of
medical care today. There is increasing drug dependence, the ease with
which even potentially dangerous drugs can be obtained freely over the
counter - with no warning whatsoever, is well known* It is all this
that makes the need for drug information sharing with the health personnel
and the consumers the responsibility of individuals and groups concerned
with ’’health” and issues related to health.
The question here is not merely of free availability of
hazardous drugs with inadequate information, but it is also a question
of the fact that many others are deprived of essential and life saving drugs.
Amongst the most widely used drugs are the analgesicsand amongst
some of the more popular brands are drugs containing analgin. ’The
irrationality of most combination drugs has been adequately shown and
a WHO Expert Committee on the selection of essential drugs disapproved
of their use.
This paper reviews some of the facts about analgin from medical
text books and medical journals. Some of these facts are not divulged by
the producers and sellers of these drugs and even if divulged’it is done
in such an ambiguous manner that either it is not understood or not taken
seriously. .
Aminophen azone (amidopyrine, aminopyrine) has been used for its
potent anti-inflammatory and analgesic action for more than 70 years.
Till 1933 casual relationship between aminophenazone and agranul©
cytosis had not been established.
(Madison F.W., and Squier, T.L. (1934): Etiology of Primary
Granulocylopaemia Agranulocytic Angina): JAMA 102:755-759
Within 2 years 70 fatal cases were published.
(plum, P- -1935 ) Agranulocytosis due to amidopyrine (an experimental
and clinical study of 7 new cases); The Lancet 1, 14-21
Reviews provided evidence to suggest that over 90^ of all cases
of agranulocytosis reported in medical literature over the previous four
years had been associated with aminophen azone.
(kracke, .R.R. and Parker, F.P. - 1935): Relationship of Drug
Therapy and Agranulocytosis:
JAMA 105, 960-966.
According to WHO Drug Information - Jan-March 1977:PDT/Dl/77. 1
’’Recognition of the danger greatly reduced the use of amino’
phenazone in several countries before the first decision to
place it under prescription control was announced in 1938 by
FDA in the USA.
Amidopyrine (also known as aminophenazone) was considered the
major cause of agranulocytosis in the 1930’3 (Jackson & Tighe 1939).'
However, following the ban on its sale by many countries, it is now one
of the less common causes,This is only true for such countries which
have banned the drug* But not so in other countries like India where
these drugs are sold like toffees and over the counter under 90 brand
names which give no clue to the content
** G.C.deGruchy: ’’Drug Induced Blood Dyscrasias” - 1975).
Amidopyrine
Aminopyrine,
Aminophenazonium, Amidozofen
Di methyl aminophenazone,
4Di methylp-piino 1,5 dimethyl - 30 x 0-2
phenylpyrazoline (Nor amidopyrine me thane sulpho rate -has the
same toxicity).
(WATCH OUT for any of the above names as a content in any analgesic
you take!!)
.. 2/-
J-9/344 (g)
aS 24.6.82
2 -
’’The risk of. agranulocytosis in patients taking amidopyrine is .7
sufficiently great to render this, drug unsuitable..for user
Administration of large dose-.of amidopyrine has'been associated
r. with renal tubular necrpsi-’'
- Martindale -
•i
From 960 patients* treated with amidopyrine there, were 11 cases
agranulocytosis
- ah ih.cidenee of .
•* These figu?^es did not justify
of
using amidopyrine in or dinar;/ p facti.ee as an analgesie« Most cases of
Amidopyrine agranulocytosis arose from the use of proprietary medicines
containing the drugr where the pre scriber was ignorant of, or forgot, its
Association of Clinical Pathologists! The Lancet 1/1951: 389
presence-
Amidopyrine might cause toxic epidermal necrosis: R.L.Baer and H<
HarrisJAMA - 1967, 202, 710
’’Amidopyrine and noi>amidopyrine induced agranulocytosis has .
high mortality and neither drug is essential.* The only possible
indication are febrile convulsions in children and rare cases of
uncontrollable pyrexia in mali^iant disease* ’’
The grave hazard of therapy with amido-pyrine and nor ami dopyrine
could be greatly reduced by proper control of the sale of these dangerous
drugs. Fatal agranulocytosis has even occurred in the new born as a
result of consumption of amidopyrine by the mother before delivery.
The clinical presentation is.usually fulminating with seyere ore
pharyngial ulceration fever.prostration and circulatory failure. Death
may occur from overwhelming sepsis despite treatment with corticosteroids,
antibiotics and blood transfusions.
Side Effects o-f Drugs
Royler &.Herxheimer 1968-1971.
,
•
Other side effects given a-e
-
Allergic reactions to skin
^maemia -
~
Anorectal ulceration and necrosis (with amidopyrine
suppository
, ■ ,
.
y I * A"
Chronic gastritis
fatal renal failure
liver damage
-
‘1
- Drowsiness,'coma, convulsions and decerebrate rigidity
have been described in cases of intoxication involving amidopyrine.
’’Amidopyrine is justified only in serious or life threatening
situations where no alternative antipyretic is available or
suitable”.
Martindale
The WHO Expert Committee considersJ analgin and other analgesics
or combinations as effective (if not less/ as aspirin (which is about
9-10 times cheaper). The WHO Committee which formulated the list of
essential drugs excluded amidopyrine - on grounds of their toxicity-.
Pyrazolone derivatives
* .
4
Antipyrine (Phenazcne)
Isopropylantipyrine
Li chlo rophen azono
WHO
PLT/L1/77.1.
These contain the same ”phexB?onen neucleus which is important in
pathogenesis of agranulocytosis and though agranulocytosis is much less
with antipyrine they cannot be assumed to be-Safe.
Ip the,. 19 601 s close relative of am'idopyriiley^ yraz al one, no rami dopyrine (dipyrene, metamazbUe)became v«ry popular*
!
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•. 3 -
0
D-9/344 (g)
a:24.8.82
3
At present, the above are only approved for use in serious conditions
in which other drugs were ineffective and on the understanding that all
preparations would carry the wamir label. This drug may cause fatal
agranulocytosis. Though no formal ..^3 riction has been imposed on the sale
of aminophenazohe, it is no longer available in the USA, since none of the
compounds containing it are registered
Further fatal cases of -?
f , "kit9g^-s
l^*withdrawal
of the Substance according to WHO PDT/Dl/7?.le
The incidence and risk of pote.ntio.lly fatal agranu? ocytosis far
outweigh any benefit that can be de rived from its use c
.•
Drugs for Human use containing Dipyrone Federal Register (1976)
41, No.173
37386-37388
There is ho justification for using oral or -parentral
dipyrone or amxnopyrine for reduction of fever unless aspirin
and other safer anti pyretics are, ineffective, poorly
tolerated, or cannot be taken orally.
Due to interaction of aminophenazone and nitrites in the stomach
a carcinogenic substance dime thy1 on trosamine may lead to malignant tumours
in the liver and the lung. This potential hazard has been the reason of
banning the drug in some countries«
The severe and lethal blood damage with aminopyrine is “well known
by physicians in the west. There? another agent called dipyrone under
such names as metamizol, noramidopyrine sulpyrine and metanpyrone was
pushed. In the 1973 edition of the AMA Drug Evaluations, American physicians
were advised, that:
• ’’There is evidence that dip rone, a derivative of aminopyrine
that shares its potential for toxicity, unfortunately is still
being misused. This is probably because it is available in
injectable form and because -''lysicians do not recognize its
similarity to aminopyrin:
f-’- is marketed under various
trade marks. Its only justifiable use is as a last, resort
to reduce, fever where safer measures have faiTe.d., Because
dipjrone may*produce fatal agr■ nudocytosis,Mother blood dyscrasias,
its use as a general analguo-i.^, antiarthritic or routine anti
pyretic cannot be condoned”, (page 262 - 267).
I
■
i
I
In 1977 it was stated that the drug had become-: obsolete in the
USA (page 341). , In the 1980 edition it is not even listed.
r Prescriptions for Death Dragging of the Third. World
(Milton Silverman; Philip h*Lee; Mia Lydecker) University
of California Press<
. „ . .
^'An international Study of Drug-induced Agranulocytosis and
Aplastic Anaemia, funded by Hoechst? is being undertaken, inter alia, in Israel
Germany, Italy and Brazil.- The results are expected in April 1983.
In the opinion of Dr.A. Iiorxheimer of. Charing Cross Hospital
Medical School,UK, and Prof. John Yud^in*"Tie study seems very well designed
to detect any associations between drug history and the development of
agranulocytosis. However, we fear that Hoechst may claim that the results
can provide a figure fpr the true incidence-of drug induced agranulocytosis.
In fact, of course, the study will excluded all patients
>1
<2
^3
who die of agranulocytosis without receiving medical care,
who die of it without having had
white-cell count.
who have undiagnosed agranulocytosis and recover from it.’1
Dr. Herxeimer and Prof. Yudkin feared that the “proportion of
cases so excluded* in each category, would be higher in countries with
poorly developed medical care. Cons yently, they fe_ j that'the study
would yield only a”minimum estimate". c i both’’incidence and mortality,”
while the ’’actual incidence could.be considerably higher”. They therefore''
wished to ’’impress Hoechst with this noint, so that they are not tempoed to
• •4-
1
i
!
■
4 -
D-9/554 (g)
as25.8.82
talk about ’’incidence of agranulocytosis” when describing the results of
the study”.
Dr- Herxheimer explained these fears to Si-r Richard Doll, one of
three ’unpaid advisory committee’ members to monitor, on bhhalf of Hoechst,
the results of the abovementioned study. Sir Richard opined that "the
purpose of the setting up of our committee was just to ensure that the
scientific report took account of the sort of points you mention, What
Hoechst does with the report, of course. is another matter over which none
This left the multinational a free hand to
of us can have any control”,
do what it liked!
The dangers inherent in the use of amidopyrine and no rami dopy rine
were later (March 1981) expressed by Dr* Herxheimer in a letter to Dr* A-R.
Scott in Tanzania* Dr- Herxheimer said: "Amidopyrine cai^ries an unacceptable
risk of agranulocytosis, and many people believe that this is true also
for noramidopyrine (Novalgin) • He added, however, that "Hoechst hope to
argue that the incidence of deaths from marrow damage will be much less
than that from bleeding with aspirin or from self-poisoning with paracetamol,
and that the drug is therefore a wonderful alternative. I find that argument
hard to accept, and prefer to do entirely without noramidopyrine, at least
for the present”.
-
WHO'recognized that the risk of agranulocytosis arising from the"
use of pyrazolone derivatives is assessed very differently from country to
country even within Europe. In the case of aminophen azone, the incidence
in the UK (based on data in 1952) was 0.8%, whereas data from the Federal
Republic of Germany in the mid-1960’s placed the comparable risk at
Is 10,000. Although the frequency of the reacion was calculated at 1:100,000
50% of the cases ended fatally and children were shown to be as vulnerable
as adults.
(WHO DRUG INFORMATION - PD-/DI/77.1S.Jan-Ma?>1977.: p.10) .
According to preliminary investigations in some countries of Europe
and Latin America, 124 cases of agranulocytosis end 82 cases of aplastic
anaemia were notified between July 1, 1980 and June 30, 1981.
ACTION IN OTHER COUNTRIES AGAINST
DIPYRONE:
Generic Names - Metamizol, Me tamp yron e> Noramidopyrine
Methanesulphonate Sodium and Sulpyrine. Some brand names
are - Cormel (Winthrop) and Novalgin (Hoechst)
These are BANNED from Sale in Australia^ Sweden, UK* They are not
available in the USA since it is not listed in the PDR. They are left for
very limited indications and taken off all common cold medicines, anti
pyretic-analgesics, etc* in Japan, the Philippines and Denmark. All
preparations for intravenous and intramuscular injections containing more
than 1 gm per vial have been withdrawn in Italy*
Bangladesh has benned the manufacture and sale of amidopyrines
along with 1707 other hazardous drugs.
In India, in 1979, the Drug Controller, asked manufacturers to
gradually withdraw amidopyrine. No deadline was set. Consequently, it
continued to be produced and marketed without even adequate warning about
its side effects. By August 1980, 33 formulations containing amidopyrine,
were being marketed. When the Maharashtra FDA banned amidopyrine, the
multinational company producing it got a stay order from the court arguing
that it was being manufactured and marketed in other states.
Writing in the Lancet on 14th November 1981, Prof. John Yudkin
said that between July and November ^980 it proved possible to obtain
CIBA-GEIGY manufactured drugs containing amidopyrine in 11 countries,
including. This was despite CIBA GEIGY’s announcement in SCRIP of August
11, 1980 that their decision to replace amidopyrine with propyphenazone
.. 5/-
- 5 i
P-9/ 354 (g)
at 25»8.82
in all their products” has been talcing place worldwide at a pace compatible
with the complexities of the risk”. Moreover, Prof. Yadkin added, there
was evidence that CIBA— GEIGY continued to manufacture preparations
containing amidopyrine and that old stocks were being sold off even after
registering the new formulations. He cited the example of having purchased
cibalgin containing amidopyrine in February 1980 - two years after'the
date given for reformulation.
I
I
And, it is well known that oibalgin is still available in India
over the counter - just for the asking!
j
‘
......
i
References
Madison, F.W. and Sq:uier,T.L (1934): Etiology of Primary Granulocytopaenia (Agranulocytic angina) JAMA 102: 755-750
Plum,P • (1935): Agranulocytosis due to Amidopyrine (an experimental
and clinical study of seven new cases) ,Lancet, 1, 14-21
Kracke,R.B. and Parker, F.p. (1935) : Relationship of Drug Therapy to
Agranulocytosis, JAMA 105,960-966
Hughley,C.M. (1964) :Agranulocytosis induced by Dipyrone, a Hazardous
Antipyretic and Analgesic, JAMA, 189, 162-165
Report of an Ad Hoc Scientific Advisory Committee on Aminopyrine
and Dipyrone (1964) , Food and Drug Administration,Wash. DC.
Drugs for Human Use containing Dipyrone, Federal Register, (1976) ,
41, No.173, 37386-37388
Discombe,G. (1952):Agranulocytosis caused by amonopyrine,Brit .Med.
•
J. i, 1270
“
Palva,I.p.,and Mustala,0.0. (1970) iDrug^-Induced Agranulocytosis,with
special reference to Ar?.inophenazone (l:Adults) , Acta med.Scand,
178, 109-115
Kantero, I.,Mustala, 0.0., and Palva, IP (1972):Drug-Induced
Agranulocytosis, with special reference to Aminop hen azone
(iV:children), Acta Med.Scand, 19g, 327-330
Lijansky, W. Greenblatt,M. (1972): Carcinogenic dimethylnitrosamine
produced in vivo from nitrite and aminopyrine, Nature New
Biology, 236, 177-178
Lijinsky,W.,’Taylor, H.W.,Snyder,D., Nettesheim, P.(1973):Malignant
tumours of liver and lung in rats fed aminopyrine or heptomethy
leneimine together with nitrite, Nature, 244, 176-178
Murray RM: The geographical distribution of analgesic nephropathy
Health Bull (Edinb) 31:1-3,1973.
Fellner,EK, Tuttle EP, The clinical syndrome of analgesic abuse,
Arch Intern Med 124:379-382 - 1969.
I
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D-9/334 (g)
26.8«82:a
References continued.
;
Agranulocytosis Caused by Minopyrine: Avoidable Cause
Discombe
9 G. Brit.Med.Journ. 1270-1273 (dune14-)
of Death,
jou±n.
Simpson, R. Q. Aminopyrine and Agranulocytosis, Dr
5334:887 (March 30) 1963
. ...
w...
Daneshek, W. a»4 Colmes.A: Aminopyrine Hypersensitivity,
r.T
" ■-'i:
1
T"'
14
Particular Reference to Effect of IMgs in Prciuction of
Agranulocytosis, J. Clin.Invest 15: 85-97 (Jan) l^SG.
Kracke, R-R- and. Parker, F*P• ? RelationshipofDrug
erap to
Agranulocytosis, JAMA 105:960-966
2
’
Effect on
w r
Hq-rdv.J.Dl and. Good.ell,Hj Measurement of Effect on
^ho"
JAcetylsalicylic Aoii, Aoet»ilii, Aoetoptoetiaxr.
Aminopyrine, Ethyl Alcohol, TAchlorethyleno, Bavtiturats, ftiinine,
SteS” iartr^te and Caffeine, Analysls of Their Relation to
Pain Experience, J.Clin Invest 20: 63-8° Oan) 1
Wintrobe, M.M: Toxicity of Aminopyrine, Letter to the Editor,
JAMA 178: 1051 (Dec 9) 1961.
Bendin, J.E. and Biederman, J.B., Agranulocytic Leukopenia
Induced by Drug Related Aminopyrine, JAMA 107.493.4y4 kAug io;
1936
4
B~io/54i(d)
..
iViSsn.23.11.83
Wlar*"
SOKE PAINFUL FACTS ABOUT A PAINKILLER CALLED AMIPOPYRIbE
WHAT ARE AMIDOPYRINES USED FOR?
Anidopyrines have analgesic,ahii'ihflaisE-titory and antipyretic icticns
but owing to tne risk of agranulocytosis its use is discouraged.
* Imalgesic - Painkilling
(Martindale ’82)
Antipyretic- Bringing down fever
* Agranulocytosis- Total shutting off production of while cells froia the
bone narrow.
But
I don’t take or prescribe amidopyrines
You nay be nistaken-in snail microscopic lettering showing the contents
of the drugs taken or given by you there Elay have been vzritten the following?
Aninopyrine
/.mi n 0 ph ena z oniuin
Atiinophenazone
Amidofen
Amidopyrine -Pyraiuidon
Dimethyl aminophenazone
Dinethyl audnoantipyrine
4- Dimethyl amino 1, 5 Dimethyl 2
Phenyl -4 Ryrazalin 3 in one
Phenyl Pyrazaline methanesulphorate has the sane toxicity.
DON’T LET THESE BIG NAMES FOX YOU. ^NY DRUGS CONTAINING THESE ARE TO BE
AVOIDED AS THESE ARE OTHER NilMES FOR AMIDOPYRINES AND ARE HAZARDOUS.
;WH0 SAID THESE DRUGS ARE HAZARDOUS?
Aminophenazone (amidopyrine, aiainopyrine) has been used for its potent
anti-inflaiaiiatory and analgesic action for more than 70 years.
Till 1933 casual relationship between aminophenazone and agranul^
cytosis had not been established.a„ T,r
,
T /_ x
(Madison F W, and Squier, T L (1934b
Etiology of Primary Granulocylopaemia
Agranulocytic Angina) JAM 102?755-739)
Within 2 ysars 70 fatal cases were published.(Plum, P-1935) Agranulocytosis
due to amidopyrine (an experimental and clinical study of 7 new cases): The
Lancet 1, 14-21)
Reviews provided evidence to suggest that over 90% of all cases of agranulo
cytosis reported in medical literature over the previous four years had been
associated with aminophenazone. zTZ
,
,
(Kracke, R R and Parker, F P- 1935:Relation
ship of drug Therapy and Agranulocytosis:
JAMA 105, 960-966).
’’Recognition of the danger greatly reduced the use of aminophen^zone in
several countries before the first decision to place it under prescription
control was announced in 1938 by FDA in the USA.
(According to WHO Drug Information Jan-iViarch
1977» pdt/di/77.1)
Amidopyrine (also known as aminophenazone) was considered the major cause of
agranulocytosis in the 1930’s (Jackson & Tighe 1939). However, following the
ban on its sale by L.any countries, it is now one of the less common causes,
This is only true for such countries which have banned the drug. But not so
in other countries like India where the drugs are available over the counter.
(G 0 de Gruchy Drug Induced Blood Ifyscraseas 1975)
WHAT DOES MEDICAL LITEPATURE HAVE TO SAY ABOUT THE USE OF AMIDOPYRINES?
"The risk d -Agr^nulccytosis in patienta taking ■-imidi.pyrine is suffici
ently great to render this drug unsaita'ble for use. Adi-iinistration of large
doses of anidopyrine has been associated with renal tubular necrosis -tinsel
of agranulocytosis nay be sudden and unpredictable”.(Martindale.’82)
Anidopyrina night cause toxic epidermal necrosis.(R L Baer and H Harris)
i
D-10/541(d)
IviSsa. 25.11.83
2
’’Amidopyrine and nor- amidopyrine induced agranulocytosis has high mortality
and neither drug is essential. The only possible indication are febrile
convulsions in children and rare cases of uncontrollable pyrezia in malignant
disease”.
(JAMA- 196?, 202, 710)
The WHO Expert Committee considers analgin and other analgesics or combina
tions as effective(if not less) as taspirin (which is about 9-10 times cheaper)
The WHO Committee which formulated the list of essential drugs excluded1 amidopyrines on grounds of toxicity.
HOW SIGNIFICANT IS THE HAZARD?
’’From 960 patients treated with amidopyrine there r.rre 11 cases of
agranulocytosis- an incidence of 1.1%. These figures did not justify using
amidopyrine in ordinary practice as an analgesic. Most cases of amidopyrine
agranulocytosis arose from the use of proprietary i e. brand names medicines
containing the drug, wnere the prescriber was ignorant of, or forgot, its
presence”.
(Association of Clinical Pathologists:The Lancet l^l^ls
The grave hazard of therapy with amidopyrine and noramidopyrine could
be greatly reduced by proper control of the sale of triese dangerous drugs.
Fatal agranulocytosis has even occurred in the new born as a result of con
sumption of aihidopyrine by the mother before delivery.
The clinical presentation is usually fulminating with severe oropharyngial
ulceration^fever prostration and circulatory failure. Death
7 . 7 may
„v occur from
overwhelming sepsis despite treatment with corticosteroids, antibiotics and
blood transfusions.
(Side Effects of Drugs- Royler &
Herxheimer 1968-1971)
Other side effects given are:
Allergic reactions to skin
Anaemia
Anorectal ulceration and necrosis(with amido
pyrine suppository)
Chronic gastritis
Fatal renal failure
Liver damage
Drowsiness, coma, convulsions and decerebrate
rigidity have been described in cases of intoxication involving amidopyrine.
’’Amidopyrine is justified only in serious or life threatening situations
where no alternative antipyretic is available or suitable”.
(Martindale 1982)
TOT ABOUT CLOSE RELATIVES OF AMDOPYRINES?
ARE THESE SAFE?
Pipyrone- is the Sodium Sulphonate of amidopyrine having similar properties
and adverse effects. Analginiun, Metamizol, aminopyrine sulphonate sodium,
sodium noramidopyrine methane sulphonate metapyrine
sulpyrine,
methampyrone
nova midazofen
natrium novaminsulfo nicum
n or-imi d0 z eph enum
noramino phenazonum
sodium N(2, 3-dimethyl-5 oxo-1 -phenyl-3pyrazolin-4)-N-met-hylar-iinomethane
sul phona t e monohy drat e.
In 196O’s close relatives of amidopyrine-pyrazolone 9 norami dopyrine
(dipyrone uetamazole^became very popular in the West.
Since this drug may cause FaTAL AGRANULOCYTOSIS; its use-carrying a
WARNING LABEL- is approved only for serious conditions in which other drugs
were ineffective.
D-10/341(d)
MS#a.25.11.83
3
WHAT DOBS THE IvISDICaL LITEKiTURE SAY ABOUT DIPYROl'IES?
The incidence and risk of potentially fatal agranulocytosis for outweigh
any benefit that can bo derived from its use.
"Drugs fc.r Human use contjining Dipyrone”,
Federal Register(1976)41,No 175, 37386-57588)
There is no justification for using oral or parentral dipyrene or aminopyrine
for reduction of fever unless aspirin and other safer antipyretics are
ineffective, poorly tolerated or cannot be taken orally.
Due to interaction of aminophenazone and nitrites in the stomach a
carcinogenic substance dimethylentrosamine may lead to malignant tumours
in the liver and the lung. This potential hazard has been the reason for
banning the drug in some countries.
The severe and lethal blood damage with aainopyrine is well known by
physicians in the Vest. There, another agent called dipyrone under such
nanes as netaiaizol, ncrai.ddcpyrine sulpyrine and netanpyrone was pushed*
American physicians were advised that;
"There is evidence that dipyrene, a derivative of aninepyrine that shares
its potential for toxicity, unfortunately is still being rdsused. This is
Probably because it is available in injectable foria and because physicians
do not recognize its similarity tc> aninopyrine since it is marketed under
various trade marks. Its only justifiable use is as a last resort to reduce
fever where safer measures have failed. Because dipyrene i\ay produce fatal
agranulocytosis, and other blood dyscrasias, its use as a general analgesic,
antiarthritic or routine antipyretic cannot be condoned".
(Alfi Drug Evaluations, 1973 &d, pg 262-267)
In 1977 it was stated that the drug had becci_ie obsolete in the USA
(pg 541)* In the 1980 edition it is not even listed.
(Prescriptions for Death Drugging of the
Third world(iViilton Silverman, Philip R Lee,
Mia Lydecker) University of California Press)
"The use of dipyrones is justified only in serious or life threatening
situations where no alternative antipyretic is available or suitable".
( Martindale pg 251
The Extra Pharnacopea 28th Ed 1982)
Out of the 1845 pages of Goodman Gilman’s the Pharmacological Basis of
Therapeutics 6th Edition only one si-xall para is deoted to ai.iidcpyrine.it says
"Clinical use of aminopyrine was sharply curtailed after its
potentially fatal bene marrow taxicity, agranulocytosis was
recognised, and antipyrine(Ehenazone, a related drug) has also
lost favour. Both drugs have virtually disappeared from the
therapeutic scene in US. zi variety of related pyrazolon deriva
tives have also enjoyed sporadic popularity for eg. dipyrone.
It, too can cause agranulocytosis".(pg 701 Goodman Gilman’s
Text book of Pharmcology ).
PYRAZOLONE DERIVATIVES
Antipyrine(Phenazone)
Isoprcpylantipyrino
Di ch1crcphenozone
1
WHO P DT/DI/y 7.1
These con ain the sane ’’phenazono" neucleus which is important in pathoge
nesis of agranulocytosis and though agranulocytosis is much less with
antipyrines tney cannot be issumed to be safe.
11-10/3410)
IVSsa.25.11.83
ACTION AGAINST AI'/ilDOPYRlNgS IN OTHER COUNTRIES
Amidopyrine is banned in over 20 countries.
Dipyrone: Generic•names- Metamizol, Metampyrone, Noramidopyrine, Methanesulphenate Sodium and Sulpyrine. Some brand names are
Cormel (‘Winthrop) and Nova!gin (Hoech st).
These are BANNED from. Sale in Australia, Sweden, UK. They are not available
in USA since it is not listed in the PDR. They are left for very limited
indications and taken off all common cold medicines, antipyretic-analgesics,
etc in Japan, Philippines and Denmark. All preparations for intravenous and
intramuscular injections containing more than 1 gm per vial have been with
drawn in Italy.
Though no formal restriction has been imposed on the sale of arainophenazone, it is no longer available in USA, since none of the compounds
containing it are registered.
Further fatal cases of agranulocytosis have led to the withdrawal of the
substance according to WHO PBT/BI/??,!
Bangladesh has banned the manufacture and sale of amidopyrines along
with 1707 other hazardous drugs.
In India, in January 1979, t'he Drug Controller, asked manufacturers to
gradually withdraw amidopyrine. No deadline was set. Consequently, it
continued to be produced and marketed without even adequate warning about
its side effects. By August 1990, 35 formulations containing amidopyrine,
were being marketed, by about 20 drug manufacturers without adequate
warning its side effects, When the feharashtra FDA banned amidopyrine, the
multinational company producing it got a stay order from the court arguing
that it was being manufactured and marketed in other states.
The Drug Consultative Coixiittee had recotiLiendod that amidopyrine
combinations should be amongst the 22 combination drugs to be weeded cut.
The Drug Technical Advisory Board felt the same though it altered some of
the others.
On July 25, 1995, the government finally issued a notification banning
22 categories of drugs, including amidopyrine. Considering the state of cur
drug control machinary the sales will definitely continue. iVukaram Bhagat
in ’’Aspects of the Drug Industry” highlights ’’the utter mismanagement and
ineffectiveness of the Drug Control Administration in India”, gives an
example of the Tamil Nadu’s government’s essential drug list for its
medical hospitals where harmful combinations, disallowed by the Central
Government like analg^Gi-x-containing phenacetin, amidopyrine and analgin
were included. Writing in the Lancet on the 14th November 1981, Prof. John
Yudkin said that between July and November 1980 it proved possible to obtain
CIBA-CEIGY manufactured drugs containing amidopyrine in all countries,
including India. This was despite CIBA CEIGY’s announcement in SCRIP of
August 11, 1980 that their decision to replace amidopyrine with propyphenazone in all their products” has been taking place worldwide at a pace
compatible with the complexities of the Risk”. Moreover, Prof Yudkin added
there was evidence that CIBA CEIGY cOntinued to manufacture preparations
containing amidopyrine and that old stocks were being sold off even after
registering the now formulation. He cited the example of having purchased
cibalgin containing amidopyrine in February 1980- two years after the date
given for rqformulation.
c7
' a ■; 3 1
. 2 ■» 1 1
■
J
-»
•
A. ••
■*
-4- ' •
And it is well known that cibalgin is still available in India over the
counter - just for the asking.
2
D-l0/?41(d)
MSsi.23.ll.83
YOUK ROLE;
We had
™ earlier
earner pressed the health groups and consumers for a voluntary
boycott ol the hazardous drugs like amidopyrine. We now ask for a different
Kind 01 action in
1.
2.
3.
4.
active infcreation sharing with others about the hazards of anidopynines
and related drugs.
Docuuentaticn about the continuing
(
availability (by buying and preserving
the cash Lienos) of these hazardous drugs.
Informing us or drug action groups in your area about continuing sales
of banned drugs.
Be willing to join in legal proceedings against unscruplous drug producers
and drug dispensaries if to cu/tail such activities it is needed.
Dr Iviira Shiva
Coordinator
Low Cost Drugs & Rational Therapeutics.
C-14, COMMUNITY CENTRE
S.O.A., NEW DELHI 110 016
Phones
668071
668072
VOLUNTARY HEALTH ASSOCIATION OF INDIA
ALL
INDIA
DRUG
ACTION
NETWORK
RATIONAL DRUG POLICY
CAMPAIGN
January 22, 1986
Dear Friend,
Several organizations deeply concerned about the drugs issue have been
making a concerted effort for several years towards ensuring the formulation
of a Rational Drug Policy.
In view of the new Drug Policy coming up in the Parliament in the coming
session, it is imperative that socially conscious individuals, health pro
fessionals and organizations make a clear statement regarding the kind of
National Drug Policy that we want for our nation.
We want a rational people-oriented Drug Policy, which ensures :
1.
1
J
J ?=*
Easy availablity of essential and life saving drugs at all levels.
This is the basic aim of the Rational Drug Policy.
Today shortages of anti-TB, anti-leprosy, several other drugs and
even iodized salt exist. Production of Vitamin ‘A' is steadily declining while
over 40,000 children are becoming blind each year for lack of Vitamin ‘A’.
Adequate production and streamlined distribution of essential drugs must
- e- O
-3
. iA
-
'X
o O
be ensured.
•-
2.
Withdrawal of hazardous and irrational drugs.
Over 43,000 formulations are sold in India. This large number of for
mulations not only creates confusion in the minds of consumers, doctors,
and chemists but also confuses the licensing and drug control authorities.
Several thousands of these formulations are known to be irrational, hazardous
and are banned in other countries. Drugs not allowed to be produced in the
parent countries of the manufacturing multinational companies are being
made and sold here
> LU OS
85
(
2
)
It is critical that we throw out irrational and hazardous drugs; that we do
not clutter and clog the drug control mechanism.
3. Need for Drug Legislative Reforms—so that legalistic loopholes
are not used against the people repeatedly and systematically.
The EP case is the cruellest of such examples. In 1976 a warning against
use of High Dose Estrogen-Progersterone combinations for pregnancy testing
had been issued, as these drugs were found to be aosociated with foetal
malformation.
In 1982, the Drug Controller of India banned high dose EP combinations
vide DO No. X19013/8/81-D.
Organon, Nicholas and Unichem went to court and managed to get a stay
order against the ban—A stay order which has to date not been challen
The sales of these banned drugs still countinue.
ged.
A point to note is that Organon (now calling itself Infar) is not allowed
to market high dose Estrogen-Prcgesterone combination in its home country
Netherlands.
4. Availability of unbiased drug information to health personnel
and consumers. This is basic to Rational Drug use.
Today health personnel depend heavily on drug companies and their
representatives for drug information. The drug information given to doctors
for the same product of the same company differs in developing countries
like India and the developed countries—which clearly shows existence of
double standards.
5.
Effective Drug Quality Control
Every fifth drug in the Indian market is substandard. Allowing produc
tion and sales of substandard, essential and life-saving drugs is a crime
against the consumers. Quality control mechanisms need to be overhauled.
There is a need for more quality control laboratories.
We need more qualified, and trained and competent drug inspectors for
drug quality control. Co-option of consumer bodies is also needed to ensure
drug control. Use can also be made of quality testing facilities of teaching
institutions.
You are requested to join the Rational Drug Policy Campaign and
do the following :
Health Ministry
1.
Write to:
Mrs. Mohsina Kidwai,
Minister for Health and Family
Welfare, Nirman Bhawan, Mew Delhi-110001.
(
i)
ii)
2.
3
)
asking for the stand of the Health Ministry regarding the drug
policy.
asking the Health Ministry to take a leadership role in formula
ting a Rational Drug Policy and not absolve itself of its
responsibility.
Dr. Harcharan Singh
Advisor, Health and Family Welfare Planning Commission, Yojana
Bhavan, Parliament Street, New Delhi-110001.
for the same.
3.
Director General Health Services
Nirman Bhavan, New Delhi-110001
for the same.
Ministry of Chemicals and Industry
4.
Mr. R. K. Jaichandra Singh
Minister of State for Chemicals and Petrochemicals,
Shastri Bhawan, New Delhi-11C001.
—asking him to clarify to the nation why the drug policy is looking
only at the pricing and production aspects totally ignoring other
aspects needed to rationalize the nation’s drug policy.
5.
Mr. N. D. Tiwari
Minister for Industries, Udyog Bhawan, New Delhi-110001.
B.
Boycott all Banned and Bannable products and all the products
of companies like Organon (Infar), Nicholas and Unichem which
are flouting our laws.
C.
Approach the Parliamentarians in your state about safeguarding
people's interest when the policy comes In the House.
(For list of Parliamentary Drug Consultative Committee and a note
on how to use the Parliamentary procedures, please contact me).
D.
Find out more about the drug and health issue and share the
information with others, help in distribution of the drug campaign
material produced by All India Drug Action Network comprising of :
(D
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
Arogya Dakshata Mandal, Pune.
Catholic Hospital Association of India, Delhi.
Consumer Education & Research Centre, Ahmedabad.
Consumer Guidance Society of India, Bombay.
Drug Action Forum West Bengal, Calcutta.
Delhi Science Forum, Delhi.
Kerala Sashtra Sahitya Parishad, Kerala.
Locost, Baroda.
Lok Vigyan Sangathana, Bombay.
Medico Friends Circle, Pune.
Voluntary Health Association of India, Delhi.
4
(
E.
)
Ensure effective drug distribution of essential drug and vaccines,
iodized salt to the peripheral areas.
While vaccines are unavailable or available with the cold chain not
being maintained. It is criminal to allow children to be crippled and
maimed for life because as a nation we are unable to ensure an
effective drug distribution system even 38 years after we have had
the total freedom to revamp our health and drug policies.
The new Drug Policy is coming in March. It is mainly looking at drug
pricing and production and will safeguard the interest of the greatest in
fluencers of our drug policy i.e. the drug industry.
We want the following to be considered in the formulation of the
National Drug Policy :
—WHO’s recommendation and criteria for a Rational Drug Policy.
—Conclusions
of two Summits
of
Heads of State of
Non-aligned
nations — Havana snd Colombo.
—The recommendations of ICMR — ICSSR report 'Health for all
by
2000 AD.
AIDAN's and VHAI’s stand is along the lines of the above national and
internationally accepted conclusions.
Drugs cannot become a substitute for basic health needs for food, water
and safe hygenic living and working conditions.
Hazardous, irrational and substandard drugs cannot become substitutes
for life saving essential and quality controlled drugs.
DRUGS POLICIES SHOULD HAVE MORE TO DO WITH
HEALTH AND LIVES OF PEOPLE, THAN PROFITS FOR
THE DRUG INDUSTRY.
People have the right to reject irrational
policies.
and hazardous drugs and
PLEASE EXERT YOUR RIGHT ! ACT FAST NOW, WE URGENTLY
NEED YOUR SUPPORT !
— Dr. Mira Shiva
Coordinator
All India Drug Action Network
and
Low Cost Drugs & Rational Therapeutics
Voluntary Health Association of India
C-14, Community Centre
Safdar/ung Development Area,
New Delhi-110016
/X‘
%
</ c
~^7y0\
I2
Ar
dl M
/V
Telegrams’: VOLHEALTH
New Delhi-110016
Telephones : 668071
668072
LCD & RTsVH/J-.pt.-l? .7.'34
XHLffSMS and magic pawiss (OBJECTION;bie
.pWTI^MgNTS)' ACT jW RIOS.
version)
- Prepared by Rani Advani, Legal Researcher5
Consumer Education Research Centre (CSRC).
.for Drug Action Network Coro Group Meeting,
rfardha.
The Precmblo of the Act i.e., ths
the purpose of the Act is clearly
laid down at the beginning and it states that the Magic Remedies Act
is an Act to control the advertisement of drugs in certain cases and
to prohibit the advertisement of those remedies alleged to possess
magic qualities.
Section 2:
This section defines:- ”Advertisement” as any notice,
circular, label or any other document and any announcement made orally
or otherwise, It is a very wide definition and can take care of most
situations.
’Drug” moans a medicine for internal and/or external use; any substance
used for diagnosis, euro, mitigation treatment or prevention of diseases
in human beings or animals; drug also includes any article which affects
in any vjay the structure or any organic function of the body of human
beings or animals.
"Magic Remedy” includes a talisman, mantra, kavacha or any other charm
which is supposed to possess miraculous powers for diagnosis, euro,
treating or preventing diseases in human beings, or affecting or
influencing the structure or organic function of the body of human beings.
i
__onNog;person is allo-wod to take any part in the publication of
Secti
any advertisement which suggests the names of any drugs meant to procure
abortions in women or increase or maintain the capacity for sexual
pleasure, or
oi’ to correct menstrual disorder in women; or to euro,
cure treat
or prevent any of the 54 diseases which are specified in the schedule
(attached hereto).
~ ‘ ‘ J-u_ No person can take part in the publication of any advertise
Section
ment which refers to a drug so as to give, directly or indirectly, a
false impression regarding the true character of the Drug, or make a
false claim for the drug which is in any wuy misleading.
~
Section
5j_ No person who carried on the profession of giving magic
remedies can take part in the publication of any advertisement which
refers to any magic remedy which directly or indirectly is supposed to
cure, treat or prevent any of the diseases which are specified in
Section 3 as well as tho schedule.
Explanation:
Taking part in a publication or publishing includes the printing
of the advertisement.
-Sectipii 7:
/iny person violating any provisions of this Act is
punishable with imprisonment upto 6 months or with a fine or both.
Where there is an earlier conviction, the imprisonment may bo for
one year or with fine or both.
V e-4/378
k/16/7/84
3 :
3.
MIDDLEMAN AND CCMMIS.S.I.ON
The unions and associations of chemists ex .-druggists have
: .become, powerful and\ they are now demanding 10% wholesellers
commission and 20% retailers commission on new introductions.
■ gradually they will make these terms applicable to existing
products as well which now give 5% wholesale and 12.5%
retail commission. Theire present demand has naturally
increased the direct burden of 12.5% and indirect burden by
13.74%. This increase is due to increased excise duty and
sales tax on increased prices. Take for example a product
presently sold for Rs. 100/- (i.e. maximum selling rate).
This price will attract roughl y Rs.13.00 excise duty and
Rs.4.00 as sales tax.
For this price the manufacturer gets a minimum price (i.e.
realisabl e price) of Rs. 84.65. Now for getting the same
realisabl e price of Rs.84.65/ a new price structure will be
as follows:
Trade rate
..
..
.. Rs.93.11
Maximum selling rate
..
.. Rs. 111.74
which otherwise means that the end consumer has paid 13%
excise duty on increased price of Rs. 11.74 and he has also
paid 4% sales tax on this increased price. That otherwise
means that by this new method/ he is paying Rs. 11.74
additional to the middle men-Chemists etc. and Rs. 1.53 addi
tional excise duty to the central government and Rs.0.45
additional sales tax to the state government.
4.
BENEFIT TO SMALL-SCALE INDUSTRY
Benefit of price etc. offered to small scale sector has
been ill-used by the multinationals and big Indian firms.
Normally a multinations is not allowed to market a new
product or its combination - and even if marketted/ it's
price is controlled by the government. In order to bye
pass these difficulties/ the manufacturers have created
their own subsidiaries as small-scale industries and are
taking maximum advantage of the benefits offered, In most
of these cases the fancy products been marketted or that
new combinations of old products have been introduced at
fancy prices.
For example :
Waiter-Bushne1
Rs. 5.47/t
Rs.273.50/100
Chymoral forte
20.58/12
171.50/100
Amclox
10.25/4
256.30/100
Met ake If in
Martel-Hammer/ Montari, Jagson-Pal, Dolphin/ Full Ford/
Blue-Cross are some such firms.
Normally the products manufactured by a small-scale indus
try are marketted by the parent multinational. The govern
ment should now allow the multinationals and other big
firms to market the products of such small firms.
Before
making any of their new product available to their own sub
sidiary/ it should be made available to any other smallscale industry. The rates of all such new products should
be controlled and fixed by the government.
E-4/378
k/16/7754
: 4 :
5.
AT LEAST ESSENTIAL DRUGS TO BE MADE AVAILABLE IN GENERIC
bfAMES
Anti-leproticr anti-malarial/ anti-tviberculour/ anti-biotics,
anti-filarial/ analgesic drugs atleast should be markctted
only in generic names and their prices reduced. Once these
products are converted into generic forms, these will not
attract excise duty and the state governments can wave off
the sales tax’. The whole-sale and r. tail margins on these
generic products should be fixed only at 5% and 12.5% res
pectively. These measures will make these essential drugs
available at virtually half the present prices. Leader
price should be fixed and any addition of anything should
not enable to increase or cross the leader price.
★★***★**
♦
I
Voluntary“Health Association of India
C-14, Community Centre,
Safdarjung Development Area,
New Delhi-110016
A.4/119
.
IS: gd: 11.02—J
V?s
j
VMA*
W V Z''
h
Telegrams : VOLHEALTH
New Delhi-110016
PhoneT 652007r66200&
CATfDOSIES -OF FIXED DOSE CCMELNAIIQNS
EtfflED
iiiiai] TO BE WEEDED OUT BT THE DRUGS
ADVISORY
BOARD
i
SAL
1.
Fixed dose combinations of Amidopyrine
2.
Fixed dose combinations of Vitamins with ant inflamatory
agents and
3.
Fixed dose combinations of atropine in Analgesies and Antipyretics
4.
fixed dose combinations of Strychnine and Caffeine in tonics
5.
Fixed dose ccmbinations of Yohimbine and Strychnine -with
Testosterone and Vitamins
✓
1
(
i
!
y
f
. i-
6.
Fixed dose combinations of Iron with Strychnine9 Arsenic and
Yohimbine
7.
Fixed dose cccflMBations of Sodium Bromide/Chloral hydrate with
other drugs
8.
fixed dose combinations of Ayurvedic, Uhani drugs with modem drugs
9.
Fixed dose combinations of Phenacetin
I,
30.
fixed dose combinations of Anti-histafflinics with Anti-diarrhooals
i
I.
Fixed dose combinations of Penicillin with Sulphonamides
12.
Fixed combinations of Vitamins with Analgesics
13.
Fixed dose combinations of Tetracycline with Vitamin C
14.
Fixed dose combinations of Bydroxyquinoline group of drugs except
preparations which are used for the treatment of diarrhoea and
dysentry
15.
Fixed dose combinations of Steroids for internal use except
combinations of Steroids with other drugs fa* the treatment of Asthma
16*
Fixed dose combinations of Chloramphenicol except-preparation, of
17.
Fixed doge combinations of Ergot except canbinations of its
alkaloid ergotamine with Caffeine
IS.
Fixed doea combinations of Prophylactic Vitamins .wLth__ariti*TB
drugs except canbination of INH with Vitamin B6
i
s
j.
I
i
r
Chlorainphenicol and Strepbcmycin
•JHt’
Source:
Drugs Controller
KLrman Ehavan
1
New Delhi
¥
May 25, 1982
I
I
E-4/3 7 8
k/16/7/84
i
J
B ac kg roun d pa p e r f o r
DRUG ACTION NETWORK (DAN)
Core Group Meet, Wardha,
July 30-31, 1984
. « *O
o
o
T S ©
■. h
. in
(,□
C cc
o O
t: 2
'9
From:’ Dr. W.V. R.ane
Dr. A o R. Patwardh an
&
2
o
.. AM PRIG Im PGL ICY
S
Introduction and acceptance of generic names would solfc all
the problems of ..pricing (barring a :few accepted combinations).
But as long as generic names cannot
------- be
— accepted.
------------------- it is advissaoie to adopt the stop-gap measures suggested hereunder.
Present system of indirect promotion of drugs to a common man
through the medical profession and eventual selling through
series of middlemen (distributors, stockists and retailers)
brings direct and indirect burden on the consumer. The govern
ment, in order to safeguard the interest of the common man has
introduced many directives - which have been ill-utilised b^
the pharmaceutical industry.
1.
CATEGORISATION OF DRUGS:
7In order to make essential drugs
available at reasonabl e rdates,z the government formed
four categories of drugs. Category I drugs were taken as
essential and a mark-up of 40% was allowed thereon.
In
order to cover tne losses if any, the government allowed
the manufacturers to charge any price on category III d IV
drugs •
xhe END_ kFSUEl': the essential drugs are not avail
able and that the tonics, multivitamins, cough syrups,
hormone combinations, anabolic steroids, ensyme etc!
products are heavily promoted and within a span of one
year the prices of these products have doubled or trebled
and that the sales have increased. This is mainly due to
indirect promotion of *not-so-essential‘ drugs through the
medical profession. More money and imagination is expended
by the pharmaceutical companies in promoting these pro
CiUCtS
ducts.. Eventual loser is the end consumer.
How can this be remedied?:
a)
fixing leader prices of not-so-essential (Category III
IV) products by grouping them irrespective
of various combinations. These groups can oe:
Multivitamins, enzymes steroids, cough syrups etc. etc.
b)
Imposing price control on <_all
' 1categories
________ _
of products
and even allowing higher mark-up (than the "present)') on
group I •& II products.
c)
Imposing certain restrictions on sales promotion of
not-so-essential products viz no samples, nc
no presents,
no fancy packings, no lay—press advertisements
]
------- and
_d no
schemes or bonus offers.
d)
Banning the visual aids-charts and strictly checking
the medical literature.
/-4/378
VW 7/84
2 :
2.
DRUG PRICE CONTROL AUTHORITY
Drug Price Control Authority was created to control prices
This authority should review the prices every two years.
No special facility should be given to any section of the
industry, A few examples of gross discrepancies are given
hereunder»
Product
A.
C orbu t y 1 ( Rous sei)
Norgesic(Cipla)
C om p os i t i on/
t ablet
Rate
Cost
100 t ablets
Dextrooropexyphene
65mg.
Paracetamol 650mg. 2.15/6
35,83
Dextropro
poxyphene
32.5
Paracetamol 325mg.
31.10
3.11/10
How can one justify
‘ \ virtually the same price for exactly half the contents?
Proxyvon
(Wockhardt)
Dextropro
poxy phene
65mg.
Paracetamol 400mg. 4.68/6
Diazepam
2mg.
78.00
What justification there can be for reducing paraceta
mol by 250 mg. and adding diazepam 2 mg. and taking
more than double the ruling (of Corbutyl) prices.
8.
Mictopyrin
(N icholas)
Acetyl salicilic acid 35 0mg.
Caffe in
2 0mg. 0.78/10
7.80
Micropyrin-C .
Aspirin
Vi t mi in C
13.50
350mg.
25 mg.0.54/4
Merely dropping 20 mg. caffein and adding 25 mg. Vitamin C
has doubled the prices.
C.
Ess idrex
(C iba-Geigy)
Hydrochlorthiazide
25mg. 0.46/10
4.60
Arkamin-H
(Unichem)
Clonidine Hcl.100mg.5v
Hydroch Iobthaizine
20mg. 5.28/10
52.80
Arkamin
Clonidine
Hcl.
100mg.4.20/10
42.00
Hydrochfor
th iazine
20mg. 1.08/10 10.80
i .c.
Now when 25 mg. tablet of hydrochlorthiazide (essidrex)
. -------------- is
available for less than 5 paise a tablets (cost of tablet£n? ^d , packing included) mere_adding of 20 mg. hydrochlorthiazide enabled the manufacturers to charge 11 paise
for the same.
There are many such instances and these should be
reviewed by the Drug Price Control Authorities.
>-9/529 (a)
MSsa 14.12.83
THE GAZETT5 OF. ITOLu EXTRAORDINARY
(PART II-SEC3(i)
NOTIFICATION
MINISTRY OP HEALTH AND FAMILY WELFARE
New Delhi, the 2Jrd July, 1985
GSR 578(E)-- Whereas the Central Government is satisfied that the
use of the drugs specified in the Table below’ is likely to involve risk to
human beings or the said drugs do not have the therapeutic value claimed or
purported to be claimed for them or contain ingredients and in such quantity
for which there is no therapeutic justification .and it is necessary and
expedient in the public interest so to do;
Now, therefore, in exercise of powers conferred by section 26A of the
Drugs and Cosmetics Apt, 1940 (25 of 1940), the Central Government hereby
prohibits the manufacture and sale of the said drugs, namelysTABLE
1.
2.
Amidopyrine
Fixed dose combinations of Vitamins with anti-inflammatory agents and
tranquillis ers.
5. Fixed dose combinations of Atropine in Analgesics .and Antipyretics.
4- Fixed dose combinations of Strychnine and Caffeine in tonics.
5- Fixed dose combinations of Yohimbine and Strychnine with Testosterone
and Vitamins.
6. Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine.
7- Fixed dose combinations of Sodium Bromide/Chloral hydrate with other
drugs.
8. Phena ce tin
9- Fixed dose combinations of anti-histaminics with anti-diarrhoeals.
10. Fixed dose combinations of Penicillin with Sulphonamides.
11. Fixed dose combinations of Vitamins with Jlnalgesics.
12. Fixed dose combinations of Tetracycline with Vitamin C.
15. Fixed dose combinations of Hydroxy quinoline group of Drugs except pre
parations which are used for the treatment of diarrhoea and
'
n
dysentry and for external use only.
14. Fixed dose combinations of Stc roids for internal use except combination
of Steroids with other drugs for the treatment of Asthma/
15. Fixed dose combinations of Chloramphenicol for internal use except com
bination of Chlor<amphanicol and Streptomycin.
16. Fixed dose combinations of Ergot.
17* lixed dose combinations of Vit.amins with anti—TB drugs except combination,
of Isoniazide with pyridoxine Hydrochloride (Vitamin B 6)
18. Pencillin skin/eye ointment
19. Tetracycline liquid oral preparations.
20. Nialamide
21. Practc-lol
22. Methapyrilene, its salts.
(No. X-11O14/1/85-DMS & PFA)
S V STORAMANIYAN, jt Secy.
I
D~9/329(a)
MS5a.i4.i2.83
THE GAZETTE qf INDIA; EXTRAORDINARY, (PART II-SEC.3(i)
PUBLISHED BY THE CONTROLLER OF PUBLICATIONS, DELHI-P10054, 1985.
NOTIFICATION
MINISTRY 01’ HEALTH & FAMILY WELFARE.
New Delhi, the 23rd July, 1985.
GSR 577(E)— Whereas the Central Government is satisfied that the use of
the drugs specified in the Table below is likely to involve risk to human
beings or animals and it is necessary and expedient in the public interest
so to do5
Now, therefore , in exercise of powers conferred by section 10A of the
Drugs and Cosmetics —
Act 1940 (23 of 1940)5 the Central Government hereby
prohibits the import into India of the said drugs, namely? —
TABLE
1• Nialamide
2. ’ practolol
5• Amidopyrine
4. Phenacetin
5. Methapyrilene, and its salts.
(No. X 11014/l/83-DMS Q PFA)
S V SrBIUMANIYAN, jt Secy.
Phones | 668071
C-14, COMMUNITY CENTRE
S.D.A., NEW DELHI 110 016
668072
VOLUNTARY HEALTH ASSOCIATION OF INDIA
ALL
INDIA
DRUG
ACTION
NETWORK
RATIONAL DRUG POLICY
CAMPAIGN
January 22, 1986
Dear Friend,
Several organizations deeply concerned about the drugs issue have been
making a concerted effort for several years towards ensuring the formulation
of a Rational Drug Policy.
In view of the new Drug Policy coming up in the Parliament in the coming
session, it is imperative that socially conscious individuals, health pro
fessionals and organizations make a clear statement regarding the kind of
National Drug Policy that we want for our nation.
We want a rational people-oriented Drug Policy, which ensures :
1. Easy availablity of essential and life saving drugs at all levels.
This is the basic aim of the Rational Drug Policy.
Today shortages of anti-TB, anti-leprosy, several other drugs and
even iodized salt exist. Production of Vitamin ‘A’ is steadily declining while
over 40 000 children are becoming blind each year for lack of Vitamin‘A'.
Adequate production and streamlined distribution of essential drugs must
be ensured.
2.
Withdrawal of hazardous and irrational drugs.
Over 43,000 formulations are sold in India. This large number of for
mulations not only creates confusion in the minds of consumers, doctors,
and chemists but also confuses the licensing and drug control authorities.
Several thousands of these formulations are known to be irrational, hazardous
and are banned in other countries. Drugs not allowed to be produced in the
parent countries of the manufacturing multinational companies are being
made and sold here
(
2
)
It is critical that we throw out irrational and hazardous drugs; that we do
not clutter and clog the drug control mechanism.
3. Need for Drug Legislative Reforms—so that legalistic loopholes
are not used against the people repeatedly and systematically.
The EP case is the cruellest of such examples. In 1976 a warning against
use of High Dose Estrogen-Progersterone combinations for pregnancy testing
had been issued, as these drugs were found to be aosociated with foetal
malformation.
In 1982, the Drug Controller of India banned high dose EP combinations
vide DO No. X19013/8/81-D.
Organon, Nicholas and Unichem went to court and managed to get a stay
order against the ban—A stay order which has to date not been challen
The sales of these banned drugs still countinue.
ged.
A point to note is that Organon (now calling itself Infar) is not allowed
to market high dose Estrogen-Progesterone combination in its home country
Netherlands.
4. Availability of unbiased drug information to health personnel
and consumers. This is basic to Rational Drug use.
Today health personnel depend heavily on drug companies and their
representatives for drug information. The drug information given to doctors
for the same product of the same company differs in developing countries
like India and the developed countries—which clearly shows existence of
double standards.
5.
Effective Drug Quality Control
Every fifth drug in the Indian market is substandard. Allowing produc
tion and sales of substandard, essential and life-saving drugs is a crime
against the consumers. Quality control mechanisms need to be overhauled.
There is a need for more quality control laboratories.
We need more qualified, and trained and competent drug inspectors for
drug quality control. Co-option of consumer bodies is also needed to ensure
drug control. Use can also be made of quality testing facilities of teaching
institutions.
You are requested to join the Rational Drug Policy Campaign and
do the following :
Health Ministry
1.
Write to :
Mrs. Mohsina Kidwai,
Minister for Health and Family
Welfare, Nirman Bhawan, New Delhi-110001.
(
i)
ii)
2.
3
)
asking for the stand of the Health Ministry regarding the drug
policy.
asking the Health Ministry to take a leadership role in formula
ting a Rational Drug Policy and not absolve itself of its
responsibility.
Dr. Harcharan Singh
Advisor, Health and Family Welfare Planning Commission, Yojana
Bhavan, Parliament Street, New Delhi-110001.
for the same.
3.
Director General Health Services
Nirman Bhavan, New Delhi-110001
for the same.
Ministry of Chemicals and industry
4.
Mr. R. K. Jaichandra Singh
Minister of State for Chemicals and Petrochemicals,
Shastri Bhawan, New Delhi-11C001.
—asking him to clarify to the nation why the drug policy is looking
only at the pricing and production aspects totally ignoring other
aspects needed to rationalize the nation’s drug policy.
5.
Mr. N. D. Tiwari
Minister for Industries, Udyog Bhawan, New Delhi-110001.
B.
Boycott all Banned and Bannable products and all the products
of companies like Organon (Infar), Nicholas and Unichem which
are flouting our laws.
C.
Approach the Parliamentarians in your state about safeguarding
people's interest when the policy comes in the House.
(For list of Parliamentary Drug Consultative Committee and a note
on how to use the Parliamentary procedures, please contact me).
D.
Find out more about the drug and health issue and share the
information with others, help in distribution of the drug campaign
material produced by All India Drug Action Network comprising of :
(D
Arogya Dakshata Mandal, Pune.
(2)
(3)
Catholic Hospital Association of India, Delhi.
Consumer Education & Research Centre, Ahmedabad.
Consumer Guidance Society of India, Bombay.
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
Drug Action Forum West Bengal, Calcutta.
Delhi Science Forum, Delhi.
Kerala Sashtra Sahitya Parishad, Kerala.
Locost, Baroda.
Lok Vigyan Sangathana, Bombay.
Medico Friends Circle, Pune.
Voluntary Health Association of India, Delhi.
4
(
E.
)
Ensure effective drug distribution of essential drug and vaccines,
iodized salt to the peripheral areas.
While vaccines are unavailable or available with the cold chain not
being maintained. It is criminal to allow children to be crippled and
maimed for life because as a nation we are unable to ensure an
effective drug distribution system even 38 years after we have had
the total freedom to revamp our health and drug policies.
The new Drug Policy is coming in March. It is mainly looking at drug
pricing and production and will safeguard the interest of the greatest in
fluencers of our drug policy i.e. the drug industry.
We want the following to be considered in the formulation of the
National Drug Policy :
—WHO's recommendation and criteria for a Rational Drug Policy.
—Conclusions
of two Summits
of
Heads of State of
Non-aligned
nations — Havana snd Colombo.
—The recommendations of ICMR — ICSSR report 'Health for all
by
2000 AD.
AIDAN's and VHAI’s stand is along the lines of the above national and
internationally accepted conclusions.
Drugs cannot become a substitute for basic health needs for food, water
and safe hygenic living and working conditions.
Hazardous, irrational and substandard drugs cannot become substitutes
for life saving essential and quality controlled drugs.
DRUGS POLICIES SHOULD HAVE
MORE TO DO WITH
HEALTH AND
THAN PROFITS FOR
LIVES OF PEOPLE,
THE DRUG INDUSTRY.
People have the right to reject irrational
policies.
and hazardous drugs and
PLEASE EXERT YOUR RIGHT ! ACT FAST NOW, WE URGENTLY
NEED YOUR SUPPORT !
— Dr. Mira Shiva
Coordinator
All India Drug Action Network
and
Low Cost Drugs & Rational Therapeutics
a-4/378(c) LCD & RT
13
The folio-wing figures specie for themselves:
Table
Category
127L
1930
I
4.5^
3.6%
II
16.7z^
13.2$
III
67.1$
68»6$
IV
11.7$
14.6$
Source:
FMR.AI News
July 1934.
The production of category I drugs i.e. essential and life
saving drugs and Category II drugs (essential drugs) is showing a
declining trend according to Ministry of Petroleum and Chemicals and
Fertilizers.
Production of antimalarial, anti-TB, antifilarial and anti
leprosy drugs have been trailing far behind the estimated demand and
while demand has increased the actual production has been falling.
In fact, production of the antimalarial Chloroquin, and the anti tuber
culosis PAS, INH and thiacctazono fell short of estimated demand by
about 84, 50, k'r and 70$ respectively in 1979-*80, except for a small
increase in INH production for all those drugs decreased further in
19S0-»8l.
Estimated demand Production in tonns MT Estimated Production
1979-30
~
79-^0
30-^1
31-82
82-83
250
40
35.16
33.49
34.62
23.15
58.96
26.02
70.00
33.00
Streptoiqycin
600
200
40
300
481.78
112.43
12.55
220.16
405.46
129.20
8.44
227.33
261.97
110.40
13.98
255.45
290.00
128.00
25.00
266.00
Antifilarial
DSC
30
21.57
18.99
16.43
13.00
28
16.20
21.05
25.61
30.00
Antimalarial
Chloroquin
Amodiaquin
j\ntit ubi er cular
P/iS & Salts
INH
Thiacet azono
Antileprosy
DDS
Ref:
Dr. W.Y. Rano - Why don’t our drugs match our diseases Science Today - October 1982.
....14/
E-4/378(c) LCD & RT
VHAI:pt:19.7.lS4:
14
Demand Projection for Bulk drugs for the period
Estimated RoQidrcmcnt
Base year
79-80
80-81
81-82
82-33
33-^4
/ntimalarial
Chloroquin
/undiaquin
2J0
40
275
46
300
53
335
61
365
70
400
80
Anti Tubercular
PAS
INH
Thiacetazone
Streptomycin
600
200
40
300
630
240
42
330
660
290
44
363
700
360
400
730
415
43
W
770
500
50
485
Antifilarial
DSC -
30
33
36
40
45
50
Anti leprosy
DDS
28
32
37
45
50
56
The Indian Pharmaceutical Industry Problems and Prospects.
P.L. Narayan, NC4ER Study National Council of /jplied Economic
Research - January 1984*
Ref:
ICMR and ICSSR study on Alternative Strategy had indicated the
grossly inadequate drug production for TB and. leprosy which happen
to be cur priority health problems.
With half of the TB patients
of the world in India our production of IN® was less than 1/3 of the
minimum requirement.
Tha Malaria deaths in Rajasthan-were not merely duo to drug
resistance and cerebral malaria, but due to non-availability of
chloroquin even at certain government PHCs. The estimated require
ment and the actual production are getting further apart and reliance
on Imports is resulting for drugs that arc so routinely noedod.
Chloro quin imports in tons
1979-‘80
1931 - ’82
1980 - ’81
Production
Imports
Production
Imports
Production
Imports
35.2
52.8
34.6
71.8
59
166.3
Ref :zr <C/ER Report - The Indian Pharmaceutical Industry.
r^^^S^fJSa^^^nomic Res car ch.
/
15/
S-4/378(c) LCD & RT
VIL''1I:pt:19.7.,S4
15
- There are an estimated 60 million iodine deficiency cases
of goitre in India, It is know, that children of' iodine
, deficient mothers are known to bo born as cretins, deaf,
mutes and mental subnormality.
Tho simple technology of production of iodized salt is known.
Merely 50 paise worth of iodized salt can make all the difference
between a child being normal and subnormal.
We still produce only 20^ of the iodized salt required.
Required amount of iodized salt is - 7 lakh tons
2 lakh t ons
Amount produced
1 lakh'tons
/mount sent to Nepal
Amount left for utilization for
the 60 million goitre eases
1 lakh tons
When adequate production of an essential low cost item like
iodized salt.,-for a National Goitre Programme cannot be assured^what
happens to production of the essential drugs for non priority national
programmes can very well be imagined.
In Kenya3 in a pilot project funded by Q/iNlDA and SIDA, supplios
of drug kits containing 39 drugs in 15 rural districts has incroa'cd the
accessibility of essential medicines for the rural population from
1C$ to W.
Be
DPCO and its negative impact on Production of Category I and II If:w: >
Under Dx CO .(Drug Price Control Order) tho mark up on Category I
drugs is limited to 4® and that on Category II is 6($. Producing category
IV drugs because- of the high mark up allowed are therefore definitely most
profitable.
For the decreasing priority being given to essential and life savirg
drugs DPCO is therefore blamed. With the decontrol of prices of 75% of
the drugs as is being recommended by the drug lobby and its supports, a
further switch ©to production of more profitable unessential drugs is
imminent. If government is serious about ensuring that essential drugs
are sold at a reasonable price - this can bo done by doing away with taxes.
c.
Poor performance of multinationals in production of essential drugs:
The outright, calcuj.ated neglect of the priority drug needs of
tho majority is well known. The following table speaks volumes. (Sec
/jinoxure II - Production of Essential Drugs by Multinat ionals and Organised
Sector)
De
Dilution of FSRA Companies - an invitation to more formulations;
With the dilution of foreign equity shares to
various
concessions arc being granted to the PER A companies so that bulk to
formulations ratio will bo increased from 1:5 to 1:10. With the drug
production pattern as it is, we can look forward to more formulations
and more unessential drugs irrelevant to our .^peoples health need.
Bulk production by foreign sector for 19B2-,S3 was Rs, 55 croros worth;
the formulation turnover according to 1:5 ratio should not have exceeded
Rs. 275 croros, however, Rs. 515 crores worth of formulations wore
produced i,e, more than 1:10 ratio when only 1:5 was allowed.
16/
^r.4Z37B(o) LCD & RT
VHS:pt: 19.7.’84
16
use of scarce resourcos:
-p ^2i^2^_scarce_fcroi^i^^
India with its level of
iJid^btodness to.IMF vforld Bank, IDA etc., can hardly afford to sqandor
ats scarco foreign exchange.for importing inessential drugs.
ii) Incssontial,. vs basic health needs; Worse still is the
enforced wastage of scarce resources of the poor on useless nonsensical
drugs,.when they can hardly afford adequate food and clothing and bare
essentials. When.the percentage of people, below or around the poverty
line happen to be around 60 - 70%' of a country's population - the very
production and heavy promotional of costly irrational and hazardous drugs
is criminal.
A strong public opinion alone can ensure withdrawal of
such.drugs, with priority being given to essential and life saving drugs.
. 1Ti,\ Igpssantial vs_ .essential drugs; Often inessential drugs
are bought at the cost of specifically needed essential drugs. For the
ignorant majority, tho difference between the therapeutic value of a
costly tonic, vitamin, digestive ensymos, antipyretic and much needed
specific drug eg. antiasthmatic, antibiotics etc.
£L1 written in the
same prescription - does not exist. This was shown by Voena Shatrugliana's
study. of Prescription viriting and •drug consumption. By ensuring
priority^ avciilabdlity and prescription of essential drugs, wo woulv be
contributing to preventing tho wastage.
scale increased; If essential drugs wore given
Parity w production, through sheer economics of scale, ^he production
cost would decrease for the manufacturer and thus the consumer.
v) Bulk purchase; to essential dru^ list can c ensure bulk purchase
of selected essential drugs,r whichl can cut down drug costs
e
F•
. market demand and thus the Dru# Production pattern in
favour of essential drugs:
-------- by choice /b^loSlat’nn50?^1
was'^^ propagated, accepted
y
licx Cx oy legislation, tins would necessarily influence the
'md honce the
demand iktte mffket? Sis would
definitely alter the drug production pattern towards essential drugs.
G•
Doer ease drug misuse and over use:
noutirJlTnf^
d°nS ^th idonfcification of - drugs which are - thera
peutically effective, safe, easy to administer, and of appropriate cost
S^oFdoubtffl10 “gr0di0^ wodl tried ciru^. The use of drugs which
are of doubtiu! vaiuc, costly, irrational and hazardous drugs Should be
avoided. Majority of the drugs available are combination Strugs. This
increases costs as these drugs .are often in'subtherapeutic and'irrational
dosages, according to Halfden Mahler, 90^ of drugs in the developing
countries are non essential.
H.
Sjovonting Iatrogenesis (Drugs induced health hazard):
As loi)g as potentially hazardous drugs with very high risk
(compared tobenefits ratio are misused and overused, unwarranted high
incidence of iatrogenesis is bound to occur •
17/
V
£~4/378(c) LCD & RT
VH££:pt: 19.7.‘W
17
In US?, where the drug control and the prescription practices
are much better controlled, the incidence of iatrogenesis is very high.
One.in 5 hospital admissions are known to be due to iatrogenesis. In
India we have such a high degree of self prescription, prescription
writing by.unqualified health personnel and by qualified personnel who
are made highly biased by drug representatives. ’ This along with poor
drug controls ensures drug misuse, overuse and iatrogenesis. Most
cases of iatrogenesis are not diagnosed in India. This of course doos
not imply that they don*t exist.
Most of the combination drugs have 2 or more ingredients. It is
known that with consumption of over 6 drugs compared to 2, chances of
drug interaction increase by 40/ as compared to 5'^ .
f- •
jfeug Information for health personnel and consumers possible:
With 30,000 drugs in the market it is impossible not to be
confused about them. ■ /i doctor may be familiar with the drugs he or she
uses routinely. Unfortunately he or she cannot be sp with the' various
brands used by others. Their prescriptions are often taken from one doctor
to another by critically or chronically sick patients.
Confusion abounds, since majority of the health personnel have no
access to pharmaceutical, index to figure out what drug has been given.
Majority of the drugs in the market, are combination drugs. Lack of
familiarity with the contents and their dosages makes matters worse.
If proscription practices for the majority of the health problems could
be based on*essential drugs? Relevant drug information about- their
relative cost, dosages, indications, contraindications, side effects and
toxicity could be made available to health personnel and consumer
caution be ensured?
Studies also indicate that it is impossible .to .remember dot an 1 s
of even 100 drugs in routine practice. Ensuring that these prescribed
drugs are the ones that people need and not what arc'most heavily pushed
by the drug companies because of their profitability, is our responsibility
Focussing on all aspects of essential drugs and rational drug use in
medical education wogld ensure their bettor use which would bo bettei’
for the nation and the patients.
J.
Ensuring better quality control:
There are 30,000 formulations in the market. Most of them are
combination drugs and one in 5 drugs in the market is substandard. With
a lesser number of drugs in the market which are single ingroc iont drugs
quality control can bo bettei* streamlined.
Making profits by promoting
unessential drugs is crazy, but to make inadequate number of essential
drugs available, with even these being substandard, is really unacceptable.
K.
Ensuring goncric proscribing:
Generic prescribing is recommended by WHO itself as it cuts down
drug costs.
Pharmacology input during medical education^ nomenclature used
in medical literature and. medical journals is based entirely on generic
names.
W/
^4/378(o) LCD & RT
VHH:pt: 19.7.^4
18
:
With a restricted essential drug list generic prescribing can
definitely be ensured. The pharmaceutical industry and government drug
control authorities would have to take greater responsibility to ensure
quality control AT ALL LSVELS. Brand name prescribing is no solution
for substandard drugs. Brand names do not prevent spurious drugs enter
ing the market as most spurious drugs arc imitations of well known
brands. Name of the specific drug house can be written if it is felt
absolutely necessary. Generic prescribing is possible with single ingre
dient essential drugs which arc quality controlled.
L*
Subsidizing costs of essential drugs:
restricted list of drugs meant for the health needs of
the majority, subsidizing is possible by removing sales tax, excise duty
and octroi for these. Ainy loss in the taxes can be compensated by
increasing taxes on cigarettes, alcohol and other such anti-health
products or more so. on luxury items meant for the rich. In conclusion,•>
demanding an essential drug programme is aimed at focussing attention
and giving priority to health needs of the majority.'
CONCLUSION/S«I/RY
Demanding priority production and distribution for essential
..drugs is accompanied by :demand for a just health care delivery system*
We know that a just health care delivery system cannot exist in isolat
ion in.a socially unjust system.
Demand for essential'drugs before un
essential drugs is accompanied by demand for employment, fair wages,
fpodj water, sanitation and all that goes to ensure good health* Our
fight for essential drugs and health care as a fundamontlal right of
every Indian, specially the deprived sections is a fight against the
unjust ice of the present socio-political system, which in reality
accepts this deprivation of health -and basic health care as a normal
phenomenon.
E-4/j7a(c) LCD & IT
VH/l:pt!l9.7.‘S4
/mnoxuro IH
ffiOpUCTIpEI OF BSSBCTIAL DRUGS BY MULTINATIONALS AND 0RGMIZ8D SEOTOR
STREPTOMYCIN
Name of the firms
J.NH
PAS
iKACITAZO®
ETHZMBUTOL
Abbott
Nil
Nil
Nil
Nil
Nil
Nil
ACCI
Nil
Nil
Nil
Nil
Nil
Nil
Hoechst
Nil
Nil
Nil
Nil
Nil
Nil
S.K. & F.
Nil
Nil
Nil
Nil
Nil
Nil
Searle
Nil
Nil
Nil
Nil
Nil
Nil
Sandoz
Nil
Nil
Nil
Nil
Nil
Nil
Roche
Nil
Nil
Nil
Nil
Nil
Nil
Parke-Davis
Nil
Nil
Nil
Nil
Nil
Nil
Sarabhai
Yes
Nil
Yes
Yos
Nil
Yes
Beobringcr Knoll
Nil
Nil
Nil
Nil
Nil
Nil
Glaxo
Nil
Nil
Nil
Nil
Nil
Yes
Ee Merck
Nil
Nil
Nil
Nil
Nil
Nil
Giba-Giegy
Nil
Nil
Nil
Nil
Nil
Nil
Pfizer
Yos
Yes
Yes
Nil
Nil
Yes
Warner
Yes
Nil
Nil
Nil
Nil
Burrough Wellcome
Nil
Nil
Nil
Nil
Nil
Nil
German Remedies
Cynamid
Stbnor
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Nil
SOURl.;
A study
Yes
Nil
Pravcntivo Disoaso in India, by J.S. Majumdar; prepared for the
Drug Workshop in Jaipur, organized by Vli/I,
w
<
Bor sharing this endeavour, we are grateful to the following
for their help and moral support in compiling the Essential
Drug List.
-f ■p’rof.-^'l M s •Ahu-j_a.,:Hea.d Department of Medicine, ..A-I- T M. S
(TenfpOraf'y Advisor)- The use of Essential Drugs/Technical
Report Series 685, WHO.
D r V S Mathur,PG-I Chandigarh, Editor Drug Bulletin
for i) providing the graded EMRO list for which he
was
a consultant
ii) for providing the PCI drug formulary
for feeing with us at Pune Workshop — January 1982
where Pune Drug List was final? zed.
Dr Qasem of Gohosasthya Kendra, for having kindly complied
to our request to send the graded Bangladesh drug list.
Dr Joel Fernando,9 Medical School, Sri Lajika for providing
the Sri Lanka drug list.
Friends in Echo and Action Medeor who sent their li^ts.
Late Mr John Agacy, Secretary Low Cost Drugs and Rational
Therapeutics, who tediously typed the first draft ofthe
Comparative Essential Drug list in alphabetical ord er.
Alphonse our Secretary of Low Cost Drugs and Rational
Therapeutics for typing this comparative drug list based
on WHO format.
July 17, 1984.
ESSENTI/iL DRUGS
_A DWM) FOR PRIORITIZATION
Prepared for
V H A I members
Drug Action Networkers
and all those who believo
in the concept
and implamentation
of Rational Drug and Health Policy
Background paper
for
Drug Action Network
Core Group Meeting
Wardha
30 - 31st JULY 1984.
COMMUNITY HEALTH cell
47H,(First
BANGALORE
Dr. Mira Shiva
Coordinator
Low Cost Drugs
and Rational Therapeutics
V.H.A.I.
E-4/37B(c) LCD & RT
.VH/l:pt:l9*7.,S4
gSgLOTIAL DRUGS - A DEMAND FOR PRIORITIZATION
- -i~ rm» m r_*«
i m ,
m—
——t. -. —■ -
-
Dr* Mira Shiva5 VHZil.
Content Outline
I. Essential Drugs - An Introduction
Courageous Efforts - Brief Review
Chile
Srilanka
Pakistan
Mozambique
Bangladesh
WHO
India
111 •
»
Qur Efforts in the area of essential drugs
• —Tke Defection of essential drugs and the ess ent ial drug progr amme
- W H 0 Recommendations.
- ---------------------—
V•
The Rationale of Essential Drugs
Drug List?
or Whgr do wo need an Essential
A.
Existing low priority to essential drugs/needed for the
priority health needs) and the deteriorating trends in output.
B.
DPCO The Drug Price Control Order and ius negative impact on
Production of Essential and life saving drugs i.e. Category I
and II drugs.
C.
Poor performance of multinationals in production of essential drugs
D•
Dilution of FERA companies - an invitation to more formulations.
E. The need for rational use of scarce resources: Controlling Cost
by:
1. preventing wastage of scarce foreign exchange by net
importing exc ess ines sent ials.
2.
ensuring preventiyo health ureasures before promoting
inessential drugs.
3.
ensuring placing os sent ial dr i igs before inessential drugs
4. increasing production of essential drugs, decreasing
drug costs through economy of scale.
'5.
ensuring bialk purchase of "selected essential drugs and
thus cutting costs.
5-4/378(0) LCD & RT
2
F.
Subsidizing costs of essential drugs
G.
Need for influencing markot demand and thus the drug
production pattern in favour of essential drugs
H.
Need to do crease drug misuse and overuse .
I.
Need for efforts in preventing I atrogenosis
J.
Need for ensuring unbiased drug information for health
personnel .and consumers.
K.
Need for ensuring better quality control
L.
Need for onsuring generic preseribing
i
.4
VI.
i
*
Graded Essential Drug List
I.
ESSENTIAL DRUGS
9
INTRODUCTION
Tire concept of essential drugs is the focal point of the drugs
issue and of the rational drug policy.
Our focussing on essential drugs does not mean that by ensuring
production and supply of essential drugs9 the health care status of
our people >111 dramatically improve^ Wc are focussing on it to high
light the fact that majority of our people are not merely deprived of
health care facilities, but whatever they are given by way of health
care does not necessarily have their interest in mind. The kind of
health care facilities, medical technologies and drugs being promoted
under the garb of ”scientificity” and "modern advances” and as "latest
break through" usually servo the interest of the "medical industry” i.o.
the drug industry and the medical establishment. Some of these modern
myths and superstitions have to be demolished. Eg. Myth I - medicine
is a noble profession brimming with selflessness^ putting patients
interest and welfare, above self interest.
Myth II - The drug industry
produces 1 pi-1 Is for every illT and is fig lit ing an unselfish battle
against death and disease. If it wasn!t for them. Lots of us would 00
sick and suffering if not dead. Myth III - India is1- a welfare state,
signatory of the Alma Ata Charter giving priority to Primary Health Care,
and that our health policies are people oriented and are guided by reco
mmendations of Committees like the BJjore Committee, 1946, Hat hi Committee
1975. Alternative strategy Health for All "ICMR-ICSSR Report 1961”and
oven the last year*,the National Health Policy Statement all of which
emphazisc that the’ health needs of the majority, have to take priority
over sophisticated, centralised, costly, high technology medical services
meant for the minority with the purchasing power.
3/
^-4/37^(q) LCD &.RT
VK/I:pt:l9.7.,S4
3
The concept of essential drugs, questions the health personnel
who are supposed to safeguard the' health of the people; it questions wliy
their prescriptions include irrational, inessential, costly combinations
and often hazardous drugs. It questions the medical establishment for
not demanding bans on bannable drugs, nor attempting to ensure and
implement such bans. It focusses the attention on’ the present day medic aJ.
services- private arid government; the proscription patterns; the groes
lack of accountability to the public or to any medical council. The
doctors bask in the prestige that comes, with the practice of ’wliite
man’s’ medicine.
It is the public that pnts them on'a pedestal (not
far below the one meant for the Almighty). In reality, they, lil<o the
drug manufacturers and their representativos are no better than salesman
and medical care is debased into a ’commercial service’.and it sells,
even if the people needing it have to bog, borrow, or steal.
If tho prescription patterns have to be based nmnodifiod
blindlj^ unchallenged on the medical text book written by and for the
West - then wo should also ensure that, their.controls go with them.
There should be registration with the medical council, need to pass
board exams after certain years of practice, medical audit and withdraw;!
of medical licenoe for unethical medical practice. If our state mechanism
is meant to ensure ai^rthing, it is to ensure total safeguard against
those who in the name of medicine, believe in making quick money, and
use their medical license, to exploit the people. Not merely are such
medical practitioners whoso number is fast increasing an insult to
medical practice, bub they set examples for others, so that medicine
has become a ’’Dlianda1’ (business) for many. Youngsters bribe, fudge
mark sheets, pay lakhs of capitation fees to get admission in medical
colleges to join their ranks - while Primary Health Centres’lip unstaffed,
unequipped and disfunctional. Rarely do the prestigious medical establish~meats raise a huo and cry over the ever increasing nodical swindles;
against the decreasing health budget of the 5 year plans; against
the drug bans that never come or arc never implemented; against health
and drug policies that arc not in the interest of tho people.
- rhe drug industry is there not to serve, but safeguard its
own intorests. The performance of multinationals in decreasing uroduct
ion o± essential and life saving drugs, and the double dealing"in giving
biased drug information; their ensuring the pnachase of drug prescript
ions for ones company by gratifying doctors with samples, gifts and
sponsored medical, conferences. With loan licensing, products of many
oi the big name companies arc produced by small scale drug outfits
with as much quality control as most other small scale drug companies.
All commorcial enterprises serve a purpose, but a few like
drug^industry start sharing the role of a tealer, server, educator
bonefactor, having touched the dizzy heights of highly technical
mystified science.
- The third nyth df course is that our health policy is.
geared to fulfil the health needs of the majority.
The ^health budget has steadily decreased. It may have been
broken up under different heads but with increasing population and.
increased need for health services, health budget should bo going up
much moi^o rapidly.
4/
^-4/373(0) LCD & RT
VlLH:pt:i9.7J^
:
4 :
How has the money boon spent? What aro the disparities existing?
What has been the role of the policy makers? What has happened to the
various recommendations mentioned earlier? The perspective should have
been set when we attained independence.. The direction being pursued now
hasn't changed.very much from the pre-indepbndoncc period. ° The public
has had no say ip. deciding the kind of doctors it wants trained with its
money and. what kind of health facilities and drugs it needs. Such an
intervention by the consumers remained impossible inspite of the numbers
because sc far they have- remained unorganized and fragmented.
i
s
Focussing public attention on the issue of essential drugs provides
a platform for organizing the consumers for focussing attention on our
health care services, on our legislations, policies, education and
legal systems.
It is to focus on the role the experts, the committees and policy
makers have played in the past (many of whom aro known to have teen
bought and sold). It focusses on the role of consumers and on their
demand for participation in decision making as a majority, for the benefit
of the majority.
Demand
for essential and life saving drugs as a prioi’ity is an
uemanu lor
exercise in demystifying medicine; it is an exercise in public education,
an exercise in ensuring that public needs guide and influence decision
. making. This demand is also an exorcise in learning to boycott drug
decisions and policies which aro thrust down peoples throats against
their will, and against the interest of the majority.
It is part of a slowly emerging consumer movement, peoples science
movemeiit and also peoples health movement. It is an integral part of a
larger process and not a piece-meal demand of a minor rectification.
The politics of health at the concrete level can only be based on
peoples action. As Fritjof Capra points out in the Scliumacho.r Lectures
’Refusal to take even a single pill is such a political .act1. On.this
■political, philosophy is based the mobilization for essential and life
saving drugs as a priority.
Just as manufacture, sale and prescriptions of hazardous and irrational
drugs is a oppressive political act, refusal to become-victims of this
oppression is a political response.
II.
COURAGSCUS EFFORTS - A Brief Review
The concept of essential drugs list is nothing new nor did it have
its origins in WHD’s Technical Report Series No. 615 (1977) as many believe.
Many efforts had been made prior to this,
just mention few.
CHILE:
As far back as 1973, the Chilian Modical Commission comprising of
Dr. Salvador Allende had believed in limiting the drugs to those that had.
demonstrable therapeutic value and thus ’scale down the pharmacopca’.
/JIends during his short tenure as President quite successfully compelled
the medical profession to serve ’’basic” rather than profitable needs.
He uroposed to ban drugs not proscribed for clients in North America
or Europe.
5/
.v.
I3^/37^(a) LCD & RT
VH/Z:pts19e7.^4
5
:
Within one wook alter the talcing over of the military, junta on
11th September 1973 the Chilian doctors who participated in this
revelutionization of medicine, these outspoken proponents of Chilian
medicine based on.community, action rather than on drug imports and
drug consumption wore assassinated. .Men with much'courageous ideas
even though they arc for the benefit of the people, are seldom
appreciated.
,cKE
In 1971 under the guidance of Senoka Bibilc^ Sri Lanka had formed
t.ho State Pharmaceutical Committee to launch its pc o pic or lent od now
Drug Policy. The number of drugs in the market were slashed dom from.
2100 to 6GO and made available mostly under generic names and obtained
by calling international tenders. Within 6 months there vjerc savings
of about
in relation to expenditure incurred earlier.
It is absolutely essential for those of us involved in drug work,
to know- haw the resistance from nmltinationals, their governments^ with
support from Sri Lanka’s own medical establishment forced the Sri Lanka
government, to give into vested interests and revert some of itsown
brave and correct decisions.
PAKISW:
Pakistan’s attempts at restricting the drug list to essentials,
v/ith rejection of unosspntials met v/ith similar resistance from the
2 most powerful lobbies in the medical industry ’the drug industry
and the medic al test ablis hment'.
INDIA:
In 1975, the Hatiii Coirmittcc in India recommended a restricted
essential drug list of 116 drugs whichjwere to be sold under their
generic names. There was no dramatic opposition to the recommenda
tions. They ware just very effectively ignored. So much so that
today for interested health and consumer groups no copies of tho_ .
Ifethi Coimittee recommendations are available, from the health myiLS .r^
Those recommendations are shrouded in cob-webs. The difference,^etweciths Indian experience with essential drugs ana that of others is th,.^
the demand for them did not qmprgo from enlightened medical proie
ionals and has till recently remained an of facial exercise.> •
"
not from people ..like Dr. Scneka .Bibile, c>f Sri. Lanka,. Dr, z,^ru_lc.
Chowdhry and Dr. Nurul Islam of-Bangladesh, Dr. SalgMoi1 W-ondo o.
Chile.
•
After its. liberation from Portuguese rule an 1975 ttw Ifozar..^geverranont tooiq sow drastic decisions regarding its health and dri^
policy. -Health was nationalized and private practice banned witlun
one Znth of independence.
The number of drugs were decreased from
to 430 mcdictoos in 1977. Bssonfci33-^g^^
in 1980 and ccntfiined only 343 drugs. ONLY TIE'SE DP.LGo COULO
PRESCRIBED.
..6/
*-
g~A/37£(o) LCD & RT
VE'JI:pt;19.7.l84
6
The result of streamlined contracts was that the drug prices of many
essential di^gs came down to 1/3 of thc:lr or spinal prices. T ho essexitial
drugs became available, to more people in remote areas, not just to the
privileged few. This could bo done with tho drug import costs the same
as they were 10 years ago because tho selection was more sensible.
W H 0:
The WHO Expert Committee on essential drugs in Technical Report Serios
615 gave the criteria for selection of essential drugs and a model of
such a list. Another report in 1979 was followed by the Technical Report
Scries 635 which dealt with the !uso of Essential Drugs1 and gave the
essential drug list for emergency situations and primary health care.
B/iNGWESH;
In June 1962 Bangladeshis Military regime under General Ershad,
promulgated a Drug Policy based on WH3 ’recommendations. 1742 drugs
were, banned because of their hazardous and irrational nature. This
of course had been preceded by educational campaigns about rational
drug use by some of tho individuals involved in pushing the National
Drug Policy. The January 1962 international conference on Health and
Pharmaceutical Policies was one such attempt organized by Gonoshasthya
Kendra. Tlirough its monthly magazine’^ ones hast hya Patrika” dealt
with this and other issues systematically. Dr* Zafrullah Chowdhury
admits that the Hath! Committee and its recommendations hold great
inspiration for evolving and for. implementation of the Bangladesh drug
In Bangladesh the resected drug list constitutes of 150
policy,
drugs. Tho grading of 150 selected essential'drugs has also boon done
based on location of utilization and level of potential users.
I
II
III
12 Essential drugs have been selected for village level health
workers.
Additional 33 essential drugs for Primary Health Care up to
Thana Health complex level.
Additional 105 essential drugs for use up to tertiary level.
There is also a list of 76 supplementary <h-ugs for restricted use which
after discussion will bo compiled to 100.
The heavy pressure, being applied to dilute or just scrap ^his
courageous pro people drug policy, which is ironically very much based
on the WHO guidelines for Rational Drug use - has come from the multi
national drug lobby and tho medical lobby. The loudest voice being
from the US based multinationals and from B M A (Bangladesh Medic A
Association). It is openly stated by the latter tnat if India c^n
allow unrostrictod sales of drugs banned in Bangladesh,,the drugs must
be safe and wonderful. After all Indian Medical bstablxstont wxth
all its brains and advanced technology can’t be wrong
(any way v
allow corhinuod manufacture and sales of drugs banned by our Drug
Controller of India and recommended for wathdrawal by our oxpur,
committoos.)
Efforts to gathor support for Bangladesh's brave drug policy had
boon made by us right from the beginning and our
of
since survival of Bangladesh dreg policy is. crucial foi vhQ peopl
Bangladesh and other third world countries including India.
.......... -7/
I
^-4/37?(o) LCD & RT
Vai:pt:19j7.'S4
7 :
ZIMBABWE;
Zimbabwe's Government has selected 376 essential drugs to be
used in the public health system. Government will not make foreign
exchange available for impoiting drugs outside this 1 i*st. t
Why, is this concept of essential drugs seen as such a big throat Lw
medical establishment and the drug lobby? The reason is very obvious.
It interferes with the drug companies profit making oven though in
reality it benefits more people.
Ill.
OUR imiATIVES IN PROMOTING AV/AREMESS OF
ESSENTI/i DRUGS
By the end of 1930, the drug issue,tho rational use of drugs and
the role of non-drvg therapy and of systems of medicine etc. had become
an important component of our training programmes; whether it was up
grading'of diagnostic and therapeutic skills of middle level health
workers, holistic health workshops, community health or health care
management training programmes.
By January 1930 a clearly defined strategy' of drug work was drawn
up. Tliis was later presented to VH/J?s general body for ensuring organi
zational support. This work strategy figures in the special issue of
Health for the Millions - April-June 19^1 and indicates the various
levels at which it was felt that intervention was required. (Right from
village hospitcxl to health personnel and their trainers; policy makers,
drug companies, multinationals and international drug and health action
groups)..
In April-Juno 1981 issue of our bi-iao'nthly wo informed our VHAE
mombors and HFM. readers of tho concept of -cssontial drugs and gave tho
Qssontial drug list meant for Primary Health Caro. Tho list of irra
tional and' hazardous drugs which was at that time -recommendod for being
woedod out, was also disseminated to warn the health personnel and
health institutions about them.
By 1931 end a serious attempt to draw up an essential drug list
of 50 drugs and recommended management of 10 commonest health problems
was made, based on the invited, views and opinions of selected academi
cians, health personnel in the field or hospitals and pharmacologists
etc. (There were too many disparities in the responses and effort
to compile a very unaxiimous and coherent result based on these responses
was abandoned. It was found that most health personnel were not
familiar with tl^ concept of essential drugs and WHJis essential drug list)
In January 1932, the first drugs workshop ’Drugs Issues and
Feasible Alternatives’ was-organized in Pune to bring socially
conscious health personnel, consumer group activists for drug action
together. Tho Hat hi Committee and WHO essential drug lists were
made available to the participants of the first Drug Workshop in Pune
as well to the participants of various training workshops and organi
zation Development (0D) seminars etc. conducted by VHAI and dissemina
ted amongst various levels of health and non-health personnel.,
A sub group constituted of doctors and pharmacologists met during
tho course of the workshop to compile a. mutually acceptable essential
drug list. (The Pune workshop list - in the comparative drug list
was an outcome of this effort). See /umexure I.
^-4/373(0) LCD & RT
VH/iIjpt; 19.7.»84
8
:
By August 1982 it was fully realised that an essential
essential drug
drug list
list
drawn up by us even as a group would not necessarily be acceptable
..x------- to
-j
health personnel. 4id
autho
nd if while attempts to influence government autLo
rities wont on side by side in the voluntary health sector, the acccptanee and implementation of this had to be ensured.
The exercise to draw up a comparative essential drug list was
undertaken for 3 reasons:
1.
ic demonstrate that' any rational drug policy formulated
had a lot in common,no matter from which country.
2.
That it was not a handful o f concerned persons but expert
committees that had drawn up these lists. The fact tliat
these experts believed in the concept of essential drugs,
we felt would have greater convincing and educational value.
3.
The rationale in making the comparative drug list available
to the^indxvmduals^in the field and solicit a response from
those informed individuals was to give a better guideline,
as well as to involve them in the evolution of a process.
±he comparative essential drug list prepared incorporated the
following drug lists:
-
WH3
Hathi Committee
PGI (Pest Graduate Institute list) Dr. V.S. Matahur
Pune Workshop list
Sri Lanka list
Restricted lists used by ECIO UK and Action Medeor (both
agencies are involved in bulk purchase of essential drugs for
third world countries).
It was obvious that those essential dru^ lists would provide guide—
linas f°r drug selection for larger medical institutions.. But for small.or
health programmes with which
— I was mainly involved in the course of my
work, there was a need for a graded essential drug list, J1based
on the
exper ienc e, qualif ic at io ns of the health personnel
-the availability or non availability of other health facilities
specially referrals
- availability of supervision, consultation and c.
on going education
- the gamut of health problems dealt with and the
.o workload
- resources available in terms of finances, manpower, diagnostic
facilities, transport etc.
o •
obtain graded essential drug lists from Bangladesh,
Sri Lante, Mozambique and BdRO have been made.
P_oaling with Hcsistancj^
The most, vocal argumont against the concent of essential dxw list
t xC extremely poor countries and not for developed countries nor o
th^tMrd^rl^t^11^^ 130St d0VG1°PGd Pharmaceutical industry in
h„ third world. Uns is far from true since drug lists of many devolone-1
countries are highly rationalized and linitod. Prolix cation^ In
essential drugs is no indicator of development .
t-
3-4/37B(o) LCD & RT
VH£E:pt: 19.7^C4
9
In 19$2 n request to the Editor MIMS was made to:
1) delete the drugs that wore roconnnendcd forbeing wooded out by
the Drug Consultative Committee
2) indicate clearly the drugs included in WHO essential drug.list,
so as to give a guideline for the readers to help them in thoir
selection process - by underlining or writing these drugs in capitals
or italics.
This evoked besides a personal response, an editorial in KEMS
where the relevance of the essential drug list only for the strug^ing
poor countries was emphasised. Dr. Halfdon Mahler, Secretary General
WHO ws quoted as saying ’’that a consignment of antimalarlais ,was
received in a certain country with as much celebration and gaity as
demonstrated at that country’s independence”. This was an attempt to
show that the concept of essential drug list is meant only for extremely
poverty stricken and not countries like ours.
This is totally untrue.
Developed countries have made more serious efforts to restrict drugs.
In UK, the
the- 65OO
6500 preparations is considered too many by the Rational
Health Campaigners and^feharles•Modawsr of Social Audit in his latest
book ’The Wrong Kind of Medicine’. Norway has about 1900 preparations.
The Norwegian authorities have licensed a total of 730 active ingredients
An attempt to have less of irrational and non—sensical drugs is not
1 innt,ed to the third world countries but developed countries themselves.
How long in tne name of ’free enterprise’ and so called ’clinical freedom1
will irrational and hazardous drugs continue to bo inflicted upon the
people specially when they are ill affordable by them at the cost of
their actual health care needs being met?
■ Today the question is not whether to include or delete a particular
drug, but for health personnel and poo pic alike to be exposed to and
to internalize the concept of css ent ial drugs, so ^t rmt they can make, an
informed choice about essential and iii'iesscntial drugs,
“The benefits of our huge drugs list are essentially to do with
trade, not health. The advantages of a restricted drug list include
having fewer bad drugs and a reduction in drug induced disease, and
bettor information about drug use and less confusion about which drugs
to use11. (Charles Mcdawor ‘The Wrong Kind of Medicine’ page 1$).
Dr. Jo Im Yudkin who has long boon concerned about third world
drug policies says ’the drug companies must not bo permitted to become
a hazard to health in the under developed world by failing to provide
information or by drawing scarce resources, away from more effective
projects’.
10/
E-4/37S(o) LCD & RT
10
IV.
SELECTION OF SSSWIAL DRUGS IIP WS FOR
na^WWING AN ESSENTIAL DRUGS PROGR/MME
"* - TO RECOMMENDATIONS
In order to ensure that an essential drugs programme is adequately
instituted at the National level, several stops arc advised:
1. Establishment of a list of essential drugs, based on recommend?
tions of a local committee constituted of individuals competent in the
fields of medicine, pharmacology, and pharmacy as well as peripheral.
he alt h wjr kor s
2. The international non-proprietary (generic) names for drugs
or pharmaceutical substances should be used whenever possible and
prescribers should be used whenever possible and prescribers should be
provided with a cross index on noproprietary and proprietary names.
3. Concise, accurate, and comprehensive drug information should
be prepared to accompany the list of essential drugs.
*+• Quality, including stability and bio-availability should
be assured through testing or regulation.
5. The success of the programme is dependent on efficient
administration of supply, storage and, distribution at every point- from
the manufacturer to the end user.
Government intervention may bo
necessary to ensure the availability of some drugs in the formulations
listed,and special arrangements may need to be instituted for the
storage and distribution of drugs that have a short shelf life or
require refrigeration.
^Tficient management of stocks is necessary. To eliminate
waste and to ensure continuity of supplies, a Procurement Policy sliould
be based upon detailed records of turnover. In some instances-drug
utilization studies may contribute to a better understanding of true
requirements.
7. Need for both clinical and pharinpceutical research under
local conditions.
Critoria for selection of essential drugs;
7
ESSEI'JTI/L DRUGS ARE TIOSE THAT SATISFY THS
HEALTH C/iZE NEEDS OF TIE MAJORITY OF TIE
PEOPLE. TIEY SHDULD THEREFORE, BE AVAILABLE
Ail i&L TIMES IN ADEQUATE AMOUNTS AND IN THE
APPROPRIxYTE DOS ACS FORMS.
Only those drugs should,.be selected for which sound and adequate
data on efficacy and safety are available. And from adequate clinical
studies and for which evidence of performanco in general use in a variety
of medical settings has been obtained.
11/
S-4/373(q) LCD & RT
VHjYI:pt:l9.7<,S4
11
Each selected drug must be available in a form in which adequate
quality, including bio-availability can bo assured. Its stability under
the anticipated conditions of storage and use must be ostaJD&Rhod.
The choice between 2 or mono drugs which are snrrilar in all the
above respects, should be’based on careful evaluation of their relative
efficacy, safety, quality, price (of the cost of taking a full course
and not merely the unit cost) -and availability.
Other criteria to be kept in mind aro pharmacokinetic proportios
and availability of facilities for manufacture or storage.
Formulations should be single ingredient drugs. Fixed dose
combinations should be acceptable only when 'a combination provides a
proven advantage over single compounds administered separately in
therapeutic effect, safety or compliance.
Soloction of Dosage forms;
Tablets are usually loss expensive than capsules, but while
the cost factor should be taken into account, the selection should also
be based on a consideration of pharmacokinetics, bio availability,
stability under ambient climatic conditions, availability of excipients
and established local prefer ance.
- A range of dosage strengths is provided from which suitable
strengths should be selected on the basis of local availability and need.
- The use of scored tablets is recommended as a simple method
of making dosage more flexible.
- There is a need to periodically revise and update the list.
But frequent and extensive clianges are clearly undesirable since they
result in disruption of channels of procurement and distribution and may
have implications for the training of health personnel.
Provision of information on ossontial drugs:
* Concise, accurate and comprehensive information on the use of
essential drugs should be available to all prescribers in a format that
is appropriate to their responsibilities and levels of training.’
Drug information sheets for the doctors by WHD’s Expert Committee
on the selection of essential drugs has been compiled in the following
format:
1. International Nonpropriotary Name(lNN) of each active
substance. and recommended dosage form.
2. Pharmacological information: brief description of pharma
cological effects and mechanism of action.
3.
Clinical information:
3•1
Indications: whenever it is thought appropriate, simple
diagnostic criteria should be provided.
3.2 Dosage regimen and relevant pharmacokinetic data:
12/
. ---ar
LG) & ig
VH/,I:pt:19.7.'84
12
:
3.2.1 x-.verage dosage and range for adults and children
3.2.2 Dosing interval
3.2.3 Average duration of treatment
3.2.4 Special situations, eg. ronal, hepatic, cardiac
or nutritional insufficiencios which require either
upward or downward dosage adjustments.
Contraindications
3.3
Precautions (reference to pregnancy, lactation etc.)
3.4
Adverse effects (quantitate by category, if possible}
3.5
3.6
Drug interactions (to bo mentioned only if
clinically relevant; drugs used for self-medication
should be included)
3.7 ' Overdosage:
’ 3.7.1 Brief clinical description of symptoms
3.7.2 Non drug treatment and supportive therapy
3.7.3 Specific antidotes
4.
V.
Pharmaceutical information.
TIE. RjglOMAEE OF ESSENTIAL DRUGS
The concept of essential drugs is the backbone of any Rational
Drug Policy. The repercussions of acceptance and non-acceptance of an
essential drug list arc too many. If there is one unanimous demand which
has to come from us people it has to bo the selection of an essential
drugs list based on the health needs of majority, for priority to bo
given to
- ensuring their production
- ensuring their efficient distribution
- ensuring appropriate stocking of pharmacies with these drugs
- ensuring appropriate drug prescription and practices to be
based on those accepted drugs.
Since 46$ of the drugs marketed
selection of essential over unessential drugs can have/a groat intoact.
specially ii this is associated with a total boycott by the consumers
and health personnel, of highly irrational and hazardous drugs-as was
done by Swedish doctors.
The boycott led by Dr. Olio Haasson, Paediatric
Neurologist in the international campaign against clioquinol, moxaform
related drugs was later joined by doctors of Norway, Denmark - totally
bj over 3000 doctors and veterans.
The implementation of essential
urugs list needs to be dono urgently and the reason why it is so crucial
arc given below*
u.ioi
tto
The.myth of ’pill for every Hit detracts from the real health
issues being dealt appropriately. The majority of drugs manufactured
J41103sential and not based on the health needs of our people. Of the
1260 crores worth of drugs manufactured in India in 1979-*SO,only Rs. 350
crores worth of drugs were essential and life saving drugs, the rest wore
mainly non-cssontial drugs.
13/
COMMUNITY HEALJH C^LL
47/l>(rirst Moor)/”
D-9/33O(c)
LCD;a.24.9.84
Sub: Banned Brand Drug List.
Dear Friends,
The banned brand drug list is being sent to you. The list is
divided into 5 classes.
Class I: Drugs banned under gazette Notification of 23rd July 1983.
Class II: Drugs that should have got banned under the same notifi
cation but were not because of the existing ambiguity of
wording . eg. See Category 4 which is strychnine Yohimbine,
-.test
ester one and tonics. Any drug containing yohimbine and
'..-iS
strychnine or test esterone in tonics is just as irrational
as a drug containing all the 4(obviously the number of dru ,s
affected this way are much less.
Class III : Drugs recommended for withdrawal by the Drug Consultative
Committee(Original list attatched -Appendix A)
Class IV; Drugs that were banned independently ie. drugs which hhd
no relation with Drug Consultative Committee recommendati r_.
Class V: Problem drugs that should be severely restricted if not
banned, eg. Anabolic steroids for children,Phenyland
oxyphen butazones.
Class VI: Irrational combination of tonics,cough syrups etc.
To be compiled by friends in the Drug Action network.
The sequence used is that given in the Gazette Notification.
The three, obliques x/x/x inddcate DCC/DTAB/Gazette Notification tc
facilitate cross checking. If there are any errors they are uninte.
You are requested to review the list, add/substract/modify
according to most recent information. T her§ is notmachinary for
sharing unbiased drug information Caracas health personnel and con
sumers would not have to spend time on this. If this list makes son
of the drug companies upset, we cannot help it, they had more than
$2 years to compile and disseminate a more accurate,more up-to-date,
more impressive banned brand drug list.
The list is as comprehensive as we can make it.
Note: - It is possible that some brands have been reformuJa ted.
eg. Some APCs may now contain Paracetamol instead of Phenacetin whi' :x
drug companies hasre actually done so and withdrawn their earlier Al-;Cs
containing phenacetin. We do not know you can of course double chec
the contents on the container.
After the Kerala High Court Judgement 1982 a directive had bee
given to State and Central health authorities to make the banned
brand drug list available to the Public. It is end of September ’84.
This list is made in Public Interest .Use it in whatever ways you ca;.. 9
share the information with others. Information and knowledge are
powerful tools for action.
YOU ARE REQUESTED TO BOYCOTT THESE PRODUCTS?AS THEY ARE DANGER
OUS AND/OR IRRATIONAL. We have a right to safeguard our health and
that of our people.
Prepared specially for upug Action Networkers and VHAI members
with help from Dr Rane and Dr Anil Filagaonkar of Arogya Dakshata
Mandal. Late Mr Agacy, Cynthia Brown have helped with the earlier
'Black Lists’. For the final version we owe our thanks to Alphonse.
In solidarity,
Dr Mira Shiva
Coordinator
Low Cost Drugs & Rational Theraptics,
i
A^>
D-9/33O(c)
LCD .a.20.9.84
y
BANNED BRAND DRUG LIST
Note:
Banned drug list is being divided into 5 classes:
1. Drugs banned under the Gazette Notification
2. Drugs that should have been banned under Gazette Notification in
absence of the ambigious wording, or modification.
3. Drugs that were recommended for being weeded out by DCC and were
not weeded out.
4. Those drugs that were banned earlier separately, eg. E P drugs.
5. Problem Drugs that should be severely restricted if not banned,
eg. Butazolidine Tandril, Hydroxyquinoline, Anabolic steroids for
children.
6. Irrational combinations of Tonics.
eg. Vitamin B Complex Liver extract and iron.
Drugs belonging to Class I are being dealt with first, the sequence
used for the various categories is based on the sequence as in
Gazette Notification.
Nos used in Category
DCC/DTAB/Ga- Banned,
zette Noti
fication res
pect ively.
Name of the
Drugs.
Drug House
Content
Source Availa-
1980/82/83
CLASS I
2/1/1
Amidopyrine and its
combinations.
Ethnor
Adysmene
Al erg in
Cipla
Aristapyrin Aristo
Gajiar’s
Arthrex
Biochem
Biopyrin
Bipipyrin
B P Labs
Bombay Tablet
Bitapyrin
Butapyrin
Inga
Butarin
Themis
Cibalgin
Ciba
Ind on
Dolorindon
Eropyrin
Eros
Esgipyrin
S G Chemicals
Mercury
Meparin
Naphapyrin
Nap ha
Nectarin
Nectapyrin
Ne o-Spaam ind on-Ind on
Optalidon
Sandoz
Oripyrin
Indo Pharma Labs
Jagson Pal
Phenorin
Phenylbutazone & AmidopyrinPharmakab
Predapyrin
Eros
I nd on
Pyrindon
Uniloids
Rumipynine
Mercury
Spasmerin
Indon
Spasmindon
Spasmo Cibalgin-Ciba
Therapeutic
Theraphen
Pharma!81
n
H
MIMS'83
Dolviran
C od opy n
Apidin
Trevpel
Bayer
Stadimed
IDPL
German Remedies
ii
CIMS ’83
.. .2. ..
Eos used in Cat eg or
DqC/DTAB/Ga- Banned,
zette Not!
floation res
pectively_____________
5/2/2
Name of the
Drug.
Drug House
Content
Source
Availa
ble in
the inp' ket or
not.
Fixed dose combinations of Vitamins with anti inflammatory
agents and tranquillisers:
Placidin
Lupin
Spasms Proxyvon-Wockhardt
Dicyclomine HCL,Dexhoproxhphene HCL,Acetaminophen,
Cloriazephoxide
Sudhinol-M-C compuund-Ranbaxy-Lexnopropoxyhene, Napeylato,
ParaxetamoL diazepham
Tylenol wj.th codeine -Ethnor- Acet am in ophen, Corcintamokt rop rophyhen,Paracet am ol,
diazephem
Cater Wallace
Walagesic
Analgin, Goedine ,phos
Citadel
Conaril
”, JPanac etaihol, d iazepam
TTR
Pharma
Paranal
Sedyn-A-Fort e
Wy£th
Equagesic
Meclozine HCl,Nicotinic
Uni-UCB
Diligan
acid,HydrOxizine HCL
6/5/3
Fixed dose combinations of Atropine in Analgesics
And Ant ipy ret i c s:
St ad med
Eythel morphine nec
Ant ispasmin
Phenolphtha leiin,Phenobar
bit one. Amidopyrin, MIMS’65
Atrophine mothonit rat e.
Eskaylab
P arac et am ol, Hy osc y am in e,
Prydonnal
scopolamine HBr,Phenobarb
Atropin sulph.
Standard
Analgin, Atropin methonit rat ,
Spasmolysin
Papaverine HCL,Diazepam.
..o5...
Ws used in Category
DC C/DTAB/G a- Bann ed.
zette Noti
fication res
pectively
1 980/82/95
Kame of'the
Drug.
Drug House
Cont ent
bouce
(
0/4/4
Fixed dose combinat..ions of Strychnine
and Caffeine in tonics.
8/5/5
Fixed dose combinations of Yohimbine and
strychnine with Testosterone and Vitamins.
9/6/6
Fixed dose combinations of Iron with Strychnine,
Arsenic and Yohimbine.
10/7/7
15/9/8
Avan
ble i.
the mu
ket C7not.
Fixed dose combinations of Sodium Bromide
Chloral hydrate with other drugs.
Gy nod ex
Retort
Ext. aletris, Ext'. Vibunui
Ext. hy©scyamus, Ext. of
ovary, Ext.of placenta,
Sodium bromide.
Phenacetin and its combinations:
Pharma185
Anti spam
Cooper
H
Asthimindon
Ind on
Bellaspin
Kibin
Cyperdine
Cyper
Dolviran
Bayer
Espico
Kirti
Influenza Tabs Bey* s, Acila
Phenacin
Kirti
.Qinarsol
Cipla
Spasjnindon
I nd on
Spasmon
Semit
Ve neo spasm in
Veniyon
Capherin
Mercury
MIMS T82
Dolopar
Micro
CIMS 82
Treupel
German Remedies
Both
Veganin
Warner
(Continued on Page. 12)
1/10/9
Fixed dose combinations of anti histaminics with
anti diarrhoeal^.
A®
Clorambin
Light Jia2)lin,Fectin,
me omyc insulph,d i iod ohydroxy quin,line belladona,
Chloraphenaramin,mebat e.
2/11/10
Fixed dose combinations of Pencillin and
Sulphonamides.
^rystastrep
Dey! s
Penitriad
M & B
Penivoral Trisulfas- Franco Indian
Pentid-Sulfas Sarabhai
Sipromide V
Alembic
SP Ltd.
Stanpen-S
5/12/11
Fixed dose combinations of vitamins with Analgesics:
Micropyrin
Nicholas
Acetysalicylic acid,Vit.C
Phenabid
IDPL
Oxyphenbutazone,Vit. C.
Nos used’ in (Cat
_/ egory
DCC/DTAB/Ga- Banned,
zette Noti
fication res
pectively.
1| 980/82/83
Name of the
Drug.
Lrug House
Content
Source
Avail -.
ble i .
the
mark ?
or nv t.
0/15/12
Fixed dose combinations of Tetracycline
with Vitamin 0.
0/14/13
Fixed dose combinations of Hydroxyquinoline group
of drugs except preparations which are used for
the treatment of diarrhoea and dysentery and for
external use only.
1/15/14
Fixed dose combinations of steroids for internal
use except pombination of steroids with other
drugs for the treatment of Asthma.
Cortihist
Ingo
Prednesolone, chlorpheneamiro
Maleate
Perideca
Merck Sharp & Dohme - Dexame theone,
cyproheptadine.
Aquivorn B12
Nicholas
Free test osterone,,vit
vit.B
.B112
Mixogen
Infar India- Ethinyl oestradiol,testostOestradiol monobenzoate 9 eron
” phyenylpropionate,
Testosterone propionate
” phenylpropionate,isocapx;
Pasuma 'Strong’-Merck
Met hy1 t e st ost erone,vit.E, 0*
Caffeine, recephedrine HCL(tab
Testosterone, Vit.E(inj)
Test iob ion
Merck
" , vit.E,B6, B12.
Hisecron Forte Nicholaso Progestrone,Oestradiol,
benzoate
(a)Sense
Vilco
MethyItestosterone,Vit.E,
Caffeine
(b )Theragran-GB
Sarabhai Ethnyl oestradiol,Methyl
testosterone,Vit.A,B1,B12,
Vit.D, E,
(c)Geriatone
Wyeth
Ethinylestradiol,methyl testostrone, Vit B1,B12,folic
acid, c-,dried ferrous sulf.
(d )Trinergic
Unichem
Methandienone, Vit B1,b6,
B12(capsule)
Methandienone,Vit B1 ,B6,B12(.l.j
Other oral(contraceptives) are combinations of
2 or more steroid.
Dexabolin
Infar India - Bexamethozone,ethynloestrenol.
»»
bocab olin
Nandrolone phenylpropionate,
desoxycorticosterone phenylpropronate.
((Duolut on
German Remedies
E P Forte
Umjchem
Menstrogen
Infar India
Norlestrin
Parke bavis
Orasecron Forte-Nicholas
Orgalutin
Infar India
Osterone
Iyka
Ovral
Vfyeth
...5...
Nos used in Category
DCC/DTAB/Ua- Banned.~
zette Noti
fication res
p actively.
1980/82/83
Name of the Drug House
Drug.
0 ont ent
Source
Aval, a
ble a
the ar
kef :r
no*
Ovulen
Searle
Lyndiol
Infar India
Minivlar ED -German India
Norcyclin
Ciba Geigy
Orlest-28
Parke Eavis
Ortho Novin -Ethnor
Wyeth
Ovral L
Primovrar
German Remedies))
3/16/15/
Fixed dose combinations of chloramphenicol for
internal use except combination of chloramphenicol
and streptomycin:
Chloramphenicol & Sulphonamides:
Blast rep
Sunways
Enteromycetin Sulfa - Dey&s
Kemisulfan "Carlo Erba
4/17/16
7/18/17
dose combinations of Ergot:
Ergatap
Oafergot
Erg ophen
Merc ury
Sandoz
Inga
Ingagen
Ingage n-s-ft
Migranil
Inga
Inga
Migril
Welc ome
Vasograin
Cadilla
H
Ergot prep.
Ergotamine tartrate,Caff ..n-Ergotamine tart erate,
Belladonna dry#ect, bench ft
Erg.cf amine tart erat 15
Methyl ergotamine maleat:
Ergotamine tart erate, Bell dona dry ext. Paracetamol
Ergotamine tart erate,
cyclizine HCL,caffeine
Ergotamine tart erate,
caffeine,parac etamol,pro
chlorperazine ,maleate.
Fixed dose combinations of Vitamins with
anti TB drugs except combination of Isoniazide
with Pyridoxine HydrochlorTde(Vit.B6):
Antic ox 450 -Unichem
Antic ox 600 Cadilla
Rifampcin,INH,B6
Rifampicin, IMI,B6
0/0/18
Pencillin skin/eye ointment:
0/0/19
Tetracycline liquid oral preparations:
Ificyclin Paed.drops -Unique -Tetracycline
Ificyclin syrup
-Unique
”
Linemett syrup
-M e rc ury
”
M IMS
Lupicyclin syrup -Lupin
n
”
Mysteclin-V Paed drops-Sarabhi-T, amphotericin”
Sandocycline susp. -Sandoz
-> ” ,broxyquinoline ,
Subamycin Paed syrup -Dey’s
M)robenzoxaidine
..A...
Nos used in Category
DCC/DTAB/Ga- Banned,
zette Noti
fication res
pectively.
1980/82/83
Name of the
Drug.
Drug House
Content
Source
Subamycin Paed drops -Dey’s
Avr .la
blc ir
the
mar :t
or
t
Tetracycline CIMS &
MIMS
Terramycin soluble Tabs- Pfizer Oxytetracycline ii
H
ti
T e rramyc in sy rup
it
tt
I!
Terramycin Paed drops
it
tt
II
T e r ramy c in Hvi In j
it
II
terramycin IV Inj
trycin/.
'
t MSD Tetracycline
MIMS
n
Alcyclin Paed S drops -Alembic
CMS
Alcyclin-0
Oxytetracycline ”
lid ocaine,anhydrous
oxytetracycline.
I-
0/0/20
Nialamide:
Niamid
.
Pfizer
0/0/21
Pract olol:
0/0/22
Methapyri3iene, its salts.
Capqu
Roc
Pharma- ’ 79
Pharma ’83
. ..17)...
CLASS II
Nos used in Category
DCC/DTAB/Ga- Banned,
zette Notif
ication res
pect ively.
1980/82/83
_Name of the
Drug.
Drug House
Cont ent
0/0/0
Amidopyrine
5/2/2
.FixQd dose combinations of (vitamins)
anti inflammatory agents and tranquillisers:
Butaproxyron
Fkamar P
Maxigesic
Rumat in
Source • Av, •'.a
bl-.,
the .
mar't;t
or :t
Wockhardt
Ind oc o
Ethic o
Nool
Drugs containing Vitamins and anti infl.ammatory agents:
Ranodine
Mgcropyrin
Phenab id
Ranbaxy
Nicholas
IL PL
0/0/0
Fixed dose combinations of Atropine in Analgesics
and Antipyretics.
0/0/4
Fixed dose combinations of strychnine and Caffeine
in tonics:
Cilt one
Buphar
Merck
Orheptal
Sant evini
Sandos
^enophos
Rallis
Toniazol‘
Boehringer Knoll
Aminovin Tonic -Smith Stanstreet
Eunova
German Remedies
Mynberrys
Juggat Pharma
Ranbaxy ’ s t onic-Ranbaxy
Aceiyisalic acid -Alcid -Bengal Immunity
Antiflu
SP Ltd.
APC
-Boots, CPL, J-'ey’s, IDPL, Op il, Kemp
Khand elmal, Nectarine, Pharmakab,
Semit, Swastik.
8/5/5
Fixed dose combinations of Yohimbine and
Strychnine with testosterone and vitamins:
Bavert
Gavarine
PMT
Cadila
Vilco
Sensa
Vig otab
Jagson Pal
Yohimbine
Atul
Yohimbine & Strychnine
Nectarine Peatles-Nectarine
E Marek
Pasuma Strong
Emetine & Strychnine
Usan
St remb in
Pharma '83
9/6/6
Fixed dose combinations of iron with strychnine,
arsenic and yohimbine.
10/7/7
Fixed dose combinations of sodium bromide chloral
hydrate with other drugs.
... 18 ...
Nos used in Cat egory Name of the Drug House
Drug.
DOC/DTAB/Ga Banned.
zdtte Noti
fication res
prctively
1980/82/83
Phenacetin and its_comb 1 nations:
13/9/8
Cont ent
Source
V 10/9
Fixed dose combinations of anti hist ami nics with
anti diarrhoeals.
2/11/10
Fixed dose combinations of penicillin with sulphonamides
5/12/11
Fixed dose combinations of vitamins with analgesics.
Mitacin
hv
blc
th •
or
Nicholas.
6/13/12
Fixed dose combinations of tetracycline with vitamin 0.
0/14/15
Fixed dose c ombinat ions of hydroxy quinoline group of drugs
except preparations which are used for the treatment of
diarrhoea and dysentery and for external use only.
1/15/14
Fixed dose combinations of steroids for internal use
except combination of steroids with other drugs for the
treatment of asthma.
5/16/15
Fixed dose combinations of chloramphenicol for internal
use except combination of chloramphenicol and streptomycin.
4/17/16
Fixed dose combinations of Srgot.
7/18/17
Fixed dose combinations of vitamins with anti TB drugs
except combination of 1 soniazide with pyridoxine
hydrochloride (Vit. B6).
0/0/18
Pencillin skin/eye ointmaet.
0/0/19
Tetracycline liquid oral preparations.
0/0/20
Nialamide
0/0/21
Tract olol
0/0/22
Methapyrilene, its salts.
ot
...t
Nos used in Cat egory
• BCC/BTAB/Ga- Banned..
zette. Noti- ■
fication res
pectively.
1980/82/83
1 3/9/8
Warne of the
Drug.
-Drug House
Content
Source
Aval? i
hie : n
the
mark t
or n. t
Phenacetin and its combinations
Acetylsalicylic ^cad, caffeine &Phenacetin:
Bengal Immunity
PharmaT83
Medinex
... -.
SP Ltd
Acila, Alma, Arora, .Belco,
Bengal Immunity,B.ombay
Drug House,BP Labs,Chemical
& Pharma,Deep^arma,Cooper,
Dey * s7 Eros, Forstar,Hima,
Ganesh,H Jules, IDPL,Inga,
Gyp er Pharma, Kanp ha Labs,
Nectarine, Nymph,. Panacea,
Phamakab, Sanitex, Sarvodjiya
Semit,Stamac,Tablets,Teecee,
Apidin
IDPL
Apihist
Bombay Tablet
Apoci ne
Mediproducts
Aselgin
Gavert
Bodryl
Parke Lavis
Capherin
Merc ury
Capramin
Glaxo
Capsin
BC , u
Godral
Burroughs Wellcome
Col it han CPA- Faildeal
Dolorin
Cal Chem
Dristan
Whitehall’
Flucut
Emkay
. Histacap
ICC
Influenza Tabs-Panaoea
Ingacin
Inga
•Nylac in
Nymph
Painkill
Paras
Panalat e
Forst ar •
Prolene Comp .65- Stadmed
Relaxin,
Franklin.
Salurin Fortej Alma
Supacin
Nymph
V eganin
Warner Hindustan
Verafen
_ :Pharmakab
Verindon
Ind on
Wescogesic
Wesco
Acetylsalicylic Acid,codeine & phenacetin:
Ant ad one
SPLtd '
Cocodin
^HP^er
Alcid
Antalgin
Anti flu
APC
Cod od on
C od op in
Codophene
Cod opyrine
C od ot ab
Cod ral
Dardona
polorin
Nectarine
Stadmed
Gavert
■
Glaxo
Jagson Pal
Burroughs Wellcome
Baidyanath
Throe odme
Treupel
Vaganin
Thio Kof
Homb urg
Warner?
few
Whe“
. .10. o .
CLASS III
Nos used in Category
DCC/DTAB/Ga Banned.
zette Notify
ication res
pectively.
1980/82/95
7/0/0
1 5/0/0
7/0/0
Name of the
Drug.
Content
Drug House
Clit one:
Dupari
Orheptal:
Merck
Avail hie i:
the
market
or Ik t.
Vit.B,Nicotinamide,
Penthenol, Sodglycere ph^s?
mangsulph,caffeine,! Aoo
liver fraction with B12,b!
Nic ot inamid e, Cal. pant hothenali,cupicichl? c^unine ,
he 1, sod glycereo, caffeine .
alcohol, mang chi
Pencillin & Streptomycin
Bistrepen
til emb ic
Bistrepen Porte-Alembic
Dicrys.ticin-S -Sarabhai
Dicrysticin-S800- ”
l!
"
S ForteSP Ltd
Hemacillin-S
Glaxo
Munomycin
Hoechst
Omnamycin
Penicillin St rept omycin- IDPL
Penmyn
Sarabhai
MSD
Penstrep
Campicillin C Cadila
Carb el in
Dy la
Sarabhai
Crys-4
Crystapen & Granules - Glaxo.
/.halgin :
Aarelgin
Adgesic
Ad ol
Algesin-0
Algiril
Alp ox
Anae et
Anadex
Analag
Analgin
Source
MIMS •83
H
tt
It
Pharma’83
Ramsons
Ethico
Acila
Alembic
P & B Labs
Alps
Semit
Concept
A TaCC
Acila,Acron,Alembic,Alkem,
Alma,Apex,A TaCC,Arora,Arya,
Associated Products,Bengal
Health,Belco,Bombay Drug
House,BP Labs,Biochem,Carewell,
Chemical & Pharma,Comet^Cooper,
Cyper Pharma,Deepharma,D WD ,
Ano ee, Fai rd eal, Forst ar, G-overt,
Ganesh,Haffkine,Hima,H Jules,
IDPL,Ifiunik,INDC,Indica,Inga,
Indian,Inventa,ICCO,Kanp^a,
KSDP,Lark,Medinex,Medirose,
Medisearch, Nulife,Nymph,Paam,
Nec t arine,P anac ea,PCI,Pharmakab,
P rakash, P ulymar, Ranb axy, Ray s,
Remedies(I),Sanitex,Sarvodaya,
Semit,SIRI,Smith,Stamac,Tablets,
Tarachem,Teecee,Veniyon,Vidarbha.
•
Nos used in Category
DCC/DTAB/Ga- Banned,
zette Noti
fication res
pect ively.
1980/82/83
e
• T 1
o
Name of the
Drug.
o
o
Drug House
Analpar
Thio-Kof
Anamol
Heiko
Anapiron
Roc
A nmol
Med irose
Anoxy
West Coast
Avalgin
Tharachem
Belgin
Belco
Branco Indian
Benalgis
Biogin
B i o-M ed
Bitalgin
Bombay Tablet
But ac ort Inchon- Ind on
But agin
Aik em,T ablet s
Butaphen Plus-Biochem
Butaster
West Coast
Canapar
U S Vitamin
Capagin .
Kon 'test
Cartagin
Indojhem
Veco
Celgal
Cemizole
IDPL
Cetalgin-D Opt ho
Dadhalgin
Dad ha
Dexabutalgin -Monoekem
Dexabutazone -Stadehem
Diapar
Navil
Dicigesic-N DC I
Die olgin
Kanpha
Dipralgin
PCI
Dizalgin
(Franklin
Dolagin
Pharmed
D ol o-Neurob in -E Merck
Indict
Doloril-A
Dolotril
Saima
Doloxan
Shree
D-Pyrone
B P Laks
Duogesic
Sanderson
DubLactin
Tablets
^ypalgin
P & B Labs
Ebejlam
Eb ers
Ep agin
Kon Test
Eucrasil
Eisen
Eargesic
Phar-East
Eevosone
Alpha
Elunil
Excel
Gavalgin
Gavert
Geecoprin
Paon
Ginol
Nib in
Histarin
La Pharma
leealgin
ICCO
Indalgin
Ind us
Ind o- Ajnalgi n-I nd oc hem
Inflagin
Kanpha
Inflar
Navil
J emjesic
Jems
Kananol
Kent
Kanopar
Kanpha
Cont ent
Source
AvalJ .
hie i
the
mark.;
or n... ’
Nos used in Category Name of the Drug House Cont ent
Drug.
DGC/DTiYB/GaT - Banned
z e'i t e Not i
fixation res
neetively.
1980/82/83___________
M Kaptab
Kapaxgin
Kel'gin ’
'Kee Pharma '
Kepoxgin
Kanpha
La-Pyrin
La Pharma
Lark
Largesic
Medalgin
Medoz
Supreme
Met abut ad ec
Acron
Met oxyl
Wesc o
Micron Plus
Molgin
Dia Pharma
Monokem
Monalgin
Myalgin
Shree
Mylogin
Chemical & Pharma
Neorin
Themis
Nictarine
Nivelgin
Petero
Novapam
Nurolgit
Nulife
Nymph
Nycin
Amee
oad
Orphalgin
Biddle Sawyer
Oxal
Dia Pharma
Oxalgin
Cadila
Oxidigin
Oasis
Min
Oxigin
Dynamic
Oxydril-DS
Bio Med
Oxym ol
Euphoric
Oxynal
Oxypose
Sims
Oxypyron
Thio Pharma
Oxy z ol
Medirose
Palgin
Chemo Pharma
Pamagin
Alkem
Paam
Pamolgin
Panalgin
Carewell
Parageic
Radicals
Paralgenol
Veco
Stade hem
Paralgicin
Emcee
Paralgin
Paralg in
G-odama
Paralgin
Stamac
Par Analgin
Bombay Tablet
G- avert
Paranalgin
Parladim
Eourt.s
Parazoll
Ganesh
Penalfine
La Pharma
Tarachem
Penalgin
Pet rag in
Thio Pharma
Medi
PEI
PRC
Alkem
Predniphenol-6~Gavert
Prim
Primdril
Pyragesic
Jamqons
Synthiko
Quikalgin
Mac .Mohan
Referin
Repalgin
Rays
Resin
Assam ^harma
Source Avail.
............. , . b-le. i:..
the.
markoi
or no
...15.
Bos used in Cat egory
DCC/DT/iB/Ga- Banned.
zette Notifi
cation res
pectively.
1980/82/83
Kame of the
Drug.
Drug House
C orft e nt
Source
•
Avalla
hie in
the
market
or noto
Ricofast
Plazma
Rumalgin
Shree
Rumasol
Excel
Selectagesic
Supreme
Rupalgin
Rup
Shormetal-D
Themis
Spalcin
Martel Hammer
Spanil
Grosons
Spasaron
Kon Test
Spasmatac
A~TaCc
Spasmate
Terce
Spasm o
Enkay
Spasmo-Amid ozone Suprachem
Spasmolyrin
Standard
Spasmogin
Indochem
Spasmlan
Ad or
Sterpose A N
Sterfil
Sunalgin
Medinex
Supralgin
Sarvodaya
Synalgesic
Geoffery Manners
Trialgin-D
Osseisule
Trigerzin
Trigger
Trig in
Biox
Tromalgin
La Pharma
Trypin
Healer
Uniprox
Unicure
Vespanil
Veco
Virgonalgin
Virgo
West Coast
Wespalgin
TOE
Zinalgin
Zonalgin
Eebro
14/0/0
Chloramphenicol with Streptomycin:
Basiplon
Khandelwal
Bichlorfenin
Medinex
Caristrep
Carewell
Cemist rep
Suprachem
Cilastrep
Acila
Chloramphenic o St rept omyci n-Sarvodaya,HA,Tablet s
Chlorocin Strep Jagson Pal
Chlorostrep Kapseals -Parke havis
Chlorostreptoseal IHLC
Chlorosulf
Ranbaxy
Chlorosoin
Dolphin
Cooperst rep
Cooper
Conti Strep
Continental
Dee Strep
Deepharma
Dynamic
Lycos
Glue ostrep
Glue ona.t e
Glyc ostrep
Glyco Remedies
Gravestrep
La Grand el
Ifistrep
Unique
Intest ostrep
East India
Listrep
Lister
...-u.
Nos used in Cat egory
DCC/DTAB/Ga- Banned
zjette Noti
fication res
pectively.
1 980/82/85
Name of the Drug House
Drug
Medistreps
Medirose
Medostrep
Medoz
Monost rep
Monokem
Niscost rep
Nishikam
0-St rep
Opt ho
Paam Strep
Paam
Pharmastrep
Pharmakab
Phenistrep
PCI
Phenistrep
Usan
Phermceostrep
Pharma Medico
Prom
Buff
Ranstrepcol
Ranbaxy
Red st rep
Duff
Rhof in
Rallis
St repcol
New Life
Strephenic ol
H Jules
St rept ac hl or
Forstar
St rept ok ep
Remedies(I)
Streptochlor
Mac
Streptophenicol Mercury
Streptosain
Sain
St reptovil
Vilco
Su nstrep
Sunchem
V ec ost rep
Veco
Vinystrep
Healer
Wilostrep
Dadha.
.
/
. i ■
Cont ent
Source
Aval
ble i
the
mark ei
or r*'/'
7
...15...
class IV
Nos used -in Category
DCC/DTAB/Ga- Banned,
zette Noti
fication res
pectively_.
1980/82/83
....___
Name of the
Drug.
Drug House
Content
Source
Avail,
ble i
the
marks
or no
Those drugs that were banned ’separatiely eg. E P drugs
Ban on 22nd June 1982 DO No*.
and Hydroxyquinoline DO No. X 19013/8/81-D dated 13.8,82
withdrawal delayed to 31.3.83 order changed to combinations
ofhydroxyquinoline group of drugs except preparations
which are used for the treatment of diarrhoea and dysentery.
E P Drugs:
E P Porte
Unichem
Hydroxyprogest- CI14S ‘83
erone,acet ete,
et hniny 1 e st rad i ol,
hydroxyzine hcl
Cumority
Secrodyl
Allenbury1s
Lut-Estron Forte- Mac Progesterone, CIM3 n
oestradiol dipropion
Menstrogen Fortv-Organon-Estradiol benzoate
Progestertone
Cestaplon
Khandelwal- progesterone, ]MIMS183
estradiol benzoate
Orasecron Fort e-^icholas-Ethist erone ,
CMS n
Ethinyl ostradiol
Disecron Forte-Nicholas-Progesterone,Oestradiol
benzoate
”
D.i-I od ohyd.rozy qviinolxhe:
Amebiotic
Pfizer
Pharma* 83
Amecure
Excel
Amicline
Griffon
Amidochlor
Therapeutic
Amidys
Sarvodaya
Ami trig
Trigger
Am oc id ol
Saima
Amoebin
Penta
Am e ob i nd on
Ind on
Bi oquin
Stade hem
C hl o rambin
AFD
Colon
Bmsons
ComHasis
Usan
Davoquin
Albert David
Diazole
G-odama
Digichlor
THP
Dinoquin
Bengal Immunity
Diodoquin
Searle
Diodys
Cadila
Di-iod ohyd r oxy quin-Semit
Di-iod ohyd r oxy quin oline-Alma
Di -i od ohyd r oxy quinoli.ne- Ap exArdra 9 As soc iat ed
Products,Belco/BP Labs,Bombay,
Cadila, Cooper,Cyper,Haffkine,
H Jules,ICCO,Ifinnik,Indica,
Indian Research,Indon,Ganesh,
Kanpha,KSDP, Nec-trine, Nymph,
Paam,Pharmakab,Pharma Products,
Sarvodaya,Stamac,Tablets,Teecee,
. ..16...
■
j
.
Nos used in Category Name of the Drug House Content
Drug.
DCCj/DTAB/Ga- Banned,
zette Noti
fication res
pectively
...... -......... Supreme
Di-Met razole
Eros
Eroquin
Eroquin-F
Phar East
Farnid
Searle
Floraquin
Revers
Furaquin
Saima
Furogil
Gluconate
Glueoline
Zandu
Hist oquin
Indo Pharma
Indosulpain
Nishkam
I nt est ren
Smith
lod ocycline
Indoco
Iodoquin Comp.
Jems
Jemeobic
Max & Kent
Kentizole
Kent
Kentroquin
Kee Pharma
Kequinsa2)l
Plazma
Lumigyl
Vita Nova
Met roquin
Ebers
Moebagyl
Kanpha
Mexogil
Medix
Mexogyl
Tercee
Hid
M & B
Hi v emb in
P &. B Labs .
Novonidagyl
Gipla ::.
Nutrozyne
Bombay Drug
Quincycline
Gavert
Quinildine
_
Sy nt hie o
Quinogyl
Quinomycin Forte. Medley
Saima
Quinop ect
Heiko
Quinozol
Ramsons
Quinsentry
Rays
Rayquinol
TCF
Saril
Stamac
Stambiquin
Sulfa Kaotin Forte-Rays
IRI
Sulphachin
INDC
Sulphazyme
Thio Kof
Thiozyme
Medinex
Trie odys
. Ramson
Tryquin
Unichem
Uni Dys
Cifiss
Vagiquin
Veniyon
Vent quin
Pulymar
Zolaquin
I odochlorhyd r oxy quinoline z
SP Ltd
Alliquin
N I Pharma
1 Ambarid
Emcee
Ambiquinol
fiotrerts
iknebid e TC
Emcee
Amb'izyme Forte
UDH
Aino echin ’
Emcee
•
ikmygil Plus
Angel
Pharma
Andocin
Remedies(l
)
Ant idys
Roberts
Aremzyme
Source
Aval.:
ble / x
the
. mark ■
or . Nv- k
Pharma ’ 8>
...17...
Nos used in Category
DCC/DTAB/Ga- Banned,
zette Doti
fication res
neelively_______________
Name of the
Drug.
Drug House
Content
Source
Avail-ble ii’
the
market
/Baidyaoath Eczema Malham-Baidyanath
Baidyanath Isabhael
”
B rad ex-Vi of orm
Gib a
Chloropectidin
Cal Chem
ulogil
M R Labs
Corto Quinol
East India
Cosmezem
•Jos Pharma
Curogyl
Shree
Darmadar
St amac
Albert David
Davoquin
Deaquin
Cadila
Depedal
Eskay
Dermo Quinal
East India
^equinol
Dey’s
Diacheck
New Life
Diarzole
Monopax
Digichlor
THP
Diogyl
Searle
Dysentol
Quality
Dysentol
Bronkol
Enapec
A TaCC
entakon
Kon Test
INDO
Ent robael
Entero Quinol
Bast India
Ent ero-Vi of orm
Ciba
INDC
Ent erot one
Ent romin
Panacea
Ent roquin
Indo Pharma
Stadmed
Entrozyme
Ent rozyvit
Amava
Forquin
Medirose
Saico
Fungrin P
Gestro Quinol
Prakash
Gquin
Grosons
I od ochlorhyd roxy quin Alm#., Ass ociat ed Product s,
Arora, Cooper, ICC ,Haffkine,
Nymph,Panacea,Semit,Sta&ac,
Tablets, Unit ed , Apex, ICC,
•,.Kanpha, De ep harm a
I od oc ort ind on
Ind on
Paam
Indochlora HCL
Id of ur
Nymph
I of ur
Apex
Metroquin
Rays
Mexaform
Ciba
NuLife
Nudy’s Comp.
Ompect ol
Ramsons
Peet oc in
Thio Pharma
.’pci
Prot oquit
P,rot ozide
India Health
Quinid ochlor
NCPW
Quinid ochlor
Amava, AtaCC
Quinimole
Min
Quinod ochlor
Forstar
Quinoform
Albert David
Stamaquin
Stamac
...18...
Name of t he Bxa^g House
Nos used in Category
- Drug
DCC/DTiW/^a- Banned
zette Noti
fication res
pectively '
Stomazole
Kanpha
Sulpha quin® Bael -SP Ltd
St erfil
Tolnacomb
Uni
c hem
Uni Dys
n
Uni Enzyme
V eniyon
Vencosarin SN
Therapeutic
Vi od oc hl or
Vilco
Vilco 12-210
Ciba
Vioform
West Coast.
Wesco -^ys
Content
Source
Av .
bl
th.
Mir
or
i
CLASS V:
Problem drugs that should be severely restricted if not banned,
eg. Butaz olid ine s,Anab olio steroids for children etc.
Phenylbutazone:
IRI
Pharmed
Usan
Alembic
Alfeesin
PCI
Amphiyrin
Aquapyrine
Vidarbha
Alkem
Arc on
NuLife
Arcure
Arogopyrin
Arora
Aristo
Aristopyrin
Remedies
Arthozolin
Sanitex
Baripyrine
Enk ay
Beesopyride
BP Labs
Bipipyrin
Bombay Tablet
Bitapyrine
Osler
Butadol
PCI
Butacort
Cadila
Butadez
Angel Labs,G-ajl£sh
But am ol
THP
Butany1
Inga
Butapyringa
Franklin
Butasule
G-anesh
But ascarbi sone
Biochem
But ap red
Butarin
Themis
West Coast
Butast er
Indoc hem
Cartagin
Veco
Celgal-P
Chemical & PhaUtia
Cepyrin
PCI
C oirtazolin
Badhapyrin Tabs Dad ha
Delta Pharma
Decapyrine
Delta- Jagozolodin-Jagsonpal
Dexabutarin
Themis
Stadohem
D exabut az one
Monokem
Dexabutalg in
Dexaphenalgin
Sims
Ac etazohe
Act imol
Abapyrin
Pharma ’ 83
n
...19...
Ayaila
Nos Used in Category IName „of the Drug House Content Source
ble
in
DCG/DTAB/Ga- Banned.
Drug
the
zette Noti
maii t
fication res
or T-'.t
pectively______________________________
Dexapyrin-D
-- Sarvod.aya
Ganesh
Dexapyrin
DCI
Dicipyrin
Ebers
Eb eflam
Erobut ol
Eros
SG Pharma
Esgipyrin
Gavert
Gavazone
Paam
Decopyrine
La Grande
Graved ine
INDC
Inapyrin
ICC
In-fcas clone
Jagson Pal
Jagopyrine
if
Jagzolodin
Kebutacine
Kee Pharma
Medi
Medic opyrine
Med oz
Med opyrin
Ramsons
Qmdex
Indo Pharma
Oripyrine
Ort hod ex
Saima
Pamapyrin
Galpha
Lister
Pancy
New Life
Parazone
SG Pharma
Parazolandin
Pharmakab
Phemol-D
Nib in
Phenamide
Sterling
Phenid opyrin
Jagson Pal
Phenorin
Cooper
Phenopyrine
Phenylbutazone
Acila
Albert David
Phenylbutazone
Apex, Bleco,B P Labs,Bombay Drug,
Phenylbutazone
Cyper,Cooper,Chemical & Pharma,
Deepharma,Ganesh,Inga,Indica,
Kanpha,Nectarine,Nishkam,Nymph,
PCI, Sain, Sarvodaya, Semit,'Stamac ,
Tablet s ,Veniy on
Phenylbutazone# Amidopyrine- Cooper, Cyper, Deepharme ?
GaneshyPharmakab,Albert David
Ravil
Prenovil
Gave
rt
P red niphenol-6
Pulymar
Pulrheuma
ICCO,Cyper,Deepharma
Pyrine
Albert David
Remail
ICCO
Ribopyrine
Shree
Rumalgin
Rhumalp out
G^lpha
Stamac
Rhumag on
Carewell
Rumatril
Robert
Rumarem
Siri
Rumatison
INDC
Rumic ort
n
Rumin
Sanipyrine
T eraphen
Thilopyrin
Thiozone
Sa nit ex
The rap eutic
Unique
Thiopyrin
Thio Kof
H
. -.20...
Nos used in
DCC/DT/iB/Gazette Noti
fie at ion respectively
Cat egory
Banned.
Name of the
Drug
Triactin
Triact in-D
Trigxyl
Udypyrine
Venoogegic
0xyphenbutazone:
Actgesic
Algiril
Al ophen
Amid ozone
Anox
Anoxy
Arden
Arodil
Best ophen
Broxyl
But acortindon
But ad ex
Butagin
■^utanil
Butaphen
Buta Proxyvon
Cetazone-D
Coxin
Cypadril
pafenoxyn
Delta Plamar
Dexopam
Diazeril
Disflam
Doloflam
Doloril-A
Doloxam
Febrogesic
Plamar
G-Oxyl
Inf land ril
Inflar
Infladol
Inflamak
Inflarid
Inflagin
Infla Proxycap
Inflavan
I not imee
I nt aryl
Jagril
Jamril
Kapflam
Kapoxgin
Kentigesic
Largesic
Maxigesic
Metrozole
Metrozole-F
Monoril
*
Drug House
Content
Source
1
ab 2
in
the
ma j'
Pharmed
it
Trigger
UDH
Veniyon
Thio pharma
P & B Labs
Alpha
Suprachem
Shanberg
West Coast
Adonis
Arora
Evans
Min
Ind on
Cadila
Tablets
INDC
Biochem
Panama
G-anesh
Carewell
Cyper
Dad ha
I nd oc o
Bombay Drug
West Coast
Standard Organic
Vilco
Indica
Shree, Healer
Feb ro
Ind oco
Grosons
Mectix
Navil
Nishkam
Novus
Radicals
Kanpha
Kanpha
Kandelwal
Keepharma
Ge no
ICC
Jamsons
Kaptab
it
Max & Keht
Lark
Fthieo
Supreme
it
Monok em
Pharma ' 83
st
...21.. .
1
Nos used in C at eg ory
DCG/DTAB/Ga- Banned
zette Hoti
fication res
pectively
Nam e of- the
Drug
Nandril
Neoril
fermy.gin
Neurodin
Neurogesic
Neuroxy
Neurovon
Nibidril
Onalpam
0 P D
Op hen
01g in
Oxalpam
Oxamol
Oxalgin
Oxal
Oxylar
Oxydon
Oxydril
Oxyt od
Oxypyron
Oxymide
Oxybutal
Oxypam
Oxypam Plus
Oxy-Triattin
Oxyrin
Oxyryl Pius
Oxidine
Oxypose
Oxohe-A
Oxydrex
Oxidigin
Oxigin
Oxypyrin
Oxin
Oxym ol
Oxyphen
Oxyphenbutazone
Paramin
Parazine
Prrin
Pent oxy
Phenabid
Phenzyn-A
Placidin
Primoxyphen
Pr'olyn
Prestigesic
Prest igen
Primoxyphen
Red uc in
Referin
Drug House
Content
S ou re e
Aval i
ble
i
the
mark '•
or n j
Nectrine
ICC
Alkem(
Medo Oftem
Beckcem
(hlaxy
Veniyon
Nib in
Khandelwal
Cifiss
Bombay Tablet
Artic hem
Nib in
Nutri Thera
Cadila
Bia Pharma
Lark
Healer
Dy namic
Entod
Thio Pharma
Cadila
Eros
Cyper
Eros
Pharmed
Themis
Tablets
Simis
Rank
Plazma
Oasis
Min
Monokem
Axar
Bio Med
B P Labs
Acron,Acila,Alma,Arora,B P Labs,
Belco, Bombay Drug,Chemical &
Pharma,Cooper,Cyper,Deepharma,
Fairdeal,Ganesh,Indica,Kanpha,
KSDP,Kent,Lark,Lupin
Artichem
Albert David
Artichem
Penta
IDPL
Past eur
Lupin
Prim
Mercury
Syntheco
Stade hem
Prim
Unique
Mac Mohan
...22...
Nos used in Category Name of the Drug House
Drug
DGC/DTAB/Ga- Banned,
zette Noti
fication res
pectively____
Reparil
Fairdeal
Shree
Rilifon
Lane et
Roxypam
ganitex
Sanoxym ol
Sidril
Sims
Suganril
S G- Pharma
Tendazone
Crystal
Thio Kof
Thiodril
Trigger
Trigerzin
Tromalgin
La Pharma
Tromin
Rays
Tromagesic
Themis
V enc o Oxypam ol Veniyon
Vikrant
Vikrapyrin
Virgo
Virgonalgin
Medoz
Zeroxyl
Febro
Zonalgin
Anabolic St eroids:
Ad royd
Anabolex B12
Dianab ol
Dianabol Tabs
Dianabol Drops
Durabolin
H
ft
Organon
0 one ept
Neurabol H
Cadila
Orab olin
Orabolin Drops
Tri nergic
Organon
Winstrol
Aquaviron B12
Aquaviron Inj
Source
' ■■ Av^-...
bl
the
m a;i
or i
Parke Lavis -Oxymetholone MIMS
-Methandienone ”
Cipla"
Vit B12,Ferric amm ci
Methandienone- Both
Giba Geigy
Leea Durabolin
Evab oli n
Trinergic Inj.
Unab ol
Content
I!
ti
tt
it
ti
Nandrolone
CIMS
phenylpropronat e
-Nandrolone decanote! ”
-Nandrolone phenyl hot'
propionate,Vit E
-Bit B1,B6,Hydroxycob.alamin,nandrolone pMen3
MIMS
propionate
both
Ethylestrenol
ti
ti
-M et hand ien one 9 MIMS
Vit B1,B6,B12
ti
Methandienone,Vit B12
it
-Nandralone phenyl hot
propionate
Cosme Farma-Stanozolol
"
-Free test ost erone
Nicholas
-Free testosterone
"
Unichem
CLASS VI
Irrational combinations of Tonics, cough syrups etc.
eg* Vitamin B Complex,Liver extract and iron
"
’*
, Vitamin C
’’
” etc.
(Would like to get your views and help from you)
340(c)
LCD.a.20.7.84
HAZARDOUS, BANNED, BANKABLE AND DUMPED DRUGS
(Prepared f pr -Drug 'Action Core Group meet at Wardha 30-31st
July. ■'84 as a Background paper for discussion)
The issue of dumped drugs for past few years has been
much in the news. The multinationals involved in manufacture
and. sales of such drugs have received their dure share of
condemnation. Foreign government policies which provided the
scope for exports of such hazardous products have been condem
ned by many of us eg. the Clayton'/amendment Act and the U.S.
Hesolution.
It is well known that sales of medical technologies and
drugs' is a commercial enterprise , the motivation is'profit
making and not 'service'. or 'welfare work'.
Realizing all this the question arises as to how much as
citizens of India, can we expect our drug control authorities
to safe guard our interests. The pressure from the drug indu
stry is immense. It is not merely money power but political
connections A influence over the medical lobby. Many of the so
called medical experts are in their pay roll, many others are
conducting 'scientific studies' sponsored by the companies,
attending conferences sponsored by the companies, receiving
gifts and samples from the companies. This affiliation is not
unexpected. Inspite of knowing this our expectations from our
drug control authorities is high. After all our pharmaceutical
industry is the most developed in the third world, ( ie accord
ing to UNIDO it belongs to Category 5,-developed enough to be
self sufficient).
We have demanded that our imports, production and sales
shPtfE give priority to essential, life saving drugs over irra
tional and hazardous drugs. This being along with WHO's guide
lines for Essential drugs prograBmie. The drug industry and its
supporters allege that concept.of essential drugs is only for
'struggling, least developed third world countries and not for
a country like India, with its well developed industry and
high add advanced level of medical expertise .However, this
same lobby puts India in the category of- less developed
countries when it comes to the issue of banning drugs and drug
control, claiming that considei^/11 of hazards over efficacy
are luxuries which we cannot, aff ord!
However, consumers' anywhere in the world have a. right to expeort
that irrational hazardous drugs are, not issued licences and
that licenses of ,®uch banned drugs should be withdrawn as soon
as possible, bans implemented, and that all drugs in the market
are quality controlled. We have 20% substandard drugs ieJin 5
will not be effective With increasing number of spurious drugs
floating in the market, the problem is beginning to take danger
ous proportion.
Since 1980 we've been concerned about this issue of dumped
and hazardous drugs. We widely circulated the list of combinat
ion drugs recommended for being weeded out and printed it in
our special issue of HEM on Drugs April-June 1981. Since then
the story of the drug ban has got more and more convoluted and
fascinating.. Our earlier belief is only reconfirmed that the
<*
government is not serious about controlling the sale of
hazardous drugs. The budget allocation for ensutin- thio
a»a the epns.ep
nothlllg
„n+ ±he.health of the nation seems to be relatively unimnor+Drl’ nn +ni10ahd by decreasing health budget. The Central
Drug Contrl authorities aliege that they have no real nSho
thlrstotpldmentatl+n tS concerned as this depends enti?ely~on
Expenditure on Health a_s ca percentage of total plan
Programme
Health sub
total to plan
FIT I FYP II FYP in FTP"T7~1TP~V----- FYP"VT"
1951-56 1956-61 1961-66 1969-74 1974-79 1980-85
3.83
3.04
2.79
2.74
1.73
1.87
toeifi'?eC+ ahWhat-is haPPeninS to the health budget '
is reeetX^nis enough
l our
wlSOS:t“e.I’rlOrltleS he31tl1
has ?eoSndedYdr^A^?r®tO?S
©o^try (Hath! Committee
aasrecommended}. The required number is one for
druv
K
+> ch®mi3t shops. Only Maharashtra, Gujarat Sd
Kerala have the -stipulated number of drug inspectors snd’sn
adequate drug control mechanism.
P
a Q ar
i
In this paper we will not touch upon the extent of the
problem of substandard and Sj.
^1
spurious
drugs and. the io.
sake
action being taken against those involved in their nameproduce
and sales„
-p 1i wil1 be on what has happened to the druvs recoConoultat^r b®an?7®eded out in 1980. In 1980 the Drug'’
Consultative ogmmitt.ee a statutary body consisting'of modicnl
Z
the
Cos^tSf let (Cental
the r-teion-Jtetv
Especial committee to go into
dXZ -hl
Z Z
ebonies of fixed dose combination
' drSTcr\lln^ ?° htU y W^ether these drugs should be withdrawn or allowed to be manufactured and sold.’
The ^criteria Used by the Co^Utep is very sensible and „straight
A Sub Committee of the1 Dr^r^ult^I^o^iTt^TT^f^
ou+SZnf
drUg controllers, has laid down well thought
. and-rational yardsticks to determine the desirability
of
0±’..druss- As Per ■bhese norms, combinations
of urugs should only oe allowed in the following cases:
a) If there is synergistic action
b) Where there is corrective action
c) When two or more drugs .are normally prescribed toge
ther and taken by the patient simultaneously.
dj When the. dosage of each of the drugs need not be
individualized.
e) Where a fixed dose combination would ensure better
.0,3.00
patient compliance due to convenience of administ ra,ti on.
f) Where-two or more drugs, . prescribed separately ?
may lead to non ingestion of one of the drugs $•
thus adversely affecting the health of the patiente
Conversely, fixed dose combinations of drugs should
hot be permitted, under the following circumstances:
a) Where adverse interactions may occur
When one of the combined, drugs becomes toxic on
prolonged use
c) When abrupt withdrawal of one of the drugs caused
wi thd mwa'l sympt oms
d) If sub therapeutic doses are used in the absence
of clinically demonstruble synergism
e) When pharmacokinetic behaviour of the individual
agents is grossly different.
d)
Thee riteria used by Bangladesh for banning 1742 drugs is
given in the appendix 1 .
We'4.} just look at what was involved: in attempts.to b^n
a few drugs, eg. amidopyrines9 High dose E P drugs. Paediatric
texracyclin. steroid combinations are dealt with later under
ambiguity is the name of the game.
The sub committee submitted its repox't? recommended a ban
°t ~C-AS11 drugs and giving their reasons for recommend
ing the ban.
cat^egories of these drugs were recommended for
late, weeding; and 7. of the cat eg orient o” be ‘ weedUl over
• a SEecified .time. Over 500 braST drugT^lcF thus”be affcTted
J. --‘•s list Qi 23 combinations and the reasons are- attached in
the appendix/;. This report was presented to the DOC nt a
special meeting oh 10.1O.^i<a?d later to DT/J3 and Ministry of
Health and Family . Welfare accepted it i-n 1981. The DJAB(Drur
technical -Advisory Board) a Statutary body under section 5 of
Drugss and Cosm.eticsjkcf Central Act 23 of 194 Cfl e comm ended
banning of T8.. fixecl J.ose comb mat ion( list atWstcried as appendix
2)
,
23 P of the DyUgs and Cosmetics act 1940
IhS-lgntral government_has had the powers to issue such
J_o_^hg_Sta.tp governments as required't.o execute
t&LDrug-act.- Und^r_sectioh_18_of_tlie;act the state government
he_p^wer^_Jjj;phib it manuf act ure, d 1st rib ut ion Vh
sale of a rugs, by a gazette notification. '
—
P5®®e
randomly selected from the Pharmaceuti. Ce.1 Guide. Out,_o^ the_se* 35O_brands_44 brands were marketed by
^V-g^n sector, 8 by public sector
'^riyatc sect’u/.
t0 note is that most of these drugs were being' produCCd + '
9cmPnnies and not multinationals.’This
W'a+u“.O2? ‘
n^l^^-<l~-^i^o..^innat.ion. According to the
authorities the purpose was to give time limit to firms who
already purchased the bulk drugs for manufacturing
t ^the^r^^com^aiLeS comPaSsion and consideration'shown
. ..4. ..
/J4 ID OP YR Iffg
The Drug Controller of India(DCI) by DO No 127^/77 ro
iSSf Ofht?^te DrUS broiler tolai ?he^leZ^Se^c^b-
inauion oi axiidopyrine on effect from 3.2.82. Orders were
■ October 31 ft°-frQffln
July ’82 and sale by
3 o
82. this ban was Later extended further to 31.5.g.
;
The DCI through his DO No. 1 9013/8/81D .dated 22.4.82
ftvXfdn lhe S^te,]?rug Controllers to ban the manufacture of
.ixed dose combinations from 30.9.82 and their sales from
t0
Sa4Xe Panel report government decision to
witndraw p50 unnecessary drugs was taken.
When Maharashtra HU d.i,d ban amidopyrines., the multina+ yiia+, mOf ?f-£ec’te(i manaSed to get a stay order on the grounds
that tne drug was allowed to be_ marketed in other states by
rfUU
In -•-^80 U fovulations of amidopyrine pro
ducedby 20 so manufactures were in the market. Multinationals
to'qiSi®- blg d^uSLouses higW -trusted by the public such
as Suhr'L^eigy, Sandos, Suhudgeigy, Unichem, Ethnor, Thems,
mdon were involved..Most of these drugs were being sold without adequate warning.
P,.„- As ?r^ful Bridwai on 19th August 1980 stated in the
-inanciax rimes Harmful drugs production still not stopped?-reluctant to lose their market share, these companies have
merely continued to produce and market amidopyrine and are
continuing to sell their preparations without even an additionai warning about the drugs side effects.
Mukaram Bhagat OontrcR for Edu’chtionUrd Bcc^entation; ■
in Aspects df Drug Industry in’India' gives the example of
amilnaau government medical list for government hospitals in
mnnhh*dr^T ^lke amidoPy-i^, phenacetin and ainalgin are very
much induced even .when, .they were considered' harmful and been
disallowed, PHEKACBTIN AND HOLOGEWED MBROXYQUINOLIKE-:
fixed dose combinationB of phenacetin and holoft&ix1 xiydroxyquinoline was to be effective from 1,11.82.
The date, of the ban-of fixed dose combination of amidopyrino,
phenacetin and halogenerated hydroxy quinolines was extended
to J1.3.83 through DO No. XI9013/8/81-D dated 13.8.82.
4.
In 1979 January the Drug Controller of India.had issued
an order to gradually phase out amidopyrine as always 'phased
d-iscontinuatioi±’ process was not meant to be implemented as
there- were no specific PE7£LIhESe
HI&H DOSE - Off E P DRUGS:
Through another DO No. 12-48/79-PC dated 26.6.82 the DGI
directed the State Drug Control].ers to ban the manufacture
of high dose e^t-rogen and progest er one combination from
31.3,83 and their sales from 30.6.83.
M/S Unic.hem Labs Bombay (OP 2927/82 of writ petition
2928/82), M/S Nicholas Labs Bombay and M/S Organoh (now known
as Infar (India)Ltd Calcutta filed writ petitions in Bombay
and Calcutta, high courts against the DC.l’s instructions to.
ban these drugs, their conie.ht'io'n
that Central government
has no powers to ban the drugs. The high court of Bombay and
Calcutta have granted stay orders and these products continue
to be available in the market.
Even though section 10A and. 26A of the amedned Drug-and
Cosmetics Act (April ’82) empower the Central Government to
prohibit importf manufacture and sale of any drugs considered
harmful/toxic or irrational etc. Since the matter regarding
. high dose E P drugs was in the court, these drugs have NOT been
included in the gazette notification of the DOI issued on
23.7.83 banning 22 fixed dose combinations.
What is absolutely objectionable is the fact that(this is
inspite of the act of the Drug Controller of India’s earlier
instruction dated 26.6.82 banning the production and sales of
high dose E P drugs from 31.3.83 and 30.6.83) M/S Organon
(INDIA) Ltd have managed to obtain ext ention of licences to
manufacture these products for another 2 years.
A sample of high dose E P drugs from Calcutta with manu
facturing date 31.12.83 indicates that the. ban is not merely
being flaunted by Organon but by other drug companies manufa
cturing these products.
The misuse of these drugs for hormonal pregnancy tests
and for attempting to induce abortions continues massively.
PAEDIATRIC TETRACYCLIN
Manufacture of Paediatric tetracyclin drops was to be
banned from 1.5.82, no date was then given for marketing.
Paediatric tetracyclin have since been banned on paper. ^They
are still available, OTC, without warning.
Paediatric tetracy&lin ban too does not figure in the
gazette notification of July 23rd 1983.
On April ’82 the Drugs and Cosmetics Act was tended
whereby the Central Government and the Central Drug Control
Authorities were given specific powers to, ’ban the import,
manufacture and sale of drugs in public interest(This was
mentioned in the drug Action Network Newsletter October ’<QT'
and ~26A
Section
—y
3(b)
v K.. / (i).
Va_ / . . was KJsubstituted
vi-Y O w _u u my itiM. cXilMand osection^
at. U J. Vll. 4
.
were inserted'
inserted in the act. This came into eff^eff"'-v<. lrom
— 1 • Jobe.
This means that had our Central Drug Co^4xO-L authorities wanted
• •
• ■ --banning t>
t
manufacture and sale of
it, gazette
notifications
' “
•
’
■
r
1_
oaken
immediately under the
these drugs could have been und
section
26A
of the act exercised>
powers invested in it und^x l_;7
.
- — —
****—-
The implications of this delay have been that certain
drug companies have challenged the drug Controller of India* s
’
Some of them have even got st,ay
authority to ban these drugs
making
these bans ineffectual and
order against specific bans,
the whole drug control authority of our nation a laughing stock.
The drug control authorities see their role as mainly advisory
and hence don’t feel particularly perturbed. Actually to come
to think of it no one in the Health Ministry at Centre or State
level seems to be particularly perturbed.
Allowing this extended time period during which imports
manufacture .and sales’ have continued amounts to ’ arbit oriness
and discrimination’ under article 14 of Constitution of India,
i-
according to Vincent Panikulangara since these drugs would be
dumped in the market,
’ ' » substitutes withheld. With our efficiency
of drug control mechanism,, ;products
'‘1 in
‘
the chemists shops will
continue to be sold and never withdrawn.
According to Section 26A- of the Erugs and Cosmetics
Act 1940
:.^o
"Without prejudice, to any other provisions cont
ained in this chapter, if the-central government
is satisfied that the use of any drug or cosmetic
is .likely to involve any ri&k to human beings or
animals or that any drug does not have the thera
peutic value claimed or purported to be claimed
for it or contains ingredients and in such quant
ity for which there is no therapeutic just ificat ion
and that in the public interest it is necessary or
expedient so to do, then that government may, b^r
not if ic.at i on in official gazette prohibit the manufacture, sale or distribution of such drug or
Cosmetic”._______________________________
Under section 10A of Drugs and Cosmetics Act of 1940 also
there is a mandate that following a gazette notification
imports of injurious drugs can be banned.
Article 47 of the Constitution of India lays down
that
■’The State shall regard the raising of the level
of nutrition and standard of living, of its people
and the improvement of public health as among its
primary duties and in particular the state shall
endeavour to bring about prohibition of the con
sumption except for medical purposes of intoxica
ting driiiiks and of drugs which are injurious to
health”.
Under section 53 P the DCI directed the State Drug Contro
llers tolban the 20 fixed-dose combinations. The State Drug
Controllers under sect ion 18 of the act could exercise their
power and prohibit their manufacture and sales by issuing a
gazette notification. According to Vincent Panikulangara, the
v-State Drug Control authorities are guilty of not exercising
their power and taking responsibility. they have thus violated
s.ectipfl -1Q Q-nd 33 . of the Drugs and Cosmetics Act and violated
the fundamental right of the public citizens to health and life
under, section 21 of the Constitution of India. Article 14 of
the Const itution is also violated by their having acted in a
arbitrary and discriminatory .manner contrary to public interest
in favour of the Drug companies. '
Kerala High Court Judge Mr Potti’s judgement on Vincent
Panikulangara*s writ petition speaks for itself.
”4s_between:..the.. lives of_ the, citizens of this
country on ’^the _one ha,nd_ and loss that may result to
the manufacture and traders by the inm^diate^ban
on the mo.hufac’ture ’j.nd ' sales on t'he_ other, ’ the
government had chosen to/yiew the latter as of
more, concern’'. It is .the” duty* of the state to
protect its ‘Citizens from injury and harm especially
when the injury is not inevitable” 0
Acting Chief Justice
1 Subramanian Potti and
Justice Paripuran
Kerala High Court, in their dire
ctive to the Union of India to release
~the list of bnid^najiies of banned drugsa
In October 1.982-M/S Nicholas(India)Ltd Bombay filed a
writ petition in Bombay High Court- against the decision to ban
the fixed -dose combination' of aspirin and vitamin C. The
Bombay high court after the hearing of the respondent ruled
that State Drug Control authorities has no power under Section
18 of the Drugs and Cosmetics Act to stop the manufacture and
sale of these products.(The high court ruled that it would be
open to the respondents-as and when the'law has been enacted
to pass any fresh order as it is considered necessary in accord
ance with the law after following procedures prescribed by the
- government).
Subsequent to thfe Drug^xinendme^nt Act coming into force on
1.2.8J the manufacturers have again gone to court challenging
the central government and sections 26a and 10A of on grounds
of ’’LACK OF OBJECTIVE CRITERION for such ban”. (A special hand
out on Rationale of the ban'is available with us).
The Commissioner of FDA Maharashtra State(which is suppo
sed to be having the best drug control mechanism) had informed
the DCI that in the light of the ruling given by the Bombay
High Court
would' not" be possible for him to t?ake .any action
to stop the manufacture’and. ’ sale of any of the 'fixed dose. .
combinations in quest ion”. (Lett er dated 9 June 1984'by Drug
Controller of India, to' us) i
It was probably the above as well as Vincent’s writ
petition against the state and central drug control authorities
for not having used their power that forced DOI to issue the
gazette notification. .1 point to note is that drugs banned earlier and at different types make the brand banned list. E P
drugs arc not ■'i nd 1 tided iK-the 'gazet-t eanctif ioat ion. x' .
\
J
The ambiguidty of the wording of the gazette notification
hit us early, when we attempted to compile the banned brand
list. It was not clear whether for eg. in Category 4 include
- any drug containing yohimbine or strychnine would be banned
(as neither of the two were considered to have therapeutic
value and infact could lead to serious side effects as stated
even by the DOC).
- or the ban was applicable to drugs containing both yohimbine
and strychnine.
""
- or to y oh imb ine a nd strychnine with test est erone or vitamins
- or ONLY to drugs which contained all 4 ie. yohimbine,
strychnine, testesterone and vitamins.
Another doubt was regarding criteria 12 ie. whether it
could effectively deal with steroid and antihistamines combi
nation which could be indicated for allergy as well as asthma.
First of all DCC had reco.-nmended a bam,of all steroid combinations. Making this exception would ■obviously encourage misuse.
Aft er all, dqesn’t the microscopic print in the medical litera
ture for high dose E P. d34ugsnow-a-doJys say only secondary
amenorrhea and isn’t it true‘that it is mostly' used for pregn
ancy testing and attempt:Jng abortion?’ changing the indication
...8...
on paper of a hazardous drug won't alter its use. Similarly
allowing steroid combination for asthma won't present their
misused for other conditions.,
The DOC had recommended banning of all fixed dose steroid
combination^ DT..AB decided to prohibit manufacture of fixed
d o^e^bomb mat ion of bronchodilators, ant ihist .aminic s and tran~
jquillizers with corticosteroids as early as October 4~, 1980.
Dr B Shankaranand, the then DOES, chairing a meeting had
s.aiu ”fhe current medical practice in.all the developed c'ountfles/s to give corticosteroids separately and fixed dose
■QlUkiRP-tions of corticosteroids with other drugs ^re bein"
discourag ed ”.
‘
:"
Prof. Harkishan, Singh of the Department of Pharmaceutical
Sciences Punjab University stated, .that there existed ’’published
evidence toshow that cortico steroids taken in small doses
over longer periods are more harmful than if taken in larger
doses over shorter time”.
The Drug Consultative Committee comprising of.all state
Drug Controllers entrusted the responsibility of evaluating
54 categories of fixed dose combination, on basis of their
rationality to a sub-committee. The sub committee comprising
of some distinguished medical experts recommended a ban on
steroid combinations. The Committee warned against compulsory
intake of ^steroid because the ’’fixed dose combinations of
steroids for internal use can produce serious side effects viz
iluid and electrolyte disturbances, hyperglyceria glycosuria,
increased suscesptibility to infection including. TB, peptic
ulcers, osteoporosis, steroid myopathy, cushings syndrome and
hersutism, combination with bronchodilators etc.”.
On December 51 , 1981, the Drug . Technical Advisory Board
constituting of exactly the same members reversed its own
earlier decision. It felt that there was a need for getting
wider medical opinion and further details and allowed the sales
of these products.
Dr Gulati MIMS Editor in his editorial MIMS India Vol. 2
Ko.5 February 1982 writing about the ”sun^rsQult on steroids”
says ’’they must have had very extraordinary’’’reason *td
a) reverse their own earlier decision
b) ignore the advise sof DOO
c ) consider the opinion of the whole battery of eminent and
d1stinguished medical specialists from research institutions
as inadequate so as to ask further details and wider mediaal
opinion”.
It would be interesting to find out how and why this
change in their stand on fixed dose combinations of steroids
took place. We would very enthusiastically have undertaken this
exercise, had obtaining information such as this, been a less
t e2Li ous, less time energy consuming and .less frustrating affair.
The' Kerala High Court judgement, in response to Vincent
Panikulangara’s writ petition OP 8439/1982 had directed the
Central and State. Drug control authorities ’’tojpublish the
list of trade/brand names and the_ names of . the manufacturers
of these drugs/This was/in 1^982. Repeated requests for the ■
same have been made, to the Cen'^ral- Drug Controllers office.
Some of the Drug Action netwoif :ers have been requested to do
the same at the State level.'
. Excuses were made that the drugs have been licenced and.
registered with State health authorities and the centre alleginvHi i
about the various formulations and brands
involved. The urug control mechanism is so inef+^-ieut that
list of, these products has taken more
th|ii one year. To ensure' their ban’ or ■’ quality control’ would
1 - simit ely take a cent ury.
It should be noted that the drug ban will be applicable
for lesser orugs than what we had anticipated. Taenite of the
presence of irrational and hazardous ingredients only those
drugs will be banned that contain all the ingredientsV^Tti an.-d
in the various categories eg. under category 5 -only thoseurugs containing all the following ie. yohimbine + strychnine +
Testesterone + Vitamins will be affected.
According to Dr Das Gupta, Asst.Drug Controller the
canned brand list will be ready in about J months. We had orepo.reu our own black lists of banned or bannable drugs as far
hack as 1982 which have been circulated amongst the health
care institutions in the voluntary sector and drug action
workers. These black lists have been for
O £li2CLyinols, hydroxy quinolines ie. mexaform and Co
21 djnidonyrines - abalgen Ergopyrine
3) Paediatric tetracyclin
4) £iphenexylate - lomotil etc.
5) Anabolic steroids
6) Penicillin and streptomycin
)
In DC0 recommendations
7) Chloramphenicol and streptomycin
8) High dose E P drugs
9) Aptiinflammat ory agents and steroids etc.
(Background papers based on the above underlined drugs had
been prepared and are available).
2-3 attempts at compiling the banned brand list based on
drug banned by the gazette notification have been made. Three
things have prevented us from widely circulating them.
U Our. expectations from our drug, control authorities to make
at i'east after' the 'Kerala High Court ‘Judgement
a^Supreme _C'ourf~writ- pofitToiu
------ --- --- : -■- ■'
ii) The
p#'. formulations
.
the State Drug" CbnifolTiuihorities.
iii) The process of .reforaulat ion “of “vari ous drugs taking place
w|th our not_hayi^'Vhy''itifo'riiiatidn''as'’to
a) which drugs were being formulated and sold as reformu
lating? '
b) Which drugs were being reformulated but their banned
formulations under the same BRAND existed ?we’re sold
unscrupulously in the market?
c ) Which were the hazardous banned drugs still being manufactured and sold as such?
Our health and drug conTrol-.authorities get extremely upset
when we mention the achievements of Bangladesh in their attempts
towards a Rational Drug Policy. Inforced to mention Bangaldesh
again. It should be noted that after the issuing of the
Promulgation banning 1742 drugs in June 1982 the time period
given to the drug companies of 3, or 6 or 9 months was given
..withdraw these products from the market, to destroy these
products, even their export to other_ countries was strictly
prohibited. We, on the other hand have failed to implement a
recommended ban by our own government comnii11ees ^nd banned
by our -.own drug controller. The drugs banned were mere^few
hundred, not over a 1000. The time period given was for the
A
...10..•
drug companies, to complete the manufacture of their formula!i^rr
and sell off their stocks. The stocks surprisingly like Med us’i.:
head never seem to finish off.
Nepal, Pakistan, i<nlnys_iaf< Sri Laiika^and Ban^adesh. feci
that_clioguinol; (hy^
f ohaulati ons . have no signi
ficant the'rapeut ic\value ’ and can .hayejiiajpr side effocts^.-Thcy
have’■'dec id ed jt o ’ b an t he s e' d r ug s. C ib a. & e igy.. makers.. _of.. m o xa f o rm
have’ announcedtheir plans t o withdraw „tho. drug froia interrationul jii ark ex. V/e continue to allow them to be sold and pro
moted under more than 90 brands (including those produced by
our public sector.)
The Drug campaigners from Bangladesh, Sri Lanka have
complained about the outrageous smuggling in of these banned
products from India. Our continuing to allow the manufacture
and sales of these hazardous and irrational products is not
merely hazardous to the health of our.people, it also cr^ptes ”
problems for our littler neighbours who are attempting to rat
ionalize their drug' policies, in the interest of t heir people.
If our government authorities cannot^make all that goes
XijA.eJls?ri^."jgTod. Jie.oTtli^ avaITaKIe ’16""itsTTOO^millToh’ people
it has ho business to allow irrational and hazardous^ drugs tjj_
b"e"” iri'fTict'ecI’up oh t’K’ehi.*’
We will compile our own banned brand list and while the
game playing goes on between the health, drug control authori
ties of centre and state;
thedrug, industry and the high
courts we will ensure that all these drugs are BOYCOTTED: by
health personnel ns well as consumers.
The DOI had in one of his meetings last year pointed out
that unhygienic conditions in the public hospitals, lack of
clean water, sanitation quackery and unethical practices hy
medical personnel were greater problems than continuing sales
of few hazardous drugs.
We want to make it clear that the issue here „is not
merely_of^banning a few hazardous and. irrational drugs but it
^s...^.9^/9£,^.*°n‘'what '*is^o2?’hg^’T)h 'in "the name“hT^ffea±th ’chfc1 o’
?.$. i-g-.?"Tight'That" when~ causes "’of “Til 'hiealThTie TIsc-'’
where in_primaVny~’‘*de^
'’vjiTTThere' cone
^bhht;.A. Tignlf1cant' change "in Th'c'TieaTt'h statTs^and "quality of
li.£e..ef_.;our_£eople?‘ There are no effective pTlTs against'.'”
poverty and the diseases of poverty. To deny people their
right to health care is' bad enough, but to let loose ’garbage
and trash in the name of medical care is is inexcusable ;. "
inflaunting- and totally unacceptable.
Dr Mira Shiva
0 o ord inator
Low Cost Drugs & Rational Therapeutics
Voluntary Health Association of India
C-14, Community Centre
D~1O/54Q(b)
101)725.5.84
Safdarjung Development Area.
New Delhi-110016
Telegrams': VOLHEALTH
A/
c
iz
o,
New Delhi-110016
T , .
668071
Telephones :
668072
Rationality in Banning Fixed Dose Combinations
M 0 Bindal, RyS Saxena(Mrs), Suman Lata(xMrs) & B P Jaju
Dept of Pharmacy & Pharmacology,
LLRM’Medical College, Meerut.
Hath! Committee (1975) appointed by Government of India
pointed out that the medicinal needs of the people in India
can be met by only 116 drugs. However, over 25,000 drug formu
lations continue to be sold and prescribed in India. Many of
th@e formulations are unnecessary variations of identical basic
drugs sold under different brand names ©r without any proven
therapeutic effect or they are too toxic for human consumption.
Unless there is a clear cut proven therapeutic superiority or
a fixed dose combination, such combinations not only put finan
cial hardship to poor patients but also expose the patients to
the undesirable effects of the unnecessary medicament(s) of
such formulations. Dr H Mahler, The Direct or General of WHO
feels that 98 % of the drugs available in the developing world
aie not essentials hence not required. The Drug Technical Advi
sory Board (DTAB) of India has recently (1982) recommended the
weeding out of the following fixed dose combinations with an
uniform cut off date of March 31, 1983.
1. Fixed dose combination of amidopyrine.
2. Fixed dose combinations of vitamins w..th antiinflammatory
agents and tranquilizers.
3. Fixed combinations of atropine with analgesics and antipy
retics.
4. Fixed dose combinations of strychinine and caffeine in tonics,
5. Fixed dose combinations of yohimbine strychnine and testosterone and vitamins.
6. Fixed dose combinations of iron with strychnine and arsenic
and yohimbine.
7. Fixed dose combinations of sodium brom ide/chi oral hydrate
with other drugs.
8. Fixed dose combinations of ayurvedic 9 unani drugs with
modern drugs.
9. Fise d dose combinations of phenacetin.
10. Fixed dose combinations of antihistaminics with antidiarrhoeals.
11. Fixed dose combinations of penicillins with sulphonamides,
12. Fixed dose combinations of vitamins with analgesics.
13. Fixed dose combinations of tetracycline with vitamins 0.
14. Fixed dose combinations of hydroxyquinoline group of drugs
except preparations which are'usod' for the treatment of
dxarhhook ahdaiysentery.
15. Fixed dose combinations of steroids for internal use except
combinations of steroids with other drugs for the treatment
of a sthma.
16. Fixed dose combinations of chloramphenicol except with
streptomycih.
17. Fixed dose combinations of ergot except combinations of its
a Ikaloid ergotamine with caffeine.
18. Fixed dose combinations of prophylactic vitamins with antiTB drugs except combinations of INH with vitamin B5
The rational for the undesirability of the above said fixed
dose combinations can be based on the forthcoming arguments
andfacts.:
...2...
1.Fixed Dose Combinations of Amidopyrine:
Fixed dose combinations of amidopyrine(.amidiopyrine) are
irrstional because amidopyrine is an outdated and obsolete drug
as it causes bone marrow depression leading to agranulocytosis
which may be fatal(Beaver 1965). Even though it has marked
antipyretic arid analgesic properties, its ’’over the counter”
sale in the ’United States had been prohibited since 1938(Moodbury 1970). In view of the recent development of newer and
safe? antipyretic analgesics, it is in public interest to drop
out amidopyrine altogether from physicians armamentarium.
2*Fixed Dose Combinations of Vitamins with Antiinflammatory Agents
and Tranquilisers:
The addition of vitamins to antiinflammatory agents and
tranquillisers in fixed dose combinations does not yield any
proven increases in the therapeutic effects of these combina
tions. In a way they are just like placesbos but certainly en
hance the cost of formulations. In most of the patients requir
ing either antiinflammatory or antipsychotic therapy, vitamin
deficiency is not an usual associated feature even in our coun
try where malnutrition is so prevalent. Hence vitamin supple
mentation with these drugs is both a walte of vitamins as well
an Unnecessary financial burden f^r. the patients.
3.Fixed Dose Combinations of Atropine with Analgesics and Anti
pyretics:
Analgesics and antipyretics reduce the raised body temp
erature to normal(antipyresis).But Atropine is known to cause
hyperpyrexia (ie. it.may’raise the body temperature). Hence
such combinations is therapeutically antagonistic and is there
fore irrational. Furthermore, even in cases of visceral pain
(eg. colics), where atropine may be advised with the idea of
its antispasmodic property, simultaneous administration of an
antipyretic analgesic, which is ineffective against visceral
pain has hardly any therapeutic advantage. All the more such
combinations unnecessarily expose the patients to the potential
toxicity of antipyretic analgesics.
4.Fixed dose Combinations' of Strychnine and Caffeine in Tonics:
Fixed dose combinations of strychnine and caffeine in tonics
areundesirable because strychnine (formerly used as an appetiser)
is now an obsolete drug and its enthusiastic use in tonics may
even induce convulsions particularly in susceptible individuals.
Similarly caffeine though, has a mild CNS stimulant effect
leading to little temporary mood elevation and relief from fat
igue, has no tonic effect on the body. Furthermore caffeine
products mild physical dependence and habitual use of this drug
in tonics may cause psychological and physical dependence for
such formulations.
5.Fixid Combinations of Yohimbine, Strychnine with Testosterone
and Vitamins:
Fixed dose combinations of yohimbine and strychnine with
testosterone and vitamins are irrational because yohimbine is
no longer regarded as therapeutically useful aphrodiasiac in
man even when mixed with methyltestosterone(Laurance,1980).
Furihhermore, yohimbine should not be used therapeutically beca
use of its side effects viz Central excitation, raised blood,
pres-sure, increased heart rate. Strychnine is also how an
obsolete. Vitamins do not play any therapeutic role.( except in
’ deficiency diseases) and simply act as placebo, of course, giving
the psychological boost to the patient.
i
...3...
6. Fixed dose Combinations of Iron with Strychnine, Arnica and
Yohimbine:
Strychnine, arnica and yohimbine combinations are used as
stimulant appetizers. Inmost of the patients (except women)
' generally there is no deficiency of iron because iron is adoquatly stored in the liver. However, in very specific anaemic
cases supplemental iron therapy may be given separately. To
add iron in these formulations is irrational and may be just
for the purpose of increasing the price of the formulation or
to seek patient rights for the formulations.
7. Fixed cose combinations of Sodium Bromid e/Chi oral Hydrate with
other drugs:
Fixed dose combinations of sodium bromid/chloralhydrate
with other drugs can now be considered irrational because both
these drugs are now obsolete due to their toxic manifestations.
Bromides on prolonged administration replace the chloride ions
of the body. Because of the slow onset of action, cumulative
poisoning, manifesting as conjunctivitis, GIT symptoms, derma
titis and mental disturbances is likely to occur. Further their
exeeding slow onset of action and low potency make these
bromides unreliable hypnotics.
Chloral hydrate, being an irritant of the rugous membranes,
causes gastritis leading to a variety of GIT symptoms eg.nausea
vomit ting flatulence and epigastric distress. Chloral hydrate
can even cause hepatic and or renal damaged In view of the
recent and more safer hypnotics there is now no justification
of prescribing chloral hydrate to patients.
8. Fixed dose combinations of Ayurvedic and Unani drugs with
Modern drugs:
Th e modern (Allopathic) drugs are well, standardiscd and
their standardization methods are official, In case of ayurvedic
and unani drugs, official standardization methods are not
available at present. Therefore, it does not argue well to have
a combination of ayurvedic and/or unani drugs with modern drugs
bevause of the standardization problems of the resulting for
mulations. In view of the lack of authentic repeatable research
data on the efficacy of fixed dose combinations of ayurvedic
and unani drugs with modern drugs, there is no justification
of such formulations to be sold for use by the general public.
9.Fixed dose combinations of Phenacetin:
Phnacctin is gradually loosing its importance because it
causes kidney damage when used in large amounts or for long
____ , Hence it has no place in routine analgesic, antipyretic
periods.
and antiinflammatory therapy. Therefore, fixed dose combinations
of pheaacetin are outdated and hazardous. Formulations contain
ing aspirin with phenacetin and often with caffeine are promoted
with claims that they provide greater analgesic effect and/or
cause fewwer side effects than does aspirin alone. In most con
trolled clinical trials such claims have not been found correct.
10.Fixed dose combination of Antihistaminics with Antidiarrhoeals:
The fixed dose combinations of antihistaminics with antidiarrhoeals is rational, only in certain specific cases where
the diarrhoea is due to allergy(like protein allergy). In these
specific cases, the antihistaminics may be prescribed separately
so that such combinations are not irrationally used in the tre
atment of all other types of diarrhoea. Routine use of these
...4...
combinations is not only a waste of ant ihi st aminic drugs but
also it exposes the patients to the undsirable effects of this
class of compounds*
11. Fixed dose combinations of Sulphonamides with Penicillins:
Even though sulphonamides and penicillins individually
do have important role in the therapy of infections. The com
bination of penicillin with sulphonanrides is undesirable. This
is because the antagonism of the antibacterial effect may result
when bacteriostatic (Sulphonamides) and bactericidal(Penicillin)
agents are given concurrently,(Jawetz and Gunnison, 1953). In
addition oral combinations may even induce penicillin sensi
tivity.
12. Fixed dose combinations of Vitamins and Analgesics:
In the fixed dose combinations of vitamins with analgesics J
the vitamins do not play any therapeutically beneficial role
and rather act as placebo. Therefore, such combinations are
therapeutically irrational. Since such formulations are likely
to be misused by the patients and if administered for longperiods because of their vitamin contents, such combinations
are likely to expose the society to a veriety of undesirable
effects of analgesics.
13.Fixed dose combinations of Tetracyclines with Vitamin 0;
There is no specific therapeutic indication of giving
tetracylines and vitamin 0 together because tetracyclines
d
do.es not cause any specific vitamin C deficiency. Therefore,
this combination is of no therapeutic superiority and may be •
produced by drug companies just for enhancing the cost of their
product. Further, in inflective conditions where tetracyclines
are'indicated, vitamin C deficiency is not an usual associated
feature, such formulations should not be routinely employed.
14.Fixed dose combination of Hydroxyquinolines group of Drugs
except preparation which are used for the treatment of Diarr
hoea and Dysentery;
Halogenaled hydroxyquinolines are indicated only in inte
stinal infection like amoebiasis. So the combination of hydro
xyquinoline with some other antidiarrhoeal and antidysentery
drugs like enzymes for the treatment of dyspepsia is undesirable
because hydroxyquinolines may induce Subacute Myelooptic
neuropathy (SMOH). Due to this toxic manifestation the use on
this drug in clinical practice has been abandoned in many ad
vanced countries. The clinical use of these formulations for
such simple conditions like dyspepsia exposes those patients
to the risk of SMON and hence should not be employedo
15.Fixed dose combinations of Steroids for Internal use except
combinations of steroids with other drugs forthe treatment of
Asthma:
In view of the acute onset of the benefical effect of
steroids in a large number of clinical conditions, their use
has tremendously increased in recent years. However, fixed'
dose combinations of steroids with other drugs are objection
able as it is extremely important to adjust the steroid dose
to the minimum that produced the desired effect and the dose,
of the other drug if altered, not on the patients need for. it
(other drug) but on his need for steroid. In view of the
widespread use of such combinations, the patients are exposed
to t&xic cumulative effects of these drugs. However, in case
...5...
of asthma, since inimumological factors play an imp.ortant role
and adrenal steroids cause nonspecific reducation of the res
ponse to the antigen antibody'react 10ns, the fixed dose combi
nations of stefbids with other drugs in the treatment of
asthma is therapeutically rational and justified.
16. Fixed dosecornbinattons of Chloramphenicol except with Streptomyciny
’ 7,’ •
Chloramphenidol is a drug of. cnoice only in the treatment
of enteric fever and gastroenteritis. Its combination .with
streptomycin in. the treatment of gastroenteritis is therapeuti
cally justified because this combination has been found thera
peutically superior to either of these drugs alone in the
treatment of mixed infections -of the gastrointestinal tract.
But combination of chloramphenicol' with other drugs(like tetra
cycline) is .irrational because both the drugs have almost the
same antimicrobial spectrum and also because chloramphenicol
is more toxic its it may cause apla'stic anaemia.
17. Fixed dose combinations of ergot except combinations of its
■Alkaloid Ergotamine with Caffeine.: Ergot alkaloid', ergotamine is1 effective in the treatment
of migrains because it is a' vasoconstrictor agent and pi events
the rhythmic distension of extracranial arteries.
Caffeine may be allowed in comb-.ination also because of its
.vasoconstrictor effect on intracranial vessels. However the
combinat ion of ergotamine with' other-drugs (like paracetamol,
prochlorperazine etc) have no.therapeutic advantage and hence
irrational.
f f
18. Fixed dose combination of Prophylactic vitamins witxh anti
tub ereular ‘drugs except combination's of I N H with vitamin Bg9
Fixed anti tubercular dr.Ug (except INH) are irrational
becuase in these combinations, the vitamines have on therapeu
tic role to play (of course uidless .tfrhere is a vitamins defi
ciency) and they simply act as placebo and might give some
psychological boost to the pat lent/.However,/because INH causes
vitamin B6 deficiency, its -combinat'ion with vitamin B6 is
rational and therapeutically justified.
Another drug combination which has been recently banned
in this country after a much’ hue and -cry from the medical
experts is that of Estrogen Progesterone (E P combinations).
.lhese combinations were'' used' for test for pregnancy. The use
.’ of E P„ hormonal preparation^ were banned in U S A by the Food
and Drug Administration (Fp’A); in 1975:*because these p . eparations were found to seriously damage the foetus.
It is often alleged th’at drug Companies levy a heavy burden
on the common man by charging more and’ more^through their
dubious multiple drug formulations which, are their ^arented
products-. For example, the'/b^hl pain filler in most dfthe
analgesic tablets is aspirin,’' the market’ is flooded with a
number of costlier pain killers containing in addition salicy
lamide, caffeine and quinine '’sulphate;- which have no proven
synergistic efficacy. Similarly, amongst anti-cold ointments 9
only menthol is said to be of any real therapeutic value.. Here
too, other ingredients of*/dubious value like camphor, turpen
tine and thymol are. Qfterf*dd^ in order-’.just to put in market
a new formulation and thu&; i’nbrease t he price of-such .a
patented formulation.
•
ilh
...6...
.• i
In our opinion such anti-social problems must be tackeled
at all levels. The responsible persons of the society in the
medical and health field, like doctors and pharmacists should
keep a close watch on the drugs banned inthe developed countries
and also on the drugs which on clinical trials have not been
found safe and effective. These responsible men should convey
all the clinical, information on such drugs or their combinations
to the appropriate authorities of the Government of India^Though
the Drug Technical -advisory Board(DTAB),Drug Consultative
Committee(DCC) arid Director General of Health Services(DGHS)
have been entrusted with this job by the Government of India
but other responsible men in the medical field will also have
to keep a vigil so that there is no oversight on the part of
the official machinery and the harmful and obsolete drugs from
developed countries are not dumped in bur country any longer.
The World Health Organizat'ion(V/HO) should also play an effective
role inthis regard and ensure that only safe aid effective •
drugs are sold to member countries. In addition, the government
must adopt the rec ©nun end at ions of WHO on essential generic
g
preparations. In, a developing country like ours, the goal must "
be to ensure availability of essential drugs to patients and
health education to all about safe water, sanitation and finally
sufficient nutritious food.
However, the major problem lies in tha fact that a large
number of drug formulations in India have not been adequately
evaluated for their safety and this again emphasises the need
to exercise strict quality control . This becomes much more
significant in the Jight of the recent statement by the (gover
nment in Rajya Sabha that 17.5% of the drug manufactured and
sold in the country in the last three years were found to be
substandard.
Over all, if employment of such fixed dose combinations
aids the busy physician and does not significantly represent
a lessoning of his individualized orientation to his patient
and are rational fr<fi the therapeutic point of view, they are
a boon to therapeutics otherwise a curse to the patient and
the society.
1
REFERENCES:
Woodbury, D M (1970) Analgesics-Antipyretics, antiinflammatory
agents and inhibitors of uric acid synthesis in The Pharmacolo
gical basis of therapeutics by Goodman, L S and Gilman,IV
Edition, The Macmillan Company, London,pp 314-347.
Beaver, WT(1965) MBld analgesics: .I review of their clinical
P, armacology. Am J Med Sci 250, 577. 604.
Jawetz E and Gunnisjon J B (1953) Antibiotic synergism and^
antagonism: an assessment ofthe problem .Pharmacol Rev.5,175-192
Laurance, D R( 198Q| linical Pharmacology, Ed fifth, E L B S
Publication, Chura^iil Livingstons, pp 351, 536,552,617,848
Source: The Eastern Pharmacist-June ’83.
Circulated by the Voluntary Health Association of India
for Drug Actio* Net Workers for information
and necessafy gction.
, .l cat
£
Wlarts Road
. 5&0 001
SCIENTIFIC SCRUTINY OF SOME OVER-TriE COUNTER KiUGS
Dr.A.R.Phadke
A host of over-the-counter medicines ■* medicines which are advertised in
the lay-press, media and can be bought without a doctor’s prescription are being marketed by various companies. As of today, there is no
independent expert body to scrutinize these medicines on scientific grounds
as to their effectivity, safety and price and to advise the consumers
accordingly. Such a body is necessary for all industrial produot®
by.
a layman; But its necessity is particularly felt in case of medicines,
because, in the field of medicine there is a lot of scope to include
unnecessary, ineffective ingrediets without the consumer least suspecting
it. Moreover a sick person is less critical about the contents and the price
of the medicine which he/she buys since he/she is psychologically more
bothered about getting immediate relief, or improving health. Health is one
area where people are prepared to pay more readily. Drug-companies know this
consumer—psychology very well and can exploit the situation to their profitoriented aims. The aim of this paper is precisely to shov empirically that,
the logic mentioned above in fact operates in our country in case of overthe-counter medicines.
Three types of medical products—are directly sold to the laity—
1. products offering symptomatic relief from minor ailments - e.g. Vicks
Vapour kub, Coldarin, Anaein etc.
2. Various types of tonics and ’’health restaratives ” - Phosphomin,
Gripe waters, Incremin etc.
3. Food substitutes—Complan, Glucon—D etc. I Uj^ve chosen a couple of most
widely used products from each category for a some what detailed scrutiny
as to their exact role, usefulness compared to their cost and compared to
the claims made or impressions created by the producers in their
advertisements. I have confined myself only to the allopathic medicines
since I have no training in other systems of health-care. I have selected
certain brands for scrutiny and discussion only for the sake of
illustration and I de not want to selectively criticize or favour any
particular company. As far as possible I have used non-technical language
and have explained some medical points assuming that substantial number
of participants in this seminar are non-medicos.
I
• i
4
Pain-Killers, anti-cold and anti-cough preparations
a) Pain-Killers - A number of analgesic-antipyretic (i.e. pain
killing and fever reducing) preparation are directly sold to the
laity- e.g. Anaein, Aspro etc.
i
’■ •
Table No.1 gives details of some of them.
is.
TABLE N0.11
~
No.
Name of the
product
......
’ "'T
Contents
I
Price per
tablet in paise
1.
Aspirin
Acytyl Salicylic
acid-300 mg.
2
2.
Aspro
1 Aspirin - 350 mg.
Caffeine - 20 mg
10
3.
Anaein
4.
5.
Avedan plus
Powerin
I
Aspirin - 389 mg.
Caffeine - 16.2 mg.
Quinine Sulfate — 8.1 mg.
8
Aspirin - 350 mg.
Acetyl-P aminophenol-125 mg.
Caffeine - 30 mg.
8
Aspirin - 350 mg.
Caffeine - 65 mg.
Codeine
125 mg.
Paracetamol — 65 mg.
Salicyl amide 65 mg.
■
■1
20
t
-2-
Unn e c e s s ary Addi ti on s
All these preparations ooutain Aspirin and in addition one or many oih^r
ingredients to get more analygesia. But standard text br^ka
Pharmacology
tell us that addition of these other analgesics have no additional advantage.
Tht\s for example, the famous Goodman— Gillman’s text book tells us "The
many mixtures of Aspirin ^ith acetaminophen, or phenacetin and often with
caf^ine and other drugs, are promoted with claims that they provide more
analgesia. None of these claims -withstand -critical scrutiny. In most
clinical trials, relief o£ pain by an analgesic mixture M
b^en >UDexi<**
to that hf Aspirin alone"? It may be argued that by adding other analgesics
to aspiriny we are reducing the dose and hence the side—effects ol aspirin.
.
But this claim too does not withstand scientific evidence "All analgesic
antipyretics alone or in combination, are adequately tolerated i-n reettmmonded dosage. Difference in the incidence of gastr£>-4jxtestiual distress and other
minor adver-se gffad^oxuara-lly ineanais'tant and of doubtful practical
significance"e
i
Opinions expmssed^in standared "text books have to be accepted than the
ones expressed by individual researchers based on their individual experiences —
Addition of other ingredients merely increases jthe cn&ir
the medication
for equivalent dosage as can be ^asily seen from table No.1.
Pure Waste - Some of the ingredients in some of these preparations are a
pure waste. For example—Salicyl amide (used in Powerin). It is "no longer
an official drug. Its effects J.n man are not reliable, and its use is not
recommended. The small doses ihcluded in "oyer—the—counter" analgesic and
sedative mixtures are probably ineffective.
Its a pure waste of patients money and of national resources to include such
products in analgesic mixtures. Similar is the case with faffeine- "In
controlled clinical trials analgesic mixtures containing faffeine have not
been found superior to aspirin for relief of headache nor has caffeine been
found to contribute other favourable effects".
!
Quinine Sulfate (used in Anacin) has not even been mentioned in the list of
analgesic drugs, though lijte some other drugs it has analgesic properties.
Besides, 8 mg. of Quinine Sulfate has obsolutely no value since the
appropriate dose is 300—600mg. Similarly addition of a mere 65 mg. of
paracetamo (therapeutic dose- 5oS mg.) or 8 mg. of codeine (therapentic
dose- 30 mg.) is also not likely to be of anly help.
t
1
i
£
i
Addition of such ingredients in such dosages helps to confuse the patient,
”justifies" a different brand name and increases the earnings of the companies
and the shopkeepers. YeS. even the retail-traders are interested in selling
these brands instead of Aspirin since they get very little margin by selling
a 2 paise-per-tablet-drug. It is necessary to stop the production of all
these fancy products and Aspirin be readily made available as over-thecounter drug.
b) Anti-cold preparationsScientific treatment Common cold is a symptom-comp lain caused
by viral infection of the upperrespiratory tract. Cold is sometimes caused
by an allergic response to changed weather, dust etc. This "allergic cold"
is characterized by sudden Onset-violent sneezing profuse watery discharge
from nose as well as to sonie extent from eyes and by its dramatic response
to antihistaminics (anti-allergic agents..)..
,.
!i
Ab is well known,
don’t have any drug to kill the virus of common cold.
It is a self limiting disease and the treatment is essentially aimed at
relieving symptoms and helping the body to get rid of the virus.
hus the
treatment of uncomplicated common cold is-rest in warm bed, plenty of
fluids and food, steam innaiation, gargles with warm salted water. If
there is a feeling of blocked nose, a few crystals of menthol ("Than&av
alias" Asman ka tara" used i^n Masula-pan) can be added to boiling water to
inhale this mentholated steaft. If headache, body-ache, and/or feVer>^~-demand, one can resort to oiie or two tablea day.
1
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-3-
Role of Vicks Vapo Rub, Rubex etc.
Table No 2 gives the ingrediets of Vicks and Rubax
ointments.
TABLE NO.2
Ingredients of Vicks Vapo Rub and Rubex per 100 gms.
of the ointment.
NoT
Vici*. ' '•L 11 '
Rubex
y.po Bub
>4 Ltlili’
in sras*
Name'W We ingredient
t
2k8
2*^2
5*25
0.10
MenXhAl
2. Camphor
3. ThymoJ
5,25
Oaia
5.5 ml.
1*41 “1
5t JEue<?JLyptus nil
I
5.6 ml*
aU ■
4< Turpentine nil.
5.5 ml.
6, Nutmeg oil
100 gms.
to make
7. Paraffin base
‘'
is blocked”.
hft*
'ta<J
>1.1 an- menthoL -can ac* as a
excessive biood supply in the nasal
a.*
wv
__
i ■— ■— -4-
Vicks^ Rubex) is -^incompatible” i
crbnMnatinri j^iji_-Camphar
fon® in
Pharmaceutical -Sciences, 15th edition 1975).
(Remington* s
Camphor, turpentine oil, menthol• 'have» counterwirritant action i.e. they
local tissue and thereby block the passage of Pai“*ul stimuli
irritate the 1--- --• . But these actions are hardly relevant
from that area, thus reducing pain,
3 pain in the nose is not at all the major symptom
in common cold—because
', These counter irritants merely give a PsVch°1®glc®-11
in common cold.
satisfaction that some "active" treatment is being taken with the he p
!
I
i
of a ’’strong medicine”,
Turpentine oil in low dosage and eucalyptus oil have a "Stimulantexpectarant" action
^t^oltVeTJcaucus.
~x»::\7pir‘t<,ry
/
,/i
f
i r
relaxing the surrounding tissue. Thus when we inhale the vapour of ic
or Rubex by putting them into boiling water, it is the steam which is max J
useful. Eucalyptus oil etc. give only psychological relief if any.
is useful only when the nose is blocked.
rules, eucalyptus oil also has
Thymol has antibacterial and anti-fungal properties
irrelevant in the treatment of
antiseptic properties. But these actions are i--common cold because common cold is a viral disease.
The five—gram tinned
tinned pack
pack or
vrcks of
ox RubvX
of Vicks
Rubex ointment costs Rs.l/-, vhereas
the nrice8of equivalent quantity of
menthol
of menthol crystals in the market is not
more than 15 Raise. According to Martindale, " Menthol with aromatic oils
in a soft paraffin base (Vicks Vapo Rub) provided a higher and more Pr°l°n®f
concentration of aromatic vapours from open vessels possibly by retenti
the molten basis on the surface of hot water". But one need
much for this. The same effect can be achieved by adding.
of menthol every half a minute jto^hot—-- —— —
*
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4
Mi si eading advert is ement s
Menthol is not necessary in each and every case of
cold. It is
therefore unnecessary to resort to these mentholated ointments
catches cold* The advertisements by the concerned companies do not tell us
this. One is less likely to go back to work or to school (smiling! ) the next
morning as is shown in the advertisements,,, because common cold, whatever
treatment you take, takes its own time to bid farewell to you. The claim
that Vicks ointment "relieves head and chest cold symptoms../’ is also mis
leading 4 These ointments can relieve headache caused only because of blocked
nos* ahd not the one due to toxic substances released in the blood. Medical
text books do not mett^on "Chest cold symptoms” which Vicks ointment is
supposed to relieve* Martindale's text book tells us that "It is dangerous
to apply an ointment contajning menthol to the nostrils of infants, e.g. for
theh; it may cause instant collapse’1.' The containers of
these preparations do not give a proper, specific warning that it is dan-gerous.
to apply this ointment to the nostrils in chiIdreri below one year. Only a
vague mention is made on the Vicks1 container - "Do not swallow or place in
nostrils ----- - Consult Doctor if’------ illness in very young children". Nobody
is going to "place" the ointment in nostrils, but many do apply it inside the
nostrils. Rubex is produced by "our" Indian Company, an associate of the famous
Alembic Chemicals* This conpany does not give even.the insufficient warning
given by Richardson Hindustan Ltd. On the contrary it advises to apply the
ointment "inside and outside of nose" without any qualification. This shows
their concern for the life of infants.
Vicks and^Rubex ointment are thus 1) very;.costly compared to the benefits they
offer (they, may relieve some of the symptoms of common cold); 2) promoted by
the concerned ccmpanies with misleading claims..... The increased price is because
of some unnecessary, useless ingredients: advertisements and the profit motive
of the concerned companies. In 1980, Richardson Hindustan Ltd. sold more than
Rs. 9 crores of Vicks-range—products (ointments, tablets,, inhalers etc.) and
earned a gross profit of a whopping 47$ of sales. The "administrative and
general expenses" of this company, which are in the main, expenses on advertis
ing ard sales promotion accounted for 37$ of sales. The consumer has to pay
through the nose so to say, all these expenses.
I have dealt1 with over-the-counter analgesics and "anti-cold ointments” because
they are the most commonly used over-the-counter medical products and because
the irrational ity of these products-especially these ointments - is not well
known even amongst doctors. I will deal with other products in a very brief
manner.
J
Role of "antl^coid" tablets .
The content of some'^f-; the "anti-cold" tablets are given in Table No. 3*
These, tablets contain analgesics’andxsome agents supposed, to act as nasal
decogestants and as 'bronchodilators' . Bpt as mentioned above, salicyl
amide, phenacetino,. caff eine (present in Action-500) are not the drugs of
choice for relief of pain. Antacids like calcium carbonate. Aluminium hydro
xide, Magnesium hydroxide have been included in these tablets to reduce the
irritation of the stomach caused by Analgesics* But as quoted above, analgescis .
"are adequately tolerated in the recommended dosage"and hence inclusion of
. <
these antacids is unnecessary. Moreover, as seen froimtable No.3, ^hey are
present in these preparations in such low dosage that they are unlikely to play
any useful role.
Phenyl ephrine (included in Coldarin). acts as a nasal decogestant when applied
1 or.ally. But "its absorption from the gut is not reliable", and hence is
not recommended .by mouLh.
/
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!
-5Elphedrine hydrochloride (included in Action—500) is a broncho-dilator used
* * 1
, Its inclusion
in the treatment of asthma or in a certain type of bronchitis,
Moreover
the
dosage
in which
in an anticold tablet is not at all justified. K,__ - :r
it is used in this tablet is ridiculously low.
Because of these unnecessary or irrelevant ingredientsj and because of
advertising, the price of these tablets is extraordinarily high, compared tn
that of Aspirin without offering any additional therapautic advantage.
C) Cough tablets and mixtures>—
f
\ Scientific treatment
Cough announces body's intention to throw away a
noxious, unwanted agent in the respiratory tract. In a sense it is a
protective reflex. But when that "noxious agent" is the mflammed, pricking
throat, the cough is useless, "unproductive". When there is accumulated
mucus in the lower respiratory tract, the act of coughing can throw it-out
and the cough is called productive cough. The symptomatic treatment of
cough in th.se two types of cough is therefore different. In unproductive
- cough, attempts have to be made to suppress the cough-reflex. In
productive cough, attempts have to be made to bring out the accumula e
sputum-.
Unproductive cough can be reduced by reducing the irritation in the throat.
This can be achieved to a certain extent by warm saline gargles, buch
gargles amongst.other things, wash the irritating agents on the surface
of the throat; relax the surrounding muscles by warmth thus reducing he
pain and irritation in the throat. Irritation can further be reduced by
chewing simple limlet tablet which increases salivery secretions from.the
mouth. Saliva is an excellent soothening agent. The "cough-centre in
the brain can be suppressed by oodeine or similar opioids.
*
f
To bring out the sputum from lower respiratory tract, various expectorants
are used. As quoted above, steam is one of the best expectorants. Other
ones are to be taken orally.
Unnecessary and irrational:- Recent additions of Goodman-Giliman's text book
make no mention of the commercial throat-lozenges I Indian text BookPharmacology and Pharmacotherapeutics- spends a few lines on throat lozenges,
These preparations act by increasing the flow of saliva the best natural
demulcent which produces a protective and soothing effect" ....
Costly
preparations like lozenges, etc. containing multiple mgrediants are usually
unnecessary and wasteful''^.
Codeine, which suppresses the cough centre in the brain is present inl some
of the cough-mixtures like Glycodin and Vicks-Formula-44 (see Table
----- No.4)
But these preparations contain some other.
1
TABLE NO.3.
”Anti-cold” preparations
No.
Brand name
Ingredients.
Therapeutir
dose.
Price per
tablet in
1
Coldarin
Aspirin—600 mg.
Phenyl ephrine-1Omg.
300 -600 mg.
Unreliable
absorption.
27
Caffeine - 300 mg.
Terpene hydrochloride
-30 mg.
60 mg.
Not recommended.
Calcium carbonate
-200 mg,
Vitamin-C - 50 mg.
1 gm.
!
•i
5
2.
Action—500
!•
Not necessary
Salicyl-rami de—390mg.
Phenacetin - 242 mg.
Aluminium hydroxide
gel - 32\^g.
not recommended
300-600 mg.
Magnesium hydroxide
- i 30 mg.
300 mg.
500 mg.
3^
ingredients which are useless, or atleast of doubtful value. Recent
editions of standard text books do not recommend such ingredients as
Antimony Potassium tartrate or Terpene hydrate in the drug therapy of
absolutely no scientific basis. As a result of these irrelevent or
ineffective ingredients, the effective cost of codeine in the adult therapeutic
dose of 15 mg. comes to about 64 paise and 105 paise for Glycodin and VicksFormula—44 respectively.
1
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TABLE - 4
Cough-mixtures
No,
1.
Brand name
Glycodin
Terp
Vasaka.
retail
price
per 5 ml.
in Ps.
46
Important ingredients
per five ml.
Therepeutic
dose- in treat
ment of cough.
Codeine phosphate llmg.
Antimony potassium
tartrate - 56 mg.
15 mg.
Not recommended
Terpene hydrate-11 mg.
Menthol - 3.75 mg.
Tolu syrup 1.25 ml*
Vasaka syrup - 47 ml.
-do—
-do-
r.
i
2. Vicks—Formula—44
35
Codeine phosphate-5 mg.
Ephedrine - 5 mg.
Sodium Citrate-250 mg.
3^. Waterbury’s
Compound. (Red)
15
Creosate-.0025 ml.
Not recommended.
Guicol - .00012 ml.
S o di mn Be nz o'ales— 5 • 6 mg..
Not recommended.
15 mg.
30 mg.
Not recommended.
/
.
i
/
Sodium iodide- .6 mg.Sodium Salicylate-45 mg. ^*3OO-mg.for
analgesia.
4.
Codeine
Phosphate tablet.
16
Codeine phosphate-1 5 mg.
15 mg.
The price of Tab. Codeine Phosphate-15 mg. is 16 paise.
I
i
Waterbury’s Compound (Red) is promoted for relief from cold and cough and also
as general tonic. Some of the ingredients have supposedly been included for
expectorant action. Of these, none have been recommended in text—books of
Pharmacology because of doubts about their utility. For example about
creosates if has been,,mentioned- ’’Large doses of creosates and guaieols have
also bi>en shown to possess this (expectorant) action in animals”?. Their
rol* ifi man has not been definitively established. ’ Moreover, these
a#<nts have been included in Waterbury’s Compound in ridiculously low
amount. Same is the case with Sodium Salicylate. This preparation is thu^
virtually useless for treatment of cold or cough.
Vicks Vapo Rub is also advertised to ’’bring out cough from the chest”. As
mentioned above, eucalyptus oil and turpentine oil contained in Vicks and
ubex ointments have expectorant action. But it is impossible to achieva the
kind of dramatic effect in one night as shown in the. Advertisement-film
on Vicks Vapo Rub. Moreover the way the ointment applied to the chest
is shown to act defies all laws of medicine.
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-7Actually application of this ointment to the chest its virtually a
useless exercise for bringing out sputum from lower respiratory-tract.
Obviously the ingredients can not possibly reach the lungs
J-he
skin. Vapours of eucalyptus and terpentine oil formed due to body heat
are in such a low concentration that they can not exert any useful effect
by entering through the nose. This particular piece should be remove
from this film.
It is necessary to educate the people through various media about the
causation and the scientific treatment of cold and minor cough. Drugs
like Aspirin, menthol should be made easily available m over-thecounter medicines. Existing over-the-eowter cow.reial preparations
Should he.banned, Only scientifically sound preparations should be allowed
to be marketed and their advertisements should also be monitored
prevent the misleading of the lay people.
. - II -
j
T 0 NIC S
Incremin, Phosphomin and. Waterbury’s Compound (Xellow) (SyxupsX*> ar«
-advertised and
Vimgran tablets and Gripe-waters
therefore used ovej^the*^ounier—tonics.
is something which "invigorates"
Gripe-waters:- Tonic in a wider sense
the body. Even in this sense, Gripe Water is not a tonic. It is not
even advertised explicitly as a tonic, But these mixtures are advertised
in such a manner that an impression has been created amongst semi-literate,
illiterate people, that‘it is a tonic^ The advertisement typically ohows
a chubby baby and carries a <caption-"For health of t^e baby" or "for a
An illiterate mother interpretes that Gripe-water is
growing baby” etc.
As a result, apart from Anacin, Gripe-water is the
a tonic for infants,
most commonly used over■the—counter—medicine in rural areas and in slums.
" ‘
, Typically it
A number of companies manufacture their own Gripe-water.
contains Anise-water, Sugar, Sodium Bicarbonate and peppermint. All except
sugar have carminative properties i.e. they help to "expel gas from the
stomach or intestines in the treatment of flatulence and in colics
colics ”. But „
claimed in the advertisements, it is not useful as and ^aid to digestion
as
’’perfectly mild and free
to make the "crisis” due to -teething problems "perfectly
or
from danger".
Disproportional Contents:- Table No.5 gives the contents of the most
widely used over-the-counter-tonics. Vitamins contained in thesen
preparations are closer to the values recommended by I.C.M.R. for daily
dietary intake. Recommended daily intake of iron in adult man is 24 mg.
of elemental iron. But as seen from the table, the iron content in
phosphomin-iron, Waterbury’s Compound and Vimgran is much less than this
amount. There is thus a disproportion in these three preparations as
regards their Vitamin and Iron content leading either to wastage of
Vitamins or an insufficient supply of Iren, depending upon how much of
these preparations are taken daily,
Basically the strategy of supplying iron in such low "maintenance" doses
through costly preparations is highly questionable. Self-administration
of maintenance doses of Vitamins for a few days after a minor illness has
some justification. But this is not the case with iron - since minor
\ ailments do not necessitate extra amount of iron. If a person develops
\symptoms of iron-deficiency-anaemia, none of these above preparations
would be able to correct the iron defiaiem^y-which requires about 200 mg.
o.f elemental iron daily for months.
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TABLE N0e5
I.
Tonics
■ ■ •
No*
!•
Jrand Nam$
Important Ingredients per 15 nl. in mg.
VitU
Vit> Vite
-Niacin
Vit.
Bl
Bv
-amide.
B12
mcg.
Pljosphomin
2
1
0.5
15
Vit.
C
Iron
Elemental.
15
Alcohol
11% v/v
Glyc er opho sphat e-s.
of Na,K9Ca,Mn.
-do—
J}—Panthenol-lmg.
I
4
I
2.
Phosphonin Iron
2
3.
Tonos—7
23
4.
inajpenin (per Sal.)
5<
Waterbury^ Coiapound(Yellcw) *>
6.
Vimgran tablet
2.5
15
15
9.5
1
25
2.5
25.2
>
r>
3
0.5
Others
5
1
3
25
18
1
20
2
50
Sorbitol 5gas«
3
Malta
50
I
i
Na—Salicylate,
-K,Na,-Salts,
Vit.A.
Vital)
I.U.
I.U.
5000.
500
Calcium
: lOOmg.
Iodine
J 0.15 mg.
Potassium : 5mg.
Copper
: 1 mg.
Manganese : 1 mg,
2inc,
s 1.5 Eiga
Magnesium f ng.
Kokic Acids 0.1ng,
2
-9-
Misleading Advertisements and wasteful ingredients!—
\An advertisement of Vimgran-shows a good looking man tilling.-xur-ihat he
takes copper with his breakfast. “Consuming popper” is shown as somathin^-.good for health. Many lay-people get attracted by this cdption and start
taking viipgru-n.- But it is not necessary at all to include pepper in_any
ovet—the—counter multi vitamin preparation — “Deficiency of Copper is
extremely rare in Man
There is no evidence that copper^ ever needs to be added to a normal diet,
either prophylacticfitliy’or therapeutically”. .Its a waste io add copper
to over-the-counter tonics. Similar is the c^se with salts af sodium,
pottassiurn,- Manganese etc., etc. Glycerophosphates included in Phoephoain
is also a waste- “In General, the phosphorus pre-sent in ordinary foods is
an adequate source of the iron. The use qf expensive preparation if
irgabuc phosphates'as tonics has no validity” •
•
V.
!i
X
.
t ■
•
’
..
: \ ■<
;
•
■
■ ’T'' ■’
The excessive cost incurred due1 to the use. of these3 preparations is not
small—because they are very costly-compared to the' utility they have.
For
example, a multivitamin tablet (Becadex-Glaxo^^oughdy pa^ridi^^
amount of vitamin costs 9 paise, whereas these syrups cqst from ^0 paise
in case of Incremin to 50 parse in. case of Waterbury's Compound for
roughly equivalent dpsage.
It is necessary to Educate the lay public through various media,
scientific principles of dietics so that they do not unnecessarily resort
. to tonics and rely more on better management of their diet,
is^also
necessary to ban the\ production of aj.1 thes^ preparations pending their
restructuring on scientific, basis. Their advertisement^ should also be
censored to prevent misleading of the lay people.
\\*\ v -I III -
\
FOOy SUBSTITUTES
^77
Of all the food substitutes, breastmilk-substitutes are the most
important. The ill—effects of thes0, milk powders are now ver^ well
known and hence there is no need to-repeat these arguments her*, I hg,ve
therefore decided not to discuss th6se preparations here.
Precooked foods: IM Maharashtra, the <irug-companies are promotjrtg weaning
foods more than milk-powders. These are more pretocked balaQded food—powders.
Hence weaning foods like Farex, Cerelac etc. are not neees^y and do not
have any additional nutritional advantage compared to thel^r price, over
home-made ordinary weaning foods. They are however not hAxardous like
milk powders which act as breast—miIkysubstitutes. Its 8 waste of money
of money to spend on such preparation^ when the child caa and should be
gradually induced from 4th month onward? to normal bala^ed diet
consumed by the family*
\ ;
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Preparations like Bournvita, Boost, Nuijramul, etr. are a^so precooked- hut
nutritionally much less useful productsl They contain cotoa, malt,
milk-powder, barley, sugar etc. etc. The exact proportion of these
ingredients are not given in their promotional literature. They are
nutritionally no better than ordinary bialaneed diet. It is deplorable that
even producers of Nutramul, a cooperative agency, should resort to
completely baseless, misleading advertising gimmicks in the form of projecting
the imagery of the ’’Nutramul Dada”.
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I O TA a
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Glucon-D--Powder>—^tjlucon—D—Powder is promoted as an energy giving
preparations. Laymen think Glucon—D is a medical, Powerful powder
because of the advertising gimmicks a^d because of the peculiar* taste this
powder has. Siswelution of this powder in water (or -saliva) is an
I
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-10endotherHiic (heat absortvug} r«action< Hence thia povdeir has a peculiar
’’cool” taste. It is the duty of all medical people to explain to the
laity that this powder has absolutely no special nutritional and/or medical
properties: that it give# no more calories pet gfatn than ordinary jaggery:
that it is not at all instantly absorbed from the gut into "Ihe blood etO4.etc<
This product should not be allowed io be advertised in the. lay^medxa*
Protein-Powders iw
’’Proteinex, Protinulesg Provitex,.Uniprotein are some of the most widely
sold over—the—counter- pjrcrtei.il
All of them contain about 50 to
60^ of proteins, and the rest is made up of carbohydrates minerals,
If used in sufficient quantity as a supplement to ordinary
diet
during convalescence^ they can be erf help* Bui- aS
"the cost
calculations made by the author in 1977 (see table No,6), the cost of proteins
derived from these pfeparaiions i$ ttnich highei (fof* equivalent amount of
protein) compared to that of proteins derived even in the costly form of milk
and egg. Egg protein hai^the higheft
highest biolagtc*!
biolagistl rajue
rslue if 95$*
95%* ’’Biological
Xalues is per cent of absorbed nitrogen when food-stuff indicated is the sole
sotn^ce of nitrogen”e It is an indication of the quality of the protein beihg
consumed. Other much -cheaper sources of proteins given in table No.6 have
lower biological valuesa But the biological value of the proteins in these
commercial powders is also not high. Substantial part of the proteins in
these powders corner from ground-nuts whose biological value is a mere 56—5-T!^
(see table No,6), The rest come from milk—powdert Thus the quality of
proteins in these preparations is not better than, the quality of proteins
in ordinary foodst Table No,6 gives biological values of some grains when
used alone. It is now well-known that foods containing a mixture of
cereals and pulsea have a biologica} value more than the arithmatic mean
of their individual biological values. Many Indian dishes contain mixtures
of cereals and pulses,
The only advantage these protein powders have over ordinary Idli or Udid—wada
etc. is their reduced bulk. But this has to be weighed against their high
price. These powders are generally taken in small amounts 20—30 grams a day,
— not more than 50 gms. a day. This will give only 30 gm$. of proteins.
Usual daily requirement of proteins of an average Indian is 55 gms. It is
much more during convalesence. Thus these powders provides much less than
half of the protqin requirements during convaleswnce. ^hese preparations
generally give rise to false sense of security. A persop is given only milk
with these powders and relatives get the impression thai^ the patient’s
protein requirements are being fulfilled.
i
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Complan has not been included in the above list because it is advertised
as the ’’complete food” and contains only 20% of proteins. The rest is
made up of 22(}) other vital foods like carbohydrates; fats, vitamins and
minerals”. It has been specially recommended for youpg Teenagers by the
manufactures under the caption ’’Growing children need complan”. For a
non—sick child, having normal appetite, obviously parents should better
spend their money over many nutrlii-ons -Indian -dishes -dJiaii-cncomplan,
/
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TABLE NO.6
Comparative coats of proteins from different sources.
No.
Name of the
Source.
Buffallow milk
Percentage
of the
proteins.
Biological Price cost of per
value %
per kg.
10 gms. of
in Rs.
proteins.____
uncoo - cooked
ked.
Rs.
Rs^
4
67
2.60
0.58
0.73
2• Hen1s egg.
13
95
5.00
0.77
0.96
3. Ground-nut
25
57
7.00
0.28
0.35
4. Proteinex Powder
56
60
71.11
1.27
5. Provitex Powder
63
60
71.11
1.12
6. Protenule powder
50
60
71.11
1 .42
7. Uniprotein
50
60
71.11
1.42
8. Bengal gram dhal
17
61
3.00
0.18
0.22
9. Red gram
22.3
72
4.50
0.20
0.26
10. Moth—bean
23.6
54
3.00
0.12
0.16
11. Green gram
24.5
54
4.50
0.18
o.ai^
12. Rice, Raw milled.
6.8
80
2.00
0.29
0.37
about
(note:- Calculations are based on prices in September 197Z< 'Protein percentages
and Biological values have been taken from ’’The nutritive value of Indian
Foods ....” (12). Cost of cooking at home is assumed to be 25% of the cost
of the grain.)
Conclusion
Most of the over-the-counter medicines discussed above are obviously too
costly compared to the benefits they render; some of them being virtually
useless. It is necessary to scrutinize exhaustively, in much more detailed
fashion all over-the-counter-drugs marketed in India and to take up a
systematic campaign against their irrational ingredients and misleading
advertising. It is only through a mass—educational movement that these
malpractices can be stopped.
References
1 • ’’The Pharmacological basis of therapeutics” - Edited by Goodman end
Gillman, 5th edition, 1975, P.349.
2. Ibid op. cit. p.349.
3. ibid op.cit. P. 350.
4. ibid op.cit. P.349.
5. ibid 2nd edition 1960, page—1068. (Later editions, do not contain much
on the medicines used in common cold)
6. Martin dale’s ’’The Extrapharmacoeia” 27th edition, 1977, Page-295.
7. ibid op.cit. page.295
8. Pharmacology and Pharmacotherapeutics - by Satoskar, Kale, Bhandarkar;
6th edition 1978, page 280.
9. Satoskar, Bhandarkar, op.cit., page 280.
10. Goodman-GilIman, op.cit. page—1326.
11.ibid op.cit.page - 1531.
12.The nutritive value of Indian Foods
id the Planning of -satlsfactory
Diets, and ICMR publication, New JDe.
1966, pages 51,52 & 145-147.
• )
I
I
D-9/334(k)
axl9.10.82
Selection of Appropriate Analgesic and anti-inflammatory Drugs
Dr* U. N- Jajoo
With advancement in pharmacology9 more and more drugs are added
to the list. A physician has choice to select a drug from a pool of
drugs having similar therapeutic properties. Under the influence of
persuasive selling practices of pharmaceutical firms, a physician tends
o neglect the rationality and believes in the claims of drug industry,
thus prescribes some costly drugs. The sufferer is the patient.
There are some guiding criteria which need to be followed by
scientific minds before selecting a drug. EaCh drug needs to be weighed
on the following criteria*i
ii
iii‘
iv
Effestivity or potency of the drug.
Toxicity of the drug
Cost
Availability in the market.
An attempt is made here to rationally analyse analgesics and antiinflammatory drugs on the above criteria.
Anal/<08ics and anti-inflammatory Drugs
A few facts to note-s
x i) There is a large variation in the response of individuals
n-i- ffQren^ anaT^e0ic*a^ti-inflammatory drugs, even when they are closely
allied members of the same chemical family.
. .
Tf drugs must be given to a pregnant woman, low doses of
aspirin are probably the safest.
.
be used in children.
k
■fck°SQ drugs which are extensively tested by time should
This commonly moans aspirin, indomethacin and ibuprofen.
.iv) Most of the diseases where anti-inflammatory drugs are used,
°ourse' This means palliative therapy with anti-inflammatory
drugs needs to be continued for a long time- Thus, out of the above listed
criteria toxicity and cost have priority consideration.
v) Fixed dose combination of different analgesice'anti
inflammatory, drugs must be denounced on the ground that their dose needs to
i" overy individual and usually sensitivity of one drug cross
reacts with others.
°
i
j
TP Time-release preparations of salicylates are of limited
value, since the half time for elimination is so long. Absorption from
enteric coated tablets is some times incomplete.
viii) SalioylamidQ is „0 longer
Offlclal drUg. It8 effeota
man are not reliable and its use is not recommended,
—> The small doses”
included in "over
the counter"
counter" analgesic
anal^esin and
prH sedative mixtures are probably
over the
ineffective»
ix) Oxyphenylbutazone, a u-L
‘ ---- of phenylbutazone, has antimetabolite
rheumatic and sodium retaining activitiesJ similar to those of the parent
drug- It is extensively bound to plasma-proteins
’ and has a half life in
plasma of several days. *It accumulates significantly during chronic
administration and contributes to the pharmacological and toxir effects
of parent drug and hence ranks low as compared to phenylbutazone.
• ••.••.See Table No.l & 2.*...
„m
„ x) Acetamenophen has less overall toxicity and is thus
usually preferred to phenacetin.
D-9/334(k)
a: 19.10.82
2 -
CONCLUSION:
Analgesic antipyretics:
i) Aspirin stands as the drug of choice, except in conditions where
gastric erosion is endangered.
ii) For long-term use, aspirin stands as the drug
of choice.
iii) Among injectable analgesics, there is,little to choose.
The cost
is prohibitory for pentazocin and toxicity for analginiv) For antipyretic effect - analgin remains the only significant
injectable drug available in India (injectable paracetamol has
recently come into the market).
Anti-inflammatory drugs:
1. For chronic inflammatory joint disorders like osteo-arthritis,
r eumatoid arthritis, ankylosing spondylitis - Aspirin remains the first
drug of choice following Ibuprofen and Indomethacin.
2. For conditions like Gout, Indomethacin and Phenylbutazone can be
used keeping in mind their toxicity over prolonged use.
3. Aspirin remains the drug of choice in pregnant women and children.
4- ^teroids score high in view of potency and low cost, but
dangerous side-effects on long-term use necessitate it to be pushed down
as a last resort. Their combination with non-steroid anti-inflammatory
drugs may be denounced and are unethical.
References:
1.
2.
3.
4.
5.
6.
7.
Which anti-iheumatic drug hy F.D.Hart. Drugs 11, 451,1976
Annual Review of Pharmacology
Vol.6 1966 page 157
Vol.II.1971 page 241
Vol.19: 469, 1979
New Eng. J.of Med. 302, 1179, 1980
it
n
302,1237,
1980
Goodman Gilman’s - ’’The Pharmacological basis of Therapeutics;»6th Ed.
J.of Applied Medicin
6, 635, 1980.
J.of Applied Medicin
7, 163, 1981
::
D-9/334-(k)
as 19.'10.8 2
Drug
TABLE - I: Analgesics, Antipyretics “ Selection of Appropriate Drug
Anal
gesic,
Effic
acy &
(Score-l)
Anti-Infl
ammatory
Effic
acy
Toxicity .
(ScoreII)
•^ose per
Day
Cost of
Treat
men t/day
(Score-
'I’otal
Score
(ixllx
III)
__ iii)____
++(4)
0
(3)
1-2 gm.
300mg- tab=
2ny»14paise
4x5x3=
60
+(2)
0
(4)
1-1.5
gm
500gm tab=
15np
45paise(4)
2x4x4=
32
- Suitable substitute for aspirin in
patients when aspirin is contra
indicated (peptic ulcer) or when
the prolongation of bleeding time
caused by aspirin would be a dis
advantage.
- A dose of 25 gm or more is potent
ially fatal.
- Chronic abuse may cause methyamoglobinaemia.
- Drugs should not be used over a
long time. Its combination in
’over the counter’drug is not
justified.
- If given should be a S.O.S.dose.
- One of the common drugs incrim
inated in poisoning with analgesics
in western world.
Codein
+(2)
0
(3)
30mg QID
2x3x1=
6
- Constipatory. Addiction potential
less.
.. Dehydro •codein
Dextropro
poxyphen
++(4)
0
(3)
60mg QID
10mg-Tab=
10 np.
Rs-1.80(1)
Not available
++(4)
0
(4)
65mg QID
Available only
in combination
0
(4)
0
(?)
50-75mg
QID
500mg QID
30mg/ml•=
Rs. 2. 5
500mg/ml«0.25Rs.
’Aspirin
D aracet* amol
(Acetaenophen)
1
I
/
T
(Comments
'INJECTABLE ANALGESICS
Inj .Penta++(4)
zocin
Inj.Analgin ++(4)
- Minimal dependence.
- Small abuse potential (dependt
ence).
- Standard pharmacological books does
not mention this drug at all.
•5. •• .
.
j
.
P-9/334-(k)
19.10.82
TABLE - 2:
Aspirin
++
Anti-.
infla
mmatory
Effic
acy
(Score-1)
++++(4)
Phenyl
butazone
++
++
Drug
Anal
gesic
Effic
acy
Toxicity
(ScoreII)
Bose
per
Bay
Anti-flammatory drugs - Selection of Appropriate Drug
Cost of
Treatment
per day
(ScoreIII)
Total
Score
(ixEIx
III)
Comments
(4)
5 gm o^iore
300mg tab=
2np:0.54p(5)
4x4x5=
80
- Extensively used over long time. Safest
drug in pregnancy.
(4)
(3)
200-400xq^»
200mg. tab=
25npi0.50Rs( 5)
4x3x5=
60
- Should not be given for more than 7 days
due to cumulative toxicity
- Oannot be used for chronic disorders for
long time,not recommended in pregnancy.
+++*(4)
(2)
200—400n q.
++++(4)
(2.5)
25- 150mg/day
75-100mg/HS
lOOmg. tab=
4x2x4. 5
25npiRs. 1(4.5) = 36
25mg. tab=
4x2.5x3
25np:Rs3. 50(3) = 30
X
Oxyphen
butazone
Indomethacin ++
- Urico-suric drug.
- More toxic than the parent drug
(phenylbutazone) •
- Hi^i incidence of severe side effect over
prolonged use
- Not safe as Aspirin or .Itbuprofen
- Urico-suric drug
- Net recommended in pregnancy
- Better tolerated than other drugs
- Not recommended in pregiant women or
lactating mother.
- cost prohibitory
»
Ibuprofen
++
++(2)
(5)
600-1200mg
Naproxen
++
+++(3 )
(?)
375-750mg.
Ketoprofen ++
Fenoprofen ++
Enfg^ic ++
+++(3)
+++(3)
++(2)
(1!
100-200mg300-600mg*
SOOmg.Twice
a day
400-500mg
750-150Omt
(5)
Flufengjic ++
Mefenamic acid^+
• J •
Steroids
0
(prednisolone)
+++++(5)
(3)
5-7.5m g
200mg- tab=
2x5x3=30
60np :Rs* 3 • 60 (3)
250mg. tab=
Rs.2»Rs.6 (1)
Not available
Not available
400mg. tab=
75npsKg.3(3.5)
Not available
it
n
5mg. tab=
25np
5x3x5=75
I
- Still under trial. An Indian product*
- More toxic, less effective
- Not to be used for more than 7 days*
- Safety during pregnancy is not established
- Brug of last resort in view of long term
side effects.
COMMUNITY HEALTH CELL
47/1,(First Floor)Si. Marks Road
BAMGALQaE-560 001
D-10/343
MS:a:5.1*82
A.
%
MISUSE OF ANTIBIOTICS
- Dr* Ulhas Jajoo
Is this a biased subjective notion or a proved fact?
a) Will you site the following examples for inappropriate use of
antibiotics?
1) A critically ill patient of meningo-encaphalitis where
cerebrospinal fluid examination shows only raised proteins
but no otherabnormality on microscopic examination or by
biochemical investigations, gets inj.Chloroquin, Inj*
Crystalline.penioi|line, Inj* Chloromycetin, Inj.Strepto
mycin and Is.oniazide (Drugs to cover up cerebral malaria,
enteric encephalopathy, pyogenic meningitis and tubercular
encephalitis)*
ii) A child with upper respiratory infection has conducted throat
sounds in the chest which are wrongly interpreted as crepit
ations and the child is treated as a case of bronchopneumonia
with antibiotics.
iii) A child with diarrhoea is given anti-helminthics (Mebendazole),
anti-protozoal (metronidazole) and an antibiotic combination
at a setting-where facility of stool examination is not
available*
Iv^ A patient with fever for more than 7 days1 duration gets
. Septran to cover up resistant malaria, resistant typhoid and
grain .negative septicemia.
b) Don’t you feel it is very difficult to evaluate a prescription uhtil
the doctor writes the diagnostic possibilities on the dame paper and
the evaluator takes into consideration the setting and the circum
stances in which prescription is written*
you think of some indirect ways of judging the misuse of anti
I) Can
biotics? (Appendix l)*
B* Why antibiotics ate misused?
to.?:;r-.C‘y
?
a) Poverty of knowledge of the pbesoriber (Appendix 2)?
.b). . Shotgun therapy as an easy substitute for the Careful diagnosis?
c) Because the detailed pathological investigations are not feasible
in routine day to day therapy?
d) Because antibiotics are prescribed by the doctors from other
disciplines of medicine such as Ayurveda, Homeopathy, Unani,etc.,
i.e., those who are not supposed to be qualified in allopathic
medicine.
’
'•
•
e) Belchuse of the conditioned mind: of doctors due to constant
hammering by drug pharmaceutical.representatives?
Ce
What harm the inappropriate use of antibiotics can inflict?
- Adverse^ reaction
- Resistant bacterial infection (Appendix - 3)
- Huge cost of the prescriptions (Appendix - 4)
D.
E-
Who is benefitted?
- Drug Industry (Appendix - 5)
- Patient
- Doctor
What can be the solution to the problem?
- Refresher course for the doctors on indication of antibiotics
in infective disorders?
- Availability of antibiotics only by the prescription from the
qualified allopathic doctors?
D-10/343
MS:a:5.1.82
2 -
- A mandatory justification by a doctor for the prescription
of antibiotics?
- Abolition of different brand names and insistence of availability
of the drug by generic name?
- Mass-education of the ’’consumersn about the indications of
antiilj^tics use in common irj^ctive illnesses?
- A cultural revolution uprooting the. marketised value system?
APPENDIX - I
The Trials have been conducted where the presoriber is infomed
in advance that his/her prescription will be screened for
. approp
riateness of the drugs prescribed or he/she is asked to fill up a form
justifying the use of antibiotics. These trials* have shown decreasingtirendq
in antibiotic use as good as up to 25^S. Other studies** where physicians
are made towrite the diagnosis it was found that antibiotics were
prescribed without any evidence of infection in as good as 62% prescript
ions. The other studies have revealed that antibiotics are prescribed
unnecessarily in as good as 80 to 90% cages. Indian literature in this
regard is very poor and I failed to trace out a trial of this kind.
********
APPENDIX - 2
Po you feel there is something wrong in the following'? Why?
i
ii
A lactating mother gets tetracycline capsule for the chest infection*
An year old child gets tetracycline syrup for acute short duration
diarrhoea.
Hi) A patient of chronic renal failure gets Sep t ran/Tetrhovc1In a for
recurrent urinary tract infection.
irv) A
A new
new born
born infant
infant gets
gets Chloromycetin
Chloromycetin syrup*
syrup*
v) A diabetic patient receives Septran for urinary infection.
vi Chloromycetin ear drops are prescribed for a case of otitis media.
vii How do you feel about the following combinations?
3
- Penicillin # Tetracyline
- Gentamycin > Kanamycin
* A patient is prescribed Ampicillin because organisms are
viii) A bactlWh&l
infection due to
inadequate and irregular drug therapy, is advised Hifampicin +
pyrazinamide-'+ INH
ix) A case of tuberculosis on short term chemotherapy gets pyrazinamide
for more than 2 months* duie.tion«
*= 1. Journ of Am.Med.Assoc. 2505, 242, 1979
2. JAMA 242; 1901, 19?9
227,1040, 1974
237,2019, 1977
227,1023, 1974
3. Annals.of Int.Med^-s 76, 537,1972
79, 55,1973
4. Med.Assoc.Jour. 116s 253, 1977
**. J.A.M.A. 213, 264, 1970
D-10/545
MSsas5.1.83
3 -
How do you justify?
- Use of Demethylcholrtetracycline
- Erythromycin Esteolate
- Penicillin-G
- Use of strepto-penicillin as a routine antibiotic?
- Prescription of antibiotics for common cold without any evidence
of secondary infection.
- Prescription of antibiotics in acute diarrhoea of short duration
in adults?
- Prescription of Inj.Chloromycetin when the capsules can be easily
tolerated by the patient.
«
.
*-
■<*■
APPggDIX - 3
Mechanisms’ for organisms getting resistant are:a; Mutation in genes which destroys affinity of the target site for
the antibiotics or modifies permeability of the Dili feo that
antibiotics can not enter :the cell and’find its target site.
b) Resistance against series, of drugs (multiple drug resistance) in
an infectious organism which can be transmitted to other sensitive
organisms of the same or different species through so called
"ttesistant factor”, i*e* transmissible multiple drug resistance.
This drug resistance is due to. ability in th? bacteria to modify the
antibiotics with-the help’of ceifein enzymes that they Can produce.
The modified antibiotics can not recognize their cellular target
and therefore have no inhibitory effect on the cells.
The fact that R-factors can be transferred to <ery genes of
Enterobacteriaseae through non-pathogenic bacteria like E.coli (normal
inhabitants of intestine), has become a major public health problem. If
a person harbours E.Coli with R-factor in the intestinal tract, they can
turn, sensitive pathogenic organ!sno like Shigella, salmonella, V.Cholera
to resistant ones. If this continues further, we may reach a situation when
the future 'of chemotherapy can appear dubious.
- Jiridepce of this type of resistance in Indian situation are many*
The studies done on healthy subjects who had not .onsumed any anti
biotics for at least one month (Bombay) 1977-78 showed 28% of them
harboured multiple drug resistant strains of E.Coli and much lower (6%)
of multiple drug resistant strains among individuals of nearby village.
The resistance was predominantly for drugs like Sulphonamide, Streptomycin,
Chloremphenicol, ampicillin, kanamycin and tetracycline whigh are most
commonly used antibiotics. The resistance to newer drugs like gentamycin
and trimethroprim has also emerged.
r.
U
*■ Science Today:
September, 1981, p.26
!
D-10/343
MS:a:5.1.82
- 4 -
APPENDIX - 4
Please scan1through the following table:Sr*
No.
Drug
Dose
1.
SulphacLiazjLne (m&B)
2.
Penicillin-V (m&B)
3.
Tetracycline (Paran)
4.
Chlor*mphanicol
(Paran)
Septran (Bruxwell)
80 mg.
Inj. Qentamycin
Lyka - 80 mg.
Kanamycin - Igm.
Amoxicillin
5.
6.
9.
8.
9.
Doxycyclin (iJS.Vit)
100 mg.
2tabs*
3times x 5
•130 mg 6
hourly x 5
500 mg.6 hrly
x 5
500 mg. 6 hrly
x 5
2 tabs*twice
a day x 5
40 mg. 8 hrly
x 5
1*5 gm total
1 tab.3 times
a day x 5
2 statjlOD
x 4 days
per tab/cap
inj. cost
Total
cost: Rs*
0*30
9.00
0.48
9.60
0.34
13.60
0.31
12.40
1.00
20.00
10.20
15.75
1.70
76.50
133.00
25.50
1.80
10.80.
APPENDIX - 5
Last year, .
..^1
bulk drugs worth
240 crores and formulation
worth Rs* 1200 croresfe bulk drug worth another 150 crares were Imported.
4^^ioti®s4Provide a billion dollar business to the multi-national
of the marketing and the sales promotion methods for antibiotics used bv
Game)
firmS wil1 exp°se the game (Please see the article: The Selling
S'--. •
r.r-
£-10° 343
MS : k : 5.1.82
: 3 :
2)
Production of all new single ingredient drugs to be
under generic names.
.2n_ wha t. we re _these recommendati ons
regarding generic drugs
based?
I
found that
1)
that 11
USe Of brMd
to
u-iiiic-ucssary increase in C2_'
because of costly promotional
activities; 2) medical students
were taught pharma^cology
using generic names.
brand names?
P-OM. Industry's Elections aqainst abolls.hing._of
1.
2.
tb^npdn1?^3 aj?P fiXed Under clearly defined
°ntrol Oraer 1979’-
St
3.
Standard medical text books use both brand
names and generic
names.
4.
Trade marks
of brand names,
■
t
J
Slit,r ’b—
*
5.
r
formulae by
Generic r
different
3 wi th
and harm patients’ health.
6.
The ban on brand r
-...
names
for single ingredient new drugs will
completely stop introduction
----- 1 of new drugs in the market.
7.
Drugs sold under brand r~
names
often have superior bid- availability than those marketed under generic’ names .
8«>
The use of generic names takes aw-.y the choice from the
doctor to the chemist.
9 «.
The general prescription is difficult to
remember a nd re proauce, lengthy and cumbersome.
10.
Th® Hathi 5onynittee recommendations would have been cruite
obse™a
results of the PeKtoT
-A- JeJtt J. XI I It- llL..
I
i1
-l
(Source: S. Viswanathan:
Business India - Sept.28
Oc tobe r 11)
What advan tage-s ere seen in having a planned generic policy?
1)
It will eliminate monopolization because of brand names
and it will encourage healthy competition.
1 '
2)
It will curb production of nsn
non-essential combination drugs
which only add to the increase
---- ‘ in price and have no
additional benefit.
For example.: Aspirin is marketed unde^two generic
names :
- acetyl salycilic acid and aspirin
- S different brand names
*
”
/
- 7 brands marketing ASA and Caffeine
19 brands of ASA and Phenacetin and Caffeine
f4‘
IJ •
{
i
i
y
D-10:343
MS : k : 5.1.82
: 4 :
Effect on Costs.:
Manufacturer
Content
Name under
which drug is
marketed
Price per
unit( Paise)
Hoechst
Analgin (.5gm)
Novalgin
20.00
IDPL
Analgin (0.5gm)
Analgin
18.27
Haffkine '
Analgin (.5gm)
Analgin
18.24
Nicholas
Aspirin (350 mg.)
+Caffeine 30 mg.
Aspro
7.75
Sarabhai
Aspirin 350mg.
Kenalges ic
Boots
Haffkine
Aspirin 3’6o mg.
22.00
Aspirin
3.60
Aspirin
2.84
Source: Indian Pharmaceutical Guide 1980
Aspirin 300 mg.
Some more examples:
Anaein
Avedanplus
Aspirin 389mg.
Anaein
Caffeine 16.2mg.
Quinine sulfate 8 mg.
8
Aspirin 350 mg.
8
Acetyl Aminophenol 125mg.
Caffeine 30 mg.
Powerin
Aspirin 350 mg.
20
Caffeine 65 mg.
Codeine 8.125 mg.
Paracetamol 65 mg.
Salicylamide 65 mg.
(Analysis -of Painkillers done by Dr. Anant Phadke
in his paper) Scientific Scrutirny of Over the
Counter drugs)
\
)
does WHO Expert Committee
?-
V
A.
(aspirin is 1/6) Arc and multlplZ other ccSlMtlo™?
91"
ghat are the loopholes being madg_use_of_in_this generic policv
fel—profit-motivated drug industry?
‘
Since the use of generic named drugs applies only ■to the 5 single
ingredient drugs it does not touch the COMBINATION DRUGS
which anyway form the majority.
Drug companies will try avoiding the issue by producino more
combination drugs and less single ingredient generic drugs.
Since BRAND NAMES fis to be ABOLISHED for all NEW SINGLE INGREDIENT
drugs, the drug industry will try introducing new drugs under
BRAND NAMES with more than two ingredients. So not only the
cost
will go up because of the use of brand, but also because of
addition of often unnecessary ingredients.
Since the government had emphasised that generic drua names should
be__displayed more prominently than brand names with effect from
1st August 1981, the drug companies complain of difficulties in
making a long chemical name more prominent on small vials, ampoules
and pleaded of accumulation of stocks inspite of 7 months• notice
i
D-10 343
MS:k:5.1.82
: 5
What are the Drug Companies doing about this?
On 13th MarChz the industry’s delegation met Mr. P.C. Sethi,
baStn^e^°fC^emiCaliS an<LPetrol^to, under which the drugs come,
in the
C^namid and Pfizer sued the Government
hAvp
lhlr ■ Hlgh court against abolishing of 'brand names and
nave got a stay order.
What is the New Drug Policy?
tion^nd^H3 ' •
following the Hath! Committee's recommenda^ion ended with the New Drug Policy. (Presented in Parliament
PetSleum^978 ^7 Mr. Bahuguna, the former Minister for
troleum, Chemicals and Fertilizers).
The NDP, the primary objectives were "to develop self-reliance
tec?Irg"toCfSsS9Ya"HtO Provide leadership role to the public
cb ' t foster and encourage the growth of the Indian sector"
under NDP several limitations were imoosed upon foreign sector '
arug companies. These included '
foreign sector
"
Mhi4.?radual Ruction of the foreign share holdings of
Multinational Corporations,
' n°e™f^heXpanSion ?f caPacity to foreign companies
engaged in the manufacture of household remedies".
the grant of licences to manufacture formulations to
foreign sector companies to be "linked with the production
high technology bulk drugs from the basic stage".
Prant of licences for the manufacture <of' 'high
' ‘ technology
supplvinoS50°? S conditional, upon foreign sector compaK^s'
applying 50%.of their production to "non-associated
formula
tormulators
tors ”
"..
(Source: Dilip ThakOre - The Ethics of.
the Drug Industry Pg. 27
Business India : July 7-20,'80?
Page 29.30)
If a multinational produced, say, Rs.100/- worth of bulk drugs,
half of it had to beg sold to the Indian sector and the remaining
half used for formulating drugs
turnover of drugs could not exceed three times the
°b“ik
drugs, if produced,, i.e.,
100
x
3
=
300
lakhs
i.e., 100 x 3 = 300 lakhs.
___ What is the DPCO?
Drug Frice Control Order, an offshoot of the New Drug Policy
passed in 1979 is aimed to restrict prices of the bulk drug and
ormulations produced by any pharmaceutical company in theorganised sector.
What are the stipulations under the DPC0?
Bulk or generic CdrU? manufacturing companies are entitled to
12-14% return on net
—t 1worth (capital +_reserves) depending upon
the complexity of the technoloov
utilized in the production
process.
Formulations (i. e. branded drugs) are divided into 4 categoriesCategory
I - Life Saving Drugs
Category II Category III
) in between
/
Category IV - Over the Counter Drugs.
--——
’’Mark ups” <above the cost of production to the extent of 40% 55°/
extent of 40%,55%,
100% are permitted by the r
Ministry
of
Petroleum,
Chemicals and
\■. Fertilizers on Category I,
, II and in after a study of the
I
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D-10:343
MS:k:5 »1•82
• 6 :
production costs to be•submitted by the manufacturing company.
1
S'tJdQfag, the Drug industry have to say about It?
According to Dr. S.K. Bhattacharya recently elected President of
the Organization of Pharmaceutical Producers of India (OPPIJ
constitutes of 62 big and 54 medium firms and produces
60% of that, total bulk drugs and formulations in the country),
the present drug..shortage of commonly proscribed drugs is because
of tne New Drug ,Policy and the rigid price control and it will
definitely get worse.
Vitlich, are the drugs which have had problems regarding availability?
*
Newsreports and A survey done by Medical Times (Glaxo’s)' Aug.
has revealed a shortage of painkillers
- antiepileptics
- anti TB drugs
*81
- anti-diabetics
- sera vaccines
I
i
1
r:-
- Cardiac glycosides
- anti hypertensive
-^Regarding prescription practices - surveyed by Medical Times
kGlaxo s) use of brand and generic was’ concerned. Almost all
the... doc tors seemed toj use brand
“
" drugs.
’
Reasons:
D
2)
3)
confidence■in the brands
less chance of substitution by chemist
convenience in remembering
^HY-J^lfo what guides prescription practices?
! A
Hyderabad.-on drug utilization revealed that
nP°Pulation surveyed (180cAurban education ]
.
--- ------ —population)
was -taking
i
drugs~on the basis of advertisements alone.
alone ♦ Only
1.72% gave satisfactory replies on the proper use of drugs.
4^ allopathy
18% homeopathy
14% naturopathy
11% ayurvedic
2% Unani
.erroneous idea about dosage schedules and mode of administration which could result in bioavailability and therapeutic
problems <
What is OPPI paying to build up public opinion against the
Government policies? OPPI has launched, a Rs*24 lakh MEDIA' CAMPAIGN
in what is says is a bid to help avert more serious shortages in
the future.
(Source.: Vanishing Drugs: Hindustan Times .
April 27, 19 80)
What is the .situation regarding Drug Contro 1?
The
Drug e.
Control
a-ne orug
on-trol situation in India is pretty bad. Onlv 3
(Maharashtra, Gujarat, West.Bengal) our of 22 States in India
have machinery to regulate the manufacture, distribution and
sale of pharmaceuticals.
y
j
D-1Q:343
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: 7 :
In Maharashtra,'acknowledged to have the most effective drug
control administration, there are only 96 drug inspectors and
1 drug testing laboratory for.over 2000 manufacturers and 15, 000
shops.
(Source: Dr. S.K. Bhattacharya of OPPI in
Medical Times - August 1981)
In Delhi for 5 million population there are 20 drug inspectors.
In Uttar Pradesh for 100 million population there are only 24 drug
inspectors.
'Source: Rajender Rainer : Delhi Repord^r
July 1981:Spurious Drugs dealing in
Death)
At the time of the Hathi Committee Report (1975) the Total drugs
Inspectors in th<. whole of India was 305 . Current estimates are
5 00.
(Source: The Ethics of Drug Industry: Business
India, July 7-20, 1980 - Pg. 33)
!
Wha..t__percentage of ..drugs, are cons ide.red .sub-standard in the Indian
:llarkeiiL. ’
Conservative estimates arc 25-30%
The Drug Control authorities accept this figure.
(Source: Spurious Drugs: Delhi Recorder,
July 8)
52% drugs are substandard according to a survey quoted by Anil
Aggarwal in Drugs and the Third World. 2% drugs are spurious
(According to the drug control authorities)•
What are the reasons of:....a.uc.h__a.._hxgh_i^jCGen
•drugs?
1)
Inadequate drug control.
The' centre" can only lay down policies, state governments have
control oyer manufacturers, sale- and distribution (the inter
state barriers are fully exploited by trade in spurious drgs).
Control, if any, is at the earlier stage of production into#
bulk form or later formulations, improper storage, etc. are not
given that importance.
"X
Shortage" of^certain brands of popular drugs gives an opportunity
to spurious and substandard drug producers to take advantage
of the situation. Linked to this is high demand of life saving
and other common drugs.
-
-
easy availability of drugs over the counter without
preseription from a qualified doctor
easier availability of drug selling licenceignorance about drug adulteration and■substitution
- the increasingly prevailing habit of chemists to stock drugs
of a company giving them commission in some areas
-
the desire of the consumer to buy cheaper drugs because of
the high cost of drugs (and his poverty in' many cases)
- the buying of drugs by chemists without any bill to avoid
payment of taxes
- only drug control authorities have been associated with
checks and control unlike food aditeration where the consumer
can play a role.
i
1^
D-10;343
MS o k : 5 • 1.82
: 8 :
I
What can consumers do to deal with this problem of substandard and
spurious drugs?
1)
2)
3)
4)
5)
6)
■
Buy drugs only from licensed chemists.
J
Read the drug label carefully, verfy expiry date, price
and seal before purchasing. Check with the price lists of
manufacturers available with the chemists.
Ask for a cash memo-give the chemist enough time to fill
entries of drugs bought, your address, etc.
Don’t swallow all the claims made by the advertisers of the
various drugs.
Avoid self medication by use of patent drugs, Don 11 medicate
yourself witl>hny drug you do not know about.
i
i
■
Follow instructions given by your doctor, pharmacist or on
the medicine label regarding mode of administration of the
drug dosage, frequency, etc., and duration. Check if in
doubt specially if deasling with patent drugs.
Avoid using left-over drugs or drugs that change colour,
taste, or look different. Keep drugs as advised - in a dark
and cool place.
8) Keep drugs away from children's reach. Keep poisonous drugs
separately.
9) Destroy old cartons, labels,’containers to prevent misuse of
spurious drug manufacturers.
10) If you feel doubtful about the quality of any medicine, contact
the Drug Control Department.
7)
11)
L
r
I
If in Delhi, ring up 22 60 18 be4ween 9 A.M. - 6 P.M..
63 40 73
After office hours and on holidays ring up 63 33 00, 62
and 63 11 16.
The punishment provided in.Sec. -27 and 27A of the 1940 Drugs and
Cosmetics' Act to safeguard the consumer is maximum imprisonment
of 10 years, increased to life imprisonment by West Bengal.
What constitutes the public sector and how are they faring?.
The public sector constitutes of -
IDPL
HAL
SSPL
BE PL
-
Indian Drugs & Pharmaceuticals Limited
Hindustan Antibiotics Limited
Smith Stanistreet Pharmaceuticals Limited
Bengal Chemicals & Pharmaceuticals Limited
IDPL and HAL incurred losses of almost 2 crores in 1979. Monthly
losses of IDPL and HAL are 2 crores.and 45 lakhs respectively.
.4
(Source: Policy Pitfails: Ranjana Kaul:
Hindustan Times, April 27, 1980)
Why arc they running at ca loss?
The reasons given are mismanagement, inefficiency, poor-coordina
tion, under-utilization of capacity, corruption, frequent machine
breakdowns.
%
i
i
Probably, one acceptable reason is the refusal of the MNC and
other private companies to go into production of essential and
life-saving drugs of Category I & II which allow mark-up of only
40 and 55% respectively (as they can make up to 100% profit on .
non-essential over the counter drugs)and the public sector
having to take on the burden.
■
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D-10:343
MS;k:5.1.82
: 9 i
FingZcial Manager of the company
According to Mr. D0B. Telang,
for every kilo of streptomycin produced, a loss of Rs<25 is
incurred.
he more esssential drugs are produced the more are
the losses incurred, Losses are due to increase in the price of
raw materials, inflation
--- 1 - 35-40%; packaging 30%, power 30%, cost
of transportation. A// this in the Presence of fixed drug prices
apparently has caused the ever increasing losses in the public
drug sector. IDPL, HAL, IDRI were instituted to break foreign
monopolization and produce a reasonably
------ ■’ cost essential- drugs for
the Indian public. But even today, 33 years we still import drugs
for Kalazar, malaria, 1leprosy, diphtheria, TB. • Losses can be made
up by raising production
—i or by asking government to alter the
pricing structure.
How self sufficient are we 1^
regarding production of drugs? What
do the MNC *s and OPPI have to say about production of essential
.drugs?
T7
——
Dr. Bh<attacharya
— of OPPI sa
business concerns. Why
I we produc
>duce anvthin^^H-.^
r
•' ‘
i actually
""" 'loss
~/ means
lesl profits)! cause incurrence of loss."
W18
What is C.P.C o?
Chemicals & Pharmaceuticals Corporation is for channalizing drugs
and regulating their availability in the country. The Corpora
tion has had problems regarding availability and prices of
imported ingredients. There are reports of essential bulk drugs
not being lifted from the C.P.C* by the drug company on account
of low profitability. On December 1>
1, 1979, CPC had 4 crore worth
of canalized bulk drugs in stock. rThese
‘J
included essential drugs
like tetracycline, streptomycin.
streptomycin, doxycyclin.
Drug
Company
Licensed capacity
in million^ tons
PAS
a) Biological Evans
b) Warner Hiiindustan
120
300
INH
a) Biological Evans
b) Ghas. Pfizer
c) Warner Hindustan
10
1.6
90
Actua L produc
tion in mil
lion tons
56.06
135.82
0.13
0.06
6.08
What are the objectives of C. P .C .
^^£■^3310 objectives of CPC in canalizing import of drugs is as
1.
Bulk purchase for all manufacturing units gave bargaining
power in world market so that concessional or low prices
could be secured.
2.
io prevent disturbance of indigenous production of drugs with
a certain therapeutic value - introduce and regulate imports
of newer, sophisticated drugs in a planned manner.
To protect the indigenous production of drugs, espc^l
’’ when
especially
the production is inadequate to meet internal demand.
3.
4.
To ensure the equitable supply of raw materials at uniform
prices, eliminating middleman’s profits,, so that formulations
from this are priced at a fixed uniform level.
J
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r-10:343
MS-k:5.1.82
o
10:
5.
To help the small scale sector of the industry whose require
ments are small and who would otherwise find it uneconomic
and impractical to import.
6.
To regulate the import of drugs whose indigenous production
is substantial enough to warrant their being given protection
so that their growth and utility are ensured with a view to
achieving ultimate self-sufficiency.
7.
To secure those drugs which have very few world manufacturers
and monopolies at reasonable prices.
8.
To regulate the import of drugs whose imports can cause public
health problems, eg., addiction forming drugs, etc.
Loopholes points 4 and 5 were to avoid middlemen but unfortunately
since small units have to give their REQUIREMENTS AND ADVANCE
PAYMENT several months prior to time of supply (promptness of which
is not assured), the small scale agencies are unable to take full
advantage and it is the MIDDLEMEN who lift the STOCK, HOARD it and
sell it at 25-30% higher than the usual rate.
10% foreign firms have not utilized 3 industrial licences and
7 letters of intent for the manufacture of 16 bulk drugs.
40 firms in the Indian private sector failed to implement the
investment proposals with 31 industrial licenses and 27 letters
of intent.
t
Of 32 items of bulk drugs covered by 13 licenses, 21 items were not
produced by Glaxo laboratories for the last 5 years.
(Source: U.S. Mazumdar: Drug Industry
Instruments of Policy)
And with all this, useless non-essential drugs are pumped into the
market while essential drugs are not produced. Very obviously,
profit- is the motive of the drug production industry and not ful
filling of the country's need as is often alleged.
The small scale sector feels itself financially ill-equipeed to
undertake any undue losses or profits and therefore also’opts for
non-essential drugs.
What does the 6th Five Year Plan require regarding drug production?
From Present
Bulk 226 crores
By 1984-85
to
665 crores
Formulation Rs. 1150 crores
2450 crores.
VIth PLAN aims at:
1)
2)
3)
Developing self-reliance in technology.
Ensuring availability of drugs with reasonable prices and
inadequate amount
Dominant role of the public sector in the industry.
What's the situation?
Growth rate of bulk drugs has fallen from 13% to 6% and for formula
tions from 10% to 4%.
1
1
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MS:ko5.1.82
: 11
IN THE FIRST YEAR OF THE PLAN, the foreign and big Indian
companies are not interested in manufacturing the drugs that yield
low profit margin.
In fact, by cornering the already sanctioned
licenses and letters of intent they are out to blackmail the
government in Order to secure substantial price rise - by starving
the market of these drugs.
(Source MNC's Fatten, Indian Die:
Dr,. Pankaj Shah: Link, Aug. 2/ 1981,Pg.10)
^h£.Multinationals give the high prices because of the ‘research1
■ -they apparently finance* What all constitutes re sea rc h ?
It includes
- basic research
- product development
- toxicity tests
- research on formulations
- mass production methods
- clinical trials, etc.
it also includes studies on colour design of product, its packaging
to promote sales, general market studies, purchase of international
patents, solely to extend the company's monopoly position abroad.
(Source:
Link, Aug. 2, 19 81, Pg. 11
Dr. Panka^ Shah)
What percentage of their sales do they put into research?
what percentage in publicity?
Glaxo in 1979-8Q spent Rs.1.52 crores on publicity on tropical diseases.
and
percent
Amount MNC 's spend on research is
of their sales turnover
compaisl to 14-15% in Developed countries. Even so research activities are seldom in tropical diseases but in diseases like
cancer
hypertension etc.
What are the country's health requirements based on priorities set
by Alternative Strategy: ICMR/ICSSR Study
Measures against
Communicable Diseases
Nutritional deficiencies
Family Planning, Fertility rate,
Basic health care
Some of the figures that indicate the seriousness of the problem
*IMR in 1976 129/1000 live births (when Sri Lanka's is 45:1 in'72
( pc • 129) )
★Maternal mortality 163 in 1976 (Percentage Distribution
(pg. 125)
*Birth rate
33.3%per thousand per annum in 1978 (Pg.13)'
Health Budget set aside for the Vlth Five Year Plan - 1821.05
Crores
50% of the Health budget earlier has been spent on curative car®*.
40% in construction and capital expenditure
/
10%
PreYentive health care (Health Statistical
Intelligence Report)
/
50% of under fives and pregnant mothers are found to be anaemic
6A-e8.Q, .% are clinically malnourishedo
50% of Indian children get
s
the calories that they
40,000 children become blind each year because of Vitamin A
defiency.
D-10:343
MS:k:5.1.82
12
*27,08,222 get malaria every year and 147 die of malaria in 1979
Incidence of T.B. is
f 2%, i.e., 8 million people. About (Pg*82)
2 million have open TB.
*Incidence of leprosy is 25,59,566 cases on Record - Mar.180
21,58,822 cases under treatment
on Record - Mar. ' 80
(India harbours 1/3 of the world’s leprosy, malaria cases).
’g - 89)
( *Source : Pocket Book of Health Statistics
’80, CBHI, New Delhi)
The incidence of malaria - even
even Falciparum
Falciparum - Filaria,
Filaria, polio,
polio.
Kalazar,
apanese ’Becephalitis has shown an increasing trend.
I
The above becomes cextra
‘
significant when we focus on the percentage
of people below or bordering the poverty level -• a figure that is
also showing a rising trend. 6''"
60% “Indians are below poverty line
(assessed in relation to average caloric requirement).
What is the production of drugs like in relation to these health
requirements:
Out of Rs.636.9 crores of drugs sold in 1980
19% were anti-biotics
10.21% vitamins
4.41% tonics
4.241% anti-anaemic preparations
4.71% cough and cold (increase in growth within
the last 5 years has been
70%) .
Talking in absolute figures 137 crores worth of vitamins were sold
in the year 1980.
Break-up of the above available in Dr. A. Pa twa rdhan ’ s pape r
1,2, and 3.
All modern drugs are available to economically well off 5%.
^asic drugs available to another 20%.
Percentage of people denied availability of essential modem drugs
is 75%.
This is when our population is 65 million.
With annual expenditure of 636.9 crores.
By 2001 the population will be 950 millions.
Amount required for drugs with inflation, increasing prices of
raw material, etc, etc., will be
Our National Formulary has over 60,000 drugs and chemicals.
(15,000 brand drugs)
68% are obsolete and useless (only about 5000 are useful and 2500
of marginal use)
The Hathi Committee has identified 117 as essential drugs and WHO
about 200’ drugs which would take care of the 90% of the EXISTING
HEALTH PROBLEMS.
---------------
!
I
D-10:343
MS:k:5.1.82
: 13 :
Regarding essential drugs production what is happening?
Out of Rs. 1260 crores worth of drugs manufactured in 1979-80
^3 accounted for Rs.350 crores only essential and life saving drugs
the rest were tonics/ <digestive enzymes, formulations of medicines
with marginal benefit.
MANY VITAL BULK ir.YZB
DRUGS IN HUGE QUANTITY HAVE BEEN WASTED WHICH
FOR MANUFACTURE OF ESSENTIAL DRUGS.
COULD HAVE BEEN UTILIZED
1--------(Source: Drugs : Industry Instruments of Policy
Anti-T.B. Drugs
19 77
Installed Produc
tion
capacity
tonnes
ronnes
- J.S. Majumdar)
1978
Production
Installed
Tonnes
capacity
p'onnes
INH
5 09
57
5 39
94
PAS and its salts
1170
56
1290
558
The ac e t a z one
153
25
153
13
Streptomycin
25 7
194
257
225
DDS and its deriva
tives
26
17
38
17
Anti-filaria
DEC citrate
56
18
56 .
23
A n t i -1 y ph oi d.
Chloramphinicol
128
95
128
95
5 87
590
170
19-5
137
157
16
156
34
176
45
■
Anti-Leprosy
Anti-Dysentery
Metronidazole
55
A n ti-malarials
Chloroquin
Pfizer Ltd,
Products
Licensed capacity
Production during
19 79
1978
5 2 MT
45 MT
INH
80 metric tonnes
PAS and its salts
110
it
it
90 MT
54 MT
Te rramyc in
14
H
H
5 3 MT
54 MT
Protienex
110
ii
it
26'9 MT
290 MT
Burrough 1s WeIcome
Septran
Licensed annual capacity
26 million tablets
Prod netion 19 80-81
187 million tablets
Similarly/ Glaxo’s 1production of Betamethazone has been increasing
‘
, serra
while production of antibiotics - penicillin, streptomycin/
and vaccines is much below licensed capacity.
Make-up of Drug Industry at a glance?
*3500 manufacuring units
*5000 pharmaceutical units
* 118 can panics in the organised
*1500 units based on loan
sector
license system
Of the 20,000 formulations in the
*45 Multinational drug companies
market - 78% formulations ip thg
which have foreign equity
hands of Multinationals, 16%
more than 4 0%
Indian priva€^ Sector, 6%sPufe.lic
■•V
-Ar .-'f 'V
1
I*
Y
V°Iuntary He3jth A
P-10 ■ 343
MS : k: 5.1.82
C~14 Commt;„„
New be^-llG016.
S.UA.,
[»
f
THE drug SITUATION in INDIA
“
Dr
.
S.lly
Co< ^ioai0r
^Cost 0ruoCoo
'russ R^na; Tl
G-14, Co CU4n A
^S5oc/aMthe solutions of theW^^e^'1 °^odia
d^gCfiluationtdetFrOblem3
OPPI, -•
who see
and the
i=Cir1i;njuftr9“i“t“”aaxsro„;s?hi"9 in
°£'What-is
I
?!
Sh3aK1BStt?ha?:S£“VJreaching
aSSref&ts
e
effects,,
^L:S,11with
w°thusthe
th.todifferent
ab;£fan,tiiar
”ith
& '<>«*£'
iiti?th"
—i the
problem, with
the psr
loop
versions of the various groups involved.
THE FACT THAT THE
TN INDIA DOES NOT LIE
BUT IN SOCIO ECONOMIC
WELL ACCEPTED BY MOST
!
J
5
i
THE mj0RITY OF THE HEALTH PROBLEMS
IN MORE PILLS,
PTT.iiv MORE DOCTORS, MORE HOSPITALS,
<S< POLITICAL POWER RELATIONS
-------- > IN SOCIETY IS W.’
OF US HERE.
greater social
the villager She
tLTtoX TaTh" f" '
SXXS/’yS “T™ alr ,£°r tgose
Jn SClth
hospital or even a teaehlS?TSplta5! h pro»»»“- •
to be
Knowing about drugs is not/limited. to their brand r~ ■,
names, dosages.
sidA effects, but also their COST <
and their availability.
The various factors influencing these need
to be analysed.
We will ]highlight
• ' - some of the more important
aspects which will
strongly .influence
, ----------- a our search for solutions.
:g5't
?-a"V
eed pla
r‘"s“
h»much of
Year
7 rs
”.o- ho»
it goes on drugs SstLJ?®
oxpendlturo
mI
S w <-
a)
1821.05 Crores (1980-85) C.ntre/state s/UMon Territory
Source .:
(6th Five Year Plan - Pg. 3 82)
b)
Traditional System of Medicine - Centre 29 Crores
oource: (Planning
(Planning Commission - N.D.)
c)
Rs. IS.05 (+ Rs. i.5i for Family
Welfare)
in
Welfare)
in 19771? of '7R
Source:.
(Pocket Book Family
of Health
Stahstics
Xdia Source
:
~~ Health Statistics
1980 Pg.37)
What p'-----percentage of the Indian population utilizes
the benefits
of. modern drugs:
TJ
<5
O
X S <=>
_
H S O
-J
S
X 52
J™
o .j
2
□
*> 'Z5 2
5 if
o
o
r;
- about 20%; dccoramg
according to some estimates only 10%
...U ow _se..If^s uf f ic ien t a re . we .. in pr oduc in g this?
We Urtill import -5 0% of the raw material atour Pharmaceutical industry h-’
^upendous rates inspite
being 3 3 years old and the
in the Third World.
biggest
What is happening to drug imports?
tDpoDUU3 trlpled between 1963-64
to 1973-74 fromi Rs • 13 ♦IJ.. c rore s
to Rs.37.50 crores ---- within next
year
it increased to Rs. 4 7^bx"ores
this constituted 35% of the bulk <
drugs utilized in :formulations.
According to Dr. S. S. Gothoskar,
the Drug Controlle r of India
lhe last 3 yrs have witnessed a
steady
increase in the requirements
of imported raw materials by nearly
./ 100 percent.
Thus while our
I!
1
2
D-10:343
MS sk’S.l.8L
production increased by only 50% from 1976-77 to 1978-79 the expenditure incurred on import of bulk drugs, intermediates,
solvents etc. rose by nearly 80%.
L
Ihe break-up of the drugs in the market is:-
Foreign Multinationals
. . 78%
Public Sector
..
Indian Private Sector
.. 16% (Source: Dr. Pankaj
Shah: Link - Aug. ‘81)
Pg. 12.
In 1978-79 MNC's produced
6%
.. 28% Bulk drugs (Basic drugs)
.- 44% Formulations
(Source: Dr. Thakor - Businss
India, July 1980,Pg.26)
Jtlhat are—the a 1 le q a t i^ons apajj
11 tin at i on a Is ?
According to the Hathi Committee Report in 19 75 the Multinationals;
block others from producing drugs for a period of 16-20
years by invoking patent production,
■I
- din the brand names into the minds of the medical
profession by employing a large force of medical detainers,
- resort to high pressure sales techniques, and,
- rig up prices to levels which have no relation to the cost
of manufacture of products or international prices.
.Hhat we.re the Hathi -Cr3mmit^tee_‘_s_ maiqrrecommen.dations2_
1)
Nationalise the Drug Industry,
2)
Foreign undertakings operating in the country should be
directed to bring down their equity to 40% with
progressive reduction to 26%**
(Under the New Drug Policy it was added that Multinationals
maintain a ratio of 1:5 for production of bulk drugs to
formulations)
**In the US more than 10% share by a foreign undertaking
classifies the company as foreign.
What were_the Hath! Committee1s recommendatian reaardina aeneric
drugs?
1)
Abolition of brand names in a phased manner, beginning
to be made with 13 single ingredient drugs:
- analgin
- aspirin
- piperazine
- ferrous sulfate
- chlorpromazine
- chlorampheniol
- s tre pt omyc i n
- Tetracycline
- reserpine
- tolbutamide
- INH
- INH & thiacetazone
Recommendations made in 1975.
In Jan. 17th 1981 decision was
taken to abolish brand names for
5 classes of drugs:
- analgin
- asprin
- chlorpromazine
- ferrous sulfate
- piperazine
!
I.
Z•
Voluntary Health Association of India
C-14, Community Centre
Safdarjung Development Area.
New Delhi-110016
A/H ^-Ao\
A VHA!
kA A
w
J-n
V
Telegrams : VOLHEALTH
New Delhi-110016
Telephones : moyi
OUE ODKCEffiLABOUT DBUGS
Inspite of. the green revolution, white revolution, industrialization,
modernization and development, the country’s increase in G1P(Ooss-U-ational
rofits), most of these things have not touched that man who hangs helplesslybelow the poverty line.
The irony of all our great development is that
the number of such people who are becoming destitutes is increasing.
Frcm 27 we can now boast of 229 Medical Colleges (Karnataka is planning- to
make a humble contribution and add /to that list). According to W»s reco
mmendations our doctor population ratio is above the requirement. Our
Pharmaceutical Industry is amongst the best in the Third World. The state
spends Rs. 9 per person per year on health. Why then do we still have such
a hi^i incidence of malnutrition? high infant mortality?
Why are there
still ID million TB patients when we have crores being spent on the National
w Programme.? Why do 27 mil lion Indians get I^phoid every year? 6 out of
100 children- are in potential danger of beconing blind with Vit. A defi en en ry
Why is it that the great major!t;
of our population has no access-to basic
health care? 80% of our doctors1 ur health budget cater to the needs of a
small minority.
I
Drug costs represent Z^-60^ of the total health care expenditure in the
developing countries (coup ared ; with 10^20% in the developed ones).
The rural urban disparity when it comes to health man power a.1 location
expenses on drugs, vaccines and other health serrices is in simple words
UNJUST. Only a very meagre percentage of Rs. 9 allo ted per person for
health expenditure reach him, who forms our ’Millions1.
.VHAI believes in making health care available to those who need it most.
Orientation towards ’’appropriate use of drugs” and non drug therapies is not
merely for those who are given the prescriptions, but also for those who do
the prescribing.
A prescription written with the high medical standards in
mind, may be highly inappropriate in. a social context where the patient
cannot afford to buy the drugs, or where buying these drugs for the famil y
members means being in and out of debt with money lenders.
Our prescript
ion practices have to be modified according to the needs of the people, our
choice of drugs for stocking the pharmacy have to keep this in mind and
most of all the emphasis has to be on people taking self, responsibility for
their health and avoiding these drugs as far as possible and using those
non drug therapies that have been recogiized to have good therapeutic effect.
Education and awareness as to how to-avoid disease and then how to handle it
-appropriately at the lowest possible cost is the crux of our approach in
low cost appropriate health care,
‘
-
The marketing of most brand named drugs speeijolly by the multinational in the
Third World works against the Health of the poor: (1) Most critically •^because Health Care'priorities are distorted by pressure to buy expensive
inappropriate drugs, which cream off limited resources, and (2) Drugs freely
..promoted in the absence of distribution controls can be dangerous.
.*
i-
?.•
*DKJGS:
(1)
?«■
The effect of promoting th expensive, branded drugs for which generic
equivalents are available xat a fraction of the cost (sometimes as
low as 10^), is to drain limited Health Budgets unnecessarily.
OXF^M PUBLIC /SFFXtRS UNIT (si.A.'SO) '
o/
r
2
-
\S
I
Third World countries spend a disproportionate amount on Drugs,
often as much as 55$ of the total health budget (compared to 11$
of NHS.budget on drugs here). Bearing in mind the very 1 j mi ted
effectiveness of drugs and curative medicine in general in tackl
ing, the major health problems - malnutrition, infectious and para
sitic diseases - public funds would be far better spent on prevent—
-ive health measures and the basic Primary Health Care infraatruct-ure. For this, WHO estimate that 200 generic drugs would be more
than adequate to meet
Health needs.
?
Thd pr emotional practices of drug cempanies, aimed at maxi mi si n g
profits, run directly counter to the health needs of the poorest.
Drug cempany salesmen (Glaxo has 500 in India alone) concentrate
their promotion on encouraging doctors to prescribe the most
expensive, latest patented drugs, claiming they are great improve
ments on far cheaper, well-established drugs.
When Beecham’s and
Wllccme!s antibiotics and antimalarials are prescribed, at public _
expense, instead of penicillin and chloroquine, the drug“budge”t is
rapidly exhausted. Because of existing imlaalances in the .he.alth
serszices, reinforced by marketing, the brunt of wasteful spending
invariably falls on the poorest, as the rural dispensaries run
short of vital life-saving drugs.
Apart- from promotion of unnecessarily expensive , but necessary
drugs, doctors are also encouraged into wasteful overprescribing /
of non-essential tranquilisers, sympton-allaying drugs, apd tonics.
Onceagain,. the indirect effect on the poor, is that Valium, being
doled out in hospitals on public funds, can mean shortages of first
line drugs in the village dispensaries. Where medicines have to
be paid for, (particularly when the doctor is remunerated for
prescribing rather than consultation) - sales talk may lead him
to prescribe unnecessary drugs e.g. several courses of antibiotics
and vitamins for a sick child, costing anything up to a months
wages*
(2)
~~
SruRS freely promoted in the absence of distribution contro^Ls can
be dangerous,
~
^G^"e-down effects of uncontrolled drug marketing in the .ab
sence of an adequate health infrastructure, trained healthhvcrkers
and controls cm over-the-counter sales can seriously endanger the ‘
health of the poor. They are most vulnerable through ignorance of
dangers and the misconception that a medicine - any medicino.. -,will
do the trick.
'
When under attack for unethical marketing practices in the '*frrird
World, the drug ccmpanies argue*1 that they stick to the letter of
the law. Quite true - But, they demonstrate a total lack of
social responsibility in promoting potent, potentially dangerous
drugs, in countries .where they know they will be freely available
over-the-counter,prescribed by local practitioners and traders
with little knowledge of medicine — let alone spphisticated drugs.
(Whilst deaths frcm adverse drug reaction go unreported in phe
Third World - in the USA they are estimated at 30,000 per year.)
v
L
The net effect is that the poor are encouraged to buy drugs - for
totally inappropriate uses and irrational self-medication -.parti
cularly of antibiotics leading to serious problems of drug resist
ance - can be fatal. First line antibiotics given to children with
diarrhoea could mean they wil 1, die later if they get TB, because
there will be no way of obtaining or paying for a: second line drug.
:
■
i •
■.............. 3/'
f ■
BRIEF OUTLINE OF VHAI'S IDLE IN LOW COST APPROPRIATE HEALTH CARE
Re^a£din£ >-ug_rel^te<i_Legisiaiion_qi n^tipn^leve]^
Forming a lobby against unethical practices of drug, canpanies^
Building awareness regarding WO endorsed code of conduct as
against that drawn up by multinationals
-
Seeking information and analysing national policies which may'
have detrimental implications, specially where drug market, is
concerned.
Linking up with medical units of various consumer societies,
other groups and individuals working on si mil ar lines: eg. Medico
Friends Circel, Centre for Studies in Science and Fhvircnment
etc. to form pressure group.
Use different seminars, workshops, medical and nan-medical joumais
to disseminate relevant information.
■I
-4
£
Questioning drug advertisements, giving incorrect information and
making false claims..
Be.gq£din£ Production—of Generic nane drugs:
Collect information of experience regarding production of drugs
and low cost health care from other voluntary groups and pro
grammes: eg. Savar in Bangladesh, Guatimala, Philippines, SriLanka, Medicus Mundi/International Organisation and seeing
applicability in our Indian context.
Fhcourage or collaborate in production of generic name drugs.
Conscientize people regarding quality control and demanding it
to prevent involuntarily having turning to the sophisticated
drug comp-anies.
To identify non allopathic drugs : eg. de Chanes, Homeopathic etc.
of cheaper and more effective to inform others.
Regarding Distribution of^drugsj. (which is the biggest problem for develop-ing countries)
(See appendix-1)
- She our aging bulk purchase at regional levels
Helping to organize distribution channels
Help collect background information based- on epidermiological
studies, other field studies
fte^a^cjing M^n^wnt— of Ph^rmacies^.
Encouraging formation of pharmacy and therapeutics committee
( See appendix 2)
Stocking -with appropriate drugs - low cost, generic, avoiding
combinations trade nanes as far as possible
Fhcouraging local preparations of liniments, ointments, syrups
and mixtures (as done by compounders earlier)
.
?
I
I
J
i
J
2
>
,
:
Helping in appropriate pricing of treatment (registration,
consultation and cost of drugs)'
Availability of information on all drugs dispensed with.
He^ardin^ dispensing-of .drugs:
Limiting range of drugs in the pharmacy to essential
drugs
Use of formulary
Encouraging use of Physicians’ Desk. Reference on extra
pharmacepea and not relying on the information given by
drug advertisements and drug representatives.
Helping in standardization of diagnostic and prescription
procedures ( to avoid unessential and limiting procedures
to the most appropriate)
^Educqiion-.ajid-Training of_Health Personnel:
Collection, analysis and dissemination of relevant inform
ation to health professionals ( and public) regarding use of drugs and their substitutes - role of drug industry
in health services - use of non drug therapies : eg.
massage, acupressure, acupuncture - investigation and use
of heme remedies and other indigeneous herbal medicines
known to be cheaper and giving good therapeutic results.
local preparations of commonly used ointments, syrups etc.
planting of medicinal plants in hospital vicinity with
specific therapeutic value.
Regarding Health_Educ^tipn_ gf_Pgtients :
Enphasis cn the concept of ...self responsibility regarding
health
Special cover age to methods of prevention of common
diseases, eg: those due to poor .hygiene, sanitation and
nutrition.
Information about the various govt, health programmes:
- National iB Programme
- MCH & FP
- For Blindness etc.
- Immuni z ation Pro gr amme s
Information regarding functions of PHC doctor, sanitary
inspector, ANN etc. for people to know their rights.
!
Sharing information with the people about therapies used
by them
Encouraging me di cal ~l y sound customs and cultural practices
- eg. use of Dathun instead of Colgate tooth paste and
discouraging the harmful ones by giving appropriate
information.
branding a child on the abdomen, nor
breast feeding a child, for 3 days..
Giving information about the misuse of - injections tonics - steroids, bottle feeds.
3/
/
3
:
Other_ Activities to_ de crease health, egre costs:
"
<
?'ainiiS °f hi^rent levels of health personnel to be able
handle o—on peoblms „ .ffectiwl7
„ ohes<Jlr
pos|!Ulle
I
i
i
°f reccramended reading list of books
and material
related to low cost appropriate health care.
1
Xm^CentiJ^f8^3^1311
worki21S on ^e sane lines
g. lire, Centre of Science and Environment
S£Zat^-X-^?UpS t0 do scientific field studies on local
opti”
j
This background paper is for discussion.
cOo
Appendix 1
Distribution of Essential drugs in Developing Countries
5
Drug distribution was identified i
as a critical factor in health care and the
aC^C^i^men^ °f a CQmPrehensive national drug^poli'cy at
the consultation
and WHO ^technical Discussion in 1973.
l^rSy'o^the^oJiti^T 3 ? distr^butiQn
Patterns depend
, X! p°llblcal 91111 econcmic system and the Administrative swtem
under whach the Govt, is operating, (effective distributSn 2 SuX
depends on nation's political will).
resources
1
-4
i
Following were the relevant factors to be considered for any system of
distribution of drugs:
?
2.
3.
45.
6.
7.
9.
10.
•t
Demography, Health Indicators
Morbidity pattern
kist of essential drugs and medical equipment
Adequate storage facilities
Sixs
Packaging material standardization and labelling
Quality surveillance and inspection
Education and regular training of staff
Drug utilization studies
»
I
I
1
i
.?
■;
K
■i
I
■
Appendix 2
1
Pie Prajnyy purposes of the Pharmacy and Therapeutics Committee
a*
Advisory
b.
Educational
'I
Functions and Scope
The following list, which is not necessarily comprehensive, is often
as a guide:
’
A.
>
To serve in ian advisory capacity to the medical staff and hospital
adminis tr ati on in all matters pertaining to theuse of drugs.
To serve in an advisory capacity to the medical staff and the pharmapharma
cist in the selection of choice of drugs which meet the most effective
therapeutic quality standards.
0.
To evaluate Objectively clinical data regarding new drugs ca? agents
proposed for use in the hospital
D.
To prevent unnecessary duplication of the same basic drug or its
combinations.
E.
To recanmend additions and deletions from the list of drugs accepted
for use in the hospital
1
F, To develop a basic drug list or fformulary
L_ v of;accepted drugs for use
in the hospital and to provide for its constant revision* ~
To make recommendations concerning drugs to be stocked in hospital
patient units or services.
H.
To establish or plan suitable educational programmes for the profess
ional staff on pertinent matters related to drugs and their use*
I.
To recommend policies regarding the safe use of drugs in hospital,
including a study of such matters as investigational drugs, hazardous
drugs, and others.
J. . To study problems involved in iproper
.
distribution and labelling of
/
medications for inpatients aid out patients.
j
K.
To study problems related to the administration of medications.
L.
To review reported adverse reactions to drugs a dm i n i s tere dT
M.
To evalutate periodically medical records in terms of drug therapy.
■
;•
<
LIST OF RELEVANT reading material dealing with drug problem
I>•
\
Drugs and the Third World
Anil Aggarwal
Earthscan
Publication
International Insti-tute for Environment
& Development
10 Percy Street
London - August 1978
2.
There is Gold in them
tharpills
Alan Klass
Penguin Special
1975
!
Poor Health-Rich Profits
Dr. Tom Heller
Bertrand Russel
Peace Foundation Ltd.
Bertrand Russel House
Gamble Street
Nottingham
1977
!
3.
4.
Social Audit
Insult or Injury ?
Charles Medawar
>
Social Audit Ltd.
9 Poland St.
London W1V3DG
1979
(
I
5.
Social Audit
Drug Disinformation
Charles Medawar
6.
Medicus Mundi Internationales
International
Gener al Se ere tari at
Organization for
of Medicus Mundi
Cooperation in
In tern ati on ali s
Health Care.
Mozartstrasse 198O
Documentation of
D-5100
the General Assembly
Aachen, BRD
Social Audit
Public Intersert
Research Centre Ltd.
November 1980
(17-19 May 1930)
7.
Essential Drug list
8.
WHO Technical Report 1979
series No. 641
Drugs and PharmaceuticalChapter from "Health for
All - An alternative strategyH1
ICMR & ICSSR
I
t
I
*
New Delhi
August 1930
i
I
9-
Hath! Camr^ssion Report
aoi
10.
Food First
Lappe Francis
Moore and Collins
11.
Medical Nemesis
Ivan Illich
1974
■
1
1930
I
II
J
t
2
12.
13.
Confessions of a Medical Heretic
The Medicine Men
- Dr. Robert S. Mendelsohn
Contemporary Books
1979
- Vernon Coleman
Arrow Books Ltd.
Essex
1975
~ Pharmaceuticals for
Developing Countries
National Academy of
Science, Washington DC
1979
Information Sources on the
Pharmaceutical Industry
- UNIDO Guides to Info.
Sources No.20
UNIDO,VIENNA
1976
16.
Pills Against Poverty
(A Study of the introduction of
western medicine in a Tamil
village)
- Djurfeldt, Goran
Lindberg, Staff an
Oxford, IBH
Pub. Co. New Delhi
17.
In Search of Diagnosis
- Ashwin J.Patel
Medico Friends Circle
Gujarat
18.
Planning Pharmaceuticals for
Primary Health Care
(The supply & utilization of
Drugs in the Third World)
- Oscar jish
Loretta Lee Feller
19.
Drugging the Indian
(Article in”Debanoirv)
- by Shivan and K ark al
July !S0
20.
The Ethics of the Drug Industry
(Article in ’’Business India”)
— by Dilip Thakore
July !S0
14.
15.
Conference Proceedings
1977
I
5
VOLUNTARY HEALTH ASSOCIATION OF INDIA
C-1 4, COMMUNITY CENTRE,
PHONES : 668071, 668072
S.D.A.
NEW DELHI 1 1 0 01 6
GRAMS : "VOLHEALTH" New Delhi 110 016
DRUGGING OF ASIA—PHARMACEUTICALS
AND THE POOR
Workshop organized by IOCU, VHAI and ACHAN
Madras 6th—9th December 1 985
=4
I
Summary of Workshop Conclusions on National Drug
Policy prepared by Dr. K. Balasubramaniam, Pharma
ceutical Advisor, Caribbean Community Secretariat
The Heads of States or Governments of Non-aligned and other developing
countries had at two of their summit conferences recommended unanimously
that each developing country should formulate and implement an integrated
national drug policy in order to ensure access of the entire population to
essential drugs at reasonable cost.
At the request of the developing countries, the United Nations Action
Programme for Economic Cooperation among Non-aligned and other deve
loping countries (UN-APEC) convened a meeting of a group of experts on
Pharmaceuticals in July 1976 in Georgetown, Guyana. This Expert Group was
mandated to prepare an Action Programme on Pharmaceuticals and present
it to the Fifth Non-Aligned Summit Conference held in August 1976 in Colombo.
The Summit Conference endorsed the recommendations of the Expert Group
in Resolution No. 25 on pharmaceuticals. In this Resolution, the Heads gave
an outline of an integrated pharmaceutical policy and also requested the
relevant UN agencies to assist developing countries by examining in depth
the pharmaceutical sector in developing countries and preparing a detailed
drug policy and programme suitable for these countries. Accordingly in 1978,
four UN agencies—UN APEC, UNCTAD, UNIDO and WHO constituted a Joint
Task Force on Pharmaceuticals and fielded an inter-agency mission to several
countries in Asia, Africa and Latin America to study the pharmaceutical
sector in these countries. The Mission had discussion with relevant govern
ment officials involved in the public sector pharmaceutical supply system and
with the private pharmaceutical industry and reported its findings to the Joint
Task Force which then prepared a comprehensive report entitled, “Pharma
ceuticals for the Third World : Policy for Health, Trade and Production.”
The conclusions and recommendations of their report contained a detailed
description of an integrated national drug policy This report was
submitted to the Sixth Non-aligned Summit Conference held in Havana in
September 1979. The Conference endorsed the conclusion and recommen
dations of the Task Force Redort in their Resolution No. 8 on Pharmaceuticals.
(
2
)
From the foregoing it is clear that the developing countries have, at the
highest political level, underscored the imperative need for each developing
country to formulate and implement an integrated national drug policy to
ensure access of.the entire population to essential drugs at reasonable cost.
The policy recommended by the Heads was based on a limited list of
essential drugs.
Of the countries represented at the Asian Seminar on Pharmaceuticals
Bangladesh alone had in 1982 formulated and implemented a rational drug
policy based on the guidelines recommended by the Non-aligned Summit
Conference. Within a period of three years the pharmaceutical supply system
in Bangladesh has improved tremendously. Essential drugs are increasingly
available to larger sections of the population at reduced costs. On the other
hand countries which had not formulated and implemented a national policy
based on essential drugs are paying very high prices for their lapse. For
example the Workshop was informed that in India. A child was going totally
blind every 13 minutes due to the unavailability of Vitamin ‘A’-—a cheap and
essential drug. Some participants believed that it would be amounting to
criminal neglect if health authorities in other countries continued to delay the
formulation and implementation of a national drug policy based on essential
drugs, particularly when our Heads have on two occasions, given clear direc
tives to this effect.
The participants therefore, appeal to the Prime Minister
of India, Mr. Rajiv Gandhi, as the Current Chairman of the Non-aligned
Movement to use his good offices to force health authorities of the member
countries of the Non-aligned Movement, particularly those in South Asia, to
formulate and implement national drug policies based on essential drugs
and suited to their needs without any further delay.
The workshop also took the opportunity to identify the major components
of a model drug policy suitable to countries in South Asia, using as guide
lines the directives given by Non-aligned Summit Conference, Countries in the
region may wish to use their model drug policy as a basis to formulate their
own national drug policies.
A MODEL NATIONAL DRUG POLICY
A national drug policy should be linked to the health needs of a country
and designed to ensure access of the entire population to essential drugs
at reasonable cost.
The supply of essential drugs involves the active participation of many
sectors including health, industry, trade, finance etc. It is, therefore, essen
tial that an intersectional drug committee with representatives from all
relevant sectors be established prior to the formulation of a national drug
policy. Failing to observe this vital point and formulating a drug policy
>
V
(
3
)
without participation of all the relevant sectors would result in floundering
at midstream at some point in the implementation stage leading to an inter
ruption in the drug supply system. In formulating the national drug policy
care should be taken to avoid undue influence of the private drug industry,
particularly the multinationals.
The following would be the major components of a model national
drug policy :
Drug Needs : National lists of essential drugs selected on the basis of
the health needs of a country should be established. Evidence from some
developing countries and the reports of the WHO Expert Committee on
Essential Drugs indicate clearly that a limited number of essential drugs of
about 250-300 would be sufficient to meet the major needs of the people.
Drug Names :
International Non-Proprietory names (generic names)
should be used whenever possible.
Quality Assurance : Appropriate steps should be taken to assure the
quality of all marketed drugs. The success of a generic drug policy is
critically dependent on assuring the quality of drugs.
Objective Information on Drugs and Therapeutics: Health Authorities
should provide objective information to health persons.
Drug Legislation : A country should enact appropriate legislation
covering registration, control of drug information including therapeutic
indication, mention of adverse reactions, contra-indication, drug interaction
price regulation and post market survey.
Price controls or monitoring should be introduced at the import, whole
sale and retail levels.
Any introduction, amendment, alteration, variation, deletion of any drug
legislation or releated laws shall be made available to all organization,
association
and individuals.
Procurement : At present drug imports are fragmented not only bet
ween the public and private sectors but also within each of these sectors.
Foreign exchange savings could be effected by pooling these purchases by
means of a centralised buying agency, some of the countries in the region
have a centralised buying agency for the purchase of the public sector
requirements but their bargaining power is limited since they do not have
the vital market intelligence.
Production : Ail countries in the region have already established drug
manufacturing units. In the majority of the countries, local production is
dominated by the private sector. The commercial practices of the private
(
4
)
sector with emphasis on creating a demand and generating profits are counter
productive to the large scale production of socially useful essential drugs.
A national drug policy based on essential drugs cannot be implemented with
the uncontrolled practices of the private sector. Countries in the region
should therefore give a leading role to the public sector and to socially
conscious manufacturers like GK Pharmaceuticals of Bangaladesh.
Transfer of Technology : The uncontrolled transfer of pharmaceutical
technology into the countries of the region has resulted in the manufacture
of a large number of non-essential expensive drugs. Production facilities
brought into the country at high costs are not being used for the manufacture
of essential drugs.
Priority technological needs of the country should be identified when the
decision to acquire technology has been made. Explore all possible sources
of technology and select the most suitable technology, if necessary with
assistance from relevant international agencies. The terms and conditions
of the technology transfer agreement should be carefully examined and all
restrictive clauses controlled
and reduced.
Priority should
be given to
acquiring technology from another developing country.
Promotion : Drug promotion by the drug industry must be controlled
by the drug regulatory authority.
Patents : All countries in South Asia except India grant patent protec
tion to pharmaceutical products and processes. India grants protection to
processes only. Product patents enable the patent holder to gaida monopoly
of the market. The host country will be prevented by its own national patent
legislation from buying the same drug from a cheaper source.
The Non-aligned Summit Conference has recommended that pharma
ceutical products and processes should be excluded from patentability. If
process patents are granted, compulsory licensing should be used for ex
ploiting the patent locally. Other alternatives relate to shortening of the
duration of patents.
Regional Cooperation : Some of the components of the drug policy
would be difficult to implement at the national level by some of the smaller
countries of the region. These would include quality assurance, collecting
market intelligence and local production. Taking these constraints into
consideration, the Non-aligned Movement recommended the formation of
regional pharmaceutical centres by developing countries so that member
countries belonging to a regional centre could take joint action to implement
some of the components at a regional level.
(
5
)
Several years of multinational negotiation would be required before a
South Asian Regional Pharmaceutical Centre could be established. However
Health authorities in the region could initiate some joint activities.
1. Market intelligence is totally lacking in the region. Countries could
exchange information on manufactures, price trends, quality of products
etc. among themselves.
2. Drug regulatory authorities in the region may wish to establish drug
quality norms and explore the possibilities of enacting
uniform drug
legislations. This would enable the smaller countries in the region with their
drug registration and quality assurance.
3. Objective information on drugs and therapeutics is another compo
nent which could be provided regionally.
The crux of the matter still remains that the cheif responsibility
for the formulation of Rational Drug Policies lies with the
National Governments.
In the view of the availability of well defined WHO criteria for
such formulation - it is possible for Asian countries to have
such rational policies provided they have the political will to do so.
For more information on Rational Drug Policy contact : Co-ordinator, Low Cost Drugs &
Rational Theraputics VHAI
VOLUNTARY HEALTH ASSOCIATION OF INDIA
C-14, COMMUNITY CENTRE,
PHONES : 668071, 668072
S.D.A.
NEW DELHI 1 1 O 01 6
GRAMS : ‘•VOLHEALTH" New Delhi 110 016
DRUGGING OF ASIA—PHARMACEUTICALS
AND THE POOR
Workshop organized by IOCU, VHAI and ACHAN
Madras 6th—9th December 1985
Summary of Workshop Conclusions on National Drug
Policy prepared by Dr. K. Balasubramaniam, Pharma
ceutical Advisor, Caribbean Community Secretariat
The Heads of States or Governments of Non-aligned and other developing
countries had at two of their summit conferences recommended unanimously
that each developing country should formulate and implement an integrated
national drug policy in order to ensure access of the entire population to
essential drugs at reasonable cost.
At the request of the developing countries, the United Nations Action
Programme for Economic Cooperation among Non-aligned and other deve
loping countries (UN-APEC) convened a meeting of a group of experts on
Pharmaceuticals in July 1976 in Georgetown, Guyana. This Expert Group was
mandated to prepare an Action Programme on Pharmaceuticals and present
it to the Fifth Non-Aligned Summit Conference held in August 1976 in Colombo.
The Summit Conference endorsed the recommendations of the Expert Group
in Resolution No. 25 on pharmaceuticals. In this Resolution, the Heads gave
an outline of an integrated pharmaceutical policy and also requested the
relevant UN agencies to assist developing countries by examining in depth
the pharmaceutical sector in developing countries and preparing a detailed
drug policy and programme suitable for these countries. Accordingly in 1978,
four UN agencies—UN APEC, UNCTAD, UNIDO and WHO constituted a Joint
Task Force on Pharmaceuticals and fielded an inter-agency mission to several
countries in Asia, Africa and Latin America to study the pharmaceutical
sector in these countries. The Mission had discussion with relevant govern
ment officials involved in the public sector pharmaceutical supply system and
with the private pharmaceutical industry and reported its findings to the Joint
Task Force which then prepared a comprehensive report entitled,'‘Pharma
ceuticals for the Third World : Policy for Health, Trade and Production.”
The conclusions and recommendations of their report contained a detailed
description of an integrated national drug policy This report was
submitted to the Sixth Non-aligned Summit Conference held in Havana in
September 1979. The Conference endorsed the conclusion and recommen
dations of the Task Force Redort in their Resolution No. 8 on Pharmaceuticals.
(
2
)
From the foregoing it is clear that the developing countries have, at the
highest political level, underscored the imperative need for each developing
country to formulate and implement an integrated national drug policy to
ensure access of the entire population to essential drugs at reasonable cost.
The policy recommended by the Heads was based on a limited list of
essential drugs.
Of the countries represented at the Asian Seminar on Pharmaceuticals
Bangladesh alone had in 1982 formulated and implemented a rational drug
policy based on the guidelines recommended by the Non-aligned Summit
Conference. Within a period of three years the pharmaceutical supply system
in Bangladesh has improved tremendously. Essential drugs are increasingly
available to larger sections of the population at reduced costs. On the other
hand countries which had not formulated and implemented a national policy
based on essential drugs are paying very high prices for their lapse. For
example the Workshop was informed that in India. A child was going totally
blind every 13 minutes due to the unavailability of Vitamin ‘A’—a cheap and
essential drug. Some participants believed that it would be amounting to
criminal neglect if health authorities in other countries continued to delay the
formulation and implementation of a national drug policy based on essential
drugs, particularly when our Heads have on two occasions, given clear direc
tives to this effect. The participants therefore, appeal to the Prime Minister
of India, Mr. Rajiv Gandhi, as the Current Chairman of the Non-aligned
Movement to use his good offices to force health authorities of the member
countries of the Non-aligned Movement, particularly those in South Asia, to
formulate and implement national drug policies based on essential drugs
and suited to their needs without any further delay.
The workshop also took the opportunity to identify the major components
of a model drug policy suitable to countries in South Asia, using as guide
lines the directives given by Non-aligned Summit Conference, Countries in the
region may wish to use their model drug policy as a basis to formulate their
own national drug poiicies.
A MODEL NATIONAL DRUG POLICY
A national drug policy should be linked to the health needs of a country
and designed to ensure access of the entire population to essential drugs
at reasonable cost.
The supply of essential drugs involves the active participation of many
sectors including health, industry, trade, finance etc. It is, therefore, essen
tial that an intersectional drug committee with representatives from all
relevant sectors be established prior to the formulation of a national drug
policy. Failing to observe this vital point and formulating a drug policy
(
3
)
without participation of all the relevant sectors would result in floundering
at midstream at some point in the implementation stage leading to an inter
ruption in the drug supply system. In formulating the national drug policy
care should be taken to avoid undue influence of the private drug industry,
particularly the multinationals.
The following would be the major components of a model national
drug policy :
Drug Meeds : National lists of essential drugs selected on the basis of
the health needs of a country should be established. Evidence from some
developing countries and the reports of the WHO Expert Committee on
Essential Drugs indicate clearly that a limited number of essential drugs of
about 250-300 would be sufficient to meet the major needs of the people.
Drug Names :
International Non-Proprietory names (generic names)
should be used whenever possible.
Quality Assurance : Appropriate steps should be taken to assure the
quality of all marketed drugs. The success of a generic drug policy is
critically dependent on assuring the quality of drugs.
Objective Information on Drugs and Therapeutics: Health Authorities
should provide objective information to health persons.
Drug Legislation : A country should enact appropriate legislation
covering registration, control of drug information including therapeutic
indication, mention of adverse reactions, contra-indication, drug interaction
price regulation and post market survey.
Price controls or monitoring should be introduced at the import, whole
sale and retail levels.
Any introduction, amendment, alteration, variation, deletion of any drug
legislation or releated laws shall be made available to all organization,
association
and individuals.
Procurement : At present drug imports are fragmented not only bet
ween the public and private sectors but also within each of these sectors.
Foreign exchange savings could be effected by pooling these purchases by
means of a centralised buying agency, some of the countries in the region
have a centralised buying agency for the purchase of the public sector
requirements but their bargaining power is limited since they do not have
the vital market intelligence.
Production : All countries in the region have already established drug
manufacturing units. In the majority of the countries, local production is
dominated by the private sector. The commercial practices of the private
(
4
)
sector with emphasis on creating a demand and generating profits are counter
productive to the large scale production of socially useful essential drugs.
A national drug policy based on essential drugs cannot be implemented with
the uncontrolled practices of the 'private sector. Countries in the region
should therefore give a leading role to the public sector and to socially
conscious manufacturers like GK Pharmaceuticals of Bangaladesh.
Transfer of Technology : The uncontrolled transfer of pharmaceutical
technology into the countries of the region has resulted in the manufacture
of a large number of non-essential expensive drugs. Production facilities
brought into the country at high costs are not being used for the manufacture
of essential drugs.
Priority technological needs of the country should be identified when the
decision to acquire technology has been made. Explore all possible sources
of technology and select the most suitable technology, if necessary with
assistance from relevant international agencies. The terms and conditions
of the technology transfer agreement should be carefully examined and all
restrictive clauses controlled
and reduced.
Priority should
be given to
acquiring technology from another developing country.
Promotion : Drug promotion by the drug industry must be controlled
by the drug regulatory authority.
Patents : All countries in South Asia except India grant patent protec
tion to pharmaceutical products and processes. India grants protection to
processes only. Product patents enable the patent holder to gaida monopoly
of the market. The host country will be prevented by its own national patent
legislation from buying the same drug from a cheaper source.
The Non-aligned Summit Conference has recommended that pharma
ceutical products and processes should be excluded from patentability. If
process patents are granted, compulsory licensing should be used for ex
ploiting the patent locally. Other alternatives relate to shortening of the
duration of patents.
Regional Cooperation : Some of the components of the drug policy
would be difficult to implement at the national level by some of the smaller
countries of the region. These would include quality assurance, collecting
market intelligence and local production. Taking these constraints into
consideration, the Non-aligned Movement recommended the formation of
regional pharmaceutical centres by developing countries so that member
countries belonging to a regional centre could take joint action to implement
some of the components at a regional level.
(
5
)
Several years of multinational negotiation would be required before a
South Asian Regional Pharmaceutical Centre could be established. However
Health authorities in the region could initiate some joint activities.
1. Market intelligence is totally lacking in the region. Countries could
exchange information on manufactures, price trends, quality of products
etc. among themselves.
2.
Drug regulatory authorities in the region may wish to establish drug
quality norms and explore the possibilities of enacting
uniform drug
legislations. This would enable the smaller countries in the region with their
drug registration and quality assurance.
3. Objective information on drugs and therapeutics is another compo
nent which could be provided regionally.
The crux of the matter still remains that the cheif responsibility
for the formulation of Rational Drug Policies lies with the
National Governments.
In the view of the availability of well defined WHO criteria for
such formulation - it is possible for Asian countries to have
such rational policies provided they have the political will to do so.
J
For more information on Rational Drug Policy contact : Co-ordinator, low Cost Drugs &
Rational Theraputics VHAI
D-377
Wg/15.1.86
January 15, 1986
ALL I ND In DRUG ACTION NETWORK (..IDaN )
C-14 Community Center, SLA, New Delhi - 110016
AIDAN WESTERN REGION MEET JANUARY 3O-31st, 1986
KHANDALA
COMMUNICATION-II
Dear friends
We will be having the"AIDAN(Western Region)
meeting on gO-31st January 1986
■|2a6, at Dr'Suchak's House
Khandala.
-
ACASH, ADM, ODD, CGSI, FRCH, LVS, LOGOS!, MFC
and VHAI representatives will be there.
If there is any possibility that any of you
cannot■ make itv to
meeting 0.0,
later
UV/ the Calcutta
U vca. lUUCUXllg,
U KJ X* , I feel It
is
:.............................
important
that you try to make it to Khandala.
Dr Ekbal this applies to you particularly. I am informing
Dr Sujit Das, Dr P K Sarkar, Amitava Guha, Dinesh Abrol,
Fr John, Sarkar (WB VHA) Dr Amar Singh Azad, in case they
can make it for the Khandala meeting - which can be seen as
the Madras meeting follow up, planning for the RDP campaign
7
so that by the time” we meet in Calcutta some
concrete things have already been done.
Dr Sujit Das
was here for the Alternative
Science Congress, after ’a discussion with him it was
decided that he should go ahead with preparation for the
AIDAN meeting 22-24th Feb. 1986
1986., in Calcutta
In view of the Drug Po2.icy coming in March '86
we may need to meet more frequently. Due to involvement
with Bhopal, we have been unable to do all that we could
and should have done regarding the drug policy,
ensuring the rationalization of which is our main agenda.
BP CYALBAiGN
Please consider the EP Campaign relaunched. At the Wardha
meet, :Delhi Science Forum had agreed to to take up the EP
case. In Bangalore Meet
Meet, they wre again requested to do
so on behalf of AIDAN, as -they have the legal help. I
checked with Dinesh Abrol today (Jan 15th)
’' ), they are
preparing the document at present. :For those of you who have
joined AIDAN recently,
I am sending
j some of the EP drug
handouts.
ACASH and CERC are also planning legal action on BP drugs.
Dr Kabra also wanted to do so a year ago in Rajasthan.
Dr Rane had agreed to confect Dr Purandare and others for
the
affidavit .. Dinesh was supposed to send a copy of
affidavits. 1 will see that it is senfi immediately, so
that doctors
affidavits are colledted and provided to
the various organizations taking legal action.
: 2 :
Since the EP campaign and the legal action will be a
high priority at the meeting, please bring your EP fileswith you. I will bring copies of all the material
produced by us in VHAI.
lUlIOLLxL DRUG POL IC Y CAMPAIGN
I think for the Rational Drug Policy campaign it will be
better to fully utilize the material already collected
for the EP campaign, diarrhoea campaign, on hazardous
analgesics haemo Denies and shortages of essential drugs.
Organizations1s contribution to RDP : in view of the short
time we have before the coming of the drug policy, kindly
discuss within your organization, prior coming to the
meeting :
- Khat ,your contribution could be for the campaign for
(in terms of work)
- all the- drug related material produced by you and
your organization and their copies for other
campaigners „ in the past and in the future
I am updating the AIDAN drug material list so send your list
soon as possible or hand it over at Khandala. I am
trying to get hold of 2 very explosive video films on
drugs
1) KILL OR CURE
2) THE PILL JUNGLE
the latter which was meant to be shown in Nairobi was with
held by WHO under pressure from MNCs.
Printing your earlier material , which may have been
cyclostyled, compiling
<
’*
it and updating it for the campaign
would be very valuable. I have requested Fr John, CHA
to reprint ’Medical Services’ special issues on drugs.
PRODUCTION OE DRUG IlAT ERL J,
Please, just drop a line to inform me in case you are
printing anything - so as to avoid unnecessary duplication.
We will need campaign posters^ so if you have already
produced some and are planning to produce more,bring them
over to Khandala to share with others. We have to go all
out to make the demands for RDP felt. Posters for consumers,
posters for hospitals, dispensaries and other strategic
places. If any of you can still work.out a drug issue
based calender and postcards, it would bo groat. We have
had unpredictible and upsetting problems with production
of our material and those of you who arc cursing us for not
having got the”banned brand drug"list ready - please accept
our apologies. The problems have been.beyond our control .
I am briefly putting down the agenda again (which is subject
to modification after getting your feed back).
1) Reporting by groups.^ by coordinator
2) Reporting of Madras,
naxivux,
Nairobi, kss'p'P meetings
5) Present status of NDP - focussing on key intervention
areas for campaign and action plans and specific
responsibilities
4) EP Campaign Update legal action planned Support required
5) Diarrhoea Campaign Update focussing on
Chloramphenicol and streptomycin combination
6) Campaign against banned and hazardous drugs urgent actionrequired
7) Campaign for shortages of essential drugs documentation and monitoring of shortages
8) AIDAU drug material collation and sharing with
AIDAN members
9) Documentation of unethical marketing practichices 9
e.g. market survey for sales of banned drugs
10) Planning for 7th April World Health Day - Essential
drugs Day and 23rd May Dr Olle Hansson’s day for
hazardous drugs day
11) Analgin Study - ADM
12) Legal Action required in drug work. CERC
Organizational matters and cooption of new members in the
Coordinating Committee - ACASH, CDMU, Alkaloid.
DRUG CAMPAIGN MATERIAL THAT COULD BE CIRCULATED AT
the workshop for the campaign
ACASH
1) Copies of lid' recommendations
2) Copies of letters to doctors seeking support
for R D P
ADM - Update on EP situation in Tune / Maharashtra
- Analgin study
- List
and copies of all major articles on drugs in
Pune journal under topics,
headings, eg.
Analgesics, anti-diarrh .eals, etc.
D - All the drug related Counterfacts
- Copies cf Mukaram Bhagatfe book "Aspects of Drug
Industry”.
CERC - Summary of the drug Act, identifcation of the
lacunea and recommendations for reforms
CHAI
Medical Service - special drug issues
- Drug articles compiled
DOCOST - Drug Information sheets
- Locost articles
LVS
- OTC Drugs
MFC
- Antidiarrhoeals
- Analgesics
- Drugs special MFC Bu^etin
s
4
s
DAF, WB
Rational Therapeutics Journal
Posters and drug booklets (Hindi/Bengali)
Compilation of Dr Sarkar’s articles in Telegraph
FRCH
2\ny material giving drug utilization pattern
Drug Needs
KSSP
MNCs in India
MFC studies on Analgesics, etc
Dr Ekbal's excellent set of slides on drugs
VHPxI
Madras Declaration
WHO and Dr Mahler's summary of Nairobi meeting
Main issuesfor consideration - a Nairobi meeting
document
EP update
How Parliamentary procedures - how to use them
Banned' Brand Drug List (hopefully)
For details of yenuev-reservation, etc., contact
Dr P aw an. Eureka at”
VI/505 Sundar Nagar
8 V Road
Maiad (W)
Bombay - 400 064
PHONE NO.
686754
other addressess
Dr Raj Ainand
55 Kavi Apartment
Worli
Bombay - 400 018
PHONE NO. 4937358
Ms Padma Prakash
11 June Blossom Society
6 0-A Pa1i Road
Bandra, Bombay - 400 050
PHONE NO. 541245
With warm regards and wishing you all a very
rational and meaningful 1986,
Yours sincerely.
Dr Mira Shiva
Coordinator
AIDZJSJ
Voluntary Health Association of India
C-14, Community Centre
%
Safdarjung Development Area
New Delhi-110016
ill
Telegrams : VOLHEALTH
New Delhi-110016
M
Itl
Telephones : HIqZI
.0-344
"■■■■ y ■— ■ ■ ■■
■■
■■■■■»■
g/2 3.9.85
PRIORITY DRUG LIST AS SELECTED BY NATIONAL
DRUGS AND PHARMACEUTICALS DEVELOPMENT COUNCIL
THE STEERING COMMITTEE
MINISTRY OF CHEMICALS AND FERTILIZERS
GOVERNMENT OF INDIA
AUGUST, 1984
ANAESTHETICS
1)
Ether Anaesthetic
2)
Halothane
3)
4)
5)
Thiopental
Lidoc ai ne/Proc ai ne
Nitrous Oxide
ANALGESTICS, ANTIPYRETICS ETC
6)
71
8)
Aspirin
Ibuprofon ★
Paracetamol *
ANTI-ALLERGICS
9)
10)
Ohio rphe ne rami ne'
Epinephrine
ANTI-INFECTIVES
Anthelmintic
Mebendazole *
(a)
11)
12)
13)
Piperazine
Behphenium Hydroxy Naphthoate
(b)
Antiomoebic
17)
Chloroquine
Metronidazole
Ampicillin
Benzathine Bonzyl Pencillin
18)
19)
20)
Benzyl Pencillin
Procaine Benzyl Pencillin
Chloramphenicol
21)
22)
Sulphadimidine
Sulphamethoxazole
14)
15)
16)
CtU-
T)SJ0‘^'
cont’d .. 2
650
ad
-
2
23.
24.
25.
26.
2
S
Trimethoprim
Tetracyclines
Oxytetracyline
E ryth romyc i n
Anti-Leprosy
27.
28.
29.
Chlofazimino
Dapsone
Rifampicin
ANTI-TB
30.
Ethambutol
31.
Isoniazide
32.
Pyrazinamide
St reptomyci n
Thiacetazone
33.
34.
ANTI-FILARIAL
35.
Diethylcarbamazine
ANTI-FUNGAL
36. Griseofulvin
ANTI-MALARIAL
37
Primaquine
38.
Amodiaquine
IMMUNO-SUPPRESSIVE
39. Busulphan
40.
41.
42.
Ch1orambuci1
Cyc1ophosh amide
Flurouracil
ANTIANAEMIC
44.
Ferrous Salts *
Folic
Acid
45.
Hydroxocobalamine/Cyanocobal amine
43.
cont’d .. 3
. -344
3
s
PLASMA SUBSTITUTE
46 o
Dextran
CARDIO VASCULAR
47.
48.
49.
50.
51.
Glyceryl trinitrate
Isosorbide dinitrate
Propranolol
Verapanil
52.
Hydrailazine
Hydrochlorothiazide
53.
Methyl dopa
54.
Digozin
DERMATOLOGICAL
55. Neomycin
56. Bacitracin
57.
58.
Bethanethasone
Benzl Benzoate
OPTHALMIC DRUGS
59. Sulphacetamide
60.
Pilocarpine
61.
Homo t roph i ne
DISINFECTANTS
62
Chlorohexidine
63.. Cetrimide
64.
Dettol (Xylenole)
DIURETICS
65.
Fruesamide
G ASTRO-1NTE NT INAL
66.
67.
Premethazine
Oral Rehydration Salts (deleted in the
meeting of Steering Committee)
cont *d .. 4
-344
2
4
2
HORMONES
68.
69.
Dexamethasone
Prednisolone
ORAL CONTRACEPTIVES
70. Ethinyl Oestradrol
71. Leve no g rge s t ro 1
72. Nerethisterone
ANTI-DIABETICS
73
Insulins
74.
Glybene1amide
75.
76.
Chloropropamide
Tolbutamide
MUSCLE
77.
78.
RELAXANTS
Neostigmine
Sux ame thomi urn
OXYTOCICS
79
Ergometrine/methyl orgomotrino
80.
Oxytocin
PSYCHOTHERAPY DRUGS
81.
82.
Amitriotyline/lmipyramine
Chlorpromazinol (substituted)
83.
Trifluperazine
RESPIRATORY
84. Ami nophy11i n/theophy11i n
85.
86.
Hydroxy Ethyl Theophyllin
Salbutamol *
87.
Ephedrine
cont'd,. 5
7 34
5
s
VITAMINS
88.
Vitamin A
89.
Vitamin D
90.
Vitamin C
91.
B Vitamins Nicotinamide
Pyridoxide
92.
93.
94.
95.
Pantothenetes
Riboflavin
Thiamine
* decided as
requiring special attention
for encouraging production.
* *
★
*
*
*
★
*
Voluntary Health Association of India
D-1O/34O(c)
c’14' Community Centre
LCTTa.20.7 .34Safdarjung Development Area,
New Delhi-110016
Az
VV
>
A
Telegrams : VOLHEALTH
7r
o,
/v
^7
New Delhi-110016
T , ,
668071
Telephones :
------------ ------—_— -------- - ------------------------- --------——
(P.XA/
668072
----------- - — ----- ------ ------------
B-AWI), BWABJtE AWHAZARDOUS,
BANKABLE AND DUMPED DRUJS
(Prepared for Drug Action Core Group meet at Wardha SO-JI st
■ July *84 as a Background paper for discussion)
lhe issue of dumped drugs for past few years has been
much in the news. The multinationals involved in manufacture
and sales of such drugs have received their dure share' of
condemnation. Foreign government policies which provided the
scope for exports of such hazardous products have been condem
ned .by many of us eg., the Clayton Amendment Act and the U.S.
ResoiLut ion.
It is well known that sales of medical technologies and
drugs is a commercial enterprise, the motivation is
’profit
is'profit
making and not ‘service’ or ‘welfare work1
’.
Realizing all this the question arises as to how much as
citizens of India, can we expect our drug control authorities
to safe guard our interests. The pressure .from the drug inciu-— astry is immense. It is not merely money power but political
connections^ influence over the medical lobby. Many of the so
,
called medical experts are in their pay roll, many others are
conducting 'scientific studies' sponsored by the companies,
attending conferences sponsored by the companies, receiving
gifts and samples from the companies. This affiliation is not
unexpected. Inspite of knowing this our expectations from our
drug control authorities is high. After all our pharmaceutical
industry is the most developed-in the third world, ( ie accord
ing to UNIDO it belongs to Category 5,-developed enough to be
self sufficient).
We have demanded that our imports, production and sales
shSiafi. give priority to essential, life saving drugs over irra
tional and hazardous, drugs. This being along with WHO's guide
lines for Essential drugs programme. The drug industry and itssupporters allege that concept of essential drugs is only for
"struggling, least developed third world countries and not for
a country like India, with its well developed industry and
high and advanced level of medical expertise .However, this
same lobby puts India in the category of less developed
countries when it comes to the issue of banning drugs and drug
control, claiming that consideffeffi of hazards over efficacy
are luxuries which we cannot afford!
i
■ i
I
6
4
4
*
*
’
•
•
I
^■
I
■
£
However, consumers anywhere in the world have a right to expecrt
that irrational hazardous drugs are not issued licences and
licenses of ssuch banned drugs should be withdrawn as soon
as possible, bans implemented, and that all drugs in the market
are quality controlled. We have 20% substandard drugs ieJin 5
will not be effective With increasing number of spurious drugs
floating in the market9 the problem is beginning to take dangerqus proportion.
“
~
Since 1980 we’ve been concerned about this issue of dumped
and hazardous drugs. We widely circulated th^ list of combinat
ion drugs recommended for being weeded out and printed it in
our special issue of HFM on Drugs April-June 1981. Since then
• 4
the story of the drug ban has got more and more convoluted and
fascinating. Our earlier belief is only reconfirmed that the
government is not serious about controlling the sale of
r
...2.. .
hazardous, drugs. The budget allocation for ensuring this, the
expertise, technical personnel, quality control labs’, qualified
drug inspectors, mechanism to keep the health personnel and
the public informed about these drugs has remained depressingly
inadequate. Inspite of. all the hue and cry raised by health
and the consumer groups^ nothing very much has happened.
The health of the nation seems to be relatively unimport
ant, as indicated by decreasing health budget. The Central
Drug.-Contrl authorities allege that they have no real powers
where implementation is concerned ..as this depends entirely on
the state drug control authorities. They argue that they have
inadequate budget- and infrastructure.
Expepdituye on Health as a percentage of total plan
Programme
Health sub
total to plan
FTP I FTP II FYP III W IV FYP V
FYP~VT '
1951-56 1956-61 1961-66 1969-74 1974-79 1980-85
5.83
3.04
2.79
2.74
1.73
1.87
One glance at what is happening to the health budget is enough
to indicate the priorities health care is receiving in our
welfare st at e.
We have 600 drug inspectors in the country (Hathi Committee
has recommended). The required number is one for
drug
units and
chemist shops. Only Maharashtra, Gujarat and
Kerala have the stipulated number of drug inspectors and an
adequate drug control mechanism.
In this paper we will not touch upon the extent of the
problem, of substandard and spurious drugs and the name-sake
action;being taken against those involved in their produce
and sales.
Our focus will, be on what has happened to the drugs - reco
mmended for being weeded, out . in 1980. In 1980 the Drug
Consultative'Ctomiitee a statutary body consisting of medical
experts under Section 7 of the Drugs and .Cosmetics Act(Central
act 23 of 1940) nominated a subspecial committee to go into
the rationality of 34 categories of fixed dose combination
drugs. They were, to study whether these drugs should be with
drawn or allowed to be manufactured and sold.
1
'
The
A Sub Committee of the Drugs Consultative Committee? com
prising state drug controllers, has laid down well thought
out. and rational yardsticks to determine the desirability
of combinations of drugs. As per these norms, combinations
of drugs should only be allowed in the following cases:
•>
i-
•
a) If there is synergistic action
b) Where there is corrective action
c) When two or more drugs are normally prescribed toge
ther and taken by the patient simultaneously.
d) When the dosage of each of the drugs need not be
individualized.
e.) Where a fixed dose combination would ensure better
■
«
1
.. .3.. ..
■
patient compliance due to convenience of admini^
v
stration.
±) Where two or more drugs, prescribed separately,
may lead to non ingestion of one of the drugs,
thus adversely affecting the health of the patient.
Conversely, fixed dose combinations of drugs should
het be permitted under the- following circumstances:
a) Where adverse interactions may occur
When one of the combined drugs becomes toxic on
prolonged use
•
•
c) When abrupt withdrawal of one of the drugs caused
withdrawal symptoms
d) If sub tnerapeutic doses are used in the absence
of clinically demonstrable synergism
e) When pharmacokinetic behaviour of the individual
agents is grossly different.
b)
Thee riterica used by Bangladesh for banning 17/?
given in the appendix 1.
ic,
•?
just look at what was involved: in attempts to ban
a few drugs eg. Jim id opy nines, High doge E P drugs. Paediatric.
.tetracyclin. Steroid combinations are dealt with later under
ambiguity is the name of. the game. "
J
The sub committee submitted its report, recommended a ban
combination drugs and giving their reasons for recommends
ing the ban. 1_|^~c at eg or i g s. of t he s e d r ugs we re rec ommend ed for ‘
imm ed iat e weeding and 7^ of' the c at eg pries, t o^ b e _weed ed_over_
a specified time. Over 500' brand drugs' wouldthus be' affected
(This list 6f_ 25 combinations and the reasons are attached in
the appendix};. This report was presented to the DOC at a
special meeting on 10.10.^ictfd later to DTaB and Ministry of
Health and Family Welfare accepted it in 1981. The DT AB (Drug
Technical Advisory Board) a Statutary body under section 5 of
tand c25?etA25
„ c.Ac.t 25 of" “f 940 rec ommend ed
banning' df’TSTixed’' dbs_e c'omb’Ination(list at'f'dnhed as appendix
2)
Under section 25 P of the Drugs and Cosmetics act 1940
the Central government has had the powers to issue such
directions to the State governments as required • to ^execute
the Drug act. Under section 18 of the act 'the 'state go ver nm ent.
has had the power to 'prohibit manuf.act ur e, d 1st rib ut ion and
sale of drugs,by .a .gazette notification.
These drugs were randomly selected from the Pharmaceuti
cal Guide. Out of these 550 brands 4 4- brands were__marketed by
foreign__sector, S by pub_lip,_sectpr~and Z98JUy.''private .’sector.
ii pdint to note is that most of these drugs were being-produ
ced by private Indian companies and not mult.inationals. This
was to be in hnphased of d iscontj-nuatj-pn. According to the
authorit iesMl>he purpose- ' was fb give ' time limit to firms who
may have already purchased the bulk drugs for manufacturing
the formulations”. What compassion and considerationTshown
to the drug companies?
*
...4...
AMIDOPYRIME
The Drug Controller of India(DCI) by DO No.1273/77 DC
directed the State Drug Controller to ban the fixed dose combmauion of amidopyrine on effect from 5.2.82. Orders were
issued to stop manufacture from 1st July ’82 and sale by
October 31st '82. This ban was later extended further to 31.5.83.
The PCI through his DO No. 19013/8/81D dated 22.4.82
directed the State Drug Controllers to ban the manufacture of
fixed dose combinations from 30.9.82 and their sales from
31.3.83. Sequal to V0c^uiie panel report government decision to
' '-withdraw 350 unnecessary drugs was taken.
When Maharashtra IDA d id ban am id opy r in e s, the multina
tional most affected managed to get a stay order oxi the gmund
that the/drug’‘was allowed' to be marketed in‘other states by
their state_ JPA’s. In 1980 33. formulations .of .amidopyrine pro
duced. by/ 2(5/ so manufactures "were in the market. Multinationals
and other big drug houses’ highly trusted by the public such
as
Geigy, Sandoz, Suhudgeigy, Unichem, Ethnor, Thems,
Ind on were involved. Most of these drugs were being sold with
out adequate warning.
As Praful Bid wad on 19th August 1980 stated in the
Financial Times'Harmful drugs production still not stopped/
reluctant to lose their market share, these companies have
merely continued to produce and market amidopyrine and care
continuing to sell their preparations without even.an additi
onal warning about the drugs side effects*
Mukaram Bhagat Cantnep^otsS^ueBi’.ugnlahdisDion;or
^u4-AfcpecLta^fdDa‘ugo£MtL3t»3iyiiinlMdia’ gives the example of
Tamllnadu government medical list for government hospitals in
which drugs like amidopyrine, phenacetin and analgin are very
much included even when they were considered harmful and been
disallowed, •
PHENACETIN AND HOLOGEgATW HYDRQXYQUIWLJLffl:
Ban of fixed dose combinations of phena,cetin and .holpgenated and hydroxyquinoline was to be effective from 1.11/82.
The date of the ban of fixed dose combination of -amidopyrine,
phenacetin and halogenerated hydroxyquinolines was'extended
to 51.5.83 through DO No. X19013/8/81-D dated 15.8.82.
In 1979 January the Drug Controller of India had issued
an order to gradually phase out amidopyrine as always 'phased
discontinuat’ion* process was not meant to be implemented as
there were no specific DEADLINES*.
HIGH DOSE OF S P DRUGS:
Through another DO No. 12-48/79-DC dated 26*6.82 the DCI
directed the State Drug Controllers to ban the manufacture
of high dose estrogen and progesterone combination from
31.3*83 and their sales from 30.6.83.
M/S Unichem Lab3 Bombay (OP 2927/82 of writ petition
2928/82), M/S Nicholas Labs Bombay and M/S Organon (now known
as Infar (India)Ltd Calcutta filed writ petitions in Bombay
and Calcutta high epurtg against the DCl’s instructions to
ban these drugs, their con^d^tia^tpn that Central government
has no powers to ban the drugs. The high court of Bombay and
4'
...5...
Calcutta have granted stay orders
•and these products continue
to be available in the market.
3??t?-0nx 10A apd- 26A of the amedned Drugsand
111 the gazette’ notification of the DCI issued on
23.7.83 banning 22 fixed dose combinations.
in
absolutely objectionable is the fact that(this is
mspite of the act of the Drug Controller of India's earlier
instruction dated 26.6.82 banning the production and sales of
?IKD
h druss fro“ 51-3-85 and 30.6.83) M/s Organon
UWIA) ltd have managed to obtain extention of licences to
manufacture these products for another 2 years.
A_sample of high dose B P drugs from Calcutta with manufacturing date 31.12.83 indicated that the.
■'
ban is not merely
being flaunted by Organon but by
a
cturing these products.
'
. ■
X'
■
'
•
-
.
.
.. 4
■
The misuse of these drugs for hormonal pregnancy tests
and for attempting to induce abortions continues massively.
PAEDIAWC TETRACYCLIN
Manufacture of Paediatric tetracyclin drops was to be
banned from 1.5.82, no date was then given for marketing.
Paediatric tetracyclin have since been banned on paper. They
are atill available, OTC, without warning.
* Paediatric tetracy&lin ban too does not figure in the
gazette notification of July 2Jrd 1985.
On April ’82 the Drugs and Cosmetics Act was amended
whereby the Central Government and the Central Drug Control
Authorities were given specific powers to ‘ban the import,
manufacture and sale of drugs in public interest1 0 (This was
mentioned in the iJrug Action Network Newsletter October ’gj).
Section 3(b)(1) was substituted and section 10A and 26A
were inserted in the act. Ttiis came into effect from 1.2.83.
This means that had our Central Drug Control authorities wanted
it, gazette notifications banning the manufacture and sale of
these drugs could have been undei-taken immediately under the
powers invested in it yndor section 26a of the act exercised.
The implications of this delay have been that certain
drug companies have challenged the drug Controller of India's
authority to ban these drugs. Some, of them have even got stay .
er against specific bans, , making these bans ineffectual and
whole, drug control authority of our nation a laughing stock.,
ine drug control authorities see their role as mainly advisory
and hence ^on't feel particularly perturbed. Actually to come
to think of it no one in the Health Ministry at Centre or State
level seems to be particularly perturbed.
Allowing this extended time period, during which imports
manufacture and sales have continued amounts to 1arbitoriness
and diScrimination, under article 14 of Constitution of India''
J
-V
...6...
according to Vincent Panikulahgara since these drugs would be
dumped in the market, substitutes withheld. With oux" efficiency
of drug control mechanism, products in the chemists shops will
continue to be sold and never withdrawn.
According to Section 26a of the Drugs and Cosmetics
Act 1940
1
z-
’’Without prejudice to any other provisions cont
ained in this chapter, if the central government i
is satisfied that the use: of any drug or cosmetic
is likely to involve t.any rl&k Vchunantb.hiirga or
animals or that any drug does not have the tnerapeutic vq. 1 ue c 1 o.imed or purported to be claimed
for it or contains ingredients and in such quant
ity for which there is no therapeutic justification'
and that in the public interest it is necessary or
expedient so to do, then that government may, by
notification in official gazette prohibit the manu
facture, sale or distribution of such drug or
Cosmetic”.___________
......
______ ________________
Under section 1QA of Drugs and Cosmetics Act of 1940 also
there is a mandate that 'following a gazette notification
imports of injurious drugs can be banned.
Article 47 of the Constitution of India l^ys down
that
"The State shall regard, the raising of the level
of nutrition and standard of living of its people
and the improvement of public health as among its
primary duties and in particular the state shall
endeavour to bring about prohibition of the con
sumption except for medical purposes of intoxica
ting drunks and of drugs which are injurious to
health” .
Under section 53 P the DCI directed the State Drug Contro-J
Ilers iwdban the 20 fixed-dose combinations. The State Drug
Controllers under section 18 of the act could exercise their
power and prohibit their manufacture and sales by issuing a
gazette notification. According to Vincent Pahikulangara, the
State Drug Control authorities are guilty of not exercising;
their power ariS taking responsibility. They have thus violated
Section 18 and 33 of the Drugs and Cosmetics Act and violated
the fundamental right of the public citizens to'’health aS" Iff
urder section 21 of the Constitution of India. Article 14 of
the Const it ut Ion is "also Vi elated? by "their having acted ip. p
arlyiiraDL-^^
mafin^r contrary, to ..p.yblic’ Interest
in favour of the Drug companies.’ ’•
Kerala High Court Judge Mr Potti’s judgement on Vincent
Panikulangara1s writ petition speaks for itself.
” A§. A^.eP.?..ts5Ov^. Qf- th?- G- of tjxis
country on the one hand_and lops that may result to
the manufacture and Vr^er^
pmiejyie manufac’ture Vnd sales on the_ other, the
government, had chosen^to_ view; the latter a.s Q?
more V one er p".” It is the’ duty of the state to
protect'its” citizens from injury and harm especially
...7...
when the injury is not inevitable”.
Acting Chief Justice
P Subramanian Potti and
Justice Paripuran
Kerala-High Court, in their dire
ctive, to the Union of India to release
In October 1982 M/-S .Nicholas(India)Ltd Bombay filed a
writ petition in Bombay High Court against the decision' t o’ban
the fixed dose combination of aspirin and vitamin C. The
Bombay high_court after the hearing- of the respondent ruled
that State Drug.Control authorities has no power under Section
18 of the Drugs and Cosmetics Act to stop the manufacture and
sale of these products. (The high court ruled that it would-be
open to the respondents ns and when the law has been enacted
to pass any fresh order as it is considered necessary in accord
ance with the law after following procedures prescribed by the
government).
Subsequent to the Drug /anendment ..Act coming into force on
1.2.83 the manufacturers have again gone to court chald en^irg .
the central government and sections 261 and 101 of on grounds
of "LACK OF OBJECTIVE CRITERION for such ban”. (A special hand
out on Rationale of the ban is available with us).
The Commissioner of FDA Maharashtra State(which is suppo
sed to be having the befet drug control mechanism), had informed
the DCI that in the light of the ruling^given by the Bombay
High Court "if would’ not’be possible for him’to take any ’action
to stop the manufacture and sale of any of the fixed dose
combinations in question". (Letter dated 9 June 1984 by Drug
Controller of India to’ us) .
It was probably the . above . as well as Vincent’s writ
petition against the state and central drug control authorities
for not having used their power that forced PCI to issue the
gazette not if icat ion. .1 point to note is that drugs banned earlier and at different tA-mes make the brand banned list. E P
d rugs
^gazetjt &ettet
ithe■ ga&ett e
notificr.,t -ion.
The ambiguidty of the wording of the gazette notification
hit us early, when we attempted to compile the banned brand
list. It was not clear whether for eg. in Category 4 include
- any drug containing yohimbine or strychnine would be banned
(as neither of the two were considered to have therapeutic
value and infact could lead to serious side effects as
even by the DCC) .
- or the ban was applicable to drugs containing both yohimbine
and strychnine.
- or to yohimbine and strychnine with test esterone or vitamins
- or OHLY to drugs which contained all 4 io. yohimbine,
strychnine, testosterone and vitamins*
Another doubt was regarding criteria 12 ie. whether it
could effectively deal with steroid and antihistamines combi
nation which could be indicated for allergy as well as asthma.
First of all DCC had reoommAnd^d ajbannof all st er oid. c omb inations. Making this exception would obviously encourage misuse.
After all. doesn’t, the microscopic print in the medical litera
ture for high'dose E P drugs' 'now-a-day3 say only second ary
amenorrhea and''isr ’ t ' it true ^that^ it • is mostly used for pregn
ancy testing and attempting abortion, changing the indication
the
...8...
on paper of a hazardous drug won’t alter its use. Similarly
allowing' steroid combi fiat ion for asthma won’t present their
misused for other conditionsThe DCC had recommended banning of all fixed dose steroid,
combination, DTAB decided to prohibit manufacture of fixed
dose. Combination, of, bronchodilators, antihistaminics and tran
quillizers with corticosteroids as early as October 4, 1980.
Dr B Shankaranand, the then DGHS, chairing a meeting had
said ’’The current medical practice in all the developed counts
fies is to give corticosteroids separately and fixed dose
combinations of corticosteroids with other drugs are being
discouraged”.
~
Prof. Harkishan, Singh of the Department of Pharmaceutical
Sciences Punjab University statedtthat there existed ’’published
evidence to show that cortico steroids taken in small doses
over longer periods are more harmful than if taken in larger
doses over shorter time”.
The Drug Consultative Committee comprising of all state
Drug Controllers entrusted the responsibility of evaluating
54 categories of fixed dose combination, on basis of their
rationality to a sub-committee. The sub committee comprising
of some distingui^hed medical experts recommended a ban on
steroid combinations. The Committee warned against compulsory .
intake of steroid because the "fixed dose combinations of
steroids for internal use can produce serious side effects viz
fluid and electrolyte disturbances, hyperglyceria glycosuria,
increased suscesptibility to infection including TB, peptic
ulcers, osteoporosis, steroid myopathy, Cushings syndrome and
hersutism, combination with bronchodilators etc.”.
On December 51, 1931, the Drug Technical Advisory Board
constituting of exactly the same members reversed its own
earlier decision. It felt that there was a need for getting w
wider medical opinion and further details and allowed the sales
of these products.
Dr Gulati MIMS Editor in his editorial MIMS India Vol.2
Mo. J February 1982. writing about the ”s-coQjrs&ult on steroids”
says ’’they must have had very extraordinary reason 'td’’
a) reverse their own earlier decision
b) ignore the advise.of DCC
. c ) consider the opinion of the whole battery of eminent and
distinguished medical specialists from research institutions
as as inadequate so as to ask further details and 'wider med ictal
opinion”.
It would be interesting to find out how and why this
change in their stand on fixed dose combinations of steroids
took place. We would very enthusiastically have undertaken this
exercise, had obtaining information such as this, been a less
te&ious, less time energy consuming and-less frustrating affair.
The Kerala High Court judgement, in response to Vincent
Panikulangara’s writ petition OP 8459/1982 had directed the
Central and State Drug control authorities "tojpublish the
list of trade/brand names and the,names of the manufacturers
oj these/drugs/'This was in 1982. Repeated requests for the
same have been made to the Central Drug Controllers office.
Some of the” Drug Action "networkers have been requested to do
the same at the State level.
< ..9. ..
Excuses were made that the drugs have been licenced and.
registered with State health authorities and the centre alleg
edly has no clue about the various formulations and brands
involved. The drug control mechanism is so ineffaoieut that
even..to^obtain. Just th& list of, these products has taken more
than one year. To ensure their b'an' or’ ’ quality"c bht’rblr would
definitely take a century.
It should be noted that the drug ban will be applicable
for lesser drugs than what we had anticipated. Tnspite of the
presence of irrational and hazardous ingredients only those
drugs will be banned that contain all the ingredients mentioned
in the various categories eg. under category 5 -only those
drugs containing all the following ie. yohimbine 4- strychnine .+
Testosterone + Vitamins will be affected.
V
According to Dr Das G-upta, Asst.Drug- Controller the
banned brand list will be ready in about 3 months. We had pre^
pared our own black lists of banned or bannable drugs as far
hack as 1982 which have been circulated amongst the health
care institutions in the voluntary sect or and drug action
networkers. These black lists have been for
1) Clioquinols, hydroxy quinolines ie. mexaforci and Co
2) Amid opyrines - abalgen Ergopyrine
3) Paediatric tetracyclin
4) iphenexy1at e - lornot fl etc$
5) Annbolio steroids
6) .Penicillin and streptomyQin
)
In DCC recommendation^
7 Chloramphenicol and.streptomycfn
8, High dose E P drugs
9) Antiinf1ammatory agents and steroids etc.
(Background papers based on the above underlined drugs had
been prepared and are available).
2-3 attempts at compiling the banned brand list ..based on
drug banned by the gazette notification have been made. Three
things have prevented us from widely circulating them.
i
i)) Our ( expect at ions, from our d rug_c ontrol _aut horit ies_t q juake
tJxtm available nt’ least 'aft er the Kerala High Court judgement
’ aSl^up'reme”' 0ouft _wfft peTit 1 on.
ii) flie diff icult‘y“"in "oBt'aini^
of .X0™ul.ations
from the" State .prug'''Control~aut.horities.
i ii) the' proc ess7 'o'f reformulation of various drugs-taking place
wi
iwith
‘ ' pur ’ not having“lany"ihforihation as lo
a) which drugs ’were’being fomulated and sold as reforiijulatim&?
b) Which drugs were being reformulated- but their banned
formulations under the same BRA® exist^Sndwlre sold
unscrupulously in the market?
C ) Which were the hazardous banned drugs still belns mann
factured and sold as such?
Our health and drug controllouthor^tics get extremely upset
when we mention the achievements of Bangladesh in their attemjte
towards a Rational Drug Policy. Inforeed to mention Bnngaldesh
again. It should
noted that after the issuing of the
Promulgation banning 1742 drugs in June 1982 the time period
given to the drug companies of 5, or 6 or 9 months was given
to withdraw these nroducts from the market., to destroy the^e.
products . even their export to other ^countries w§is ...strictly,
prohibited. We. on the other hand have failed‘to implement a
reconjmended ban by ou,r own govornm.ent commi11 ees and banned
by owrowown drug eqntrpller. The drug's” banned were more few
hundred, not over a 1QOO. The time period given was for the
■i
I
«
*
...10..•
drug companies to complete the manufacture of their formulation
and sell off their stocks. The stocks surprisingly like Medusas,
head never seem to finish off.
- Nepal, ^Pakistan, felaysia, Sri Lanka_a»l Ba^adesh feel '
inaTA hyuroxyquinoline) f oriaulati ons. have, no signi
ficant therapeutic value and can hnvejiiajor side effects^ >-®fey
have-decided ^to; ban thea^ru^S. lib a ..Gei^?Q^ers_p/..m./4..3f3ra
nave announced their plans to withdraw the drug from international market. -We. continue to allow them to~be sold "and "pro
moted under more than 90 brands (including those produced by
our public sector.)
The Drug canpaigners from Bangladesh, Sri Lanka have
complained about the outrageous smuggling in of-these banned
products from India. Our continuing to allow the manufacture
and sales of these hazardous and irrational products is not
merely hazardous to the health of our people, it also cre.^ass
problems for our littler neighbours who are attempting to rat
ionalize their drug policies, in the interest of their people.
-.Lf 13:r government authorities cannot make all that aoes
ensuring goocT healtK? ~ availaKIe ~To~iTs VUg^mi'IIi ih' people
it has no .business to allow irrational~and”hazardous 'drug3 to
b'e~iri'fIict~ecI'~'up’5h~t'rie:aT--------------------------------------- --------------
We will compile our own banned brand list and while the
game playing goes on between the health, drug control g.uthi'ri-'
ties of centre and state,and the drug industry and the high’
courts we will ensure that all these drugs are BOYGOTTM)i»by
health personnel as well as consumers.
The DC± had in one of his meetings last year pointed out
that unhygienic conditions in the public hospitals, lack of
clean water, sanitation quackery and unethical practices by
medical personnel were greater problems than continuing sales
'of few hazardous drugs.
■
We want to nake it clear that the issue here .is not
fcw hazardous and * irrational drugs but it
is......9_£J¥on *ifT^iie mm^bfhc^JIth”cnrbr. ‘
tL
A-P- ^eaTt'h lie^els'^'
dealing witK“thW~6Jone ’driTr'there'^come ’
IklSl. change"in'~tlie 'Kealt’F sfarus^ahcl ' quality of
our^eople? There are’'r.o eTfccTlve ’pTIXs'"'against’’*
poverty- and the diseases of poverty. To deny people their
right to health care is bad enough,, but to let loose ^arpage
ana trash in the name of nodical care is is inexcusable rgnd
inf^W#MlW. arh t ot ally unaccept able.
■
" ¥'
•%
Dr Mira Shiva •
Coordinator
•3
Low Cost Dx’u^s & Rational Therapeutic^..
■
r
ft
■%.
*
•
ALL INDIA
DRUG ACTION NETWORK MEET
January 30-31, 1985
List of Participant^.
Name
Address_______ .
1.
Claude Alvares
Almeida Vaddo
Parra - 403 51 0
GOA
2.
Dr* Maheswara S.B.
Vivekananda Giri-
Special Are3s of Intere-st,
Educating public on Health
related issues.
Health work in the Communjana Kalyana Kendara ity - in particular B. R. Hills 571 317
tribals of B.R. hills.
Mysore (Dist. }
5.
Dr. Ganesh Murthy
1 90 Nagarthpet
Bangalore 560 002
4.
Dr. W.V. Rane
2117 Sadashiv
Pune 411 030
5.
Dr. H. Sudarshan
V.G.K.K.
6.
Dr. Narendra Gupta
Drug information &
PRAYAS
Action.
Village-Devgosh(Deoli a)
via-Pastabgarh
Chittargasu Dist
Rajasthan 31 2 624
7.
Y. RamaKrishna
Prasad,
61 Income Tax Layout
Vijaynagar E xtn.
Bangalore 560 O4O
Drug information
8.
Dr. Amar Singh
Azad
Street No.3
Guru Nanak Nagar
Gurbax Colony
Patiala 147 001
Punjab
Health issue including
drugs.
B.R. Hills 571 317
Mysore Kist.
(People* s Health
Group, Punjab)
9.
Dr. Anant R. Phadke 50 LIC Quarters
Pune 411 016
10.
Dr. Sujit K. Das
s/3/5, Sector III
Salt Lake,
Calcutta 700 064
11 .
I. Chandraipouli
Indian Express
No.1 , Queens Road
Bangalore 560 001
1 2.
K.S. Dakshina
Murthy
2261, 9th Main Road
II StaeO, Rajajinagar
Bangalore 560 01 0
Health Education
Drug Action & Community
Health
Health conscientization.
Organisation:
Drug Action Forum,
West Bengal.
- 2
Name
address
Special areas of Interest
13.
-Amitava Guha
572/21 Russa Road East
Calcutta 700 O55
1 4.
M. Sarkar
7, Aurobind.o Road
Calcutta 700 075
West Bengal Voluntary
Health Association
8, Rawdon Street
Calcutta 17.
'15.
Dhrur Mankad
1877, Joshi Galli
Nipani - 591 257
MFC
1 6.
Amar Jesani
2/72, Geleki,
ONGC Officers' Flats
Reclamation, Bandra (w)
Bombay 400 050
F R C H
17.
Prema Menshi
eE.S.I. Dispensary
Indal
Yamnapur, Karnataka
MFC
18.
Mrs. Chandra Kannapiran
Voluntary Health Assn,
of India
C-14 Community Centre
Safdarjung Dev. Area
New Delhi 110 01 6
1
A. M. Jha
1/19, Tilak Nagar
Chembur, Bombay 89
MFC
20.
Ravi Duggal
F R C H, 84-A
R.G. Thadani Marg,
Norli, Bombay 18
F R C H
21 .
Dr. Navnit
Sarvoday Parivar
Pindval
Tai- Dharampur
Dt. Valsad, S. Gujarat
396 050
Health Education
Training of CHW
22.
Dr. Ashwin Patel
’ARCH’ - Mangrol
via - Rajpipla
Di st. Bharuch 393 150
MFC Locost
23.
Dr. Dara Patel
24.
Dr. L. K. Khanra
P0 Tamluk
Dist. Midnapore
W. Bengal 721 656
25.
Sr. Anita
Navajeevan Health Centre
Rajavailipuram
Tirunelveli Dist.
60? 559
Fozdar
-do-
Federation of Medical
& Sales Representatives’
Associations of India.
M F C
MFC
Health situation in
rural areas, including
drugs
- 5 26.
Ulhas Jajoo
Dept, of Medicine,
M.G.I.M.S. Sevagram
442 1 02
.:..U
MFC
..
27.
Dr
28.
Thelma Narayan
526, ,5th Main, 1st Block
KQramangala, Bangalore
560 O34
29.
Dr. Kashalikar
Shriniwas
Dept, of Physiology
Seth G.S. Medical College
Parel, Bombay 400 012
50.
Dinesh Jibrol
Delhi Science Forum
B-I, Ilnd Floor
LSC, J Block
Saket, New Delhi 110 017
A.R. Patwardhan
Arogya Dakshata Mandal
1915 Sadashiv Peth
Pune 30
MFC'
Tel. 665036
51 .
Dr. B. Ekbal
52.
Dr. P.K. Sarkar
KSSP, Parishath Bhavan
Trivandrum - 695 O37
P254> Block B
Lake Town, Calcutta 89
55.
54.
Fr . John Vattamattom,
Catholic Hospital Assn.
SVD
of India (CHAl)
CBCI Centre, Goldakkhana
New Delhi 110 001
Tel.310694/522064
Dr. C.M. Francis
55.
Mr. D. Rayanna
Executive Secretary
56.
S. Srinivasan
57.
T.K. Narain
57.
Gnana Surabhi Mani
C.M.C., Vellore 632002
DAF, W.B.
Promotion of Comm.
Health, Primary Health
Care, etc.
Continuing education
of health professionals
AP.VHA, 10-5-511/7/2
Vijayanagar Colony
Hyderabad 500 457 AP
LOCOST, GPO Box 134
Baroda - 390 001
Karnataka Consumer Service
Service
Society & Consumer Protection Board
4th Floor
Floor, "Kaveri Bhavan”
Kempegowda Road, Bangalore 9
Resource Centre forr^
v±,l^'’s Edn.
People
& Development, 10 Jawaha^
- -------- ■
.J
II street, fS. S .Colony
Health issues
& Action.
Madurai 16 625 016
58.
Mahil Carr
SURFACE(Students United Representation
for a
Clean Environment}
Oberlin Hall, American College
Tallakulam, Madurai 625 002
59.
Rev. John Samuel
40.
Dr. George Joesph
Executive Director
T T S, Arasaradi, Madurai 10
Health issues
C S I Synod Council for Healing Ministry
0 S I Synod Secretariat, Cathedral Compound
Madras 600 006
ALL INDIA
DRUG ACTION NETWORK MEET
January 3° - 319 1385
ist of Participant
Name
Address
__
Almeida Vaddo
Parra - 405 51 0
GOA
Special Areas of Intere-st
Educating public on Health
related issues.
1.
Claude Alvares
2.
Dr. Maheswara S.B.
5.
Dr. Ganesh Murthy
1 90 Nagarthpet
Bangalore 5&0 002
4.
Dr. W.V. Rane
2117 Sadashiv
Pune 411 050
5;
Dr. H. Sudarshan
V.G.K.K.
B.R. Hills 571 317
Mysore Kist.
6.
Dr. Narendra Gupta
1R
xxY«.3
Drug information &
PRAYAS
Village-Devgosh(Deolia)
Action.
via-Pastabgarh
Chittargasu Dist
Rajasthan 312 624
7.
Y. RamaKrishna
Prasad,
61 Income Tax Layout
Vijaynagar E xtn.
Bangalore 560 O4O
Drug information
8.
Dr. Amar Singh
Azad
Street No.5
Guru Nanak Nagar
Gurbax Colony
Patiala 147 001
Punjab
Health issue including
drugs.
(People1s Health
Group, Punjab)
II-‘ *
Health work in the CommunVivekananda GiriKalyana
Kendara
ity - in particular jana 1_ .
tribals of B.R. hills*
B. R. Hills 571 517
Mysore (Dist.)
Health Education
9,
Dr. Anant R. Phadke 50 BIC Quarters
Pune 411 016
10.
Dr. Sujit K. Das
s/5/5, Sector III
Salt Lake,
Calcutta 700 064
11 .
I. Chandragiouli
Indian Express
No.1, Queens Road
Bangalore 560 001
1 2.
K.S. Dakshina
Murthy
2261, 9th Main Road
II Stace, Rajajinagar
Bangalore 560 01 0
Drug Action & Community
Health
Health conscientization.
Organisation:
Drug Action Forum,
West Bengal.
2
Name
address
Special areas of Interest
13.'
Amitava Guha
372/21 Russa Road East
Calcutta 700 O55
14-
M
Sarkar
7, Aurobindo Road
Calcutta 700 O75
West Bengal Voluntary
Health Association
8, Rawdon Street
Calcutta 17.
15.
Dhrur Mankad
1877, Joshi Galli
Nipani - 591 257
MFC
1 6.
Amar Jesani
2/72, Geleki,
ONGC Officers’ Flats
Reclamation, Bandra (w)
Bombay 400 050
F R C H
17.
Prema Menshi
eE.S.I. Dispensary
Indal
Yamnapur, Karnataka
MFC
18.
Mrs. Chandra Kannapiran
Voluntary Health Assn,
of India
C-14 Community Centre
Safdarjung Bev. Area
New Delhi 110 016
1
A. M. Jha
l/l 9, Tilak Nagar
Chembur, Bombay 89
MFC
20.
Ravi Duggal
F R C H, 8'4-A
R.G. Thadani Marg,
Norli, Bombay 18
F R C H
21 .
Dr. Navnit
Sarvoday Parivar
Pindval
Tai- Dharampur
Dt. Valsad,, S. Gujarat
396 050
Health Education
Training of CHW
’ARCH’ - Mangrol
via - Rajpipla
Dist. Bharuch 595 150
MFC Locost
*
Fozdar
22.
Dr. Ashwin Patel
23.
Dr. Dara Patel
24.
Drw L. K. Khanra
PO Tamluk
Dist. Midnapore'
W. Bengal 721 656
25.
Sr.. Anita
Navajeevan Health Centre
Rajavailipuram
Tirunelveli Dist,
60? 359
-do-
Federation of Medical
& Sales Representatives’
Associations of India.
M F C
MFC
Health situation in
rural areas, including
drugs
A
-rs
iC rxJ
4b
/'T.
. .-•
P-10/344
LCD/a/28.2.84
Recommended Reading
For Self Education in Drugs Issue
for Social Ao bion
/Insult or injury?
Charles Medawar
2. xBitter Pills
5.
4-
5.
6.
7-
Di anna Me 1 ro s e
Drugs & the Third
Anil Aggarwal
World
There is gold in
Alan Klass
than Pills;
an enquiry unto the
medical Industrial
Poor Healthirch’
Profits. Tom Seller
Limits to Medicine, Ivan Illich
Me di ca l n ernesis
iihe Health of nations; Mike Muller
A north
Social Audit
1980 1J9PP Rs. 18 Highlights marketing and sales of British
Oxfam Public aff-1982
airs Unit
Earthscan
1978.
Penguin Special
1975
Spokesman Books
1977
Bertrand Russel
Peace Foundation Ltd
Nottingham, UK.
Pelican Books,
I960
London.
Faber & Faber Ltd 1982
277ps
food and drugs products. Illustrated,
easy reading.
Rs. 80 A very well documented convincingly
written book about the tragic drug scene
in_tne third world and existing courageous
initiatives. Initiatives that are possible
around the world are highlighted, which
gives us a sense of solidarity.
A very comprehensive overview of the drug
situation in the 3rd vcrld and the.’prcbl^s and
Discloses how suppression of unbiased drug causes.
CaU:
information, and the arethical marketing
practices by MHO’3 have repeatedly taken
place-far greater profits.
Describes malpractices cf BJC’s in the 3rd
world.very helpful in understanding practices
likes tied purchase, patent laws etc.
An excellent critical analysis of contemprory medicine.
The book deals with the disparities and the
real causes of ilthealtii and the existing
health care in th a third world countries.
Shows how results of capital intensive western
medical care were in no way superior to the
i ligenous,traditional, medical"care- generally
considered inferior and unscientific.
256pp
8.
PjJls ^-gainst povertyGoran Djurfeldt Oxford IBH,Pub.C0I976
(a study of the intro Staff an Linelberjfew Delhi.
duction of western
medicine in a Tamil
’ Village)
9- Pills Profits &
Milton Silverman Lee Berkeley University 1974
Politics
California Press
4O5pp
Highlights malpractices indulged in by Drug
Companies & the r He of medical personnel in
propagating irrational drugs by irrational
prescribing.
4
A
I'
10. presorxptxcn for Death
Milton Silverman
Drugging of the 3rd world.Philip R Lee &
IVlia Lydecker
Berkeley, University
of California Press
1982
186pp
4
11• Drug Pi sinforuat ion
Charles Medawar
Social .Audit,London
I960
49PP
12. Drug PiploHiacy
Charles Medawar & Social Audit London
Barbara Freese
1982
119PP
1J. The People’s Pharmacy i Joe Graedon
a consumers guide to pre
scription drugs dangerous
drug interactions brand
name medications & money
saving home remedies.
14* The People’s Pharmacy II Joe Graedon with
15• Geneva Press Conference
on SLO Proceedings
1• Drug induced suffering
(Proceedings of the Kyoto
Conference)
A very systematically
done analysis
of drug promotion & drug sales practices
of MNC’s in the 5rd void d gives suggest
ions as to what can be none, the bock
is convincing enough to aemand action
with its contents.
Shews the double standard of drug MNC’s
as regards the drug infermation given to
Doctors in UK and Irelancv *Thid- is a study
of LUMS UK & MIMS Ir fiand, gross disparit
ies in the informati >n between MIMS UK &
IvilMS of a Jrd world, country' cnn veiy
well be imagined.
Describes vividly the battle between G D
Searle (the American drug company producing
Lomotil) with Social ^udit a public interest
group: demanding consumer caution & warning
for use of lonotil in children .A lesson
in courage /; perseverence & systematic scratiny of so called scientific studies.
A very informative book fcr consumers, deleted of mystifying medical jargon^ Unfortunately
deals with American brands, though the drug
information is applicable in our context too.
Avan Book, USA
1977
Avon Press
1980
Consumer guide for choosing reliable drugs,
information on arthrites medications, vita
mins, -valium.
Japan
1980
Discloses some of the less known facts about
the SMON problem, presents the drug industry’s
response, its apology to t>i^ SMON victims in
Japan. .
An impressive book ab xit drug induced suffering,
covering pharmacological, clinical & research
studies. Valuable as .an exposure of the medi
cal graduates to drug related issue.
Organizing ComLiittee
Japan
...J...
1?•xi^escriptions for Change Virginia Beardshaw HA I
■v
?■
18. Selection of Essential
Expert Committee
19. Eaerapeutic guidelines
Upunda, Yudkin et- al
1983
WHO Technical
series 615
1977
641 - 1981
685 - 1983
African Medical
Research & Edu
cation Foundation
Nairobi Kenya. 1981
A stimulating book cf acti m, ideas for drug
_ campaigners.
These deal with the basic'principles of •
Rational ‘drug therapy and Technical Sep<^t
series- 685 gives the modified essential drug
list.
.in excellent guideline for rational therapeu
tics giving special emphasis on ■‘•he drug cost
as criteria for choice cf drug, diagramatically
shewn. Practical,simple and higniy recommended ' ~
or doctors and tmined middle level workers.
A pack of drug related infirnative. Articles
1 and bibliography on drugs indi the third world.
Bill-Bering the poor:Drugs PrcducAd by Inter- 475 Riverside
gid.the 3rd
world
fith
. ----------- -, an
— Centre
-- - on
Drive,Room 566
information & action pack Corporate Respon- *Rew York, N Y
n-,
sibility,
USA 10115,
21 • DRCTaD maj^-r issues in Tra
United
Nations
Beals with issues related to transfer of t ech
nsfer .■£ Technology to Deve
Conference on
•l975 63pp nclcgy, their impact and choices left to the
loping countries.A case of
Trade& Develop
third world countries.
the pharmaceutieal industry
ment
’
TD/B/C 6/4
‘ •
22 • ifiarmaceutical & Health
Blum,Andrew
Holmes & Meier
Polices International perspe Herxheiner.,
Publishers
1981 267pp Hole of MNC, drug policies, os
essential
drugs
sent ial drugs
ctives on Provision & control
economies
dealt
within
an
authoritative
way in
of Medicines.
a
collection
cf
excellent
art?.
•les.
23* Pills that don’t work
Sidney wolffe & International
Coley
Research group
for Drug Legis
lation &'Frogs.
New York Farrar,
- Extre ely informative book, deals with ineffeStraus girauy 71981 223pp ctive highly promoted drugs in US Market itself.
24* 44 Brohleia
__ drugs:a
____ consumer I 0 C IT
May 1981
Very methodically gives information about 44
action & resources kit on
problem drugs along with articles by some of the
Pharmaceuticals .
leading drug campaigners.
For Reference on DDrugs
___ and~ ~Pharmacology
____
1. Martindale-The extra pharmacopeia -'28th Edition
The Pharmaceutical Press* Rs.700 The world’s m0 3t comprehensive souri-e
drug informiticn in a single- volume.
2. Go.cdi'an gillman .- Macmillan Publishing
_
Co. Inc , 866,3rd Avenue,New York 10022.
3. Physicians,desk reference - Medical Economics co. Inc, Oradell, N J 07649,USA.
4.
Medicine BQpk. - Orient Paperbacks, 36 C*Connaught Place, New Delhi 110001. Rs.30
>• Drug Interactions,.
4
For deeper nnderatanding of the Indian Drug Scene
1.X Hatixt^Gannittee . Report 1975 Government of India
2.
Some aspects of the
Indian Drug Industry
5.
Alternative Strategy
Health for all
4.
6.
. Mukarram Bhagat
__ “.Reprinting
J 4-x. i I for public avail-ability should be
(Not available
demanded as Hathi Committee Recommendations, the Hathi Committee
essential drug list would provide the foundation for a demand for
a Rational National Drug Policy.
CEB Bombay. Rs.19 (3 Sulaiman Chambers, 4 Battery Street,
. Behind Regal Cinema, Bombay 4C^n39«
1981 ICSSR"& ICfflastudy Report Highlights the gap between- peoples health needs & our health
care delivery systems and shortages of essential drugs eg.anti
leprosy and anti TB drugs.
360pp A study conducted by the National Council of applied economic
The Indian Pharmaceutical
P L Naravana
Research undertaken as a response to OFPI’s requost to assess*
industiyTproblems' and 1984
the present drug status, identification of factors unpending
prospects.
growthneeds. Other aspects covered- are the Indian and Inter
national pharmaceutical industry, technology trends, price control
and their impact on production and profitability^
A philosophical statement criticizing its own ea/lier hospital,
Statement of, the National
Ministay of Health
curative care centred health policies. It discusses all the pri
Health Policy
198$ Govt, of India.
ority health issues including drugs, .tin importai.t tool for the
people to ensure implementation of governments own statement of
the National Health Policy.
PharmacouticaXss^ third 1978 Available from Dean^ 64PP- Rs.10/£1/$2
world experience Seneka
‘“
•Faculty
of Medicine
A tribute by his friends to this architecht of a courageous phar
Bibiles the Man and his
Colombo campons
maceutical policy in Sri Lanka, brought out in commemoration of
work.
University of Srihanka his death on 29th September ’77 in George Town Guyana where he
Colombo & Sri Lanka.
had gone as UNCTAD pharmaceuticals advisor to help in the prepa
ration of a Regional drug policy. His survival would have ensured
major changes in the third world drug and health policies. SriLanka
experience was net a failure as made out to be by the critics of
rational drug policies- if there were problems they were created
purposely by the vested interests. Sri Lanka experience helps us
to identify them.
.--•rfx
J
-
-•U-
Brag Related Ferieditsis
1- ______________________
Drug Information Bulletin WH 0
2. The Medical. Letter on Drugs 56 Harrison Street,New Rcchell,
and Therapeutics
New York, USA 10801.
5. Drugs & Therapeutits Bulle
tin U K
Consumers Association London
4- Health Action International IOCU, P 0 Box 45, Penang, Malaysia.
HA! News
c
5* The Rational Health Campaign Rational Health , Oxfam,274 Banbury Road
newsletter
Oxford 0X2 7D2, UK..
6. Consumer currents
IOCU, Penang, Klalaysia.
7• Consumer Interpol
8. Contact
Geneva
An unbiased drug inferaation bulletin.
Very informative newsletter covering
world drug news of special relevance for
us in the third world.
Gives information about the drug action
groups in UK.
Covers consumer issues, specially focus
on MG’S.
Christian Medical Commission
Available from VHAI
World Council of Churches
Arogya Dakshata Mandal,2115 Sadshiv Peth -monthly-Subsciption Rs.lO/yr.
9. Pune Journal of Continuing
Health Education
___________
____
Pune, Kiaharashtra.
10. Medico Friends Circle Bulle- 50 LIC Quarters, University Road
■tin
Pune, Maharashtra.
monthly- Rs. 15/yr.
i1• Drug Action Network newsletter. Low Cost Drugs & Rational Therapeutics•Cell
Voluntary Healthzassociation of•India
C-14, CoEoinity Centre,SDA New Delhi-16 -bimonthly-so far complementaiy for Drug Action
network only.
12. Health for the Ml lions
April-June ’81-special issue
on drugs-’’Bangladesh drug Policy”
VHAI address as above.
biiaonthly - Rs-12/yr.
13- Counterfact
CED Bombay.
Issues like hormonal pregnancy tests, depo3 Sulaiman Chambers,4 Battery Street,
provera, blood trade etc have been covered.
Behind Regal Cinema, Bombay 3914* Eastern Pharmacist-Independent
507 Ashok Bhavan,95 Nehru Place,
Rs.100 annual subscription. Deals with the
organ of pharmaceutical industry New Delhi 19.
industry related issues as well those dealing
trade and profession.
with the policyand rational drug use. Reco
mmended for Drug Documentation centres.
15* Heal tn .-•ind Society
P-Jl, Raipur, Garia, Calcutta-84 .
16.
Monthly. Jndex^oX MediG^L..SpaQiali±ies MIMS India, 90 Nehru Plaie
New Delhi 19.
17.
Current Index, of Monthly... age cialife.
Bio-Gard Medical Services
88/1,10 Cross, Post Box 518
Bangalore,56OOO3.
(Prepared specially for the.Drug Action Network*
and state V H A!s)
*•
Subscription Rs.60/yr
Relevant for Drug Action
Docuiaentation centres7
for scrutinizing the '
Subscription Rs.3B/yr. as well as the drugs
indicluded in MIMS and
CIMS, the drug informa
tion, made available
by the drv.g Industiy.
to comaient on their
rationality of drugs
and drug disinformation
. /is 'yfA Cl
f
Dr Mira Shiva, Coordinator,
Low Cost Drugs & Rational Therapeutics
Voluntary Health Association of India
28/2/198/;
. .
P
'I
ALL INDIA DRUG ACTION NETWORK?
““
‘
'
T7
.
. .
■■
'
■
••
• •
N’T
VOUJNTAJW [nlEALTIH] ASSOCOATIIONI OF OWfA
3rd July 1992
PEHA PP-l(l)
Dear
Two days ago the P.M. met the Parliamentary Consultative
Committee it seems that the drug policy will be presented in
the Parliament after being velted by the Cabinet Committee
on Economic Affairs(CCEA)•
The Parliament Session begins on 8th July and the Drug Policy
will be presented in the Parliament session, as expected the
areas to be dealt with will relate primarily to drug pricing
and licensing.
1) Drug Pricing
I had requested Dr.Anil Pilgaonkar to look into the area of
Drug pricing, since we must have industry data to discuss
anything.
How unremunerative is production of essential drugs becoming,
if certain drugs are becoming unremunerative we must recognize
it, but ensure that under their name, we should not allow
the argument that drug production is becoming unremunerative
as ours are the lowest prices in the world to be swallowed.
I am again requesting
Dr.Anil Pilgaonkar
ACASH
Dr.Rane
ADM
Cheenu
LOCOST
to please look into the matter of drug pricing, the extent
of price increase etc.
If AIDAN must make a submission it should be based on home
work. In view of the urgency could I request you to please
send the relevant information to others besides sending a
copy to me. So that we don’t contradict each other, it will
be better to arrive at the minimal consenses. If you think its
important to meet and you all can meet in Bombay do so, if
you think its better to meet in Delhi, let me know.
2.
Drug Price Control List
Dr.Rane and I had done the analysis of the proposed price
control list/besides being submitted to Dr.Chinta MOhan,
copies had been given at the last AIDAN meeting.
3• Essential Drugs
In view of the Health budget cut specially for TB, Leperosy,
’
Tong Swasthys Bhavan.
40 Institutional Area. Near Qutab Hotel Nev, Delhi-110016. INDIA
L'i 665 ‘T
655c"-
..2/-
. ■iT
‘
: 2:
Malaria etc. and the increase in drug prices the issue of
not meeting health needs and threat of epidemics etc. can
be addressed to put some fear and also to ensure that shortages
of drugs for diseases does not occur and there pricing shots
up unreasonably.
4. Mon action on Lentin Commission and the numerous tragedies
and the state of quality control must be addressed to high light
the need for quality assurance aspect of drug policy and
linking up of GMP with cancellation of licenses.
5. Pressure for WHO’s Ethical Criteria for marketing of
Pharmaceuticals to highlight the unethical nature of the promotion
is also one of the areas we could focus on.
On 17th July VHAI we are organizing a Consultation Meeting
on the Marketing Code for Baby Food since the Code is also
coming up in the Parliament for enactment.
I will let you know immediately on hearing about the date
on which the drug policy will come up in the Parliament
It would be good for some of the drug activists to be
present at that time.
I will keep you informed.
With sincere regards,
Dr.Mira Shiva ( MD
Head Public Policy Divn.
:MS:
Newdiug policy during tie
H onsoai session: Rao
3- >
discussions , If some modifications
are required to be carried out, they
would be subsequently incorporat
THE PRIME minister., M?V Nar- ed in the
. new
„ document. Given »..
thev
asimha Rao, has promhitthat the fact that issues relating to drug polinew d******
—
—
——
ii
A—
—
_
.
j_.
>
>
.
.
•
°
drug policy will bemdy for cy and prices have always been poapproval in the monsoonaBsion of iitically sensitive, the Prime Minis| Parliament. Mr Rao w&speaking ter perhaps wants a consensus to
on
>tj Wednesday at a meeaig
meetig of the emerge in Parliament on some of
consultative
committee atshed to
die basic
problems raised by the
----------- w KOOIL
piUUlCl
the
minictr-v nf
/ drug policy.
the ministry
of chemicabaadvw»t_
pet- mam
aew
rochemicals.
• In the normal course ,the new
; The policy is expecteda-oe
con- drug policy need not have been
r
—
---------l_?_^__
________
sidered V.-.
by the_ _____
cabinet
oremittee
placed in Parliament for approval.
on economic affairs (CCffi^ some- • Sources said that the new policy
A
*1.- ____ • J 11
/*
•«! 1
«
«
• •
•
%
time in the middle of th&sonth . will
be read along with the drug
Prior to this, the commiateof sec policy of 1986 . The Drug Price
retaries will meet to prade the Control Order of 1987 , which was
finishing touches to thepairy .
framed under the Essential Com
There is some confussar., how modities Act to provide the legal
ever, over the Prime
Miifttr
re- powers to enforce the ’86 policy
— ’s—
----- - ------mark that jhe policy will kt laid in will, however, have to be amended
Parliament for discusswaas. It is to implement the proposals of the
only after this that the pdiw docu new policy now underformulation
ment will be given final shaoe.
*
Well placed sources ■» the
The new drug policy will try and
Prime Minister’iofficesaid^fcat
the I.™
__________
iccr.sh. policies
.cj h.
keep the ’.licensing
in line
rrcA*1611* will
vetted
t^ie*
l^e new industry policy as laid
CCEA before going to Parlament. down in the Industrial DevelopHowever,
in thn
the eeurre
course d'House
H
owpvpf m
cfHeuse ment and Regulation Act - There is
Our Naw PethEBumt
s
NEW DEL»«2 JULY
I
II I
A 5
8
•4
o
3
C- >
a
some confusiB on whether a sepa
rate licensiigsystem will have to
be evolved fc drugs because the
new industaS policy has made it
clear that limsing for the sector
will be detewhed by the drug poli
cy formulate by the ministry of
chemicals aiiEpetrochemicals . If
this becomeshe ease , it is not yet
known whedr the implementa
tion and mowbring of the drug li
censing policrwill become the re
sponsibility 4 the department of
chemicals an&etrochemicals.
But with ft department unwilling to take w the onerous task ,
claiming thai^is the ministry of in
dustry whichhas been given the
job to look in&all issues pertaining
to industrial Sensing , it is likely
that the In&strial Development
and Regulatrw Act will have to be
amended to Corporate the provisions with n$»rd to licensing as
would be laitMbMm in the new drug
policy.
pvuiy .
. Meanwhile, a section of the industry has ssrted lobbying hard
against a new industrial licensing
policy for theiriig
theatug sector. ■
4
New policy to provide sops for
drug output from basic stage I
Santanu Saikia
cals, Ik Chinta Mohan, the new
policy ahis time is expected to go
throu$ «•»«;
the ‘necessary
governmenruv XTiriAT J
nuvujF
1' vcwaiy guvvt
iinirii.. .
drug policy will call for tai approvals fast. The prime minis©iminauon oi industrial licensing ter is reported to be keen in seeing
® the pharmaceutical sector in the that a new policy is announced
aa
hng run. An appropriate tariff
" soon. -Dr -Mohan
- is also known to
nechanism
nechanism to provide the neces have substantially pared down his
sary- incentives
for
manufacture of Criticism of the policy.
C
’
'
---------------------drugs from the basic stages will be
The note stated that the mini
introduced instead.
mum turnover criteria for inclu
For the time being, however, li sion of drugs under price control
censing will apply only to those will be Rs 2 crore in the new policy,
bulk drugs and intermediates Further, all
excluded
J! drugs will
--- be----’™J
where there is a danger
c_
of regres- only on an experimental basis. Desion to manufacture from tater pending upon how prices behave,
stage imported intermediates.
future
decisions will be taken on
t..
t
These proposals are contained whether the drugs concerned
in the
by the
. agenda
- note circulated
-----------...v should be continued to be kept out
°f 5“emic?ls and P^ro- of Price control. '
chemicals for discussion on a new
The new drug policy will apply
drug policy at the consultative com
the Kelkar committee criteria for
mittee meeting to be held on 1 July.
July
exclusion based on market compe
Pie Prime Minister, Mr P V Nara
Tim
tition (drugs which have m
at least
' ynlfethedraft-drug^p
’re- five bulk producers and a minimum
meeting.
of 10 formulators will be exempt
pared in January this year, which ed) across the board. This will be
was ^tailed because of opposition over and above the turnover crite
from among others, the minister of ria that will be adopted simulta
state for chemicals and petrochemi
neously for exclusion. The assumpNEW DELHI 29 JUNE
tion for using the Kelkar yardsack
is that market forces will kep
prices under check. But if pricesgo
beyond a critical limit they will
again be put back on price control,
Tlie new policy will aJso provide a
three-year adjustment period be
fore the list of drugs reserved for
the public sector is pruned from the
existing level of 15 drugs to five.
The note underlined the fact
.
that some aprice increases
will become inevitable if the new drug pob
icy
icygoes
goesininfor
forlarge
largescale
scaledecontrol,
decontrol.
/At present as many as 143 bulk
drugs and thousands of formulations are under a pricing regime.
“The apprehension that reduo
tion in span of control will lead to
spurt in prices of drugs lias to be
seen in the background of declining
profitability of drug companies, the
growing demand for medicines and
the need for further investments.
As against
o
the present
r
demand
of Rs 4300 crore, the demand by
the end of the decade is estimated to
be Rs 15,000 crore (1979-80
prices). It is noteworthy that 30 per
cent of the production of medicines
is in the small scale sector which is
outside the purview of price control. Further, single ingredient formulations under generic names are
already outside price control for ail
sectors. Ayurvedic and homeopath
ic medicines are also outside the
pricing system. A balanced view in
this matter is necessary”, the note
says.
The note also made it clear that
it is not administrativelytfeasible to
handle the price fixation of many
drugs. There are more than 500
.
bulk drugs and 50,000 formula
tions, including various sizes of
packs. At present, the available machinery is able to take up price fixa
tion of about 25 bulk drugs and
3000 formulations in a year.
After the consultative commit
tee discussions, a special commit
tee formed under the ageis of the
department of chemicals and petro
chemicals secretary, Mr M S Gill,
will provide the finishing touches
to the policy. Sources are hopeful ,
that a draft policy for consideration '
of the CCEA will be prepared by
next month.
J
I
Name of the Paper
:
INDIAN EXPRESS
[ Name of the Paper
:
THE BUSINESS & POLITICAL OBSERVER
i•
Published at
;
CHANDIGARH
Dated
7-^ JUN 199Z
r Published at
Banned, outdated
Irugs in GH stores
T.
. EXPRESS NEWS SERVICE
CHANDIGARH - The Central
Bureau of Investigation has reco
vered large quantities of banned
drugs, including morphine injec
tions and mandrax tablets, from the
stores of the General Hospital in
Sector 16.
f
t
Official sources here said the ban
ned drugs, which are no longer used,
by doctors, were detected in the
hospital stores during a surprise
. raid. The date of expiry of the drugs
had passed a long time back. The
CBI is ttrying
. < to 'find’ whether
’ ’
the
drugs were sold in the open market.'
saving drugs, were outdated, it is
leamt.
The sources said that investiga
tions into the supply of these out
dated medicines to patients in the
hospital and government dispensar
ies nad begun. “We have asked the
hospital authorities to submit the
record of the purchase and supply of
medicines during the past three
years”, they said.
Hospital officials, however, de
nied that the outdated medicines
were ever supplied to patients or to
any of the 30 allopathic dispensaries
in the Union Territory. But they
admitted that the expiry date of
hundreds of brands of medicines
lying in the stores had lapsed before
March. 1991. Even a huge quantity
of cotton and bandages lying in the
Both morphine and mandrax
were banned under the provisions of
the Narcotics and Psychotropic Sub<*
*
" .- stances Act. Dr A.C. Chaudhry,
*dd(;d
Medical SupenntendenCof .uthe hos s(ores was ou(datedpital, said the drugs had been lying
in the stores for “a couple of years”.
The sources further said that
The CBI officials had raised an medicines worth several lakhs were
objection when the staff concerned either found in excess or short in the
had failed produce the relevant re- stores. The store records were not
I cord immediately. Dr Chaudhiy properly mami?.-"**'! and the hospit-said, and claimed that the matter al officials used to create artificai
had been resolved when the regis- scarcity of medicines, the sources
ters showing the entry of morphine * said, adding that there w-as a big
and mandrax were produced before shortage of X-ray films, needles.
CBI officials.
oinments.
oinments, and tincture etc.
i
The CBI has also detected hugediscrepencies in the official records
and actual stock of medicines Anumber of medicines, including life-
The Medical Superintendent.,
however, said that the stock books
could not be properlv maintained as
the storekeeper had been unwell.
1*
Dated
NEW DELHI
17 JUN 1994
(
Drug, pharmaceutical patents
India seeks 15-year
transition period
and pharmaceuticals compames
have enjoyed a weak patent
''
NEW DELHI
regime for far too long.
But, they say that even the
INDIA has conveyed its willing
ness to accept some of the fresh proposal has not found
clauses relating to patent pro much support from developing
icvuvn m
mv Dunkel draft on
— countries. Only the EC has
tection
in the
trade related aspects of intellec- supported India ahd that too on
tual property rights (TRIPS) sub- the condition that certain
ject to the condition that a changes be incorporated in the
transition period of 15 years is proposal.
They say that even if India is
-- allowed.
The clauses, contained in ar able to push for its proposal, its
ticle 31 of the TRIPS text, relate patent laws will have to be
....o of
— amended for a more stringent
to the compulsory licensing
drugs,
patents
in
the
d-Tc compulsory licencing regime and
pharmaceuticals,
food
and for government use of patents.
’ chemical industries and their For instance, an Indian firm
a compulsory
acceptance will involve changes which secures
.
in India’s patent laws to provide licence will not be able to use
multinationals with stronger pat- the commodity for export pur
poses.
ent protection.
poses.
Officials say that India’s readiThough the Indian Patents
ness to accept these provisions Act has a provision for compulunder article 31, which is titled sory licencing,
^ct
to foods,
•‘other use without authorisation patents not applicable
’
r
of .be right hi’iccr"', was cm pharmaceutical'; and chemicals
veyed in Geneva earlier during A more simplified version referthe year during the negotiations red' to> as the automatic licence
of right also exists.
for the GATT talks.
'
While most officials are tightIndia has said that until the
mon period
penuu lapses,
mpava, lipped about India's stand on
15-year transition
the country should be allowed other articles under trade-related
a special dispensation for com aspects of intellectual property
pulsory licensing in the case of rights, some say that once India
these three industries. While accepts article 31 on TRIPS, it
even this will involve changes will have little room to main patent laws, it will still not noeuver.
Drug industry sources, how
accord the patent holder much
ever say that in meetings with
protection.
Officials defend the shift in the government, considerable
India’s stand on the ground pressure has been brought to
bear on them to accept product
th.it it (!<><•■. not rrnlly have
patrnls. They feel that India
much intri n.itlonal support
will have to accept a more
• lus issue. The view, which
also shared by many devolopiim stringent patent regime sooner
.
that Indian drugs than later. .
1 Id
Sodha Bhatia
< - ■ X'
•
The Morning Sup
Dhaka Friday May 1,^392
fbt md
onforn
of p ers
f
'he
cn
ler
'
n:
- "f ;,
Depositors rush at the head oil ice ol the Bangladesh Commerce and Investment Ltd (BCI) al Moiijhccl yesterday while police
guarding the gate.
3 m Voltaren tablets to be burnt
A Sun Report
1
i
i
r
Ciba Geigy who have invested a sum of Taka 30 crorc for a new
pharmaceutical plant a few years ago are now in utter frustration.
Voltaren an imjxjrtant drug was being imported by Ciba atTk 5.50
|>cr tablet several years ago. The local production of Voltaren in
Ciba's new plant was assessed at Tk 4.50 but when the plant came
into actual operation the product cost was reduced to T;ka 2.50
inclusive of duties, etc. But the price till dale bar. -.rt been
approved by the Health Ministry.
The local companies have been producing the same with raw ma-
The Mommg Sun
Dhaka Tuesday May 5,1992
Gano
Shastya
Dissolve Gano
Shashtya trustee
board: BMA
SlatT Correspondent
Board, if would hinder impartial
The Bangladesh Medical
and proper investigation into die •
Association (BMA) in a
statement yesterday strongly
affairs of the Gono Shastya
Kendra.
deplored die continued and-people
activities of Dr Zafarullah
Dr. M A Majed. President and
Chowdhury and demanded that
Dr. Ga/.i Abdul I loque. Secretary
General of Bangladesh Medical
immediate investigation be
conducted into the affairs of the
Association in a signed statement
also said :
Gono Shastya Kendra. The BMA
also demanded that the
"Bangladesh
Medical
government should without
Association has long been very
further delay dissolve the present
critical about Dr Zafarull.ih
management of the Gono
Chowdhury's anti-|»eople role,
Shastya Kendra and appoint a nc.w
specially in different policy
board of trustees.
making bodies of the last
aut<x:ralic regime.
The Bangladesh Medical
Association pointed out that Dr.
He
masterminded
and
Zafaruiiah Chowdhury had
influenced the Ershad regime to
influenced
the
previous
introduce, amongst other things,
government in formulating a
the anti-pcoplc health policy
damaging anti-people drug policy.
which was rejected by the jKople
The Association which is the
and the profession and the
countn s apex national body of . resulting movement ultimately
culminating in the fall of the
medical practitioners also stated
that unless Dr. Zafarullah
Ershad Government. For his anti
Chowdhury was removed
people and anti-professional
immediately from the Trustee
Last Page Col - 4
Contd. from Page 1
activities
Dr. Zafarullah
Chowdhury’s
B.M.A.
membership was cancelled in a
general meeting of BMA in 1990.
A high powered investigation
committee was set up during the
interim Government to probe into
the affairs of Gono Shasthya
Kendra activities. Preliminary
• report was submitted by the
committee and some suggestions
were made but due to
collaboration by some interested
persons, and some of them of
high official standing the
recommendations of the
committee have not yet been
implemented.
Il seems that Dr. \
Chowdhury's presence in and
control-oyer the organisation arc
the main obstacles to the proper
investigation.
Now that a democratic and
accountable
Government is
running the country as such every
organisation including that of Dr.
Zafarullah Chowdhury is
accountable. So. BMA demand ,
for the sake of proper
investigation and justice that a
new board of trustees be
appointed as per hw and
recommendations of the probe
committee without any further
delay and projicr actions be taken
against.the guilty persons.”
ed by the Editorjrom Progoti F
/
kz
{i
3 m Voltaren tablets
Contd. from Page 1
■ everything in inc nr ....^
absentee Sadck. by personation.
'Dr Zafarullah's role ami-people'
lerials from other sources and sell their product at sixty paisa per
tablet. Tyus, they have captured the market in the absence of
Voltaren. While taking into account the pricing, the cost of pro
duction is not considered at all, complained the manufaciur-.-rs.
Ciba have a valid point when they say that they cannot lowr- ilv->r._
international standards for the sake of Bangladesh only. If they sell
^I’rodti' i lh ‘l is m?dc in G ?rmany it m.rn;i much with their product
made in Bangladesh. The v4hole drug industry is m a flux and the
Last page col 1
market conditions demand a withdrawal ol pice control.
The western world are no more keen to keep their industries alloat
in third world countries, because with the World Bank
conditionality of free economy and free imports, more finished
products will be imported from the West. This will result in more
employment for their factories as well as more profit, phis a
strangle bold on the market. This is one reason why more of, the
Western ambassadors do not go out of their way to speak to the
government in favour of their industries located in B.iugk.dcstt.
ICI, a British company, has alrca<ly sold out. alongwiih SKP,
Squibb have closed down anti activities of many other pharmaceu
tical companies are shrinking simply Irecause of pricing |x>iicy.
If this be the situation the government can kiss international in
vestment good bye.
Ciba Geigy being unable to gel the minimum production cost for
Voltaren have decided to destroy it rather than sell it al underprice
:ls a matter of (rrinciplc.
The moment Ciba Geigy burns 3 million tablets it will become
head line news round the word. Il may be mentioned that Vollarcn
is being smuggled into the country from as faraway as Pakistan anti
as close as Thailand and being sold between Taka seven .niri .arp’.'’—
tablet. It is not marketed under this name in India and therefore ij ■
not smuggled in from there.
■
Wa-’
w’^ n€Ver Kel :,s
51 market as before for Vokarcr I
because other brands are chea|>er. Only those who can afford it will I
go for it.
U
The point we are trying to stress on and which the Government "
orchestrates regularly is the need for new foreign investment.
This will never come if we are unable to keep the one that have I
been serving us for so long.
We ho|)c the health officials will act swiftly so that the burning
ceremony of Voltaren will never take place. Only this may clir rk
the further closure of multinational companies.
P / /
Mnscod in full control
Public Policy DhttlB
Voluntary Health A^cUtion of India
■. THE TIMES OF INDIA
Name of the Paper
•
ublished at
-I
new DELHI
. 2 8 JUN IWI
Dated
v ’
(City puition)
sharp rise in drug prices
schedule H drug such as Lasex for
Name
Function
example, cannot be substituted un
Price rise (In Rs.)
NEW DELHI, June 27.
less the doctor prescribes so. But
'T’HE scarcity of several life savTetracycline
Antibiotic
7.50 to 10.50
with the price increase a large
(Generic name)
1 ing and other vital drugs in the
number of people are opting for a
city for the past fortnight has been
Erythromycin
Antibiotic
19 to 28
cheaper substitute which is accom
accompanied by a massive increase
panied with the danger of being
Rifampicin
~ ..foti-TB
Ttol
in the prices of more commonly
spurious.
used drugs which arc outside the
Quadriderm
GOVERNMENT POLICY :
Skin ointment
7.50 to 16
purview of the price control policy
of the government.
Adding to this confusion is the fact
Protein-Ex Powder
Protein supplement
31 to 50 :
that while controlled drugs are.
Patients with acute asthma, for
priced-inclusive of the 40 per cent
example, have had to cough up
Celestamin Steroid
Anti - allergy
3.50 to 7.50
tax that is mandatory on all drugs,
almost thrice the amount for
Pectocab
the decontrolled ones are not. The
Anti - diarrhoea
salbutamol inhalers, the price of
10 to 14
contradictions in the government
which has increased from Rs 28 a
Caladril Lotion
Anti - prickly heat
6.50 to 13.50
policy are best illustrated by the |
few weeks ago to Rs 64 today.
pricing of Rifampicin which
I
Proxyvon
Similarly, the price of the widely
Pain killer
8.20 to 10.50
used for the treatment
prescribed cough expectorant - Abdec Drops
tuberculosis - the combination 01
Multi - Vitamin drops
Benadryl - has also registered a
6 to 10.50
lor children
the drug is costlier than its single
sharp increase in price from Rs 9
Gastenen
component forming leaving the
to Rs 16.
Anti - abortion
17 to 22
hapless consumer Utterly confused
Other medical items which have
Eno Fruit Salt
Digestion
with the price rationale.
14 to 17
registered a phenomenal increase
The price of Oyarol - an oral
in the past few weeks include .
------.
Savlon liquid which has increased by 'n.®re ,than 200 Per
rise contraceptive used by women —
per cent.
cent. Also,
Also, they
they have
have no
no role
role in
in the
the orice
price rise.
from Rs 8 (100 ml) to Rs 9.80 (75 contributing in no small measure is On the contrary because the r*' has increased by almost 75 per
; re- cent. The government has done
mJX lodex (Rs 11 to Rs 14), Elec- the/act .that the unrealistic price tailers’ commission remains conslittle to correct this increase despite
tnOR Ri78?<v^i,0)’ IsaP8o1 <Rs 11 men1!0 imposed. by the govern- tant
at
between
16
to
25
per
cent
tant at between 16 to 25 per cent,
to Rs 13), Vicks ointment (Rs 18 mkent <>n . major drug and they too lose out on total SPes its pledge to the national health
to Rs 34) and Band Aid by almost for^a5eu!lcal Producers has when
when the
the price
price of
of drugs
drugs increases
increases. programme, an important compo
50 per cent.
forced the latter to make up the he says
g increases, nent of which is family planning.
PRODUCTION COSTS : The d*ffenence by hiking up the costs of Moreover, he points out, the con Similarly, Chloromycetin (generic
name), us for the treatment of
pnee increase has been attributed tbe decontrolled items produced by sumer is being forced to
opt tor typhoid, has registered a 100 per
to the spiralling production costs substitutes because of this price
- not only are the
consumers however
'•"* increase. The danger in this iis that cent increase in price. The price of
ie packaging j. e. ^*»u»*crs
nowever arc
Primoulot-N, a hormonal prepcostlier than greeting
thev icwh
retail the substitute is often sub
materials far more ccstlicr
~ their ire agamst lxl
—
tfwO stan
lndY 7brc ear,ier. but P°wer’ water Pal Oupta, "presi^e^^f t^South dard, specially if produced by the aration for gynecological use gone
small scale sector over which there up by 50 per cent. Insulin prepara
and other costs have also gone up Delhi Chemists Association,
says is very little quality control. A tions for the treatment of diabetics
has gone up by over 70 per cent.
Tj>e Times of India News Service
*6
*
and
Zi bv Ihedtoory UKUes of
Ihr.unws.
Verves De
contemptuous attitude of Dr
Zarrullah Choudhury
i.-
SI
I
I
ffl
II
Shawal26,14l2Hijri
Saishak 17.1399
.alhursday April 30; 1992
PM's intervention needed
I
A Sun Report
the infamous drug policy, the
How Gano 'Shasthya a
* NGO with its chiefs political
Bangladesh Non-GovcrnmcBl
chml has successfully jettisoned
Organisation (NGO). can thwart
the Health Ministry's decision to
the government directive for an
allow insjxxtion and verification
’ enquiry by a high-powered
of its assets.
investigation committee ’i»n
Gantt Shasthya Kendra was
multiple
complaints "I
registered as a charitable trust in
corruption, misappropnatwa.
1972 widi the declared objective
unethical practices and forocM
of providing health and other
occupation of others land 5os
social services to the members of
come to light recently in a rqvrt
the public. Il is alleged, that its
of an Enquiry committee hcatfcd
chief. Dr Zafarulluh Chowdhury
by Maj. General Anis Watz.
has illegally and forcefully
'Headed by a doctor turned sooccupied land belonging to local
called social worker and
people, taken over a pharm
poliGcian. Or Zaforulbli
aceutical company without
Chowdhury who was a c»sc
making payment, deprived the
’
..swciaie of lhe f.llcn presricnl
employees of their dues, harassed
Ershad and the main arcmica 01
r
disband tite ptuly.
the local people ar^m.sused (he
raw materials f« medicines
received fn>m donoraninincs.
Complaints <ainst Dr
Zararullah Chowdhry and .us
Kendra have bec» paring in
since « early « I!®- d“"nC ll'c.
Martial Law reg»W«- Some ol
these were investigated mm by
the Zonal Martial Law
Administrator, wh,>
recommended uctK« “» be taken
by the Ministry ofH»mic Allairs.
but nothing cventorily haj^pened
as the head of thc«*gam/ation
by his intense M>bying and
power Gil connecti*»s persuaded
the officials conccwtcd not to take
Last P.ipcOrf • 4
LXiluiia/aira manoP»*u:- , •>«*'•
1
<
"k‘
It
employee^ of lheir dues, harassed
eras ma tnc mam architect of
Last Page Col-4
\\
Dofahazara memorial hospitaL \
>
dtsWJ the party.
Gano
li
e-
Conld. from Page 1
I
r
■
anjcKUun.
'fcally. aflCT the fall of Ershad
aAcsunation of democracy, the
lhe
omplainants had taken up
can again with the government,
ftfcwing which the Adviser of
Haith and Family Planning of
ihr interim government and
pRmJent of BMA Dr. Majed had
fumed a high level Enquiry
CflBmittcv on February 23. 1991
wit Major General Anis Wai/, as
thcchaimian.
Ihc committee Included Dr A
TSddiqui. now Director General
Haith. Ka/.i Rakibuddin. now
Cktirman. BC1C Mr Fa/lur
Ibhnian. an additional Dcslricl
Jsige and Mr Na/.imuddin
Cbudhury. of the Defense Audit
IVpartmcnt as members • and '
Major Mahboob Kamal asman her secretary.
The committee had started llieir
w«rk in right earnest only io be
faKraicd by the dilatory tactics of
the NGO. They were denied
access to all papers and
documents to carry out their
ianrstigalion. Officials of the
Gano Shaslhya Kendra were also
rqnrtcd to have hurled insults at
lhe committee. The committee
fMaliy informed the Health
Advisor
of the
interim
go»cmment,df the position and
.'trnmmcnddd the dissolution of
Ac existing Trustee Board and its
replacement by a management
Board as they found enough
irregularities from whatever
documents and evidence they
from different sources.
The committee suggested that
an experienced doctor be
appointed as die chief executive
«*f lhe Kendra to conduct lhe
financial and administrative affairs
of all its projects. The other
members were to be a
representative each of lhe
founding members, the NGOs
functioning in the country, a
government officer of the status
«f a joint secretary, donor
countries.
representative,
employees representative, a
pharmacist, a legal advisor and an
economist.
The Health Ministry, then
asked for the advice of the
Ministry of Law which had called
for some papers and documents
regarding the NGO. lit spite of
Organization. In a complaint to
several reminders, the NGO has
the commilcc they said that
not complied with the Health
during the autocratic regime. Dr
Ministry’s directive and has not
Zafarullah Chnudhury had
furnished diose documents. In the
misappropriated a large sum of
mean time, the aggrieved persons
money forcefully extracted from
complaints remain unresolved
lhe supposed beneficiaries of the
while the Kendra is alleged to be
four extension projects of the
continuing its corrupt and
Kendra. Besides, expenditure of
unethical practices.
lhe Kendra was shown in an •
Gano Shaslhya Kendra, was
highly inflated way to lhe donor '
founded in 1972. on the plea of
countries and agencies, and the
continuing the work of the
money received from them was
Bangladesh Hospital which was
misappropriated by him. On the
sponsored in London during the
other hand, lhe regular salaries of
liberation war by six doctors,
die employees were not paid on
none of whom is any longer
flimsy guunds. they alleged.
connected with the Kendra except
Informed quarters expressed
Dr Zafarullah Choudhury. the
surprise at the inaction of the
present head. The Kendra was to
government in taking appropriate
render medical service to lhe
measures to regulate the irregular
people by establishing a chain of
and unethical activities of the
hospitals in the rural areas. The
NGO and to set right its affairs
pilot project at Savar was started
by reconstituting its management
with the donations received from
board. They expressed their
some local and foreign donors
bewilderment al the continued
including the International Rescue
contemptuous attitude of Dr
Committee and Torres De
Zafrullah Choudhury towards the
Homines.
government even al a lime when
One of the complainants, to
his mentors were no longer in
the committee Mr M A Huq of
Lalnullia. Dhaka said that he and
They feel it was lime such
others had a piece of land
gross irregularities by Dr
measuring about 8 bighas in
Zafnrultah Chowdhury who had
Savar where they had started a t
done incalculable harm to the
poultry farm which had been
growth of the phx’maceutical
forcibly occupied by Dr
industry in die country be Firmly
Zafarullah Choudhury. On lheir
dealt
with
and
the
earlier complaint, the law and
recommendation of the Enquiry
order authorities had taken some
Committee
implemented
action, but later, al lhe instance
forthwith. Continued defiance of
of some influential quarters, ibcy
this nature by an NGO will only
had withdrawn themselves.
encourage others Io follow suit.
Mr M Harasatullah of Gulshan
It wdl be in the interest of
in ,i complaint hnlged with lhe
doner’coon’rier -r,J
t”
commitice said that ne was the
allow an immediate probe into
Managing Director of a
lhe allegations which can only be
pharmaceutical firm named.
done effectively if lhe activities of
Pharmachcini.
which
Dr
Zafarullah Chowdhury is frozen.
Zafarullah Choudhury purchased
If the people Find lhe allegations
at a price of Taka two crore and
to be false Zafarullah can be put
twelve lakh. The amount was to
back with a clean slate. There arc
be paid in four instalments, but
also rumours that huge amounts
he had not received any payment
of unaccounted funds arc being
after the initial payment of Taka
placed in the hands of politicians
fifty lakh though in lhe
to destablise the government
meantime six years have elapsed.
Funds are also finding there way
Employees of the Kendra have
into the hands of a section of
alleged that the head of the
young doctors to disrupt any
organi/.Mtion is involved in
changes in the drug policy which
rampant corruption, gross misuse
was implemented through
of power, unethical practices,
Zafarullah Chowdhury. These
harassment of employees and
rumours cannot be substantiated.
high handed behaviour with the
Only a probe will reveal the true
local people creating an
(MiMtion.
incongenial atmosphere in the
icd by the Editor from Progoti Printing & Packaging, 15/1 South Kamalapur. Dhaka. Phones :
J
\
I
Dhaka Friday May 1,19.92
The Morning Sun
15/1, South Kamalapur, Dhaka
Anwdrul Islam Bobby
•
u —• -
Defiance is order
of the day
Anwarul Islam Bobby
Dr Zafarullah Chowdhury
appears to be the mightiest man
in the country. He intends one
day to become President of
Bangladesh say persons who
prefer anonymity as they arc loo '
scared of his power, his money
and his growing base. In
yesterday’s issue of the Sun
appeared a report which says how
he is frustrating a move by the
government to investigate GanoShaslhya Kendra.
Doctor Zafarullah, as it will be
seen, defied all orders to allow the
investigation team set up by the
interim government s Health
Adviser and President BMA Dr
Majcd to visit his plant. The
team headed by Maj General An is
Wais consisted of the present
DG. HcallW and four other senior
officials including a judge. In
spite of regular written
approaches made to visit the
premises al Ganasalhya Kendra
(Savar) excuse after excuse was
made to discourage the team from
doing so. In utter frustration the
investigators advertised in the
press asking for anyone who had
genuine complaints against the
Ganaslhaya to meet the
investigating team. Only a few
who had die guts to complain did
so. The others were loo familiar
with Zafarullah s tactics to come
forward.
•,
.
The complaints varied from
land grab to acquiring ai
pharmaceutical firm without
payment and misappropriation of
Defiance is order
funds. The committee being
unable to gel to the books and
physical
inspection
was
convinced that there were many
now.decided to start a private
Contd. from Page 1
things wrong. Since this was an
medical college. Huge salaries arc
papefs which have never been
NGO. like any other NGO the
being offered to job seekers
produced although the ministry
committee recommended that an
which is.another ploy to divert
sends diem letters to do so every
administrator ' be appointed
attention and neutralise the
two to three months. Already the
alwngwith a committee which
matter has been delayed by which
profession.
*
was to include even a labour
The Prime Minister must now
lime many loopholes and lapses
representative to replace the
prevail.
and documents may be lost. The
let the rule of la
present trustees.
Chowdhury's
Z a f a r u 11 a h
Directorate of Social Affairs.under
The recommendation and the
has
to
be
organisation
which all NGO’s function and are.
report of the high powered
investigated on the basis of the
registered
which have
committee was submitted to the 1
high powered committees re|x»rl.
categorically said the law permits
Ministry of Health for immediate
Gann Shaslhyas
If by chance the Gana
the lake over of any NGO by the
action. The same committee had
defiant altitude is successful, die
government or suspension of its
also investigated into the affairs
same pattern will be followed by
activities.
of Bangladesh Association of
each and ever)' NGO. cooperative,
If the Health Ministry was
Voluntary Sterilisation. Their
really keen to investigate and • bank and industrial organisation.
Findings were not only approved
properly run Ganashasthya
Failure to replace the present set
by the'Ministry of Health but
through a new board of • up al Gana Shasthya will only
actions taken on the basis of the
management it would not delay
establish that the Khaleda
findings.
the implementation of •the
government is incapable.
In the case of Gana Shasthya.
The Health Ministry officials
Committees recommendation by
the petty officials of the Ministry
finding lame excuses. “Zafarullah ’ who have been delaying this case
of Health began finding devious
must be taken up with the
Chowdhury a close associate of
means of delaying the whole
harshness they deserve. A few
former President Ershad is still
process, they decided the
organised telegrams from abroad
government could not implement | very powerful and has enough
in favour of the present set up of
clout to handle non-dccisivc
the decision of the committee
Gana ■ Shasthya should be
o
----- like the present
unIess lhc clearance of the Law
considered as "interference in the
onc,“ said a former colleague of
Ministry was obtained. For the
internal affairs of our country.
Zafamllalt. Zafarullah Chowdhury.
Law Ministry to study the case ;; who used the guns of. Martial
And besides an enquiry might
they needed the terms and ;
even help clear Dr Zaffarullahs
; Law on the shoulders of Prof
conditions and registration deeds ,
reputation. Why should not the
' Nunil Islanl to ygpducc a dreadful
el Tin'^lhe11 well heeled peuy , <I">S
pnli^aThas
crippled lhc
•
— - - -sponsor donors want an official
probe ?
has
Heallh Ministry officials BolUreiri national
nat.onal industrial
.ndns.r,.-.! policy
........
h«
opportunity. They wrote to j
- •_______ __________________
Ganashasthya for the relevant
Editor : ANWARUL ISLAM (B
Last page col 1
J
. ■ government, nc spoxe alter
Kabul.
AMMM
All India Drug Action
Network (AIDAN)
zAJl India Drug Action Network
(AIDAN) is a coordinating body of
Voluntary Health, Consumer, Science
Organizations and individuals actively
involved in this field, from different
parts of India; set up to :
i Work towards a Rational, Propeople Drug Policy in India and to
' ii Exchange ideas, experiences about
different aspects of alternative
practices at grass root level
pertaining to the production,
distribution, use etc. of Rational
Drugs.
PERSPECTIVE
AIDAN realizes that the health of
people depends primarily on nutrition,
sanitation, living and working
conditions, social culture..etc and that
availability of health services especially
of drugs, has only a secondary role to
play. But at the same time, in India,
where infectious diseases predominate,
drugs can save large-number of lives
and remarkably reduce sufferings. The
Rational Drug Policy, can therefore,
play an important role as part of a
Rational Health Policy. However,
during the last thirty years, along with
a rapid increase in the range and
volume of drug-production, there has
been a more rapid rise in the
irrationalities at all levels of the drug
policy (i.e. Research, Production,
Distribution, Marketing, Education
and Use) due to a lack of scientific
approach coupled with the profiteer
ing by the drug industry. Secondly
even 39 years after independence, the
multinational drug companies con
tinue to dominate the drug scene in
India; self-reliance continues to be a
dream. As a result, essential drugs are
in short supply, out of the reach of the
majority of the people who need them;
whereas there has been a plethora of
high-cost, useless, hazardous drugs in
the market.
There is, therefore, a dire need to
work for a Rational Drug Policy
which should have the following
objectives:
A Assessing the real drug-needs
1 To identify the real drug needs in
consonance with the health need of
the people, particularly those
required for primary health-care; to
prepare a graded essential and
priority list of drugs for different
levels of health-expertise in keeping
with actual health needs of the
people.
2 To eliminate irrational, useless and
hazardous drugs. (This has become
one of the most important problems
today).
B Production, Price and Quality
control
1 To produce and make rational
drugs available at low prices to the
people, particularly the essential
and priority drugs. Adequate
supply of free drugs to the poor
people through the state health
system.
2 To ensure strict quality control of t
all drugs.
C Drug Distribution
To establish a national corporation
for the distribution of drugs;
retailing of drugs through appro
priate channels and government’s
health infrastructures.
D Drug Information & Ethical
Marketing
1 To ensure a drug information
system for health personnel and
consumers.
2 To ensure ethical marketing
3 To abolish brand names and
introduce generic names of all
(drugs)
E Self-reliance
1 To develop self-reliance in drug
technology.
2 To foster and encourage the growth
of the Indian Sector and to provide
a leadership role to the public
sector.
3 To aim at quick self-sufficiency in
the output of drugs with a view to
reducing the quantum of imports.
F Research and Development
1 To promote research and develop
ment for self-reliance and to meet
the real health needs of the Indian
people.
2 To evolve strictly ethical mode of
medical research.
G Legislation and Administration
1 To provide comprehensive drug
legislation and administrative
support to deal effectively with and
implement all the above aims and
objectives.
2 To ensure smooth Centre-State
relations and inter-departmental
coordinations for effective drug
production, drug control and drug
supply.
H Human Power Development
To fulfill the needs for the above
Rational Drug Policy, different
types of technical personnel (e.g.
druggists, paramedics technicians
etc) need to be adequately and
appropriately trained in adequate
numbers.
Some elaboration of these
objectives ( A to H) has been
published in the form of a 16 page
pamphlet “Rational Drug State
ment” of AIDAN and is available
for Rs. 1-50 from Dr. Mira Shiva,
Coordinator, AIDAN. A substan
tial document “A Rational Drug
Policy” (see at the end) gives a
much more detailed account.
EVOLUTION & ACTIVITIES
Some groups and individuals
concerned with misuse of drugs came
together in 1981 and launched a
campaign against the high dose
combination of estrogen and proges
terone. The campaign proved to be
effective and the Government had to
ban this combination. Encouraged by
this success, attempts were made to
rouse public opinion against irrational
and hazardous drugs. Through the
interaction during these campaign, it
was felt that there was a need for a
regular network to co-ordinate this
work; to lobby for a rational drug
policy as a whole and not only about
hazardous drugs. A loose co
ordinating network was formed in
1983. A series of prolonged and
intense discussions were held amonast
those who had been consistently active
in this collective work during those
couple of years and a Rational Drug
Policy Statement (RDP Statement)
was prepared outlining our basic
common
understanding
briefly
elaborating the points enumerated
above.
Within the perspective of this RDP
Statement, member organisations &
individuals have tried to create public
awareness through various means
(articles in periodicals, pamphlets,
meetings..etc.) On different aspects of
the drug policy, particularly the
relationship between plethora of
irrational drug combinations and the
paucity of ess'ential drugs and that
between high prices of drugs and the
domination of multinational drug
companies. (At the end, a list of
publications in English on the drugs
issue by member organisations has
been given.)
From 1984, a new drug policy by
the Government was quite in the air
and hence AIDAN as a collective
focussed its attention on this new
policy. A detailed critique of the report
of the steering committee of the new
National Drugs and Pharmaceutical
Development Council (NDPDC) was
submitted to the Government; a spate
of newspaper articles were written,
concerned parliamentarians were
appraised of our perspective and
demands by providing substantial
material. A signature campaign
amongst doctors enlisting medical
demands about new drug policy was
carried out in different parts of the
country.
After the announcement of the New
Drug Policy on 18-12-86, its anti
people, pro-industry, irrational charac
ter is being exposed in the eyes of the
public.
Apart from lobbying about the
policy issues at the National level,
some member organizations of
AIDAN have been active in educating
doctors, paramedics and the lay people
about Rational drug use in their
practice. For example:
★ “Drugs Diseases Doctors” by Drug
Action Forum, West Bengal, is a
periodical for doctors which is
almost exclusively devoted to
rational use of drugs and to
highlight misuse of drugs.
★ Voluntary Health Association of
India has been training their
paramedics in rational drug use and
has published health related
booklets.
★ LOCOST has been trying to evolve
a method of supplying good quality
generic name drugs at cheaper rates,
to the voluntary sector and
promoting rational use of drugs.
WHAT YOU CAN DO FOR
AIDAN
1 To become an active member of
AIDAN please write to the cooridnator on the following addres
Dr. Mira Shiva C-4/14, S.D.A.
New Delhi 110 016.
2 To study the substantial material
published during last few years by
AIDAN members or by other
fraternal groups; and to write in
various periodicals with the help of
this material.
Please do not forget to send a
copy of the cuttings of published
material to the AIDAN Co
ordinator.
A list of such publications is
given at the end of this brochure.
3 To sell this material to appropriate
groups, socially conscious doctors,
activists, Journalists...etc.
4 To foster Rational Drug Polic
Celis in your area or within already
existing appropriate organizations
to carry out the above work of
lobbying as well as to promote
rational knowledge and use of
drugs in your area. For example, a
local group can launch a campaign
' amongst doctors as to why they
should not accept any drug samples
from any drug company, or why
they should not use hazardous
drugs like E.P. forte, Analgin,
Butazones, Anabolic Steroids,
Clioquinol, Combination of strepto-
mycin with chloramphenicol or
with penicillin...etc.
Campaign amongst the people
about primary importance of oral
Rehydration in diarrhoea; and try
to start “dianhoea-treatment cent
res” by paramedics under the
guidance of a doctor and about the
wastage of money involved in the
use of most of the highly advertised
over-the-counter drugs and the
alternative to these brands.
Lobby with the Government on
the basis of awareness amongst the
people about★ The urgent need to make
available measles vaccine on a
priority basis in the Government
centres or to shelve the plans to
give NET-EN injections to
women.
Lobby with the professional
bodies like in Indian Academy of
Paediatrics, IMA to
★ promote rational use of medi
cines amongst its members; to
conduct seminar on the new
drug policy;
★ to pressurize the Government to
immediately make available the
measles vaccine in its pro
gramme.
★ to prepare and distribute healtheducational material for parents
on child-health and about do’s
and don’ts about drugs.
Only a couple of illustrative
examples have been given above
about some of the types of activities
that you can take up. Many such
instances and also other types of
activities are possible depending
upon resources.
5 If you are interested and are in a
position to do academic work; this
will also be helpful. If you' are a
doctor, you can contribute to the
above mentioned periodicals or you
can prepare a study of various
formulations belonging to any one
of the groups of drugs (cough
mixtures, haematinics, antacids., etc)
that are available in the market to
assess their rationality. Studies
conducted by the Medico Friend
Circle (see at the end) offer such
examples and have proved to be
very useful in re-education of
doctors.
If you are an economist or
sociologist, you may study from that
angle, various aspects of a rational
drug policy-for example, the real needs
of the Indian people about different
drugs for example, how much of
isonex-the antitubercular drug-would
be required to treat all the TB-patients
in India? How much money is
wasted, concretely speaking, on
irrational drugs? What is the impact of
the new drug policy on the ex-FERA
companies, Indian monopoly drug
companies, medium size companies?...
etc. If you are an artist, you can draw
posters, cartoons, prepare songs, make
a slide show...!
This is a movement and different
types of people with different skills can
make valuable contributions. Let us all
together work towards a ‘Rational
Drug Policy”.
LITERATURE ON DRUGS IN
ENGLISH PUBLISHED BY
AIDAN MEMBERS
I AIDAN Materials:
i Rational Drug Policy statement:
pp 16, Rs. 1.50, VHAI (see below)
ii A Rational Drug Policy; pp.162,
2nd edition 1986, Rs. 20.00 (This
book and C1 - see belo w-are very
substantial resource books on
different aspects of Drug Policy)
Published by Voluntary Health
Association of India for AIDAN
40, Institutional Area, South of
I.I.T. New Delhi-110 016.
iii Critique of the New Drug Policy,
April 1987 (under preparation)
available at VHAI and CED).
iv Drug Alert-Hazardous Drugs, pp
52, Rs. 6/II Material Published by AIDAN
Members:
A Arogya Mitra Mandal 2117,
Sadashiv Peth, Pune 411 030 —
Our Health, Our Medicines,
Rs. 10/B Catholic Hospital Association
of India (CHAI) PB 2126,
157/26 Staff Road, Secunderabad
500 003
1 Health Action — a monthly
published by Health Accessories
for All (HAFA) propagates
Rational Drug Therapy and
Critical approach on Health Care
delivery.
Subscription Rate:
Life Membership
: Rs. 1000/
Annual — Individual
:Rs. 60/
Annual — Institutional : Rs. 80/
Foreign-Annual
: USS 50/
Foreign-Life
: USS 500/
Single copy
: Rs.
7/
Themes covered by past issues in
1988 include Immunization, Infec
tious diseases, Tuberculosis, Nutri
tional Anaemia, Diarrhoea, Acute
Respiratory Infections, Antenatal
Care, Rational Drug Therapy,
Nutrition, Leprosy, Addictions and
Blindness.
1989 — Sports and Health,
Growing Child, Hypertension,
Mental Health, Accidents and
Poisoning, Diabetes, Community
Health, Allergies, Dental Health,
Universal Immunization Pro
gramme, Cancer and Shelter
(Housing).
2 Buyer’s Guide —
A purchase guide to Health Care
products and services — useful for
Hospitals and Dispensaries.
Price Rs. 175/3 Herbal and Home Remedies —
Loose Leaf format. Photographs
and sketches of herbs used
commonly as home remedies.
Price Rs: 40/4 Mini-manuals in Hindi (set of 10
titles) — Illustrated guide to deal
with common health problems in a
simple and rational way, giving
both allopathic and home remedi
Topics covered are Scabies,
Pneumonia, Tuberculosis, Polio,
Care of Eyes, Ears and Teeth.
Price: Rs. 15/- for whole set.
C Centre for Education &
Documentation, 3 Suleman
Chambers, 4 Battery Street,
Behind Regal Cinema, Bombay400 039
i Aspects of Drug Industry in India,
M Bhagat, pp. 130, 1982. Rs. 19
ii Brief List of the Literature on
Drugs and Drug-related issues
available at C.E.D. with facility
for xeroxing and sending by post.
Most of the literature in this list is
available for sale with C.E.D. and
V.H.A.I.
iii Injecting NET-EN into Inc
Mira Savara, June 86 Rs. 5.
D Delhi Science Forum, B-l, Ilnd
floor, ‘J’ Block, Saket, New Delhi110017
i Drug Industry and the Indian
people, Dr. Amit Sen Gupta.
(ED.) co-publisher-F.M.R.A.I.
Patna, pp 333, 1986, Rs. 40-00,
Harbdound Rs. 100-00
E Drug Action Fon^1 West
Bengal
i DrugDisea^^octorCQ^e^y);
Ed. Dr- P-K. Sarkar, P. 254,
BlorA-B, Lake Town, Calcutta-
ii
F
i
ii
iii
G
i
ii
iii
V
H
i
700 089. Annual Subscription
Rs. 12-00.
Poster: Drugs for the people or
People for the Drugs, Rs. 3/Kerala Shashtra Sahitya Parishad (KSSP) Parishad Bhavan,
Marvencheri Lane, Trichur 680
002.
A decade after Health Committee,
Ed. Dr. B. Ekbal, Rs. 35/Drug Alert-Hazardous Drugs
(AIDAN) pp. 52, Rs. 6/National policy for Universal salt
lodization-A critique, Dr. K.P.
Arvindan, Rs. 3/Medico Friend Circle
Rational DrugPolicy Cell^O, LIC
quarters, University Road, Pune411 016.
“Tonics how much an economic
waste ?” by Dr. Kamala Jaya Rao,
xeroxed 6 page article from MFC
Bulletin: Rs. 5-00 (available free
of charge with V.H.A.I)
“Scientific Scrutiny of some overthe-counter-drugs” by Dr. A.R.
Phadke, xeroxed copy of the
reprinted article in “Medical
service” Oct-Nov. 1985, 7 pages:
Rs. 6-00
“Multinationals in the Indian
Drug Industry” by Dr. A.R.
Phadke, xeroxed copy of the 5
page article from MFC bulletin,
Rs. 4-00 iv) Dipyronp, Hoechst
and the Boston study, Wilbert
Bannenbcig, reprint from MFC
Bulletin No 123, December 1986,
4 pp. Rs. 2-00
Drug Alert-Hazardous Drugs,
pp 52, Rs. 6/Pondicherry Science Forum
Issues involved in drug policy. (A
brief account of some of the issues
discussed in I,II and Di published
by Chennai Books; 6, Thayar
Sahib Street, II Lane, Madras 600
012, pp 56; revised edition,
Februrary 1987 Rs. 10-00
I Voluntary Health Association
of India (VHAI) 40, Institutional
Area, south of HT, New Delhi110016
i Banned and Bannable Drugs, pp.
67, Rs. 15-00
‘ii Drug Information pack; Rs. 15-00
iii The use of Essential Drugs
(reprint from WHO) Rs. 10-00
(for other books, see T in the
beginning)
iv “Do you really need all these”, a
leaflet, Rs. 2-00
V Reprints from: “Where there is no
Doctor”, Right and wrong uses of
modem medicine: Re. 1/Instructions and precautions for
Injections: Re. 1/-. The uses,
dosage and precautions of
common medicines, Rs. 2-50
vi Leaflets of Rs. 0-50 each: The
declaration of Alma Ata,
Drugging of Asia, WHO essential
drugs, Bangladesh drug policy,
Hazardous bannable and dumped
drugs, Our concern about drugs.
Essential drugs, The Courageous
Bangladesh.
vii Fosters: Murder in the name of
medicine, profits before the people
Rs. 5-00 each ‘Can you
understand the small print’, Ban
Bannable drugs, Drugs can be
dangerous too. Don’t judge a
medicine by its packaging, Rs.
3-00 each.
For a list of other publisher’s books
on drugs available at VHAI, please
write to the publication officer, VHAI.
For mode of payment, postage., etc,
please write to individual publishers
listed above.
(articles in periodicals, pamphlets,
meetings..etc.) On different aspects of
the drug policy, particularly the
relationship between plethora of
irrational drug combinations and the
paucity of essential drugs and that
between high prices of drugs and the
domination of multinational drug
companies. (At the end, a list of
publications in English on the drugs
issue by member organisations has
been given.)
From 1984, a new drug policy by
the Government was quite in the air
and hence AIDAN as a collective
focussed its attention on this new
policy. A detailed critique of the report
of the steering committee of the new
National Drugs and Pharmaceutical
Development Council (NDPDC) was
submitted to the Government; a spate
of newspaper articles were written,
concerned parliamentarians were
appraised of our perspective and
demands by providing substantial
material. A signature campaign
amongst doctors enlisting medical
demands about new drug policy was
carried out in different parts of the
country.
After the announcement of the New
Drug Policy on 18-12-86, its anti
people, pro-industry, irrational charac
ter is being exposed in the eyes of the
public.
Apart from lobbying about the
policy issues at the National level,
some member organizations of
AIDAN have been active in educating
doctors, paramedics and the lay people
about Rational drug
’ ; use in their
practice. For example:
★ “Drugs Diseases Doctors” by Drug
Action Forum, West Bengal, is a
periodical for doctors which is
almost exclusively devoted to
rational use of drugs and to
highlight misuse of drugs.
★ Voluntary Health Association of
India has been training their
paramedics in rational drug use and
has published health related
booklets.
★ LOCOST has been trying to evolve
a method of supplying good quality
generic name drugs at cheaper rates,
to the voluntary sector and
promoting rational use of drugs.
WHAT YOU CAN DO FOR
AIDAN
1 To become an active member of
AIDAN please write to the cooridnator on the following addres
Dr. Mira Shiva C-4/14, S.D.A.
New Delhi 110 016.
2 To study the subsUntial material
published during last few years by
AIDAN members or by other
fraternal groups; and to write in
various periodicals with the help of
this material.
Please do not forget to send a
copy of the cuttings of published
material to the AIDAN Co
ordinator.
A list of such publications is
given at the end of this brochure.
3 To sell this material to appropriate
groups, socially conscious doctors,
activists, Journalists...etc.
4 To foster Rational Drug Polic
Celis in your area or within already
existing appropriate organizations
to carry out the above work of
lobbying as well as to promote
rational knowledge and use of
drugs in your area. For example, a
local group can launch a campaign
' amongst doctors as to why they
should not accept any drug samples
from any drug company, or why
they should not use hazardous
drugs like E.P. forte, Analgin,
Butazones, Anabolic Steroids,
Clioquinol, Combination of strepto-
I
Shawal26,1412 Hijn
Saishak 17.1399
.alhursday April 30.1992
PM's intervention needed
r
r
A Sun Report
the infamous drug policy, the
How Gano ' Shasthya a
* NGO with its chiefs political
Bangladesh Non-GovcrnmcM
clout has successfully jettisoned
Organisation (NGO), can ihwart
the Health Ministry’s decision to
the government dircciivc for an
allow inspection and verification
’ enquiry by a higHi-powcrcd
vf its assets.
investigation committee -on
Gano Shasthya Kendra was
multiple
complaints «»
registered as a charitable trust in
corruption, misappropnaiwo.
1972 with the declared objective
unethical practices and forvcMl
of providing health and other
occupation of others land tos
social services to the members of
come to light recently in a rq*»rt
the public. Il is alleged, that its
of an Enquiry committee headed
chief. Or Zafarullah Chowdhury
bv Maj. General Anis Waiz.
has illegally and forcefully
'Headed by a doctor turned sooccupied land belonging to local
called social worker a«d
people, taken over ■ pharm
politician. Or Zaf.rulbh
aceutical company without
Chowdhury who was a close
making payment, deprived the
associate of the fallen prcsidcnl
employees of their dues, harassed
Etihad and the main architect ol
disband liic ptuty.
the local people aniwts^^d the
raw materials f<w medicmes
received from donor»»«niries.
Complaints gainst Ur
Zafarullah Chowd^y xid ms
Kendra have bee* pouring in
since as early as I**- during the
Martial Law regm*- Some o
these were invested ini'* by
the Zonal
Law
Administrator. whn had
recommended acti*’* ,o be u en
by the Ministry ofiH»*nic Affairs,
but nothing cvcnturfly happened
as llie head of ihc«rg«n’zaU<’nby his intense Maying and
powerful conneciwes. persuaded
the officials concawrd not to take
Last H.igcOd •4
Dolahasaira maiwf* r.u?
Public Policy DfeWca ,
1
' Voluntary Health Association of Ir>d»
-r
I
...........................................
’
------------- X X
’
’
crwi ana tnc mam architect of
employee^ of their dues, harassed
dXiuicpmy.
'
" ■
Last 1 are Col 4
x
fchhazaramemorialhospiut
Gano Shasthya
51
Organization. In a complaint to
several reminders, the NGO has
the commitcc they said that
not complied with the Health
during the autocratic regime. Dr
anjartiuru
Ministry's directive and has not
Zafarullah Choudhury had
fcally. ■ftcr the (all o( Ershod
furnished those documents. In the
misappropriated a large sum of
adbcSlnratMm of democracy, the
money forcefully extracted (mm
oMaplainanis had taken up the . mean time, the aggrieved persons
complaints remain unresolved
the supposed beneFiciarics of the
can again with the government,
while the Kendra is alleged to be
four extension projects of the
(•flawing which the Adviser o(
continuing its corrupt and
Kendra. Besides, expenditure of
H^th and Family Planning o(
unethical
practices.
the Kendra was shown in an •
it* interim government and
Gano
Shasthya
Kendra,
was
highly inflated way to the donor ‘
Pnidcnl o( BMA Dr. Majed had
founded in 1972, on the plea of
countries and agencies, and the
hmed a high level Enquiry . continuing the work of the
money received from them was
Caanmtev on February 23. 1991
Bangladesh Hospital which was
misappropriated by him. On the
wifl Major General Anis Wai/, as
sponsored in London during the
other hand, the regular salaries of
lhechairman.
liberation war by six doctors,
the employees were not paid on
lhe committee Included Dr A
none of whom is any longer
flimsy pounds, they alleged.
TSddiqui. now Director General
connected with the Kendra except
Informed quarters expressed
Haith. Kazi Rakibuddin. now
Dr Zafarullah Choudhury. the
surprise al the inaction of the
Chipman. BCIC Mr Fa/lur
present head. Pie Kendra was lo
government in taking appropriate
Rjfcman. an additional Dcstrict
render medical service to lhe
measures to regulate the irregular
J-RC and Mr Nazimuddin
jieoplc by establishing a chain of
and unethical activities of the
Ciaudhury. o( die Defense Audit
hospitals in lhe rural areas. The
NGO and to set right its affairs
IXymrimcnl as members • and *
pilot project at Savar was started
by reconstituting its management
Major Mahboob Kamal aswith lhe donations received from
board. They expressed their
man her secretary.
some local and foreign donors
bewilderment at the continued
The committee had started tlieir
including lhe Inlcmalional Rescue
contemptuous altitude of Dr
in right earnest only to be
Committee and Terres De
Zafrullah Choudhury towards the
faBtrated by the dilatory tactics of
Homines.
government even al a time when
the NGO. They. were denied
One of lhe complainants, lo
his mentors were no longer in
access to all papers and
the committee Mr M A Huq of
power.
dacuments to carry out their
Lalmaiia. Dhaka said that he and
They fee) H was lime such
iwestigation. Officials of the
others had a piece of land
gross irregularities by Dr
Gano Shasthya Kendra were also • measuring about K bighas in
Zafarullah Chowdhury who had
reported to have hurled insults at
Saviir where they had started a ' done incalculable harm to the
the committee. The committee
poultry farm which had been
growth of the pharmaceutical
fmally informed the Health
forcibly occupied by Dr
industry in the country be Firmly
Advisor of the
interim
Zafarullah Choudhury. On their
dealt
with
and
the
gwcmmcnt,df the position and
earlier complaint, the law and
recommendaiion of the Enquiry
.-<rr>mmcndtkl the dissolution of
order authorities had lakcn some
Com mil tee
implemented
Ac existing Trustee Board and its
action, but later, al the instance
forthwith. Continued deFiance of
replacement by a management
of Mime influential quarters, they
this nature by an NGO will only
Board as they found enough
had witlnlrawn themselves.
encourage others Io follow suit.
irregularities from whatever
Mr M Harasalullah of Gulshan
Il will be in the interest of
documents and evidence they
in ,i complaint lodged with the
doncT*co”n’ricr
«>
from dirfcreni M'urces.
commilice said that nc was the
allow an immediate probe into
The committee suggested that
Managing Director of •
the allegations which can only be
an experienced doctor be
pharmaceutical firm named,
done effectively if the •divides of
appointed as die chief executive
I’harmachemi,
which
Dt
Zafarullah Chowdhury is frozen.
«f the Kendra to conduct the
Zafarulluh Choudhury purchased
If the people Find the allegations
financial and administrative affairs
at a price of Taka two crore and
to be false Zafarullah can be pul
of all its projects. The other
twelve lakh. The amount was to
back with a clean slate. There arc
members were to be a
be paid in four instalments, but
also rumours that huge amounts
representative each of the
he had not received ;iny payment
of unaccounted funds are being
founding members, the NGOs
after the initial payment of Taka
placed in the hands of fxdilicians
functioning in the country, a
fifty lakh though in the
to destablise the government.
government officer of die status
meantime six years have elapsed.
Funds arc also finding there way
of a joint secretary, donor
Employees of the Kendra have
into the hands of a seclion of
countries,
representative,
alleged that the head of the
young doctors lo disrupt any
employees representative, a
organization is involved in
changes in lhe drug policy which
pharmacist, a legal advisor and an
rampant corruption, gross misuse
was implenicnicd through
economist
of power, unethical practices,
Zafarullah Chowdhury. These
The Health Ministry, then
harassment of employees and
rumours cannot be substantiated.
asked for the advice of the
high-handed behaviour with lhe
Only a probe will reveal the true
Ministry of Law which had called
local people creating an
for some papers and documents
|x>siiion.
incongenial atmosphere in lhe
regarding the NGO. Irr spite of
Contd. from Page 1
r
S.I
■
.cd by the Editor from Progoti Printing & Packaging. 15/1 South Kamalapur. Dhaka. Phones :
J
1
Dhaka Friday May 1 1992
XZ
7.^ / >•
The Morning Sun
15/1, South Kamalapur, Dhaka
Anwdrul Islam Bobby
Defiance is order
of the day
Anwand Islam Bobby
Dr Zafarullah Chowdhury
appears to be the mightiest man
in the country. He intends one
day to become President of
Bangladesh say persons who
'
prefer anonymity as they arc too
scared of his power, his money
In
and his growing base. I..
yesterday’s issue of the Sun
appeared a report which says how
he is frustrating a move by the
government to investigate GanoShasthya Kendra.
Doctor Zafarullah. as it will be
seen, defied all orders to allow the
investigation team set up by the
interim government s Health
Adviser and President BMA Dr
Majcd to visit his plant. The
team headed by Maj General Anis
Wais consisted of the present
DG. Hcalll? and four other senior
officials including a judge. In
spite of regular written
approaches made to visit the
premises at Ganasalhya Kendra
(Savar) excuse after excuse was
made to discourage the team from
doing so. In utter frustration the
investigators advertised in the
press asking for anyone who had
genuine complaints against the
Ganaslhaya to meet the
investigating team. Only a few
who had die guts to complain did
so. The others were loo familiar
with Zafarullah s tactics to come
forward.
.
The complaints varied from
land grab to acquiring a
pharmaceutical firm without
payment and misappropriation of
Defiance is order
funds. The committee being
unable to gel to the books and
physical
inspection
was
convinced that there were many
now.decided to start a private
Contd. from Page 1
things wrong. Since this was an
medical college. Huge salaries arc
papefs which have never been
NGO, like any other NGO the
being offered to job seekers
produced although the ministry
committee recommended that an
which is,another ploy to divert
sends diem letters to do so every
administrator ‘ be appointed
attention and neutralise the
two to three months. Already the
alwngwith a committee which
matter hits been delayed by which
profession.
i
was to include even a labour
The Prime Minister must now
time many loopholes and lapses
representative to replace the
prevail.
and documents may be lost. The
let the rule of la
present trustees.
Chowdhury’s
Z a f a r u 11 a h
Directorate of Social Affairs under
The recommendation and the
has
to
be
organisation
which all NGO's function and are
report of the high powered
investigated on the basis of the
; registered
which have
committee was submitted to the
high powered committees rcjx»rt.
categorically said the law permits
Ministry of Health for immediate
If by chance the Gana Shaslhyas
the lake over of any NGO by the
action. The same committee had
defiant altitude is successful, die
government or suspension of its
also investigated into the affairs
same pattern will be followed by
activities.
of Bangladesh Association of
each
and..ever)' NGO. cooperative.
If the Health Ministry was
..............
Voluntary Sterilisation. Their
really keen to investigate and • bank and industrial organisation,
findings were not only approved
Failure
to replace
the
properly run Ganashasthya
F
,’
‘ .present sei
by the Ministry of Health but
through a new board of • Up a( Gana Shaslhya will only
actions taken on the basis of the
establish that the Khaleda
management it would not delay
findings.
the implementation of •the
government is incapable.
In the case of Gana Shaslhya.
The Health Ministry officials
Committees recommendation by
the petty officials of the Ministry
finding Lime excuses. “Zafarullah ’ who have been delaying this ease
of Health began finding devious
must be taken up with the
Chowdhury a close associate of
means of delaying the whole
harshness they deserve. A few
former President Ershad is still
proers’:. They decid'd the
organised telegrams from abroad
very powerful and has enough
government could not implement ! clout to handle non-decisivc
in favour of the present set up of
the decision of the committee
Gana • Shaslhya should be
governments like the present
unless the clearance of the Law
considered as ’’interference in die
one.** said a former colleague of
Ministry was obtained. For the
internal affairs of our country.
Zafarullah. Zafarullah Chowdhury
Law Ministry to study the case
And besides an enquiry might
who used the guns of. Martial
they needed the terms and
even help clear Dr Zaffarullahs
Law on the shoulders of Prof
conditions and registration deeds
reputation. Why should not the Nurul Islam to gfpducc a dreadful
etc of the Trust.
sponsor donors want an official
Thus the well heeled petty drug polittf^fhal has crippled the
probe ?
Health Ministry officials got tfieir national industrial policy has
opportunity. They wrote to
Ganashasthya for the relevant
Last page col 1________ j
. - government nc spoxe alter
Kabul.
Editor : ANWARUL ISLAM (B
Cholayil Herbal Garden
^0$ < ‘Am VIDA
i
J:•-
•II1
OC.W4
ITUATED ON the Vengal-Seethancheri Road,
near Uthukottai, around
V
SO Km. North of Chen
nai, is Velakapuram, a pictur
esque village of farmers. In this
village is situated a 120 acre
farm called Cholayil Herbal
Garden. On one side of the Gar
den is plain forestland and on
the village side is a 50-acre wa
ter reservoir of the Velakapu
ram village. The lake extends to
the Herbal Garden and about 5
acres of the land is submerged
in it.
A lot of cultivation activity is
going on at the Herbal Garden,
which includes different herbal
plants that are used in the man-
ufacture of various drugs by the
Medimix group. For this pur
pose Tulsi, Datura, Sakralata,
Karpooravalli, Kantakari, No
chi, Vasaka, etc. are being culti
vated
to
cater
to
the
requirements of Medimix.
Apart from this, a number of
medicinal plants are being cul
tivated in small plots, to study
the best cultivation methods to
get better harvests without low
ering the medicinal properties
of the plants. Some of these
plants are Tippali, Vallippala,
Kattarvazha, Lemon grass, Ba
la, Kacholam, Manjal, Iruveli,
Hibiscus, Bhrami, Peppermint
tulsi, Vacha, Aratha, Aswagandha, Adapathian and Musali.
Yet another activity of the
Herbal Garden is the study of
different, rare medicinal plants
which grow in special climatic
conditions, such as Aroota, Arogya Pacha, Ela, etc. For this
purpose, special green houses
have been constructed, where
these plants are grown in pots.
r____________
_ .added to
______species
More
are being
the green house to study their
growth pattern.
The Herbal Garden also
grows a variety of ornamental
plants and vegetables.tThere is
I 0 ■
also a nursery to develop sa
plings of various medicinal
plants. These saplings are kept
in the green house for future
use.
HE HISTORY of ayur
veda began 5000 years
ago in the great Hima
layas, when one of
The Garden is irrigated by greatest sages of India, Srila
four big wells interconnected Vyasadeva wrote the Vedas for
with a drip irrigation system. the first time. He included Ay
Pinna nro afoot to install a urveda (Avur: life and Veda: sci
sprinkling system also for mass ence) or the Science of life as a
part of the vedas. The story goes
cultivation of plants.
that Vyasadeva entrusted the
It is interesting to note that original copies of the texts with
no chemicals or synthetic fertil his enlightened disciples who,
isers are used on the farm. Bio along with other great sages,
fertilisers and bio pesticides are performed a long, sacrificial
used only for medicinal plants ceremony for hundreds of years.
as studies showed that the us During this time, they studied
age of chemical fertilisers and and discussed these ancient
pesticides lowered the medici texts with their own disciples L-Jr
who in turn expanded and de
nal properties of the plants.
veloped these original and eter
An Ayurveda product manu nal truths without changing Kaya
facturer cannot cultivate all the them. After the conclusion of cine),
medicinal herbs used for pro this sacrifice, copies of the Vedic and
duction, at their own farm. The texts were placed in temples bhrit
aim of Herbal Garden is to de and libraries throughout the tantr
velop into a good referential country. These texts, written in (geri£
farm where one can see authen Sanskrit, could be read and un ence
tic,
recognised
medicinal derstood by the general public.
Sir
plants. The intention of the MeAyurveda, the earliest medi
dimix group is to cultivate and cal science on positive health is vedic
mam
grow herbs to meet their exact- a part of the atharvaveda pra<
bapic
ing standards and compare the tised from the vedic perioo.
quality of herbs purchased from Apart from Vyasadeva’s compi be fo
other sources.
lation of hundreds of herbal as a
drugs in the Vedas, there were icine
descriptions of ayurvedic sur comr
geries, later on, by other re nonr
nowned sages like Sushruta, vaidj
Charaka and Kasyapa in their guidi
was around 30 years ago Samhitas. The subjects covered heap
Dr.V.P.Sridhan introduced the included prosthetic surgery to If a
MEDIMIX bath soap to the poor replace limbs, cosmetic surgery, wan*
masses of India as a cost-effective brain surgery and even caesa were
way to prevent skin problems. Us rean section, though they were The
ing 18 powerful herbs in pure co known by different names then. to t
conut oil base Medimix Ayurvedic Archaeological evidence proves spre
Soaps are formulated to protect that some of these operations cour
and nourish skin from ailments in were successfully performed be spre
addition to cleansing it.
tween 3000 and 5000 years ago. tries
The
development of a child lays
Medimix uses herbs like Kutawithin
the womb of the mother gove
ja, Chopchini, Vidangam and
urvedic formulation taken from Jyothishmathi that beautify com was also explained with great kno’
the palm leaf manuscripts of Cho- plexion, Usheeram, Sariba and accuracy by sage Charaka. In ya v
layil family was very effective Dhanyaka that prevent prickly the period between 1000-500 catif
against skin diseases. Dr.V.P.Sid- heat, Guggulu, Devadaru and BC, Ayurveda was divided into devi
ity.
han, an Allopathic Doctor by pro Nimba Twak which are antisep two groups — The school of pl
prat
fession and an Ayurvedic tics. Chitraka and Dharutharidra sicians (Atreya) and The scho.
Physician by tradition, hails from prevent pimples, Vanardraka, of surgeons (Dhanwantari). selv
the famous Vaidya Family "CHO- Krishnajeeraka and Jeeraka are There were six disciples in the
A
LAYIL" of Kerala which is famous for deodorising, while Vacha, Ba- first group and eight in the sec tion
for traditional Ayurvedic Vai- kuchi and Yeshimadhu are for ond. These disciples wrote inst
dyas.
fighting dandruff. Hence Medi books on ayurveda and spread the
It was Dr.V.P.Sidhan who ex mix Ayurvedic Bath Soap acts as knowledge of the system. This Cou
perimented with the above Thai- the real beauty soap, with clean period is known as the Samhita forr
the
lam and made it more user ing properties, antiseptic and an age.
Ayurveda has been divided the
friendly by converting into a Bath tifungal properties but also
c.-- x:----- prickly
into eight schools in Ayurvedic the
Soap. Thus, by the application of functions
effectively
traditional wisdom and knowl heat powder, antiseptic lotion, compendia and they are known low
edge together with the modern pimple cream, deodorant and an as Salyatantra (surgery) Sala- ern
science led to the birth of an Ay ti-dandruff shampoo, providing kyatantra (Otorhino — laryn the
gology including opthalmology, sea
urvedic Bath Soap MEDIMIX. It value for money.
A boon to the common man
GAPS WERE usually considered only as cleaning
agents for quite some
time. Medimix was one of
the first few soaps to break this
myth and add value addition to
the cleaning properties of soap.
Cleaning in a broader sense is re
moving of dirt and grease from
the skin but Medimix Soap with
all its 18 herbal ingredients not'
only cleans but also protects the
skin from harmful bacteria which
cause skin diseases.
Skin diseases are broadly de
scribed as Kushtaroga in Ayurve
da and minor problems of the skin
such as pimples, heat boils, black
pigmentation, boils, dandruff,
etc., are described as Khudrakustas, Mukhadooshika, Rajika,
Vyanga, Visphoda and Daranam.
They are often found vitiated by
the Tridoshakopa of the modem
life style. According to Susrutha
Samhita these skin diseases oc
curs in the seven layers of the
skin. External applications in dif
ferent forms like thailam, lepam,
etc. play a great role in the man
agement of these skin diseases.
A Thailam made from the Ay-
PR
IBB
History of Ayurveda
H B =2.8 II I CD
DRY of ayur.. V '.
-rr
____
doctors have to only do in-depth cepts in Ayurveda is Sankhya
n 5000 years
study and apply their knowl- (the
great Hima(the analytical
analytical study
study of
of the
the eleele
edge practically. It is also im ments that comprise the uni
len one of
portant
to
translate
and
India, Srila
verse). According to Sankhya ,
present our knowledge in a there are twenty-four e’
,he Vedas for
snts,
manner that the layman under of which five are the fot ation
included Aystands.”
ind Veda: sciof the gross world: Earth, Wa
?e of life as a
Philosophy of Ayurveda
ter, Fire, Air and Ether. These
he story goes
Ayurveda believes in the holi five elements, when joined in
ntrusted the
stic philosophy of life and em different combinations, make
he texts with
phasises prevention rather up the tridoshas which consti
sciples who,
than cure of diseases. It states tute the Prakruti or nature of
great sages,
that life is the union of body an individual. When air and
sacrificial r,
ether
combine
or
(sharir), sense organs (indriya), Xl,• .• «, we.-• get Vata
--------1 •
»•
eds of years.
psyche (mana) and soul (atmaj Jhe
biological mode. Vathey studied I
/-■
is that
that . whlc
which
and aims at bringing about a ta 1S
b causes all
ese ancient
X
perfect balance between the movement in and out of the
wn disciples
, ...
body, mind and spirit. Ayurve- bpdy, namely breathing, urinaded and dedefecation,
etc. The
combi
da is based on the theory of tri- tion, '1^
—
------lal and eterNirgundi
dosha or the three biological nation of fire and water gives us
it changing
forces - Vata, Pitta and Kapha. Pitta or the transformative bi
□nclusion of Kayachikits (internal medi- which functioned in the same Diseases arise when there’s im ological mode. Pitta mutates or
cine),
Bhutavidya
(bacteriology
lines as the Indian Council of balance among the tridoshas transforms the outside ele> of the Vedic
in temples and psychiatry), Kaumara- Medical Research. The central ......
------health W
„UWB when
wne[1 ™en.ts
the macrocosm into
and good
follows
bhritya
(paediatrics),
Agadhacouncil was divided into two — there’s harmony among them , e m81c*e elements of the body
ughout the
s, written in tantra (toxicology), Rasayana the Central Council for Re m
’ aim
• of" ayurvedic
’• therapy
•’
The
is‘ (microcosm). Pitta governs the
ead and un- (geriatrics) and Vajikarana (sci search in Ayurveda and Siddha to bring about the required digestion of physical, mental
ence
of
aphrodisiacs).
leral public,
and the Central Council for Re equilibrium.
and emotional elements. Kapha
Since ancient times the Ayur search in Unani, Homoepathy
rliest medior the structive biological mode
In
Ayurvedic
therapy,
an
in
ve health is vedic system has undergone and Yoga. The councils started dividual’s Prakruti or constitu is the combination of earth and
j transformations but the
V11C funding various research pro
'aveda prac- many
water. Kapha is that hich
ICMR. Now there are tion plays a vital role in makes for both lubricat.
idic period. basics of the science continue to Jects
mu
determining the drugs and diet
3va’s compi- be followed. It was first started separate councils for Unani Ho suitable
cus,
synovial
fluid)
and
struc
for him. The argument
J of herbal as a hereditary system of med moeopathy and Yoga. The Insti
ture (bones, muscles, fat, joints
goes
that
when
individuals
dif
comprising
n of Excellence
---------------r
there were icine (parampara system) and tutes
fer vastly in internal constitu etc). It is believed that most
rvedic sur- community practice was the the yentra* Research Institute,
tion
and characteristics, they people are a combination of two
y other re- norm. Each community had a Regional Research Institute should
not be prescribed the modes but there are exceptions.
Sushruta, vaidya, a spiritual leader or and Regional Research Centres same drugs, diet and exercise.
According to ayurveda, this
were
also
started
to
develop
re
_ipa
jr_in their guide
„
who was aware of the
theory identifies not only hu
Ayurveda
relies
on
historical
search
and
jets covered health conditions of its people,
propagate Ayurveman constitution but also ap
family da. These institutes
-----still
L” exist analysis and physical examin plies to animals, vegetables,
surgery to If anyone outside the ^family
ation
done
almost
entirely
by
tic surgery, wanted to study Ayurveda, they °ut not much has been achieved
observation (with the exception plants, herbs, geographical lo
3ven caesa- were admitted lo the Gurukula. by them.
of
pulse reading), to ascertain a cations, seasons of the year, and
i they were The gurus imparted knowledge
person
’s original nature and de everything in the universe. The
Ayurveda
is
now
becoming
sishyas who in turn
amesthen. to their
*’
tect
imbalances.
A diet and constitution, imbalance and the
popular
with
more
and
more
mce proves spread it to various parts of the
various causes of the disease in
herbal
cure
is
then
prescribed each
operations country. From India, Ayurveda people accepting its holistic ap to an individual according
individual is studied into
rformed be- spread to neighbouring coun proach to healing. There are the his/her needs and the im depth to determine the nature
) years ago. tries like Tibet, Sri Lanka, Ma around 168 Ayurveda colleges balance corrected.
of the imbalance whether, Vata,
3f a child laysia and Singapore. But the in India, with Karnataka and
Pitta, or Kapha and medicines
The basis for all other con- prescribed accordingly.
the mother government felt that imparting Maharashtra boasting of the
maximum
number.
There
is
a
. ---------- ----- - - «
with great knowledge from sishya to sish- KT ..
haraka. In ya would affect quality of edu- ^a^onal Institute of Ayurveda
in
Jaipur
Tr‘”' and1 the oldest
,
* univer
1000-500 cation ultimately and wanted to
ivided into device a method to protect qual sity is in Banaras. Post Gradu
mol of phy- ity. So they asked ayurvedic ate studies in Ayurveda started
The school practitioners to register them in the South at the Government
Ayurveda College, Trivandrum.
nwantari). selves.
Through
Ji the years, rapid
pies in the
After Independence, institu
in the sec tional training was started and strides have been made in de
ies wrote institutions were affiliated to veloping Ayurveda. What the
nd spread the University. The Central system needs now is plenty of
stem. This Council of Ayurveda was nurturing to elevate it to a pre- I
e Samhita formed and this body designed mium position and bring it on i
par with modern allopathic |
the syllabus and framework of medicine. As Dr Rajalakshmi, a !
m divided the
-.J ayurvedic course. Now visiting doctor at IMPCOPS J
Ayurvedic there is a standard syllabus fol~
J,
„
Hospital and a practitioner at !•
11
U.S
.
.
___
are known jilowed
by all the states. The gov- her clinic, Arya Vaidya Agency, fi
ery) Sala- ernment of India also
started
also started Triplicane, puts it, “Everything
— laryn- the Central Council for Re- has been discovered in Ayur- i
lalmology, search in Indian Medicine vedic medicine. Students and
Brnhmi
Report of the AIDAN Meeting
at Mumbai, February 10, 2007
1) Agenda
The following agenda was decided for the day.
a. Pre-grants opposition on Moxifloxacin
b. Novartis issue and Mashelkar committee report
c. Cabinet note on drug policy
d. AIDAN manifesto
e. Participation in NHA-2
f. Other issues to be discussed if time permits (pulse polio, anti-rabies
vaccine, etc.)
2) Pre-grants opposition on Moxifloxacin
a) The salient points in the case were reviewed by Ramya of Lawyers’ Collective.
The group was in agreement that it is an important case especially as Moxiflaxacin
was an important second line anti-TB drug. It was confirmed that AIDAN and mfc
would be petitioners for the pre-grant opposition of Moxifloxacin. It was also
confirmed that LOCOSTand DAF-K will also join as co-petitioners. Anurag will
check out with the JSS team for including JSS as one of the petitioners. Mira would
explore with JSA (Ekbal, Amit, Amitava) if ISA would also like to be petitioners, and
to confirm it by the end of February 2007.
b) Anurag will send a note to Ramya detailing the importance of Moxifloxacin as a
second line anti-TB drug and as a public health issue by the end of Feb 2007 - in time
for filing the pre-grant opposition.
c) Ramya will add the point in the petition that “the information provided by Bayer is
not sufficient.”
d) There needs to be a demand for price control on second line TB drugs, and for its
inclusion in the National List of Essential Medicines. It should also be produced by
the public sector companies. In addition, all TB treatment facilities (including DOTS)
should be made available in conjunction with adequate diagnostic facilities.
(put this under price control)
e) Twelve pre-patent grant oppositions on HIV drugs have been filed. In that, one
(Combivir) has been withdrawn by the company, while another (Kaletra gel) has been
rejected. Thailand is in the process of issuing CLs to Kaletra,.
3) Novartis Issue and Mashelkar Committee Report
a) Gopa’s critique of the Mashelkar committee report was circulated. It was also
reported that many sections of the Mashelkar committee report were a direct copy
from
a
paper
published
earlier
in
2006
by
the
IP
Institute, a UK-based industry think tank -.pro-big pharma lobby submissions. An
initial draft of AIDAN’s response was prepared by Naveen. Some modifications were
suggested. He will complete the draft of the AIDAN statement by incorporating these
suggestions and circulate to all by the next week.
b) Press conference on our response to Mashelkar committee being planned in Delhi
for Feb 12, 2007.
c) National Working Group on Patents is compiling various responses against the
Mashelkar committee report. Gopal will send AIDAN’s final statement to them.
d) Gopal will send the AIDAN statement, along with a request asking MPs to raise
the issue in Parliament and to call for a discussion in the budget session. To be sent to
Parliamentary Doctors Forum and other MPs (Gopa to send the e-mail ID of this
group to Gopal). Parliament Standing Committees of the Commerce and Health
Ministries and to other MPs known to CMAI (Joe to be contacted). The statement is
also to be sent to Smt. Jalaja (Jt Sec in MOHFW), Smt. Asha Thomas (Director,
WTO issues in MOHFW) All AIDAN members will also also send the statement to
MPs from their states.
e) Gopal will draft a letter to the Standing Committees on Commerce (Chairperson;
Shri. Murli Manohar Joshi) and Health asking them to call for a meeting to discuss
Mashelkar Committee Report. Mira and Gopa will follow up with them, on our letter.
f) Anurag will draft a personal letter to Soli Sorabjee and Shanti Bhushan on behalf of
AIDAN, expressing our anguish at them supporting Novartis against the Indian
people’s interest.
g) Gopa will send materials on the Mashelkar PIT to Chinu, Gopal and Mira. The
information from the PIT will be put on the AIDAN website.
4. Cabinet Note on Drug Policy
a) Anant will prepare a revised note stating our demands on the drug policy and drug
pricing issue. A more detailed draft is to be used for public education.
b)Chinu will prepare a summarized briefing note for AIDAN’s lawyer on SC case.
c) Gopal to draft a letter to Group of Ministers (GoM) (and follow-up with reminders)
asking for an appointment to present our views on the proposed Pharma Policy.
Members include Sharad Pawar (Chair), Kapil Sibal, M.S.Ahluwalia, Kamal Nath,
Ram Vilas Paswan and Annbumani Ramdoss). All AIDAN members will write to
Paswan with copies to Satwant Reddy (Secy, MOCF) asking for meeting of GoM on
pharma policy issue for presenting our case.
d) Gopa will organize a briefing for MPs on drug issues during the next parliament
session.
e) Other issues of concern to us in the policy, other than drug pricing include clinical
trials, patents and TRIPS, price monitoring of drugs outside price control, availability
of essential medicines, revitalization of PSUs, pharma parks issue, concern over
capacity building of Indian patent officials by the US, mechanisms for approvals
based on rationality and cost-effectiveness of drugs.
5. Other issues
a) Other issues which needs to be taken up by AIDAN: nutraceuticals, its definition,
safety standards and approval mechanisms.
b) TB related issues of concern: branded and generic drugs, combination, pricing,
MDR TB, etc. Gopal will write to DGCI stating that WHO recommendation states
that only drugs with proven bio-availability should be allowed. AIDAN to ask for list
of drugs that were approved for TB, and to ask in how many cases do we have proof
of rtheir bio-availability. AIDAN will write to the Health Minister/Paswan asking
why MDR TB drugs are not under NLEM and under price control.
c) AIDAN will use RTI (to DGCI) asking for approval letters of all new drugs
approvals, rationale for approval and safety warnings on the following drugs:
Becosules, Liv-52, cough syrups, Revitalin and Nimuselide. Anurag to coordinate this
effort.
d) Issue of Independent People’s Tribunal (IPT) on World Bank and task force of
consumer education for safety of food and medicine was also discussed. Anurag will
submit their argument about the deleterious effect of the TB Control and Leprosy
eradication programme funded by the world bank. Suggestions were offered to Chinu
for putting up issues of relevance at the IPT. Mira will do whatever she can to
formally involve some of AIDAN members in the Task Force.
On behalf of AIDAN Chinu will make a presentation during the parallel session on
Access to Essential Drugs during the NHA II. Anurag will give inputs, suggestions to
Chinu, but would not be able to come for the Bhopal NHA II.
6. Next Meeting
The mid-annual meet of AIDAN can be held on 29th June in JSS, Ganiyari,
Chhattisgarh, prior to the MFC mid-annual which is scheduled for 30th Jun and 1st
July 07. The other possibilities for meeting are on the sidelines of NHA-2 in Bhopal
from 23-25 March, 2007 and the drug information meeting being planned in
CENTAD (dates are not finalized).
Participants:
Anant Phadke, SATHI CEHAT
Anurag, JSS
Chinu, LOCOST
Gopa, CENTAD
Gopal, DAF-K
Mira, mfc
Naveen, CHC
Prasanna, AID
Ramya, Lawyer’s Collective
I
‘ All India Drug Action Network (AIDAN)
Towards a people oriented, rational, drug policy!
Tuesday, 13 March 2007
Mr Shanti Bhushan
Senior Counsel and Former Law Minister of India
B-16, Sector 14,
Noida, U.P.
Dear Mr. Bhushan,
An Appeal
Why are we writing to you?
We are writing to you on an issue which is of critical concern, both to present and future generations
of Indians, i.e., of access to essential medicines, which are available and affordable. We are writing
to you particularly as you have served with distinction, as the Law Minister and otherwise, to
represent issues of public interest in the highest court of this land and you have the reputation of
being a public-spirited person.
Our people suffer one of the highest burdens of diseases in the world: every third malnourished child
lives in India, we have the largest number of patients of tuberculosis and diabetes in the world, and
the second highest number of patients with HIV disease. The list could go on. And here is a paradox.
In spite of having one of the largest pharmaceutical sectors in the world providing drugs at the
cheapest prices in the world, we have also the world’s largest population without access to essential
medicines. Medicines are neither available in the public health system nor affordable in the private
health system. Illness and healthcare costs are now one of the biggest reasons for perpetuation of
poverty.
Novartis and Imatinib Mesylate
It has come to our notice that you have decided to represent Novartis in a case, the outcome of which
will not only determine whether thousands of Indians with a particular type of cancer will live or die,
but also all other diseases. This is because Novartis has not only challenged the order of the Patent
Controller, but also section 3(d) of the Patents Act 1970, which ensures that evergreening does not
take place and thereby allows competition and keeps prices of drugs low. The outcome of this case
shall also determine whether people, not only in India, but all over the world, who depend on the
ability of Indian companies’ to provide lower priced generic medicines shall die for want of
affordable medicines. Indian generic companies supply 67% of the drugs in the developing world.
Novartis is a multinational company which was one of the many which fought the South African
government which was doing its duty and trying to save the lives of millions of HIV affected in
South Africa by making drugs available to them. The case was precipitated by the drug companies
refusal to offer drugs at lower prices and the dramatic offer of an Indian company to do so at only
3% of the price charged by the multinationals.
High drug prices do not reflect merely the high costs of R&D. Much of the basic research work that
underlies any new drug development occurs in public funded institutions like the National Institutes
of Health. It was so even with imatinib mesylate the drug which is at the centre of this case, which
Page 1 of 2
Addresses for Correspondence:
Mira Shiva, A-60, Hauz Khas, New Delhi. Tel: 011-26855010, 09810582028. Email: mirashiva@yahoo.com
Gopal Dabade, 57, Tejaswinagar, Dharwad 580002. Tel: 0836-2461722. 09448862270. Email: drdabade@gmail.com
All India Drug Action Network (AIDAN)
Towards a people oriented, rational, drug policy!
myeloid leukaemia which was done at public expense. Even the demonstration of the spectacular
efficacy of this drug specifically in chronic myeloid leukaemia was due to the initiative and
persistence of Dr. Druker of the Oregon Institute of Health Sciences.
How Prices are Determined?
Pharma companies spend more on advertising and promotion, and earn more profits every year than
they spend on R&D. Finally, even in drugs which have long gone out of patent, and whose
development costs have long been recovered drug companies charge artificially high prices. In fact
the lack of connection between drug prices and R.& D costs were admitted by no less than the CEO
of one of the leading Pharma companies in the world, Merck, who said “Price of medicines is not
determined by their research costs. Instead it is determined by their value in preventing and treating
disease. Whether Merck spends $ 500 million or $ 1 billion on developing a medicine, it is the
doctor, the patient, and those paying for our medicines, who will determine their true value." Can
Indian patients decide then that the true value of imatinib mesylate is Rs.8000 per month rather than
Rs. 120,000 being charged by Novartis?
The drug industry's position on both patents and price regulation is completely in line with concern
for ever-increasing profit and lack of concern for the human implications of this unstinted greed for
profit. A great poet of the last century, Pablo Neruda said while speaking of the poet’s duty,” I
determined that the posture within the community and before life should be in a humble way of
taking sides.”
On whose side are you?
On whose side will you stand Mr. Bhushan? On the side of your people and their distress or the
balance sheet of a multinational company? Is the cause you now represent, in line with what you
championed not so remotely in the past? Another illustrious lawyer of this land stood on the side on a
company responsible for one of the worst industrial disasters in history for which thousands have
paid the price. We appeal to you to stop representing Novartis in this vital case and assure you that
your example shall long be remembered by both lawyers and the people of this vast and suffering
nation. In our appeal we are only reminding you of the words of one of the most illustrious lawyers
this country has produced, “There is a higher court than courts of justice and that is the court of
conscience. It supersedes all other courts.” The lawyer was M.K. Gandhi.
Sincerely,
Dr. Mira Shiva
Dr. Anant Phadke
Dr. Gopal Dabade
Mr. Naveen Thomas
Dr. Sathyamala C. 6
Mr. S. Srinivasan
Dr. Anurag Bhargava
zi
Mr. Prasanna Saligram
Mr. Gopakumar
Mr. Siddharth Narraig^W^*^
Ms. Priya Pillai
Ms. Jaya Nair, Udaan +
Mr. Loon Gangte
Mr. Naresh Yadav
Mr. K. K. Abraham
Ms. Rukmini Pillai
Mr. Vinod Bhanu
.
*
A ddresses for Correspon deuce:
Mira Shiva. A-60, Hauz Khas, New Delhi. Tel: 011-26855010, 09810582028. Email: mirashiva@vahoo.com
Copal Dabade. 57. Tejaswinagar. Dharwad 580002. Tel: 0836-2461722. 09448862270. Email: drdabade@gmai I .com
All India Drug Action Network (AIDAN)
Towards a people oriented, rational, drug policy!
Tuesday, 13 March 2007
Mr Soli Sorabjee
Senior Counsel and Former Attorney General of India
Sundarnagar
New Delhi I 10 003
Dear Mr. Sorabjee
An Appeal
Why are we writing to you?
We arc writing to you on an issue which is of critical concern, both to present and future generations
of Indians, i.e., of access to essential medicines, which are available and affordable. We are writing
to you particularly as you have served with distinction, as the Attorney General and otherwise, to
represent issues of public interest in the highest court of this land and you have the reputation of
being a public-spirited person.
Our people suffer one of the highest burdens of diseases in the world: every third malnourished child
lives in India, we have the largest number of patients of tuberculosis and diabetes in the world, and
the second highest number of patients with HIV disease. The list could go on. And here is a paradox.
Inspite of having one of the largest pharmaceutical sectors in the world providing drugs at the
cheapest prices in the world, we have also the world's largest population without access to essential
medicines. Medicines are neither available in the public health system nor affordable in the private
health system. Illness and healthcare costs are now one of the biggest reasons for perpetuation of
poverty.
Novartis andImatinih Mesylate
It has come to our notice that you have decided to represent Novartis in a case, the outcome of which
will not only determine whether thousands of Indians with a particular type of cancer will live or die,
but also all other diseases. This is because Novartis has not only challenged the order of the Patent
Controller, but also section 3(d) of the Patents Act 1970, which ensures that evergreening does not
take place and thereby allows competition and keeps prices of drugs low. The outcome of this case
shall also determine whether people, not only in India, but all over the world, who depend on the
ability of Indian companies’ to provide lower priced generic medicines shall die for want of
affordable medicines. Indian generic companies supply 67% of the drugs in the developing world.
Novartis is a multinational company which was one of the many which fought the South African
government which was doing its duty and trying to save the lives of millions of HIV affected in
South Africa by making drugs available to them. The case was precipitated by the drug companies
refusal to offer drugs at lower prices and the dramatic offer of an Indian company to do so at only
3% of the price charged by the multinationals.
High drug prices do not reflect merely the high costs of R&D. Much of the basic research work that
underlies any new drug development occurs in public funded institutions like the National Institutes
of Health. It was so even with imatinib mesylate the drug which is at the centre of this case, which
Addresses for Correspondence:
Mira Shiva. A-60. Hauz Khas. New Delhi. Tel: 01 1-26855010. 09810582028. Email: niira^v^yaho^eorn
Gopal Dabade. 57. Tejaswinagar, Dharwad 580002. l ei: 0836-2461722. 09448862270. Email: drdabadeCa-gmaiIxom
Ali India Drug Action Network (AIDAN)
Towards a people oriented, rational, drug policy!
would never have been developed but for work on the chromosomal abnormality underlying chronic
myeloid leukaemia which was done at public expense. Even the demonstration of the spectacular
efficacy of this drug specifically in chronic myeloid leukaemia was due to the initiative and
persistence of Dr. Druker of the Oregon Institute of Health Sciences.
How Prices are Deiermined?
Pharma companies spend more on advertising and promotion, and earn more profits every year than
they spend on R&D. Finally, even in drugs which have long gone out of patent, and whose
development costs have long been recovered drug companies charge artificially high prices. In fact
the lack of connection between drug prices and R& D costs were admitted by no less than the CEO
of one of the leading Pharma companies in the world, Merck, who said “Price of medicines is not
determined by their research costs. Instead it is determined by their value in preventing and treating
disease. Whether Merck spends $ 500 million or $ 1 billion on developing a medicine, it is the
doctor, the patient, and those paying for our medicines, who will determine their true value.” Can
Indian patients decide then that the true value of imatinib mesylate is Rs.8000 per month rather than
Rs. 120.000 being charged by Novartis?
The drug industry's position on both patents and price regulation is completely in line with concern
for ever-increasing profit and lack of concern for the human implications of this unstinted greed for
profit. A great poet of the last century, Pablo Neruda said while speaking of the poet’s duty,” I
determined that the posture within the community and before life should be in a humble way of
taking sides.”
On whose side are you?
On whose side will you stand Mr. Sorabjee? On the side of your people and their distress or the
balance sheet of a multinational company? Is the cause you now represent, in line with what you
championed not so remotely in the past? Another illustrious lawyer of this land stood on the side on a
company responsible for one of the worst industrial disasters in history for which thousands have
paid the price. We appeal to you to stop representing Novartis in this vital case and assure you that
your example shall long be remembered by both lawyers and the people of this vast and suffering
nation. In our appeal we are only reminding you of the words of one of the most illustrious lawyers
this country has produced, “There is a higher court than courts of justice and that is the court of
conscience, it supersedes all other courts.” The lawyer was M.K. Gandhi.
Sincerely,
Dr. Mira Shiva
Dr. Anant Phadke
Dr. Salhyamala C.
Mr. S. Srinivasan
Dr. Anurag Bhargava
Mr. Prasanna Saligram
Mr. Gopakumar
Mr. Siddharth Narrain
Mr. Vinod Bhanu
Dr. Gopal Dabade
Mr. Naveen Thomas
Ms. Priya Pillai
Ms. Jaya Nair. Udaan+
Mr. Loon Gangte
Mr. Naresh Yadav
Mr. K. K. Abraham
Ms. Rukmini Pillai
(MU
Addresses for Correspondence:
Mira Shiva. A-60. Hauz Khas. New Delhi. Tel: 011-26855010. 09810582028. Email: mirashivaffiyahoo.com
Gopal Dabade. 57. Tejaswinagar, Dharwad 580002. Tel: 0836-2461722, 09448862270. Email: drdabadeffigmail.com
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— Original Message----From: Gopal Dabade
To: Anant Phadke
Cc: sahajbrc ; Naveen ; sathya mala ; anurag ; Ramya Sheshadri; mirashiva@yahoo.com ; gopa
kumar; Bhargava Anurag ; Prasanna Saligram
Sent: Sunday, February 18, 2007 9:02 PM
Subject: Re: Proceedings_AIDAN_10Feb07
Dear all,
Thanks to Naveen.
I have incorporated the inputs both by Chinu and Anant. Thanks to you both.
Pl find attached the corrected version.
I spoke to Naveen and asked him if we discussed about the next AIDAN meet. Is it
Bhopal? If so do we mention it? I may not be able to make it to bhopal.
Also in addition I need some clarification regarding minutes.
I am not able to recollect what exactly was discussed under:b) TB related issues of concern: branded and generic drugs, combination, pricing,
MDR TB, etc. Gopal will write to DGCI stating that WHO recommendation states
that only drugs with proven bio-availability should be allowed. AIDAN to ask for list
of drugs that were approved for TB, and to ask in how many cases do we have proof
of their bio-availability. AIDAN will write to the Health Minister/Paswan asking why
MDR TB drugs are not under NLEM and under price control.
I remember verz vaguely that Anant and Anurag made some comments on
bioavailabilty. But I am not able to get exactly as to what descion we arrived at (I was
in a hurry to catch the bus). Can any one of you clarify?
Best wishes
GOPAL
On 2/18/07, Anant Phadke <amoljp@vsnl.com> wrote:
Dear all,
Thanks to Navin for his timely efforts.
In the attached file, I have added a few points which were missed. My additions have
been highlighted in yellow.
With Warm Regards,
Sincerely Yours,
Anant Phadke
— Original Message---From: sahajbrc .
To: Naveen ; Anant Phadke ; sathya mala ; Gopal Dabade ; anurag ; Ramya Sheshadri;
mirashiva@vahoo.com
Cc: gopa kumar; Bhargava Anurag ; Prasanna Saligram
Sent: Friday, February 16, 2007 1:24 PM
Subject: Proceed!ngs_AIDAN_10Feb07
Naveen,
Attaching my corrections in track changes.
Chinu
Report of the AIDAN Meeting
at Mumbai, February 10, 2007
1) Agenda
The following agenda was decided for the day.
a. Pre-grants opposition on Moxifloxacin
b. Novartis issue and Mashelkar committee report
c. Cabinet note on drug policy
d. AIDAN manifesto
e. Participation in NHA-2
f. Other issues to be discussed if time permits (pulse polio, anti-rabies
vaccine, etc.)
2) Pre-grants opposition on Moxifloxacin
a) The salient points in the case were reviewed by Ramya of Lawyers’ Collective.
The group was in agreement that it is an important case especially as Moxiflaxacin
was an important second line anti-TB drug. It was confirmed that AIDAN and mfc
would be petitioners for the pre-grant opposition of Moxifloxacin. It was also
confirmed that LOCOSTand DAF-K will also join as co-petitioners. Anurag will
check out with the JSS team for including JSS as one of the petitioners. Mira would
explore with JSA (Ekbal, Amit, Amitava) if JSA would also like to be petitioners, and
to confirm it by the end of February 2007.
b) Anurag will send a note to Ramya detailing the importance of Moxifloxacin as a
second line anti-TB drug and as a public health issue by the end of Feb 2007 - in time
for filing the pre-grant opposition.
c) Ramya will add the point in the petition that “the information provided by Bayer is
not sufficient.”
d) There needs to be a demand for price control on second line TB drugs, and for its
inclusion in the National List of Essential Medicines. It should also be produced by
the public sector companies. In addition, all TB treatment facilities (including DOTS)
should be made available in conjunction with adequate diagnostic facilities.
(put this under price control)
e) Twelve pre-patent grant oppositions on HIV drugs have been filed. In that, one
(Combivir) has been withdrawn by the company£while another (Kaletra gel) has been/ C
rejected. Thailand is in the process of issuing CLs to Kaletra,.
3) Novartis Issue and Mashelkar Committee Report
a) Gopa’s critique of the Mashelkar committee report was circulated. It was also
reported that many sections of the Mashelkar committee report were a direct copy
from
a
paper
published
earlier
in
2006
by
the
IP
Institute, a UK-based industry think tank -.pro-big pharma lobby submissions. An
initial draft of AIDAN’s response was prepared by Naveen. Some modifications were
suggested. He will complete the draft of the AIDAN statement by incorporating these
suggestions and circulate to all by the next week.
b) Press conference on our response to Mashelkar committee being planned in Delhi
for Feb 12,2007.
c) National Working Group on Patents is compiling various responses against the
Mashelkar committee report. Gopal will send AIDAN’s final statement to them.
d) Gopal will send the AIDAN statement, along with a request asking MPs to raise
the issue in Parliament and to call for a discussion in the budget session. To be sent to
Parliamentary Doctors Forum and other MPs (Gopa to send the e-mail ID of this
group to Gopal). Parliament Standing Committees of the Commerce and Health
Ministries and to other MPs known to CMAI (Joe to be contacted). The statement is
also to be sent to Smt. Jalaja (Jt Sec in MOHFW), Smt. Asha Thomas (Director,
WTO issues in MOHFW) All AIDAN members will also also send the statement to
MPs from their states.
e) Gopal will draft a letter to the Standing Committees on Commerce (Chairperson;
Shri. Murli Manohar Joshi) and Health asking them to call for a meeting to discuss
Mashelkar Committee Report. Mira and Gopa will follow up with them, on our letter.
f) Anurag will draft a personal letter to Soli Sorabjee and Shanti Bhushan on behalf of
AIDAN, expressing our anguish at them supporting Novartis against the Indian
people’s interest.
g) Gopa will send materials on the Mashelkar PIL to Chinu, Gopal and Mira. The
information from the PIL will be put on the AIDAN website.
4. Cabinet Note on Drug Policy
a) Anant will prepare a revised note stating our demands on the drug policy and drug
pricing issue. A more detailed draft is to be used for public education.
b)Chinu will prepare a summarized briefing note for AIDAN’s lawyer on SC case.
c) Gopal to draft a letter to Group of Ministers (GoM) (and follow-up with reminders)
asking for an appointment to present our views on the proposed Pharma Policy.
Members include Sharad Pawar (Chair), Kapil Sibal, M.S.Ahluwalia, Kamal Nath,
Ram Vilas Paswan and Annbumani Ramdoss). All AIDAN members will write to
Paswan with copies to Satwant Reddy (Secy, MOCF) asking for meeting of GoM on
pharma policy issue for presenting our case.
d) Gopa will organize a briefing for MPs on drug issues during the next parliament
session.
e) Other issues of concern to us in the policy, other than drug pricing include clinical
trials, patents and TRIPS, price monitoring of drugs outside price control, availability
of essential medicines, revitalization of PSUs, pharma parks issue, concern over
capacity building of Indian patent officials by the US, mechanisms for approvals
based on rationality and cost-effectiveness of drugs.
5. Other issues
a) Other issues which needs to be taken up by AIDAN: nutraceuticals, its definition,
safety standards and approval mechanisms.
b) TB related issues of concern: branded and generic drugs, combination, pricing,
MDR TB, etc. Gopal will write to DGCI stating that WHO recommendation states
that only drugs with proven bio-availability should be allowed. AIDAN to ask for list
of drugs that were approved for TB, and to ask in how many cases do we have proof
of rtheir bio-availability. AIDAN will write to the Health Minister/Paswan asking
why MDR TB drugs are not under NLEM and under price control.
c) AIDAN will use RTI (to DGCI) asking for approval letters of all new drugs
approvals, rationale for approval and safety warnings on the following drugs:
Becosules, Liv-52, cough syrups, Revitalin and Nimuselide. Anurag to coordinate this
effort.
d) Issue of Independent People’s Tribunal (IPT) on World Bank and task force of
consumer education for safety of food and medicine was also discussed. Anurag will
submit their argument about the deleterious effect of the TB Control and Leprosy
eradication programme funded by the world bank. Suggestions were offered to Chinu
for putting up issues of relevance at the IPT. Mira will do whatever she can to
formally involve some of AIDAN members in the Task Force.
On behalf of AIDAN Chinu will make a presentation during the parallel session on
Access to Essential Drugs during the NHA II. Anurag will give inputs, suggestions to
Chinu, but would not be able to come for the Bhopal NHA II.
6. Next Meeting
The mid-annual meet of AIDAN can be held on 29th June in JSS, Ganiyari,
Chhattisgarh, prior to the MFC mid-annual which is scheduled for 30th Jun and 1st
July 07. The other possibilities for meeting are on the sidelines of NHA-2 in Bhopal
from 23-25 March, 2007 and the drug information meeting being planned in
CENTAD (dates are not finalized).
Participants:
Anant Phadke, SATHI CEHAT
Anurag, JSS
Chinu, LOCOST
Gopa, CENTAD
Gopal, DAF-K
Mira, mfc
Naveen, CHC
Prasanna, AID
Ramya, Lawyer’s Collective
ALL INDIA DRUG ACTION NETWORK
C-14 COMMUNITY CENTRE S. D. A. NEW DELHI 110016
PEHAPP-1 (1)
May 9, 1991
Deir Friends,
BAILED DRUGS
Another list of drugs that have been banned are being sent to you as
per the information received from Dr.Prem Kumar Gupta in his communication
dated 24th April 1991.
Th= notification number is No.X 11014/4/90 DMS & PFA dated 13th February
1°-1, as published in the Gazette of India under GSR No.69 (E) dated
llzh February 1991, prohibiting the sale of 10 additional combinations
of drugs.
Since LOCOST had worked on cough syrups I will request them to please
draw up the banned brands and manufacturers list of category 36, 39 and 40.
If DAFWB could do the listing for category 35,37 & 42 i.e. related to
anci-diarrhoeals, it would be a great help. I will be working on this
myself. 33,34,38,41, I will request Dr.Rane of Arogya Dakshata Mandal.
Dortors from Udaipur Medical College had been requested to compile the
list of brands and manufactures of the previous list. If the list can
be got ready by 24th of May and be made available it would be very
useful tying it up with Dr. Olle Hansson’s Day.
DT..9LLE HANSSQNS DAY - ANTI HAZARDOUS DRUGS DAY
XfTb
Since some brands of Chloramphenicol Streptomycin combinations and Steroid
Coubinations are still in the market inspite of their being banned and
since DAFWB, ACASH had been involved so intensely in the campaign against
Chloramphenicol Streptomycin it would be only correct to highlight the
status of the ban and also highlight the role of other hazardous anti
diarrhoeals. Diarrhoeal diseases are a major killer and the seasonability
of the disease (i.e. summer and monsoon) is well known. Focussing on
n Wanzidiarrhoeals would be very worth while in view of our past experience
wich Rational Diarrhoea Care work and AIDAN’s ongoing campaign against
irrational anti diarrhoeals. I am enclosing an article from Lancet,WHO
bosk review and HAI Press Release on the book Irrational Antibiotics
used in diarrhoea care. Focus on anti mortality drugs eg. Lomotil,
Loseramide, need for standardization of ORS packets.
..2..
2
Information material on antidoarrhoeas':
Rationality study of antidiarrhoeals
MFC
Handouts on irrational antidiarrhoeals
Taste of Tears
VHAI
Chloramphenicol Streptomycin campaign
DAFWB in Drug Disease Doctor
Antidiarrhoeals
HAI
Rational Diarrhoea Care
WHO
I.V. Contamination report
VHAI
Trans Jamuna Cholera epidemic report
Mahamari Janch Samiti
Incide Ciba Geigy
Dr. Olle Hansson
WOMEN AND PHARMACEUTICALS
The Supreme Court case on Net En trials is still going on trials of Nor
Plant, Long Acting Injectable Contraceptives are going, as are on RU 486
i.e. the Abortion Pill. Background information on these as well as
Centchromon researched by CDRI i.e. the weekly pill is enclosed.
A workshop to discuss some of these would be required of drug activists,
health activists, women activists and women health activists, to under
stand the various issues involved and take a collective stand as we did
for EP.
RATIONAL TB CARE
There is a strong feeling amongst those involved in health work in Bihar,
Madhya Pradesh and Rajasthan in TB Care that the incidence, incertain
parts is definately increasing. While diagnostic and treatment facilities
are lacking in certain areas, there seems to be circumstantial evidence
that patients are not responding to the drugs available, how much of
it is due to default or to substandard nature of drugs and how much due
to emergence of drug resistance.
The adverse drug reactions due to anti TB drugs are not being adequately
monitored. According to Dr. Kabra the incidence of toxic hepatitis as
adverse drug reaction to Rifampicin is fairly significant. Patients being
stastarted on Rifampicin must be given a warning to return immediately in
case of any such problem.. Some of us in’MFC and VHAI have in the past have
been involved^i^-TB-prografflmes-aRd-TB-work—There-is a need to review
some of our experience, review of literature etc. (TB enthusiasts—Dr.Ullhas
Jajoo, Binayek Sen, Mira Sadgopal, Thelma & Ravi Narayan, Sita of NTI had
been associated with TB work in the past. Since the.problem in different
areas is definitely worse and there are no new anti TB drugs on the horizon
we need to take stock at least in our own areas of work.
3
3
DR. ARUN BAL REINSTATED
You all would be very happy to known that Dr. Arun Bal of ACASH who was
facing tremendous- probTems“re^rliljig^is“job^froni“his^employee^ on the
behest of the drug companies ha$ been instated. For all the tremendous
work Dr. Arun Bal has done regarding the drugs issue especially related
to Analgin everyone in AIDAN is extremely proud.
AMNOCENTESIS BILL
A copy of the bill had been sent to you all and you must have seen that
a 5 year period behind bars and Rs. 25,000 fine is being proposed as
punishment for the WOMAN undergoing amnocentesis by the member presenting
the bill. The Maharashtra Bill had Rs. 50 fine. In principle, every
one agrees that the WOMEN undergoing amnocentesis for sex determination
tests is a victim of social discrimination and further victimizing her
and punishing her is not just, as the real perpetuators of this discrimination go scot free.
Let us against hope that the election brings to power those who can
demonstrate at least some concern for the people.
With warm regards,
Yours sincerely,
i
Dr. J4ira Shiva ND
H^id, Public Policy &
Coordinator,Low Cost Drugs &
Rational Therapeutics
•■
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REGISTERED NO. D. (D.N.) 1Z7<
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EXTRAORDINARY,
OTT H—3—(i)
PART II—Section 3—Sub-section (i)
MITU4)I<
ycbllSfcr
PUBLISHED BY AUTHORITY
13, 1691/RH 2 4, 1912
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NEW DELHI, WEDNESDAY, FEBRUARY 13, 1991/MAGHA 24,5912
No. 59]
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THE GAZETTE OF INDIA : EXTRAORDINARY
2
r
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7
38. 3<iWnkmt^ mx rn^/qrrfer^
«
Fixed dose combination of Etharnbutol with
4NH-otheF than-the following :
40.
- - „
—Vzr srtm
T=rT H
STihfTH
rW
5fTT/^T ^Ts
'<•
fitHIcIMl
41. ^fr OXH
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fa fen
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1
vfr
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h
Km
45 KW
mnfc jT mrpPT *
Kfi t^r l"
4
sh -rsrras n *
- feu™-**.
■‘TI75 *
1984
Fixed dose combination of Salbutamol or
any other bronchodilator with centrally
acting anti-tussive andior a antihistamine.
37.
Fixed dose combination of laxatives and’or
anti-spasmodic drugs in enzyme prepara
tions.
38.
Fixed uose combination of Metoclopramide
with other drugs except for preparations
containing metoclopramide and aspirinl
paracetamol.
39.
Fixed dose combination of Centrally acting,
anti-tussive wih antihistamine having high
atropine like activity in expectorant".
40.
Preparations claiming to combat cough
rssociatcd with asthma containing centrally
acting anti-tussive and'or an antihistamine.
11.
Liquid oral tonic preparations containing
glycerophosphates andjor other phosphates
□nd;or central nervous system stimulant and
such preparations containing alcohol more
than 20* proof.
Fixed dose combination containing Pectin
and'or Kaolin with any drug which is^
systemically absorbed from G1 tract excen^
for combinations of Pectin and or Kaolin
with drugs not systemically absorbed”.
5. *n. WT fit
ministry OF HEALTH & FAMILY
WELFARE
NOTIFICATION
New Delhi, the 11th February, 1591
G.S.R. 69(E).—Whereas the Central Government
is satisfied that the use of the drugs specified in me
Table bllow are likely to involve risk to human
beings or purported to be claimed for them or con
tain ingredients and in such quantity for which
there is no therapeutic justification and is neces>a y
and expedient in the public interest so to do ,
Now, therefore, io exercise of the powers confeirtd
by section 26-A ot the Drugs and Cosmetics Act,
1940 (23 of 1940), the Central Government hereby
makes the following further amendment ir. the notifi
cation of the Government of India in the Ministry
of Health and Family Welfare, No. G.S.R. 578iE),
dated the 23rd July, 1983 namely •—
In the Table appended to the said notification,
after serial No. 32 and the entries relating thereto
containing more
36.
(«) fimr 3 Kt 1984
(Department of Health)
800 mg.
Fixed
FixeJ dose combination of anthelmintic
with cathetric purgative except for pirerazine.
2. in- wn. fit- w 322 (
fw. W. 863 (W)
S'1984
3- wt
..........
•CT. fKW 700 (K) feW ISKH, 1988
4 ’U...........
i99ocjra
(st) rs*li4* 26 E........
300 mg.
35.
57K1'’1
!.
600 mg.
Fixed dose combination
than one antihistamine.
4r
*»
n^-11014(4]90-fr
200 mg.
34.
i
ii 20 fen
•q
Etharnbutol
INH
I
7TTSI
_______________ s
entries shall be
sdH-
fowlin’
?r
-----39.-eadct!KS- H
—■_
the following senal- numbers and
added, namely :—
“33.
i
[Part II—Sec. 3(i)1
42.
[No. X. 11014,4l90-DMS & PFA]
BALBTR SINGH. It. Secy.
FOOT NOTE:
The Principal notification was published in the
Gazette of India vide G.S.R. No. 578(E),
dated 23-7-1983 and subsequently amended
by
1.
2.
3.
4.
5.
G.S.R No. 49(E). dated 31-1-1984.
G S.R. No. 322(E), dated 3-5-1984
G.S.R. No. 863(E), dated 22-11-1984.
G.S.R. No. 700(E), dated 15-6-1988.
(E), dated 26-12-1990.
G.S.R. No.
Printed by the Manager, Govt, of India Preta, Ring Road, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054, 1991
15th February 1991
teaith Action international
HAI- Europe
Jacob van Lennepkade SS4 T
1053 NJ Amsterdam
------------- The Netberiands
teh + 31 (0) 20 OSS 36 S4
fex: + 31 (0) 20 6S5 50 02
telex: luxemburg
(+402) 6105915 gmaiu
l-y.
NO JUSTIFICATION FOR CONTINUED PRODUCTION AND SALE
OF ANTIDIARRHOEALS FOR CHILDREN, states new WHO report
The World Health Organization has just published a report, The rational use of drugs
in the management of acute diarrhoea in children, which critically reviews the
evidence on effectiveness and safety of the drugs most commonly used for childhood
diarrhoea. "...Studies of current patterns of diarrhoea treatment have shown that a
large number of pharmaceutical agents of dubious efficacy and potential toxicity are
widely used/ states the report Health and consumer groups who are campaigning
against inappropriate drug treatment for diarrhoea welcome the ciear, concise
information in this report
Approximately 4 million children under 5 years of age die each year as a result of
diarrhoea. Over half of these deaths could be prevented by a simple, but highly
effeaive therapy — oral rehydration therapy (ORT). As long as inappropriate drugs are
marketed for the treatment of childhood diarrhoea, children who could be helped by
ORT will receive useless and often harmful drugs instead. These drugs have an
indirect as well as a direct toll on children's lives; where resources are scarce, money
spent on drugs is unavailable for food and other basic necessities. Drug treatment is
only needed in approximately 5% of cases of childhood diarrhoea- antibiotics for
diarrhoea caused by dysentery or cholera, and antiparasitics tor amoebiasis or
giardiasis.
The WHO report concludes that there is no justification for continued production and
sale of the following antidiarrhoeals for children:
• diphenoxylate, an anti-motility drug which has been associated with sev^^e
central nervous system toxicity.
• loperamide, an anti-motility drug. Following reports of fatal side effects in intants
and young children, the maior manufacturer has withdrawn the drop formulation.
However, liquid and syrup formulations are still in use in some areas.
• streptomycin, an antibiotic which is widely used in spite of its ineftectiveness in
the treatment of any diarrhoea, regardless of its cause.
• neomycin, an antibiotic contained in many anti-diarrhoeal preparations. It is
ineffective in treating all forms of diarrhoea and may actually prolong episodes.
• halogenated hydroxyquinolines, which can cause severe neurological disorders.
They are ineffective for routine diarrhoea. More effective treatments exist for
amoebiasis.
• non—absorbable sulphonamides, or systemically absorbed sulphonamides other
than co-trimazole.
• adsorbents such as kaolin and pectin combinations, activated charcoal, and
attapulgite and smectite which do not prevent fluid and elecuolyte loss from
diarrhoea and can interfere with antibiotic effectiveness.
<--------Following pressure from the medical profession and consumer organizations, specific
products nave been withdrawn from the market Examples are the withdrawal of
Imodium drops by Janssen and Upjohn's recent announcement of an 18 month
phased withdrawal of Kaomycin. However, gradual product-by-product withdrawal is
not enough. National regulatory authorities should adopt measures which fully reflect
conclusions of the WHO report The paediatric formulations of all of the products
listed above should be de-registered immediately and removed from the market
The rational use of drugs in the management of acute diarrhoea in children is a
thorough review of the medical literature which cites over 300 references. Copies are
available from WHO Distribution and Sales, 1211 Geneva 27, Switzerland.
(price SwFr 14 or SwFr 9.80 in developing countries)
HLMTH ACTION INTIXXATZOXAL IS AN INFORMAL NETWORK OF SOME 100 CONSUMER. UEALDL DEVELOPMENT ACTION AND OTHER PUBLIC INTEREST
GROUPS INVOLVED IN HEALTH AND PHARMACEUTICAL ISSUES IN 60 COUNTRIES AROUND THZ WORLD. HAI ACTIVELY PROMOTES A MORE RATIONAL USE OF DRUGS
ALL DRUGS MARXZTID SHOULD MT FT JUAL MEDICAL NEEDS. HAVE THERAPEUTIC ADVANTAGES. BE ACCEPTABLY SAFE AND OFFER VALUE FOR MONEY
CXb«r CDW<MAXieg HAI aAcflC
KA1 arwtafWam/Acto W Uotul Dr^> for AMa CAXDA) €/• IOCUPO k* ICKS 10C3O PmMg Malin* tet • (CO4) mW6 fca: • («M) 566306 trkx MA 40164 apocr
a. -.-Hl—1
T%-
vunpl A- •
7
1
WORLD HEALTH ORGANIZATION
PUBLICATION'S ■'
NEW BOOK ANNOUNCEMENT
Ths Rational Use of Drugs ' This statement is then substantiated through a
■ thorough renew of data on antidiarrhoeal drugs
in the Management of Acute widely used in paediatric practice. These in
clude two antimotility drugs (diphenoxylate
Diarrhoea in Children
hydrochloride and loperamide), four antimicro
bial agents (neomycin, streptomycin, hvdroxquinoiines and nonabsorbable sulfonamides), and
five adsorbents (kaolin and pectin, activated
charcoal, attapulgite and smectite). For each, the
book provides a critical evaluation of experi
This ciear, authoritative, objective and well-ref mental and clinical data on pharmacology, mecha
erenced book provides information essential to nism of action, efficacy, adverse effects, and
those concerned with improving the rational drug interactions. Criteria for evaluating effiuse of drugs in the management of acute diar- cacy center on the ability to reduce stool water
rhoea in infants and young children and with ; an^ electrolyte losses.
tackling the immense problems posed by the [
prescribing of clinically useless and potentially | Dn the basis of this review, the book concludes
dangerous drugs. Noting that diarrhoeal dis- |
none of these preparations has any docueases continue to claim some 4 million young ! mcnted benefits, some actually prolong diarlives each year, the book gathers the informa- 1 rhoea, and others have been shown to' produce
lion needed toargue against the widespread use severe and, in some cases, fatal side-effects. The'
of medicines that have no established clinical book further concludes that the continued pro
benefits, are frequently harmful, and — most duction, promotion, and sale of these preparaimportantly — may delay or replace effective tions for paediatric practice cannot be justified.
'.990, iv 71 pages (avaiiabie in English; Frer.cn and
Scamsn in precaraticn)
.ISBN 92 4 156142 4
Sw.fr. 14-:USS12.60
In aeveiODing countries: Sw.fr. 9.E0
Orcer no. 1150255
treatment measures. The book also responds to
the problem of antibiotic resistance and the cor- ; Drafted by officials in the WHO Diarrhoeal
responding need to curtail the unnecessary'
unnecessary1 ' Disease Control Programme, and checked for
widespread use of antimicrobial medications.
accuracy by an international group of experts,
■ the book presents information of vita! imporDrugs judged effective are dealt with concisely tance to the sound and effective management of
in a table listing four first-choice antimicrobials, ; acu
acute
^e diarrhoea in children. Its clear and auand six alternatives, useful in the management thoritative advice should prove useful to paeof cholera, shigella dysentery, amoebiasis, and ' diatricians, pharmacists, and teachers 0: medigiardiasis. Apart from these cases of specific ' ca^ students and nurses as well as to orncials in
—--->------—.-J-. 1---- 1 • j national diarrhoeal disease control programmes.
etiology,
readers
are-----------informedj that antidiarrhoeal
drugs and antiemetics should never be used for |
children, as none has any proven practical value
See reverse for more information
and some are frankly dangerous.
WHO •
Distribution
and
Sales
•
1211
Geneva
27
•
Switzerland
-
...
VOL 337: JAN 19.1991
THE LANCET
169
Medicine and the Law
slight change in stool consistency, and thee is no evidence chat they
can reduce the severity or duration of diarrhoeal illness. They can
also inter:ere with the etf.cacy of andbioocs when these are needed.
The same is true for acavated charcoal, which has the additional
Compulsion in DNA paternity tests
disadvantage of binding digestive enzymes and micronutrients.
Attapulgite and smectite likewise have no antidiarrhoeal activity
DNA rir.grrpmzng can establish paternity beyond
•and should not be used in children.
The book offers objective scientific assessments of drugs that
statistical douh:. buz reluctant putative fathers who refuse to * *
have been grossly overrated and are widely misused. It will be
. donate blood fo =e purpose cannot be compelled to do so.
important everywhere, bur vitally so in dev doping countries, where
In England,T- ur ±e Family Law Reform Act 1987, me
heakh workers, drug seders, pharmaceutical companies, and
courc may din : me taking of a blood sample, but not
regulatory omcals should implement its conclusions without delay.
without consezL naw-ver, in the event of non-cooperation
“the court may cr*w such inferences from that fact as ...
1. The nacmi me of drufj in de earagtment of xinr durrtma m diudrm. Gom;
appear proper”. Nzc so in Scotland.
An acemp: m xe remr Sheriff Court to obtain a decla rarion that
a named man was me nmer of an illegitimate failed. Tne woman’s
lawyer sough: a rocrx creer mat the man should attend for a DNA
fingerpnnnng res: a: me ceparcnent of forensic medicine,
Royal Innrmary. n sc rnerr to establish the paternity of the cfolfo
Tie motion was renseti is mat court and on appeal An appeal to
foe Scottish Cour: a: .'xronon also failed, despite a plea that me court
should not cmy mdr me advantage of considering any real
endence which moGero szer.ce could make available”. The Court
of Session oiose r.vea: to follow the 1958 decision in Whitmail v
^"nitenalL Lord
said that to compel a party’ to uugaoon to
be subjected x c
procedure to provide material on wxch
foe opposite parry ncoes to build up a case “offends foe pnnepie of
fairness on wtii~ Scmnsn law is based". “... the avil courts m
Scotland cave co row er to order anyone of full age and rorrarrry to
supply a sample cf trooc against his wiH". So the use of DNA tots
in evil proerrm-p ocrootis on consent to samples bemg
Scotland has co sneutmy provision allowing conclusions to be
drawn fom a refosal to provide a biood sample in paternity suits.
This earnest destit to ce enr to a defendant does seem to be bemg
achieved ax the expense of me child. (IfDNA tests could be done on
saliva, would fon too oe too much to ask of an individual?) The bw
in Scotland is lixrrr a pc brought into line with that in England,
since the Scocrah Law Commission has recommended a rhangr
Tome r T umer. C*r sf Semen, June 26,1990 (Lords Mayfidd, Cipt«i
and Cameron of Lomoqeu Sou Loa Tuna 718.
Diana Brahams
Noticeboard
Antidiarrhoeal drjgs (not) for children
In developing cwmc^es acute diarrhoea is a I fading cause of deadi
in children under 5 ye» of age, and in addition it aggravates
undemutnoon and r .^.-ivAjses to death from other diseases. The
essentials of raxxxui masagmient are the prevenDon and treatment
of dehydraoon wnz era; rehydratjoa solution, adequate feedmg
durmg and after ssrrooea. and the judicious use of annbxxics for
cholera and dysesxrv. Yer ansdiarrhoeal drugs of dubious efficacy,
some of them es-m harmfol. cocitinue to be used on a vast yalr The
VTorid Heal± Orp.-w. ix: has now published a detailed cnucal
resiew of the e^cacy a=c safety of the drugs commonly used a
anndiarrhoeal prrp4.a.ui s,1 cmng almost 300 reftTmr»n.
The book deals
me antimotility drugs diphenoxylate yd
lopcraaude, annm' —ocui drugs, and adsorberus. The review of
topetide indudes =x=ral published in 77k Lanett last year.*-4
Neither diphenoxytc- nor joperamide can be recommended for use
in children, “and mere a mus no rationale for the producnon and
sale of liquid and syrup formulanoos for pardiarrir use”. The
review condudes fox «ai su upturn yen or dihydrostrrptomycm,
oral neomycin, byeroxyquinolmes, and non-absortsbie
sulphonamides should not be used in the treatment of diarrhoea (at
that the proth^^on and sale of preparations containing
these drugs cannot be ytanfird. Kaolin and pectin induce only a
Tand rianh Orprusooo. 1990 Pp 71. ISBN 9241561424. Sw fr 14 in
arrxjont counma Sw tr 930L
- Shira TL Tam- KJ. Looen.—pooorunj tn dnittrw.
1990; J3S: 363.
3. Ance. Looerwrjae poaor.ru rt saiGran. Lanui 1990; Bfc 1394.
Z
4. Gtum RZ. •ynaanwu of mrKnxle dropi. Law 1990; 335; 1603.
/
Surgeons and HIV
If a surgeon or other member of the operamg ream is injured
durmg an ooerauon on a panent at high risk for HIV mfecuon, the
surgeon nas me right to res: that panenr for HIV without consent,
savs the Roval College of Surgeons in a ^arrm-nr issued last wr^r
The panen: should be mx'ormed after the openmou, the college says.
The coilege council, which neither defines “high risk” nor suggests
how serious an injury should be to justify xsung, claims that this
policy is consistent wim advice relanng to “excepuonal
emmmseznees” given by me General Medical Council in 1988 in its
guidance to the medical profession on ethical consioeraoons
cooceming HIV inieooon and AIDS. The GMC, however, while
agreeing mat the RCS guidelines are “broadly coonstmi’' with its
own, fears that the college recommendaxioas may be interpmed as
meaning that a surgeon may routinely test paoenrs without then
cmvs t tn me event of any needlestick or sharps mjury. The GMC
guideiines scare dearly that testing without expiiot consent can oe
justified oufy “where a test b imperative in order to secure the safety
of persons ocher than the paoent, and where it b doc possible for the
poor consent of the panenr to be obtained”. The GMC, in a
statement responding to publication of the RCS guidewarns
that it does not give surgeons the go-ahead to test without consent as
a rouune. automatic reacnoo to mjury during an operatxxi. It warns
doaon to “think carefully, on esTry occasion, about rhe necessity of
testing without consent”. If they deade to proceed, says the GMC,
they must do so in the full Knowledge that they will have to justify
thcr acoons if a complaint is bodged with the GMC or if legal acoon
is taken igxzns: them.
The RCS recognises that testing of all surgical pinenes for
HIV—which it regards as the ideal—would be impracncaL
However, a endorses the Chief Medical Officer's view that
members of ±e public who consider themselves to be at high risk of
HIV should vohmonly submit to testing.
The college recommends that all panenn judged to be in the
high-nsk caregory should be offered an HTV anabody test,
provided max counselling b available both before and after the rnr,
If rhe panmr refuses, however, extra precauoccs should be taken to
prevent hadvertmt contact of the patient's biood and body fluids
with the skin or coajuncnva of the surgeon and his tc^ti and to
tnmnmse the risk of inoculanoa injuries.
The codege reports that no cases of transmissioQ ofHTV infer-tinn
from a surgeoa to a patient have been enr.n rrrvri xnrl judges the mk
to be exueuriy small. It therefore does txx recommend regular
screening of surgeons for HIV antibodies. However, it advises
surgeoos who know they are HTV positive to srrfr specialist advice
on the enrr.r to which they should limit their profcssxxial pracnce.
This would normally mean gjvmg up major invasive surgery. The
college council suggests mat the Department of Health has a
responsibility to issue clear guidance on bow mdustnal
compensxnon should be provided ’for a surgeon who becomes
infected with HTV during the course of his or her work.
T
pWSI !
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CENTCHROMAN
____________________________________ £___________________ _______________ -••■•-
•_____________ _.■. _■;__________ ±2_________________________:___ -._________________
(A New Weekly Oral Contraceptive)
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17 February, 1991
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C E N T C H R 0 M A N
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(A new weekly oral Contraceptive)
Centchroman,
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a new weekly oral contraceptive pill for
female has been developed by Central Drug Research Institute,
(a premier research institution of CSIR) with support
Lucknow
of Health & Family Welfare, Government of India.
It is a novel non-steroidal chemical moiety unrelated to any
from Ministry
used contraceptive and
clinically
cross sensitivity.
hence possess no danger of
Centchroman is only anti-implantation agent
approved for clinical use in any country of the world. It re
major breakthrough in the international efforts to
It exhibits unique combination
develop better contraceptives.
of weak estrogenic and potent anti-estrogenic properties which
presents a
not allow
the fertilised ovum
to
implant on the surface
of the uterus thus avoiding pregnancy.
Centchroman has been
co
approved for inclusion in the National Family Welfare Programme
and social marketing programme of Ministry of Hedth and Family
Use of Centchroman pills
is
re
commended for all women of reproductive age group who want
Welfare,
Govt, of India.
to space their children.
Advantages:
I
The major advantages of Centchroman over’ the existing
r
steroidal hormonal pills are given below:
1.
The
contraceptive efficacy
is
due
to
its
interference
with implantation of fertilised ovum in the uterus unlike
i
hormonal pill which interferes with the ovulation itself.
It does not cause imbalance of estrogen and progesterone
and thus maintains normal ovulation cycle.
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2.
User compliance is excellent among rural and urban populations due to lack of side effects.
It needs to be
taken twice a week for first three
months followed by
weekly use reducing problems of
compliance required
for 21 day regular intake of hormonal pill ,
3.
Babies
born to user failures present normal
r. ilestcr.es
and have no congenital anamolies.
4.
Centchroman does not cause nausea,
vomiting, dizziness,
weight gam and breakthrough bleeding and has no eriect
of platelet function, lipid profile and HDL cholesterol
as is frequently
seen with the steroidal contraceptives.
5.
The user experiences r.o side effects except prolongation
of about 8% of the menstrual cycles beyond the
normal
range.
6.
The
contraceptive effect is readily reversible
six months and subsequent pregnancy is normal.
within
Human safety & Clinical Efficacy
An extensive safety evaluation has been carried
in labo
ratory animals of different species.
It is found to be safe
in rat and monkey upto 10 times
contraceptive cose given daily
or weekly for upto one year .
It does not produce teratogenic,
mutagenic and carcinogenic effects and has
excel_ent therapeutic
index .
The
safety and
<contraceptive efficacy have also
been
proven in clinical trials> covering aoput
ibuu
women
about 1500
cf repro
ductive age croup for nearly 20,000 women months
of use with
d^ratlon of use upto 5 years
txcellarj;
(ttart
*
•
2>0S).
pregnancy prcusctiCvv
Intensive clinical monitoring, haematology and biochemical
tests as well as laparoscopy and ultrasonography examination
of the ovaries and uterus of
women have shown that the drug
is very safe.
V----
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Estimated Range of Failure Rates*
For Major Contraceptive Methods
Under Um Conditions Worldwide
30
29
28
27
26
25
24
c 23
03
c 22
ff 21
£ 20
o 19
3>»
= 17
I- 1615
c 14
o
E 13
I 12
o 11
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C
j
<£
e
a
7
6
5
3-2--
■s
1
0
o
s
!
PERCENT OF WOMEN . WHO WILL BECOME
PREGNANT DURING THE FIRST YEAR OF
CONTRACEPTIVE USE
POPULATION,
MAY
1985.
DATA SUPERIMPOSED.
; 1
I
CENTCHROMAN
1
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-€
I
SIDE EFFECTS IN CLINICAL USE
CENTCHROMAN
I.
MINOR SIDE EFFECTS CAUSED
1.
2.
3.
4.
5.
6.
7.
II.
NAUSEA
HEADACHE
SORE BREAST
WEIGHT GAIN
SPOTTING
DIZZINESS
DELAYED MENSES
NO
YES
NO
NO
YES
YES
NO
NO
NO
ABOUT 8%
CYCLES
YES
YES
YES
NO
NO
YES
YES
RARE BUT SERIOUS SIDE EFFECTS
CAUSED
1.
2.
HIGH BLOOD PRESSURE
BLOOD CLOTS IN LEGS OR
LUNGS
3.
4.
HEART ATTACK OR STROKE
CANCER OF BREAST
5.
CANCER OF CERVIX
NO
NO
(BENEFICIAL)
NO
* POPULATION REPORTS, NO. 8, 1990
*
COMBINED
ORAL PILL*
YES
YES(?)
YES(?)
■
i
Dose Schedule & Instructions for Use
Cen tchroman
a
pregnancy
protection
in
mg
twice a week (Pearl
Index 2.53) for
followed
by
once-a-week
till
The Pearl
Index
months
is desired.
excellent
30
schedule of
dose
three
provides
ceptive failures per
(30
mg)
protection
is an indirect measures of contra
hundred women years of use and a value
upto 6 is acceptable internationally .
The first tablet should be taken on the first day of mens
cycle (eg.
trual
is
tablet
and
day L
on
taken
subsequent
of bleeding
fourth
the
tablets
are
is on Sunday),
then second
cycle
(i.e.
Wednesday)
day
every week
of
day
taken
on
the
same
(say Sunday and Wednesday) at fixed time (say bed time) as shown
below:
. Initial dosage schedule : 1 Tablet twice-a-week for 3 months
ONTHS OF USE
FIRST
Bleeding days
J !l nhv V vi VH
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8
Bays of use
M
T
SECOND
w T
S
F
1 2 3 4 6 6 7
8 0 10 1 1 12 13 14
16 16 17 18 102021
222324 ?527 28
29 30
S
M
T
T
THIRD
F
S
1 2 3 4 6
7 e 0 10 1112
131416 18 17 18 10
6
20 2 1 22 20
___ 24 25 26
27 28 2Q30 31
I
II.
r
8 M
T]
4
6
8
T
F
S
1
2
7 8 o
10 1 1 12 13 14 16 16
17 18 10 20 21 22 28
24)25 28 27 26 20 30
6
Subsequent Dosage schedule: 1 Tablet once-a-week till protection desired
on th of use
FOURTH AND SUBSEQUENT MONTHS
8 M
tyS Of use •
1
T W T
F
S
2 3 4 5
0 1 0 -m 2
6
7
2 9 2 Z 10 102021
22|23
24• 28 a.20
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v 27
« *28
d
20 30 31
SUNDAY
PILL
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Caution
(I)
The
first
tablet should be
strictly on
taken
the first
twice a week,
day of
the menstrual period and
3
apart for 3 months followed by once-a-week same
days
thereafter
day in every week for as long as contraception is desired,
since deviations may lead to pregnancy.
(2)
Biweekly and weekly schedules are to be continued irrespec
tive of menstrual periods.
Precau tions
(L)
Delay of periods
(i)
consequence
Menstrual
delay
have not
been missed. An occasional cycle is likely
to
be
fixed
is
prolonged
days
some
in
should
no
of
be
users
but
continued.
If
15 days, consult your doctor
(ii)
if
the
tablets
tablet of
exceeds
delay
to rule out pregnancy.
If pregnancy is not diagnosed, continue using tablet
on
fixed days
and menses will
occur automatically.
(iii) If menstrual delay continues beyond 6 months, with-
draw tablet and use Nirodh till the onset of periods.
the
Restart
on first day of
tablets
bleeding with
a biweekly schedule for 3 months followed by a weekly
schedule as described above.
(2)
Pregnancy
r
In case delay is diagnosed due to pregnancy, Choice-7
pills
normal
should
discontinued
pregnancies
failures,
(3)
be
have
termination
of
immediately.
Although
resulted
following
pregnancy
is
use
recommended.
If the tablet is missed
(i)
A reliable contraception cannot be guaranteed without
ill
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- 7 -----------
T
1
the
scheduled
is
to be
use
Of
tablets.
tablet
missed
The
taken as soon as possible and
the normal
schedule days adhere to.
(ii)
In
i
case
less.
than 7 days,
alsoi
use
Nirodh
or more days,
missed by 2
is
tablet
continue
as
the normal
addi tional
bu t
schedule and
precaution
till
the
next period.
tablet is missed for more than 7 days, re-
(iii) In case
initiate
like
a
new
user
i.e.
biweekly
schedule
for 3 months and thereafter weekly schedule.
Contraindications
:
Centchroman
oral
family
planning
pills
should not be taken by women suffering from the following dis
orders:
(l)
Absolute
(i)
Recent history of jaundice or liver disease
(ii)
Polycystic ovarian disease
(iii) Chronic cervicitis or cervical hyperplasia
(2)
Others
(i)
Severe allergic conditions
(ii)
Chronic
i1Iness
1 i ke
tuberculosis,
(iii) Nursing mothers in the first 6 months
renal
diseases
ALL INDIA DRUG ACTION NETWORK
19.11.1990
Dear Friends,
You must have received the copy of the Health Ministry’s
Essential Drug List and the Fax message received from
Dr. Zafrullah. GPL’s office in Dhaka was ransacked and
almost burnt down by miscreants - including their vehicles,
raw materials and formulations etc.
With the change of government, Mr. Gurupadaswamy departs,
who must have been a matter of great relief to the
Pharmaceutical Industry. Mr. Khan who was in Chemicals
Ministry earlier and was later Chief Secretary, Gujarat
may join as Cabinet Secretary. He has been sympathetic
towards the industry in the past. With the increase in
petroleum prices there will definitely be a price hike.
From 18th onwards the Pharmacy Week begins and in India
International Centre., major pharmaceutical companies and
drug control authorities will be participating in it.
It is time that we meet as AIDAN, even if it is just for
a day since many of you will be coming for the People’s
Science Congress which is from 25th to 28th December.
Could we meet on 24th December.
The Producers and Promoters for Rational Drugs had met in
Hyderabad at a Consultation called by CHAI on 10th, 11th
of November. There it was felt that since Bombay is easily
accessible to AIDAN members in Gujarat and Maharashtra and
since others would be coming for the Peoples Science Congret s.
we could tie it up and meet on the 24th. I had requested
Dr.Anil Pilgaonkar, Convenor, MFC to see if there was some
place we could meet, but if worst comes to worst he was
willing to let us meet in his home. His address is:
Dr. Anil Pilgaonkar
34-b, Nashir
Bharucha Road
Bombay 400 007
Tel:
022-468033
Please contact him as he will be our local contact. With
Dr. Arun Bal, ACASH; Dr. Amar Jessani, Dr.Ravi Duggal of
FRCH and a very strong MFC Bombay group along with WIDAN
z_ _
—
—
1
that
it x.rori
won* ’+•t
(West
India Drug Action XTNetwork)
, we hope +-ybe too much troubleo
o. 2..
:2:
Dr. Amit Sen Gupta has asked me to extent the invitation
to you to attend the Peoples Science Congress especially
the health sub congress. He is v/riting to you separately.
On 26-28th January ^clashing with the MFC meeting is the
Eastern Region Rational Drug Therapy workshop being
organised by CDMU for which some of the AIDAN members
have been invited as resource persons. It mav be difficult
to link up the AIDAN meeting with the MFC meeting.
If some of you feel that we need to meet for two days
instead of one i.e. 23rd and 24th December, please immediately
intimate me and Dr.Anil Pilgaonkar
~'
and- the
.
others.
regards
the agenda, I will send you a tentative programme on hearing
from youo
Amongst the other things we would like to discuss is
irrationality of commercial ayurvedic preparation on which
Dr.Unnikrishnan is working.
Drug Pricing:
Dr. Anil Pilgaonkar,MFC
Dr. Srinivasan, LOCOST
Dr. W.V. Rane, ADM
Mr. Amitava Guha, FMRAI
Dr. Amit Sen Gupta, NCCDP
Dr. Dinesh Abrol, DSF
Brief update on the
Situation of Drug
Policy:
Dr. Mira Shiva, VHAI
Rational Drug Use in
Medical Education:
Dr. Ekbal, KSSP
Boycott updates
Drug Action Forum, West Bengal
Dr. Sujit Das/Dr« Sarkar
Producers &
Promoters of Rational
Drugs - update of Activities
plans and expectations
& Quality Control and CHAI' Dr. K.R. Antony
Adverse Drug reaction LOCOST, ICSA (Dr.Jesudas)
CDMU (Dr.Sarkar, Poddar)
Monitoring activities
Women &. Pharmaceuticals
Dr. Mira Shiva
Dr. Sathya
: 3:
Drugs Legislation and our experience
so far
Dr< Kabra
Lentin Commission update
Dr. Arun Bal, ACASH
I.V. contamination update
Dr. Mira Shiva, VHAI
Pills, Profits (Jamia Milia)
Screening of newer drug
film if possible.
Action and Media
(This is important in view of all
the Media campaign by the
Pharmaceutical companies)
Padma Prakash,
These are absolutely tentative ideas. Please reply at the
earliest and send a copy to Dr. Anil Pilgaonkar.
With warm and sincere regards.
Dr. Mipr Shiva MD
Coordinator, AIDAN
x
e.
ALL INDIA DRUG ACTION NETWORK
AlDAN-l(l)
March 21, 1990
Dear friends,
In view of the drug policy being reviewed, I hope that you have made a submission
of your views to the Health Ministry and the Chemicals Ministry.
Some of the drug and health activists attending the All India Health Activists meet
as part of the 3rd People’s Science Congress. Had discussions regarding the Drug
Policy, 1986 and our views on it. On 11th and 12th in a joint meeting of AIDAN
and NCCDP it was further discussed.
I have made 2 submissions, one on behalf of VHAI before the Bangalore meet and the
other on behalf of AIDAN after the Bangalore meet. Dr. Antia on behalf of FRCH has
also sent in his views to the Ministry. DAFWB and ACASH are doing likewise. In
view of more inputs required in the pricing area and paucity of submission and from
health groups side it was felt that NCCDP’s submission could be separate. Amit
and I are working on the pricing front.
I am sending you copies of few of the recent articles connected with the drug policy
in case some of you have not seen them by separate book post.
A much more thorough and detailed discussion was required regarding drug pricing,
which we hope to have in Mid April or Early May. Amitava Guha of FMRAI and Amit
Sengupta of DSF took responsibility for it. Dr. Narendra Mehrotra of Academy of
Young Scientist, Sandhya and Mrinalini of NISTADS are also working on it. A small
group would meet at the earliest to do indepth work in this area. Amitava’s earlier
paper on Pricing will be circulated from Calcutta itself.
An expert Committee has been formed by the government to go into Pricing and Trade
Commission. It is possible that more (drugs
’
will be brought under price control,
There had been discussion in Bangalore regarding our demanding a uniform mark up.
The mark iup suggested there was 55% which I personally felt was too low with removal
of overall profitability. control.• . The break even mark up from various sources with
whom I have discussed is 80% according to Dr. Nityanand
90% BICP
100%
(Industry sources - who suggest that 150% uniform
mark up with Profitability limit of 8% would be OK for
the 1st year 9% for 2nd and 10% for the 3rd year)
2...
All India Drug Action Network is a network of health consumers, science groups organizing people's science movements
and socially conscious health professionals & concerned individuals. AIDAN believes in Social Justice in Health
Care and has been involved in making efforts towards e Rational Drug Pol icy & Rational Drug Use.
■
- 2 -
AIDAN
We have been making desperate attempts to get ORG data and other figures
difficult to make a good analysis.
but so
extremely
^coov'oi TXPXS KlaSt Week had 3 SpeCial insert on Pharmaceuticals,
a copy or I would have sent you photostats.
I do not have
I will keep you all informed about the drug
pricing.
^rugs Legislatron - ACASH had taken main responsibility for it
Bal will alongwith others make a submission with indepth comments I inhope
thisDr. Arun
area.
S^Ce, the drU§aP°^y is being reviewed it would be good to push for changes in
all the other
u
drug policy. I will be out of station in the last
week of March, Kindly keep me and each other informed about your activities and
submission.
I am sending a list of addresses is to whom you could send
a copy of your
submission.
Mr. Nilamani Routray
Minister of Health and
Family Welfare
Nirman Bhawan
New Delhi 110011
Mr. Gurupadswamy
Chemicals Minister
Shastri Bhawan
New Delhi 110001
Mr. R. Srinivasan
Secretary
Health and Family Welfare
Nirman Bhawan
New Delhi 110011
Mr. Rajni Kothari
Planning Commission
Yojana Bhawan
Sansad Marg
New Delhi 110001
With warm regards,
Yours sincerely,
P.S.:
Dr. Mira Shiy^-^MD
Coordinate^i
AID AN
We are hoping to meet on 16-17
of the persons concerned.
fl
ALL INDIA DRUG ACTION NETWORK
PEHAPP-l (1)
July 31, 1990
ACTION ALERT
rDear. Friends,
As you are aware the drug policy is being reviewed. The drug
policy of 1986 was not in the interest of the people nor was it
in keeping with the health policy statement of 1983.
While the drug industry which includes multinationals, Indian
sector and small scale have joined hands with trade i.e. whole
sellers, retailers, chemists and druggists to campaign agressively
by publishing their view points jointly^.as Numerous advertisements
including publishing of an open letter 'to the Prime Minister in
national -dailies.
r
<•
. ■
The latest pressurizing strategy adopted by
the drug
industry and the trade is to threaten to go on a nationwide"
strike on 7th & Sth of August. They would like to see the
drug prices made more remunerative, less drugs under price
control, non payment of dues to the government for drugs over
priced by them in the past under Drug Price Equalization Account.
The entire drug ^debate has now became reduced to remunerative
drug pricing7 or'threat of diversification and non production^(6f
essential drugs.
The casuality in all this is bound to be the consumer specially
the poor as the decreasing production of essential drugs for
Primary Health Care, and life saving drugs yzhich are- under price
control will be further reduced/and the drug prices will further
spiral, and there will be further thrust in production of more
-remunerative non essential and irrational drugs.
/
- -
Mr© Gurupadswamy, “the Chemicals Minister has been deeply
concerned about the drug situation and against tremendous
pressure has given a serious hearing to the health and consumer
groups© Some of the changes being visualized by him
if allowed to be implemented would be in the interest of the
people.
The entire process,the drug policy review is at a critical
juncture. To revert the focus to the various aspects of a
rational drug policy, it is important that those involved with
health care awareness building social action express their
views and concern to the Chemicals Minister, the Prime Minister
and the Health Minister (on your organizational letterhead),
regarding focussing on the entireurational drug policy ^rather
than mereQdrug pricing."
-..2.0
: 2:
The health and consumer activists have been demanding that
unless there is^rationalisation of the drug policy/ no further
"price increase should be permitted/
By rationalisation
we mean:
- Ensuring production'and distribution of essential drugs;
- Withdrawal of hazardous and irrational drugs;
- Ensurance of quality control;
- Availability of unbiased drug information.
The strike by the manufacturers and trades clearly shows the
need to have alternative drug manufacturing initiatives and
distribution channels. Manufacture of essential drugs by the
public sector units or voluntary initiatives like LOCOST,
CDMU, Essential Drugs Unit, ICSA) and distribution through
peoples pharmacies, primary health centres etc. will need to
be evolved. If the strike of the manufacturers and traders
is successful it would have set an unfortunate precedent.
A copy of the letter sent by us to the Prime Minister is enclosed
herewith. If you could send a copy of your letter to us, it
would be helpfulo On 8th August several organisations, DSF,
FMRAI etc. and trade unions are joining hands to protest in
front of the drug units at 1.00 p.m. from Methi Chowk to the
Prime Minister’s residence. For details of the Sth programme
please contact (Dr. Dinesh Abrol/Dr. Amit :Sen Gupta, Delhi
Science Forum, B-l 2nd Floor, Local Shopping Centre, J Block,
Saket, New Delhi-17 Tel: 665036 Res: 643056/6864670).
Dr. Azrun Bal of WIDAN, Dr. Sarkar, DAF-West Bengal, Mr. Sriniuasan,
LOCOST, Baroda, Gopal Dabade, Vanaja Ramprasad, DAF-Karnataka.
Dr. Ekbal, KSSP, Dr. Rane, Pune would be coordinating regional
drug action. NCCDP (National Campaign Committee for Drug Policy),
■ All India People Science Network are also protesting against the
strike andtheir members are getting mobilized for demanding a
Rational Drug Policy.
With sincere regards.
Yours sincerely,
Im
I
/
hiva MD
Dr. Mir,
r Coordinator
All India Drug Action Network
encl:
as s/a
VOLUWABV Health Ass©ciati©h of Ondja
July 30, 1990
PEHAPP/4 (4)
To,
_The Prime Minister of India
New Delhi.
Dear Hon’ble Prime Minister,
The proposed strike by the multinationals, Indian Drug Manufacturers,
the Chemists and Druggists to put pressure on the government merely
goes to show that sectors who have never seen eye to eye to safeguard
their own individual interest, are willing to join hands, so that
every.one can have a bigger cake to share, at the cost of the
consumer.
Had their been gestures of sincere attempts at rationalization of
formulations, self regulation where quality or withdrawal of hazardous
products was concerned or even attempts at giving consumer caution
'"* mayr not have seen this
and unbiased drug information then the public
strike
merely
as an exercise in
exercise of threatening to go on t
self interest.
It must also to be noted that the two occasions previously when the
Chemi sts_ and Druggists went on strike was - to protest against the
Pharmacy Amendment Act, whereby only trained pharmacists would be
authorized to dispense drugs and second time it was against keeping
of receipts in triplicate for schedule X drugs (i.e._ Psychotropic
drugs). Both these acts had been formulated by the government to
protect the consumers who are the ones who pay for- the drugs.
Mr. Gurupadaswamy’s courageous stand inspite of tremendous pressure
is extremely, commendable. The health and consumer groups sincerely
hope that the show of money power by way of huge advertisements in
the national dailies, publishing of the "open letter to the Prime
Minister" paid articles in the press, threat of going on strike will
not make the government deviate from the promises made to the public
: in-its election manifesto. /
. ; .
'p.; <
C2->-
’
i
..
}
I
S.
The public would like you to ensure that there should be
NO. LIBERALIZATION WITHOUT RATIONALIZATION.
. .
t
Tong Swasthya Bhavan,
40 institutional Area, Near Qutab Hotel New Delhi-110016, INDIA
Phones: 668071.668072. 665018 655871.652953
Fax_D11-^76377
‘ Grams. VOLHEALTH. N.D. 16
L
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All these health consumer organisationsaconcerned about the
deteriorating trend in the drug market. The issues related to drugs,
'instead of focussing on_’essentiality-’, ’efficacy’, ’safety-', ’value
for money’ for the consumers,the focus seems to have shifted to
’remunerativeness of the drug industry and trade’.
The 1986 drug policy was announced as ’’Measures for Rationalisation
for Quality Control and Growth of the Drug Industry”. The major
concerns of the public and other major criteria for a Rational Drug
Policy were not incorporated, and assurance was given that these
would be handled later. The Drug Price Control Order of 1987 made
it clear that the Drug Policy of 1986 was basically a pricing policy
and in line with the policy of further decontrol and liberalization.
r;_Er.on|._343—drugs».the. number . of drug under price control^ were decreased
to 166 which was further decreased to 124 and even if at a later
date 21 drugs were brought into price control, these constituted
a small number. Moreover the mark ups for both Category I & II were
increased from 40% to 75% and from 55% to 100%.
The differential pricing has continued to make production of non
essential and irrational drugs more remunerative. Instead of 100%
and 125% mark up for Category I & II as suggested by the drug manu
facturers , 'finere should be a uniform mark up of 75% till an unbiased
study of drug pricing is done or 85% as Bhatti Committee suggested,
'must be implemented. There has already- been a significant increase
in drug prices, further blanket increase of prices is not warranted.
This is specially so because around 60-70% of the drugs in the market
are irrational combinations.
There has been increase in drug prices as shown in the enclosed table.
(Annxure.I).
It must be remembered that the pharmaceutical industry had been very
happy with the 1986 Drug Policy and at that time did not seem to
have any problems, with the so called dual control i.e. of ’product’
and ’profitability’ control. Inspite of this from 9000 pharmaceutical
units the number of units has increased to around 20,000, with
pharmaceutical shares going up even of those manufacturers who were
only in pharmaceuticals.
I
IRRATIONAL & HAZARDOUS DRUGS
1
’
> on basis of rationality.must be
Immediate
categorization of_drugs
and
irrational
and
hazardous
drugs identified. In keeping with
done <-- --------the Kelkar Committee recommendations strong disincentives must be
given for formulation of irrational and hazardous drugs and which
must be weeded out of the market by making them totally unremunerative
or banned.
.3..
Ann. I
DRUG PRICE INCREASE
Product
Baralgaon
Company
Hoechst
Packing
Aug.85
MIMS
Nov.86
Apr.88
Feb.90
7.
10T
3.78
3.77
3.85
4.93
30.42
12.96
12.96
13.23
30ml
Buscopan
Ger.Rem.
10T
5ml •
6.64
4.95
1.45
6.24
2.13
9.25
3.13
39.31
115.86
Dulcolax
Ger.Rem.
10T
1.46
• 1.46
3.00
3.55
143.15
ovalgin
Hoechst
10T
30ml
2.72
2.95
12.75
3.87
4.46
12.50
75.00
Calmpose
Ranbaxy 5 mg
10T
60ml
2ml
1.92
6.88
1.92
8.27
1.86
3.25
102.60
2.14
3.89'
8.27
2.40
Nevrovitamin-4
Franco-Ind
50T
6.95
6.95
12.50
13.40
92.81
Avomine
M & B
4T
0.76
1.93
1.93
1.94
155.26
Stemetin
M & B 5 mg
25 mg
10T
10T
4.25
6.50
5.99
8.73
6.02
8.78
6.02
8.78
41.65
35.08
Mazetol
SG Pharma
10T
8.10
8.10
17.89
16.89
108.52
Encephebol
Merck
10T
10T
100ml
31.41
25.90
32.42
17.24
31.34
41.30
19.31
35.75
41.30
23.31
35.95
58.83
48.67
38.80
81.46
Succislyl forte
Raptakos
50T
6.28
22.19
22.19
26.43
420.96
10T
23.50
23.48
27.91
40.00
70.21
100 mg
200 mg
Syrup
jjuphoston Duphar
Orgametril
Infar
10T'
9.25
9.25
15.75
16.00
72.97
Mycostatin
Sarabhai
12T
14.50
14.50
24.00 10T/20.71
71.74
Iberol
Abbot
25T
90ml
7.63
11.12'
7.63
11.12
13.68
11.28
80.21
13.75
12.04
!
Ann. I
DRUG PRICE INCREASE
Product
Baralgaon
Company
Hoechst
Packing
Aug.85
MIMS
Nov.86
Apr.88
Feb.90
7O
10T
3.78
3.77
3.85
4.93
30.42
12.96
12.96
13.23
30ml
Buscopan
Ger.Rem.
10T
5ml -
6.64
4.95
1.45
6.24
2.13
9.25
3.13
39.31
115.86
Dulcolax
Ger.Rem.
10T
1.46
• 1.46
3.00
3.55
143.15
.ovalgin
Hoechst
10T
30ml
2.72
2.95
12.75
3.87
4.46
12.50 •
75.00
10T
60ml
2ml
1.92
6.88
3.25
102.60
Calmpose
Ranbaxy 5 mg
.
1.92
8.27
1.86
2.14
3.898.27
2.40
Nevrovitamin-4
Franco-Ind
50T
6.95
6.95
.12.50
13.40
92.81
Avomine
M & B
4T
0.76
1.93
1.93
1.94
155.26
Stemetin
M & B 5 mg
. 25 mg
10T
10T
4.25
6.50
5.99
8.73
6.02
8.78
6.02
8.78
41.65
35.08
Mazetol
SG Pharma
10T
8.10
8.10
17.89
16.89
108.52
Encephebol
Merck
10T
10T
100ml
31.41
25.90
32.42
17.24
31.34
41.30
19.31
35.75
41.30
23.31
35.95
58.83
48.67
38.80
81.46
^uccislyl forte
Raptakos_
50T
6.28
22.19
22.19
26.43
420.96
10T
23.50
23.48
27.91
40.00
70.21
100 mg
200 mg
Syrup
Duphoston Duphar
Orgametril
Infar
10T
9.25
9.25
15.75
16.00
72.97
Mycostatin
Sarabhai
12T
14.50
14.50
24.00 10T/20.71
71.74
Iberol
Abbot
25T
90ml
7.63
11.12'
7.63
11.12
13.68
11.28
80.21
13.75
12.04
I
I
i
Hem™ Assocdmto^ of IIwda
ALL INDIA DRUG ACTION NETWORK
PEHAPP-l(l)
April 3, 1991
Bear Friends,
BAWTvq or ipjTGS
I am sending you copy of the communication received from the DOI
regarding banning of a few drugs.
1. AWOCB^STS BIIL
Copy of the Amniocentesis Bill is also being sent. A large number
of groups have been working for a central legislation and it was
to come up in the Parliament Session and will hopefully come after
the elections. The phenomenon of mushrooming of amniocentisis
clinics for sex determination is worsening and so also the
malpractices associated with it serious concern about ratiferation
of abortion clinics without proper norms.
2. BABY FOOD BILL
The Baby Food Bill is also being presented in the next Lok Sabha.
Efforts by various groups have led to few positive.amendments i.e.
inclusion of Infant Foods, Bottles and other equipment earlier it
was mainly Breast Milk substitutes. While some felt that pacifiers
must also be included there is a risk of the Bill again going into
limbo. As with the drugs issue the punishment section is extremely
weak. In consultation with some lawyers hopefully we will be able
to draw up something proper and then ask for its inclusion as an
amendment. If you would want the complete Bill please drop a line.
3. EP DPTTGS
SELECT
Dr.Faruna from Dachod had sent a pack looking identically like the
En Porte drug. Only on close inspection it is found it to be
Ergotfnot Estrogen ) Progestrone combination manufactured in Indore.
In several other towns drugs like DP Porte etc. are being sold.
High dose Estrogen and Progestrone seperately yet in a single pack
apparently are also available. If it is possible please purchase
samples in your area and the costs will be reimbursed.
The manufacturers of ’SELECT’ were planning a big seminar on Punsavan
Prayeg i.e. practices recommended in Ayurveda regarding selection
of the sex of the child. Vijay of LOCOST will keep others informed
regarding this.(LCCOST, GPO Box No.134, Baroda 390 001).
..2..
u
L
2
i
4. tap PQ^TE^S ON
The Indian Academy of Daediatrics has brought a set of very simple
and effective drug posters Rs. 50 per pack available from Dr. R.K.
Anand, 55 Xavi Apartment, Worli, Bombay 400 018 and Indian Academy
of Paediatrics (IAP), Department of Paediatrics, AIIMS, Ansari Nagar,
New Delhi 110 029.
5. GATT, SPECIAL 301 Z INTELLECTUAL PROPERTY RIGHTS
India continues to be on the Special 301 list of U.S. i.e. pressure
to change our Patent laws is more serious than before in view of
the charged global political situation where the remaining super
power is in a better position to dictate trade terms to the third
world and our poor financial situation is forcing us to look for
yet another IMF loan with the IMF conditionality going with it.
As part of the National Working group on Patent Laws, Some of us
have been working in this area for the last 2| years and brought
out information that the socially conscious groups and individuals
must have.
6. 'TIE ESSENTIAL DRHG LIST prepared by the Health Ministry copies
of which were sent to you has not yet been taken up by the Chemicals
Ministry. rrom the past experience it is evident that unless there
is a major overhaul of the Drug Policy - any implementation of the
Essential Drug List is extremely unlikely.
7. PARTONAl DRWG WORKSHOPS in which I have been involved in
conducting in the past few months. Rajasthan VHA $ VHAI organised
a 1 day drug Core Group Workshop in Jaipur. Dr.Kabra as the
Coordinator is actively involved in a case of spurious drug makers
and has recently filed a writ petition regarding X-rays. For further
details contact him directly (Dr.S.G.Kabra, Santokba Durlahji
Mem.Hospital-cum-Medical Research Institute, Jaipur 302 015.
With APVHA in Warrangal Medical College, with Bihar VHA two Rational
Drug workshops in Bettia and Patna, with EHA in Rajpur, with TJPVHA
in Dehradun CDMU-VHAI in Digha, West Bengal (organised workshops).
8. A Dialogue on CHAI-CMAI-VHAI on Women & Health was held in
Hyderabad on 27th & 28th of February 1991. Issues related to Women’s
nutrition, health and disease, gender was Rational Use of
contraceptives and abortion, medical technologies, infertility,
gynaecological disease, women and pharmaceuticals, women and
violence, women and work etc. The objective was to identify areas
of common concern as national health associations and to ensure
that these concerns are reflected in the work of the associations
and their member institutions. Specific responsibilities were taken
to do some ground work to report at the follow up meeting.
10. We have been deeply concerned about Dr.Zafrullah and his well
being. His contribution in defining health and his contribution
in formulation and implementation of the Bangladesh drug policy
and later formulation of the National Health Policy has been
-
3
tremendous. With the change in government the vested interest alongwith others is trying to identify the drug policy as Ershad's man.
An attempt is also being made to hold him responsible for the killing
of the Bangladesh Medical Association Secretary.
For all that Dr.Zafrullah has stood for and the support he has
provided to the drug and health groups in India it would be good
if letters of solidarity are sent to the new Prime Minister, Begum
Khaleda, expressing the hope that she will do great things in health
care specially where women are concerned and ensure that Bangladesh’s
drug policy continues to inspire other third world countries. (Begum
Khaleda, c/o Bangladesh Embassy, 56-Mahatma Gandhi Marg, lajpat
Nagar ITT, New Delhi 110 024).
With regards.
Yours sincerely,*
T)r. Mira Shiva MT)
Head, nublic policy T)Vn.
Coordinator
Low Cost Drugs ® Rational Therapeutics
I
NeolB-4/88-DC
Fr*«
The Drugs Centreller, India
Dte. General ef Health Services
New Delhi, 4ated
Te
Dr.
Shiva,
Voluantar^ Health Associatien
ef India.
40, Institutional Area,
South of I.I.T., New Delhi-16
Madam,
A copy of the Government of India Notification
No.X*11014/3/88-DMS&PFA dated the 26th December, IffO
as published in the Gazette of India under G.S.R.
No.PM(E), dated the 26th December, 1990 prohibiting
the following drugs is enclosed for your information:Io
Fixed dose combination of sedatives/ hypnotics/
anxiolytics with analgesic antipyretics®
2.
Fixed dose combination ef Pyrazinamide with
other anti-tubercular drugs except combination
of Pyrazinamide with Rifampicin and INH as per
recommended daily dose given belows—
Druos
Rifampicin
INH
Pyrazinamide
Minimum
450mg.
300mgo
lOOOmg.
Maximum
6 00m §<>
400ag.
ISOOmg.
3.
Fixed dose combination of histamin H2- receptor
antagonists with antacids except for those
combinations approved by the Drugs Controller, India
4*
The patent and preprietary medicines of fixed
dose cominations of essential *ils with alcohol
having percentage higher than 20% proof except
preparation given in tfce Indian Pharmacopoeia.
5o
All pharmaceutical preparations containing
Chloroform exceeding 0.5% w/w or v/v whichever
is appropriate*
Yeurs faithfully,
=.
I
i
(»r. Prem K® Gupta)
DRUGS CONTROLLER (INDIA)
w
REGISTERED NO. D <D.N.) t27
)’127
Ft
1
91 Kef
^he <S»a£ette of JMuia
I
3r?rTci 1 <a*i
extraordinary
jrnr H—3—(i)
PART II—Section 3—Sub-section (i)
5ll?4cb|< # srotef
PUBLISHED BY AUTHORITY
5 58]
No. 558)
2 6, 1990/qt<T 5, 1912
SWT,
NEW DELHI, WEDNESDAY, DECEMBER 26, 1990/PAUSA 5, 1912
O’
ufam
F" Vfft
srnft
shut
st
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Scpnr;-:e Paging is given to this Part in order that it may be filed as a
separate compilation
M?<<4K 4>
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4. niwvqr fan far vfar^r % ffanr qr-ai # fafarvvifa'
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450 fa.TH.
300 fa. iTT.
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1500
fa.
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PEOPLES EDUCATION FOR HEALTH Arr*™-'
VOLUNTARY HEALTH ASSOCTATmv -if \T>»r
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3429 GI/90
40, Institutional Area, (Near Q^r^h
South of 1 I T,
New Delhi - 110 016.
Ph. : 66807 J 668072.
arn; w, faftrr nrqnx,. fatafa vk sthtett htw vfaffarfa
1940 ( 1940 HV 23)
UFTi 26^ ffRf 5^T STfafaT ?n
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Fltf^TT H. Hf.qn.fa.H. 578 (v), afafa 23 Wit
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(1)
THE GAZETTE OF INDIA : EXTRAORDINARY
2
(29) frnHfaffar
qr sfaritn far^
sfa
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1000 fa.trr.
1500 far.tn.
(30) smfa VWTT (snxer) ttu
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# 4414’1 5
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fa^r 20% sit h
( 32) ’fat
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fafafaffait, fa’fa 0. 5%^7./^4
11014/ 3/ s s-ir
q vfafa faq,
percentage higher than 20% proof except prepara
tions given in the Indian Pharmacopoeia.
5. All Pharmaceutical preparations containing
Chloroform exceeding 0.5% w/w or v/v whichever
is appropriate.
’■4
’147
ex
fefafaawf
[Part II—Sec. 3(i)J
sffa fr
tlfad
fatqoff
*4 (^-4
M fad IT
H.OT.TiT.fa.tf. 578 (st) rTlTW 23
1983 TT
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fan fa fad ■Hfu^ddi’Mi ski faqr
49(?l) cTRFa 31-1-1984
1. ’rr.TT.fa’.
2. Hr.^T.PT. 322(sr) dlfra 3-5-19 84
3. HT.^T.FT. Sb:3(5F) qRfa 22-1 1-1985
15-6-1988
700 (St)
4.
1 057( 3T)
31 1-1938
s.
MINISTRY OF HEALTH AND FAMILY
WELFARE
(Department of Health)
NOTIFICATION
New Delhi, the 26th December, 1990
G.S.R. 999(E).—Whereas the Central Govern
ment is satisfied that the use of the following drugs,
namely
1. Fixed dose combination of sedatives/hypnotics/
anxiolytics with analgesic—antipyretics.
2. Fixed dose combination of pyrazinamide with
other anti tuberculer drugs except combination of
Pyrazinamide with Rifampicin and INH as per
recommended daily dose given below
Prugs
Minimum
Maximum
Rifampicin
INH
Pyrazinamide
450 mg.
300 mg.
1000 mg.
600 mg.
400 mg.
1500 mg.
3. Fixed dose combination of histamine Ha—
receptor antagonists with antacides excerpt for those
combinations approved by Drugs Controller (India).
4. The Patent and Proprietary medicines of fixed
dose combination of essential oils with alcohol having
do not have the therapeutic value claimed or pur
ported to be claimed for them or for which there is no
therapeutic justification and it is necessary and
expedient in the public interest so to do;
Now, therefore, in exercise of the powers con
ferred by section 26A of the Drugs and Cosmetics
Act, 1940(23 of 1940), the Central Government hereby
makes the following further'amendment in the noti
fication of the Government of India in the Ministry of
Health and Family Welfare No. G.S.R. No. 578(E),
dated the 23rd July, 1983 namely :—
In the table appended to the said notification,
after S.No.27 and the entries relating there fo, E
following serial numbers and enterics shall be addc_,
namely :—
(28) Fixed dose combination of Sedatives/hypnotics/
anxiolytics with analgesic—antipyretics.
(29) Fixed dose combination of Pyrazinamide with
other anti tuberculer drugs except combination
of Pyrazinamide with Rifampicin and INH as per
recommended daily dose given below
Minimum
Maximum
Drugs
600 mg.
450 mg.
Rifampicin
300 mg.
400 mg.
INH
1000 mg.
1500 mg.
Pyrazinamide
(30) . Fixed dose combination of histamine H2 —recep
tor antagonists with-antacids except for those
combinations approved by the Drugs Controller,
India.
(31) The patent and proprietary medicines of fix- 1
dose combinations of essential oils with alcoL
having percentage higher than 20% proof except
preparations given in the Indian Pharmacopoeia.
(32) All Pharmaceutical preparations containing
Chloroform exceeding 0.5% w/w or v/v which
ever is appropriate.
[No. X-11014/3/88-DMS & PFA]
BALBIR SINGH, Jt. Secy.
The
Principal notification was
Foot Note :
published vide G.S.R. No. 578(E), dated 23-7-1983
amended by
1. G.S.R. No. 49(E), dated 31-1-1984
2. G.S.R. No. 322(E), dated 3-5-1984
3. G.S.R. No. 863(E), dated 22-11-1984
4. G.S.R. No. 700(E), dated 15-6-1988
5. G.S.R. No. 1057(E), dated 3-11-1988
Printed by the Manager, Gnyt. of India Press, Ring Road, New Defhi-110064
and Published by the Controller of Publications, Delhi-110054, 1991
S...
TO BE INTRODUCED IN THE RAJYA SaBHA
PEOPLES EDUCATION FOR HEALTH
. VOLUNTARY HEALTH ASSOCIATION nV
40. 'r
-'iJ'-na) Area, (Near Q,;uah Huiel)
S- - 1 r ITT.
N -v D. ihi - 110 016.
Pb. : 668071, 668072.
RAJYA SABHA
A
/
I
BILL
to provide for b£n on pre-birth sex determination tests and for matters
connected therewith.
(ShTimoti Bijoya Chakravarty, M.P.)
Bill No. XLVII of J«90
THE BANNING OE PRE-BIRTH SEX DETERMINATION TESTS
BILL, 1990
A
BILL
to provide jor ban on pre-birth sex deiermination. testa and for matters
connected therewith.
Be it enacted by Parliament in the Forty-first Year of the Republic
of India as follows: —
5
1. (2) This Act may be called the Banning of Pre-birth Sex Deter Short
mination Tests Act 1990.
title and
commence
(2) It shall come into lorce with immediate effect.
ment.
2. In this Act, unless the context otherwise requires, ‘sex determina Defini
tion test’ means scientifically gaining knowledge of the sex of the foetus tion.
by means of use of amniocentesis or by any other mode or technique
used to determine the sex of the foetus of the pregnant woman.
10
3. Al] types of pre-birth soc determination tests are hereby banned.
Ban on
pre-birth
sex
deter
mination
tests.
I
2 ■'
Penalty.
4. Notwithstanding any thing contained in any other law for
time being in force—
the
(a)
medical practitioner or any person who conducts the
test to determine the sex of the foetus of a pregnant woman; or
(b) any expectant mother who undergoes such pre-birth sex 5
determination test, shall be punishable with imprisonment for a
term which may extend to five years or with fine which may extend
to twenty five thousand rupees or with both.
Power to
raase
rujes
5. The Central Government may, by notification :n the Official
Gazette, make rules for carrying out the purposes of this Act.
n
STATEMEL’T OF OBJECTS AND REASONS
Presently pre-birth sex determination test centres are being run
throughout the country. For the last few years such centres have
flourished and have earned a lot of money from the people, These tests .
are being increasingly used by the parents and the medical practitioners
for pre-birth sex determination with the intention of aborting the female
foetus. This inhuman practice is gaining momentum day by day and
if this is allowed to continue, it would result in imbalance in malefemale ratio in the country which will be disastrous. This is high time
that a legislation is brought forward to ban such tests in the country
and provide for deterrent punishment to stop this inhuman practice.
Hence this Bill.
BIJOYA CHAKRAVARTY
MEMORANDUM REGARDING DELEGATED LEGISLATION
Clause 5 of the Bill empowers the Central Government to make
rules for carrying out the purposes of the Bill. These rules will relate
to matters of detail only and as such the delegation of legislative power
is of a normal character.
I
As introduced in Lok Sabha on
J
LOK SABHA
A
BILL
to amend the Medical Termination of Pregnane}' Act. 2971.
(Shrimati Jayawanti N. Melita, M.P.)
Bill No. 16$ of 1S90
THE MEDICAL TERLIINATION OF PREGNANCY (AMENDMENT)
BILL, 1990
By
Shiumati Jayawakti I\. Mehta, M.P.
A
BILL
io amend the Medical Termination oj Pregnancy Act, 1971-
Be ii enacted by Parliament in the Forty-first Year of the Republic
of India as follows: —
1. This Act may be called the Medical Termination
(Amendment) Act, 1990.
34 of 1971.
5
10
of Pregnancy
2. In section 3 of the Medical Termination of Pregnancy Act, 1971
(hereinafter referred to as the principal Act), in sub-section (2), before
E^.ajiation 1, the following proviso shall be inserted, namely: —
“Provided that no pregnancy of a woman shall be terminated
by a registered medical practitioner or practitioners, as the case may
be, if he or they have reason to believe that such termination is
sought with intention to commit female foeticide after having deter
mined the sex of the child to be bom by a sex-determination-test”.
Short
title.
Amend
ment of
section 3.
I
Amendzzcr.x of
section 4.
3. In section 4 of the principal Act, after clause ^).
proviso shall be inserted, namely: —
tne following
purpose of
“Provided that no dace shall be approved for_. the
1
are
held
in such
this Act by Government if sex-determination tests :
place and it is privately owned.”.
STATEMENT OF OBJECTS AND REASONS
I
I
!
!
Since the paismg of the Medical Termination of Pregnan^ Act, 1971,
it is found that notv-a-days the provisions are misused by those wTho
desire to have only male children. There are private sex-determination
clinics which carry out tests and once the foetus is discovered to be a
female, the pregnant mother often goes to a Government or municipal
hospital to have the abortion. In some cases even the sex-determination
clinics also carry out abortions on request. Sex-determination tests and
selective abortion, or female foeticide amount to misuse of science and
technology, social oppression of women and abuse of human rights.
Hence this Bill.
New Delhi;
October 5, 1990.
J AYAW ANTI N. MEHTA
u
F
rxTRAds xbom. THE-Medical Termination df-Phe=nancyact:7L37I
(Act No. 34 of 1971)
When
pregnan
cies may
be termi
nated by
register
ed
medical
practi
tioner.
, To3rt (’l) ^ora'ltnst21icing anything contained in the Indian Penal Code
that^ode
praCTitioner sha11 not be guihy of any offence under’
that Coae or under any other law for the time being in force if anv
pregnanm is terminated by him in accordance with the promsions of this
(2) Subject to the provisions of sub-section (4),
W, a
be terminated by
_ a registered medical practitioner,—
pregnancy may
(a) wnere the length of the r“‘
pregnancy does not exceed twelve
weeks, if such medical practitioner is.. or
(b) wnere the length of the
pregnancy exceeds twelve weeks
but does not exceed twenty weeks, if not less than
two registered
medical practitioners are.
of opinion, formed in good faith, that—
(i) the continuance of the pregnancy would involve
the life of the pregnant woman or of grave injurr to h' a risk to
r physical
or mental health; or
J ~
(H) there is a substantial risk that if the
child were bom. it
would suffer from jsuch physical
or mental abnormalities as to be
seriously handicapped.
Explanation 1.—Where
any pregnancy is alleged by the pregnant wnman to have been caused by rape. the
such pregnancy shall be rpresumed to constituteanguish caused by
a grave injury to
the mental health of the pregnant
: woman.
result of failure
caused bv 2S
•
?
,i!enU”ber °!
anguish
a the-snensaThS^
♦
Place
where
pregnancy
may be
termi
nated.
4- No termination of pregnancy shall be made
this Act at any place other than—
*
in
accordance
with
a hospital established or maintained b
Place for the time being approved for the
or
purpose of this
4
I
As INTRODUCED IN LOK SABHA ON
\
Bill No. 5 o£ 1991
THE INFANT MILK
FOODS, FEEDING BOTTLES AND .-T^ANT
FOODS, FEEDING BOTTLES
FOODS (REGULATION OF PRODUCTION, SUPPLY AND-....
DISTRIBUTION) BILL, 1991
.
r
ARRANGEMENT OF CLAUSES
_______ ______________
’■■■X
-
Clauses
I. Short title, extent and commencement.
2. Definitionsdp^rCertZirj- prohibitions in
[
relation to infant milk foods, feeding
bottles and<jnfant foods?)
A Prohibition of incentive for the use or sale of infant milk foods, J
feeding bottl^s-x^-LixZk^^AZ^^^’d
j
5. Donations o^nfant milk foo^'or feeding bottles or equipment
or materials relating thereto.7
fccd^ bcJftx
6. Inform at ion on containers and labels of infant milk foods er
<finfant foods^?
7. Educational and other materials relating to feeding of infants to
contain certain particulars.
8. Health care system.
9. Inducement to health worker for promoting use of infant milk
foods, etc.
10. Special provision relating to employees^ of person who produces,
sells mie^rt
*. supplies, distributes or t-IL
e~ _mrtkrfoodsr-etcJ--------------—
II. Standards of infant milk food feeding bottles of infant foodsT'X
12. Powers of entry and search.
13. Power to seize infant milk foods, etc,, or containers thereof.
14. Confiscation.
15. Power to give option to pay cost in lieu of confiscation.
16. Confiscation not to interfere with other punishments.
' j
1^. Adjudication.
y
tn
the
own
er
of
the
seized
infant
milk
>
18. Giving of opportunit;
food, feeding bottle( or infant foodXjr container thereof.
19- Appeal.
20, Penalty.
(X21. Cognizance of offences.
22? Offences by companies.
23. Offences to be cognizable and bailable.
24. Protection of action taken in good faith.
’S
' '.‘*25. Application' of Act 37 of 1954 not barred? ;■ 26. Power: to make rules.
f
4-
STATEMENT OF OBJECTS AND REASONS
Every child has a right to be adequately nourished as a means of
attaining and maintaining health. Infant malnutrition is a major contri
butory cause of high incidence of infant mortality and physical and
mental handicaps. The health of infants and young children cannot be..
isolated from the health and untrition-of- women^-The mother and- -her—
infant form a biological unit. Breast-feeding is an integral part of/ the
reproductive process. It is +he natural and ideal wav of feeding the infant.and provides a uniaue biological and emotional basis for healthy child
development. The anti-infective pronerties of mother’s milk protect infants
against diseases. The effect of breast-feeding on child spacing, on the
health and well-being of the mother on family health, on family and
national economy and on food production is well-recognised- Breast
feeding is, therefore, a kev aspect of self-reliance and primary health care.
It is. therefore, essential to protect and promote breast-feeding and to
protect pregnant women an nursing mothers from any influence that .
could disrupt it.
” 4v-.-.'
•I
. 2., Inappropriate feeding practices lead to infant malnutrition, mor
bidity and mortality in our children. Promotion of infant milk foods and
related products like feeding bottles and teats do constitute a health
hazard. Promotion of infant milk foods and related products has been
mare extensive and pervasive than the promotion of information con
cerning the advantages of mother’s milk and breast-feeding, and contri
butes to decline in breast-feeding. In the absence of strong interventions
designed to protect, promote and support breast-feeding, this- decline can
assume dangerous proportions subiecting millions of infants to greater
risks of infections, malnutrition and death.
3. In the light of the foregoing considerations, and in view of the
vulnerability of infants in the early months of life to the aforesaid risks
and the risks involved in inanpropriate feeding practices, including, the
. unnecessary and improper use of infant milk foods, feeding accessories
and infant foods, it has become necessary to regulate the marketing of
such products. For the proper nutrition and health of the world’s children,
the World Health Assemblv adonted in Mav. 1981. an International Code
of Marketing of Breast Milk Substitutes- The Government of India re
cognised this code and adopted the “Indian National Code for Protection
and. Promotion of Breast-Feeding” (hereinafter referred to as the Code)
in December, 1983.
.
4. The Code envisages that there shall be no advertising or other*
form of sales promotion of infant milk foods feeding bottles and’ teats.
The Code, in accordance with this general principle, enioins the health
authorities to encourage and protect breast-feeding, and also prescribes
several measures to control the marketing and promotion ofjnfant’ miRt
foods, feeding bottles, teats and infant foods.
-
5. The Bill proposes to give eSect to the principles and aims of the
Code. Accordingly, it prohibits advertisements of infant milk foods and
.feeding bottles and also prescribes measures to ensure that in the market
ing of infant milk foods, no impression is given’ that feeding of these pro
ducts is equivalent to, .or-bBiter- thaiVbreast.feeding-„ The provisions rela
ting to labelling and quality control of infant milk foods, feeding bottles
and- infant foods are proposed to. he implemented.- through the concerned
departments, in the State Governments and-Union Territory Ariminfctrations under the overall’ control of the Ministry of Health and.Family Welfare,' Contravention, of'the provisions of the Bill will Hr punkhphle''
with’ imprisonment for a term which' may extend ta three-years..or■ with^
fine which.may extend to five thousand rupees..or with both. However^
the contravention of certain provisions of the Bill relating-tn labelling.-pr
quality control of such foods will be punishable with imprisonment .for’
a term .which shall not be. less.than six months but which may extend to
thre$ years, and with fine which.shall. not be less than two thousand '
rupees'.
...
------
The Bill seeks to achieve the above objects.
•’• ■NiW’ Delh^ ■
(
RAMJILAL-SUMAN.
1S9L -
J
i
i
..
J
% 11 o / y
o
D.O.No.DDG-ND/.lO/l/OO
• nixtr rrom
FIIW
cTfv(n
nV fcrft-11001 1
GOVERNMENT OF INDIA
MINISTRY OF HEALTH Oc FAMILY WELFARE
NEW DELHl-l 100 1 I
q kj era enr^
M. S. Dayal
Dated September 3, 1990.
j. Secrotary {Health)
No. 301 7481)
•i
DearShri Gilij
The Health Secretary had sent a list of ‘ drugs commonly used
In various .National '< Health Programmes, (copy enclosed for ready
. ■ • reference);
He hdd also T prohilsecjto send a list .of essential drugs.
Accordingly, d list of drugs commonly required by medical practitioners
and ’ Specialists has been . compiled by the Dte. General of Health
• Services in consultation with-experts belonging to different disciplines
■ of medical sciences; The drugs have been classified system-wise under
different therapeutlc/pharmacology classification.
The newer drugs’
which are more expensive do not figure in tiie list.
The selection
of drugs, is - based ’ on prevalent diseases pattern
for combating
emergency. The criteria adopted for selection of drugs are one erf
the more,of'the following:-
/
!
I
the
treatment
1.
The drugs v/hicli are popularly prescribed
of diseases or for symptomatic relief.
2.
The drugs having broad spectrum of ’action.
3.
The drugs
effect.
4.
The drugs having better bioavailability and lesser side effects.
having
action
restrictive
but
for
specific
or
desired'
Alullst of these drugs is enclosed.
It may be pointed out that
most of the drugs considered, essential by Hath! Committee also find
a place in this list.
This li^t of essential drugs has been compiled with the object r' e
these
medicines should be available’ in plenty and in quality
that
the market and there should not be. any shortage of these medicir. s
Various constraints responsible for shortage of these medicines sho
be removed. The drugs commonly used in National Health Programmes
are not represented in this list because the list of these drugs ha-^e
already been made available., to the Department of Chemical and Petrc-
l
----- --- _____________ ____
j
Ili
t
"*
~
I
......................
I
X
/
7 y-
. 2 .
Chemicals. However, the drugs In both the .lists havto be made available In plenty and in quality and there
should not be any shortage of these medicines.
like production,
factors
other
Various
be
examined
and
may
distribution,
pricing,
etc.
Chemicals
and
Petro
considered by the Department of
Chemicals.
With regards,
Yours sincerely,
/I
I
i
(M..?.Dayal)
Shri M.S.Gill,.
Secretary,
Deptt. of Chemicals & Petrochemicals,.
Shastri Bliavan,
New Delhi.
2
9.
)
•« n • I -'''' ’
Trifluoperaainc
Amitriptyline.
Imipramine Hcl.
Chlorpromazine-
1.
2.
3.
4.
Diab^ControU-^^
10.
Insulin injection.
Glibenclamide tablets. .
1.
2.
Cancer
11.
___ _ Mustard injection.
Nitrogen
Bleomycin injectio
Mitomycin injection.
Methotrexate injectio
Vincristine injection,
fluorouracil injection.
Vinblastine injection.
Cisplatin injection.
Melphelan tablet,.
Procarbazine tablet.
Etoposide tablet/capsule.
'Tomaxifen tablet.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
12.
Control_ProSramme
Guinea Worm
Eradication Pro^ramne
No specific drug.
13.
Diarrhoeal
1.
14.
Control Prosraiz-ethe WHO recommended rormula.
ORS containing
Health Activities
Maternal and Child
(Iminunization)
Vaccine 1
DPT
1.
OPV
2.
BCG
3.
Meales.
4.
D.T.
5.
T.T.
6.
Vitamin Deficiency
and Folic Acid tablets.
Iron
1.
Vitamin A. '(f.r-h1”
a
f:
r -**
Gastrointestinal Drugs
AntZhelmintkic
Mebendazole (tablet, suspension)
Piperazine (tablet, elixir, syrup)
Pyrantel Pamoate (tablet, suspension)
Albendazole (tablet, suspension)
Antiamoebic
Diloxanide (tablet)
Metronidazole (tablet)
Dilodochlorohydroxyquinoline (tablet)
Antibacterial
Furazolidone (tablet, suspension)
Cotrimoxazole (tablet)
Sulphaguanidine (tablet)
Norfloxacin (tablet)
Antacid/Anti-ulcer
Dried Al. hydroxide gel (250mg) + Mg. trisilicate (500mg)
(tablet)
Propantheline (tablet)
Isopropamide (tablet)
Oxyphenonium bromide (tablet)
Ranitidine (tablet, syrup, injection)
Antiemetic
Metoclopramide (tablet, injection)
Prochlorperazine (tablet, injection)
Pheniramine (tablet, injection, syrup)
Antihaemorrhoidal Drugs
Antihaemorrhoidal ointment (Hydrocortisone acetate 4- Lidocaine 5%
+ zinc oxide)
Antispasmodics
Atropine (injection)
Hyosin Butyl Bromide (tablet, injection)
Analgin + Beralgal Ketone (injection)
Cathartic drugs
.Senna (tablet)
Bisacodyl (tablet)
Liquid paraffin
Glycerine suppository
Antl~anaemic drugs
Iron with folic acid (tablet)
Folic acid (tablet)
Hydroxycobalamine (injection)
Iron Dextran (injection)
Antibacterial/Antiviral drugs
Procaine penicillin (injection)
Crystalline penicillin (sodium pencillin G)
Benzathine penicillin (injection)
Amoxicillin (capsule, suspension, injection)
Chloramphenicol (capsule, suspension, injection)
Cioxacillin (capsule, injection, suspension)
Erythromycin (tablet, injection, suspension)
Tetracycline (capsule)
Gentamicin (injection)
Cephalexin (capsule, injection, suspension)
Sulphadiazine (tablet, injection)
Sulphadimidine (tablet)
Sulfasalazine (tablet)
Sulphamethoxazole + Trimethoprine (tablet, injection, suspension)
Acyclovir (cream)
5-amino salicylic acid(5ASA)(tablet)
Urinary antiseptics
Nitrofurantoin (tablet, suspension)
I
i
Nalidixic acid (tablet, suspension)
Norfloxacin (tablet)
Oxytoxics
Ergotmetrine methylergometrine (injection,
tablet)
Oxytocin (injection)
CNS-ACTIVE DRUGS
General
anaesthesia
, . Ether (liquid)
Halothane (liquid)
Ketamine (injection)
Oxygen (gas)
Nitrous oxide (gas)
Thiopental sodium (injection)
Local anaesthetics
Lidocaine (injection - plain and with adrenalin/ jelly)
Bupivacanie (injection)
Cardiovascular diseases
Glyceryl trinitrate (sublingual tablets)
Digoxin (tablet, injection)
Hydrochlorothiazide with or without triamterene (tablet)
Isosorbide dinitrate (sublingual and oral tablet)
Methyldopa (tablet, injection)
i
Verapamil (tablet, injection)
Nifedipine (tablet, capsule)
I
Dlltiazem (tablet)
Propranolol (tablet, injection)
Atenolol (tablet, injection)
Labetalol (tablet, injection)
Furosemide (tablet, injection)
Spironolactone (tablet)
Captopril (tablet)
Enalapril (tablet)
Sodium nitroprusside (powd
Hydralazine (injection.
II
I
er for injection)
tablet)
Quinidine (tablet)
Procainamide (tablet. injection)
Streptokinase (injection)
Dopamine (injection)
Ephinephrine (Injection)
Clonidine (tablet, injection)
Bronchial Asthma
Ephedrine (tablet, syrup)
Aminophylline (tablet, injection)
I
Salbutamol (tablet, liquid, injection, inhaler)
Terbutaline (tablet, liquid, injection, inhaler)
Theophylline (tablet, liquid, capsule)
Disodium cromoglycate (oral inhalation,
cartridge)
Beclomethasone (inhaler, nasal spray)
. fi
Allergic disorders
Chlorpheniramine maleate (tablet, injection)
i !
Promethazine (tablet, liquid, injection)
Pheniramine (tablet, injection)
I
il
Prednisolone (tablet)
Hydrocortisone (pellet, injection)
Dexamethasone (tablet, capsule, injection, eye drops)
/
zzZLes Meilitus
X Insulins (Injection)(fast, intermediate and long acting)
Tolbutamide (tablet)
Chlorpropamide (tablet)
Glibenclamide (tablet)
Metformin (tablet)
Skin diseases
Benzylbenzoate .(lotion)
Salicylic acid (powder, ointment)
I
Ketoconazole (tablet)
Miconazole (lotion, cream, vaginal pessaries)
Nystatin (oral & vaginal tablet)
Benzoic acid (powder)
Neomycin + Bacitracin (ointment)
Grisefulvin (tablet)
Calamine (lotion)
Betamethasone valerate with or without neomycin (cream/lotion)
Hydrocortisone (ointment or cream)
Gentian ciolet (solution 1%)
Coal tar (ointment)
Silver nitrate (solution)
Psoralen (tablet, ointmetn, solution)
1
Autonomic drugs
.
Adrenaline (injection)
Atropine Sulph.
(injection)
Dopamine Hcl (injection)
Neostigimine .(injection,
tablet)
Physostigmine (injection, tablet)
Isoprenaline (tablet, injection)
Edrophonium (injection)
I
Skeletal muscle relaxant
Gallamine (injection)
Succinylcholine Hcl (injection)
D-tubocurarine Hcl (injection)
Methocarbamol (tablet)
Anticoagulants & coagulants
Heparin (injection)
Warfarin Sodium (tablet)
Protamine Sulph.
:■
i: '■
(injection)
Vitamin K (injection)
Blood products S blood substitutes
Dcxtran-70 (injection)
Human Albumin (inj ection)
Factor VIII concen trace
(II,VII,IX,X)
TV rate
. >rwTTTrr
-.:.z lexical pre p-arations
a)
Anti-infectives
Idoxuridine (drops, ointment)-
Silver nitrate (drops)
Sulphacetamide (drops/ointment)
Tetracycline (ointment)
Gentamicin (drops)
Chloramphenicol applicaps
Polymyxin B
b)
Anti-inf lamina tory
Hydrocortisone (ointment)
c)
Local anaesthetic
Tetracaine (drops)
d)
Miotics & Anti-glaucoma
Acetazolamide (tablet)
Pilocarpine (drops)
Timolol (drops)
e) . Mydriaties
Homatropine (drops)
Phenylephrine (drops)
Hormones & their synthetic substitutes
Ethinylestradiol (tablet)
Ethinylestradiol + More this terone (tablet)
Ethinylestradiol + Levonorgestrel
Prednisolone (tablet)
Norethisterone ('injection, tablet)
Testosterone (injection)
L-Thyroxine (tablet)
Carbimazole (tablet)
Lugol’s iodine solution
ACTH (Corticotropin)
(injection)
Tamoxifen (tablet)
Megestrol acetate (injection)
Diuretics
Furosemide (tablet, injection)
Mannitol (injection)
Spironolactone (tablet)
Hydrochlorothiazide (tablet)
■
Chlorthalidone (tablet)
/ •
rcotic analgesics & antagonists
Morphine (injection)
*
Naloxone (injection)
Pentazocine (injection)
Pethidine (injection)
Analgesic-antipyretics, NSAI, intigout & antimigrane
I!
Aspirin (tablet)
!!
Allopurinol (tablet)
Colchicin (tablet)
Probenecid (tablet)
Analgin (injection, tablet)
. Diclofenac (tablet)
Ergotamine (tablet)
Ibuprofen (tablet, syrup)
Indomethacin (tablet, suppository)
Paracetamol (tablet, syrup)
Oxyphenbutazone (tablet)
Naproxen (tablet)
Anti-epileptic agents
Carbamazepine (tablet)
Phenobarbitone sodium (tablet, injection, syrup)
Phenytoin sodium (tablet, injection, syrup)
Sodium valproate (tablet)
Diazepam (injection)
Anti-parkinsonian agents
!
Levodopa (tablet)
Carbidopa (lOmg, 25mg) + Levodopa (lOOmg,250mg) (tablet)
Biperiden (tablet)
Immunologicals
Tuberculin (PPD)
(injection)
Human Anti-D immunological (injection)
Antirabies. Hyperimmune serum (injection)
Anti-snake venom serum (injection)
Human normal' immunoglob.
(injection)
Diptheria antitoxin (injection)
Tetanous Antitoxin (injection)
Tetanous Toxoid (human)
(injection)
Rabies vaccine (antirabic vaccine carbolized and human diploid
cell vaccine)
!
J
I >
. >*■
I
II
1
Vitamins
iA.scorbic acid (tablet, injection)
Ergocalciferol (capsule, solution)
Vitamin-B complex (tablet, capsule, syrup)
Pyridoxine (tablet)
Retinol (oral solution, capsule/tablet)
Riboflavine (tablet)
Thiamine (tablet)
Calcium gluconate (injection)
Solutions correcting water, electrolyte and acixi-base balance
ORS powder (WHO formula)
Potassium chloride solution
Calcium chloride solution
Dextrose (injection 5%,
10Z, 20Z)
Potassium chloride (injection)
Sodium biacrb.
(injection)
Normal saline (injection)
Dextrose-saline (injection)
!
Ringer lactate (injection)
Water for injection
Peritoneal dialysis fluid
Hemodialysis fluid
Antidotes to poisons
Charcoal activated (tablet, powder)
Desferoxamine (injection)
Naloxone (injection)
Sodium calcium edetate (injection)
Sodium thiosulphate (injection)
I
D-Penicillamlne (tablet)
Diagnostic Agents
Amidotrizoate (injection)
Barium Sulph. powder
lopanoic acid (tablet)
Propyliodone (injection)
lohexol (injection)
lotroxate (injection)
■*
I ■
The experts who were identified to compile list of common.! v
required essential drugs had also suggested certain drugs which
wouxd fall under the list of drugs required for National Program
They had recommended the following additional drugs under Cane
Control Programme’, ’Mental Health Programme’ and ’Diabetes Cont
Programme’.
1.
Cancer Control Programme
Cyclophosphamide (tablet)
Doxorubicin (injection)
Mercaptopurine (tablet)
Vineristine (injection)
Calcium folinate (tablet, injection)
Vancomycin
Interferons
Ceftazidime
Methicillin
Carbenicillin
Piperacillin
Amphotericin
Cefazolin
2.
Mental Health Programme
Diazepam (tablet, injection, syrup)
Haloperidol (tablet, injection)
Lithiumcarbonate (tablet/capsule)
Pimozide (tablet)
3.
Diabetes Control Programme
The final list of drug required under Diabetes Control Pis given in the list of commonly required drugs.
This list sb
be considered as final and the earlier list of drugs given un
Diabetes Control Programme may be amended accordingly.
•uIST OF ORVGS COMMONLY USED_ln2Al
HE.XLTH PP'OGR^-’-L^
)
•S'7
Mai aria Eradication Programme
Chloroquine tablets.
1.
Amodiaquine tablets.
2.
Primaquine table ts.
3.
tablets.
Quinine
4.
tablets.
Sulphadoxine Py.Comb.
Py
5.
Quinine injection.
6.
1.
KALAZAR
Gluconate/scipronatc,1 .
1
--.e inj. (Sodium Antimony
Sodium Stibogluconat
1.
injection.
Pentamidine Isethionate
-----2.
filaria Control^ro^amme
DEC tablets. •
1.
Trljr^v Eradication Programme
3.
Rifampicin capsules.
Clofazimine capsules.
Dapsone tablets-
1.
2.
3.
Tuberculosis Conr~ol Programme
4.
1.
2.
3.
4.
5.
6.
5.
6.
INH tablets.
Tbiacetaaone.
Combination
and Thiacetazone. •
Ethambutol tablets.
Rifampicin capsules.
Streptomycin injections.
Control of 31indr.ess Progragte
Silvernitrate solution (e>eyr°ps^
1
Tetracycline eye ointment
Solution
9
Hydrocortisone eye ointment i...
3
Acetazolamice taolets '
4
Pilocarpine eye crops
5
Tinolol eye drops 0.25/., J.o/.6
Gn-ir.re Control rrosrame
Mo drug.
7.
Q
-red Diseases Con tr o1 Programme^
Sexually Trans
Penicillr:
1.
Tetracycl r.e
'.O*-- c I
2.
Nystatin
3.
/
Amp ho t e r r c -n 3.
AIDS Control
Mo specr
roaramme
crug.
■
\
ALL INDIA DRUG ACTION NETWORK
PEHAPP-1 (1)
November 1, 1990
Dear Friends,
Essential Drugs:
The list of 280 drugs prepared by the Health Ministry is being sent. It
is for the first time they have undertaken this exercise. It is extremely
unfortunate that drugs like analgin, hydroxyquinoline and oxyphenbutazone
have been included, in spite of my having protested against their inclusion
the Essential Drug List. The number of drugs in certain therapeutic
categories is also quite large - but as long as they are rational and their
inclusion have a greater acceptability of the concept of the Essential
drug list - may be it is better to let it be, for the time being. The
concept of essential drugs has to be popularized and due credit for even
attempting the formulation of a list has to be given, in the larger interest
of getting the concept accepted. The Chemicals Ministry and the Industry
would be delighted to get it all sabotaged as being controversial.
Drug Pricing:
A government Standing Committee has been formed to look into the categori
zation and pricing. There is no representation from the Consumer Groups
or health groups. The reasons are obvious.
/
If ever the need comes up for regarding AIDAN representation for drug
pricing and categorization. I suggest that Dr. Anil Pilgaonkar,. MHC; or
Cheenu Srinivasan, LOCOST; Dr. Narendra Mehrotra or Academy of young
scientists should deal with it. Obviously on going study of the drug
pricing issue is required. Anil had done an excellent study for AIDAN
of the performance of different drug companies which had impressed
Mr. Gurupadaswamy very much at the joint meeting with drug industry trade
and consumer groups. I am sending some additional material to the above
three, hoping that they will make their analysis of the situation available,
eg. what are the implications of 5% ceiling of price rise as apparently
(based only on news paper reports) announced by Mr. Gurupadaswamy. The
price fixation exercise is basically the territory of BICP, what will be
the relationship between BICP and the Chemicals Ministry?
Should the price fixation be left with BICP when it has alleged that it
is unable to do price fixation of merely 20-30 drugs per year, and BICP
itself is in favour of automatic pricing? What are the implications of
further 15% price increase due to increase of cost of petroleum products,
when the industry had already demanded increase of markups to 100% to 150%
for category I & II?
..2..
4
:2:
How would the changes envisaged regarding changes in the packaging cost
really alter the drug prices, significantly or unsignificantly?
Since the industry and trade are threating to go on strike in Novemeber,
We must have a clear pricture of which are the more significant and insignificant
areas in the area of drug pricing the issue of conversion cost, packaging cost,
price increase, ceiling, uniform pricing and altered differential pricing.
Drug Manufacturers Meeting:
On 10th and 11th November CHAI is organising a meeting of the drug producers
in the voluntary sector to link up with the quality control Lab that CHAI
may be setting up to provide unbiased testing results. This would be a
great contribution to consumer and health groups, where besides drug testing
food testing for hazardous chemicals etc. could also be undertaken. We
hope that CDMU, Calcutta; LOCOST, Baroda; essential medicinal project,
Madras; will be able to do more indepth work regarding drug prices, taxation
structure — as they affect essential drugs, the MNC’s and the Indian sector,
public sector and small scale sector, implications of OGL in importing
essential drugs and useless drugs - their prices, and the effect of OGL
on indigenous drug production.
The questions that need to be answered are many but as has been our experi
ence in the past long term consistent said work is required by a few to
make it available to others for further dissemination.
Coalition to counter Drug Industry Pressure
Several Trade Unions as; well as MARD & MFC have come together in Bombay
twisting tactics by the drug industry, which
to protest against the arm
.
is threatening to go on strike. For more information please contact Dr.Amar
Jessani, FRCH or Dr. Anil Pilgaonkar, MFC.
PATENTS Intellectual Property Rights and GATT
By the first week of December GATT negotitations will be completed in Geneva.
Major changes which are not in the interest of the Third World countries
are expected. At a crucial time like this it is unfortunate that clear
guidelines by the government to the negotiators may not be forthcoming.
It is for the first time that issue of intellectual property rights invest
ments and services eg. banking, insurance, etc. will be discussed in GATT
and decisions taken and enforced. A lot of work has been done on Patents
by the National Working Group on Patent Laws. Chakraborty Raghavan s
'Recolonization’ is an excellent book on the subject brought out by the
Third World network subsidized cost of Rs. 100/-. Those of you who are
interested in the subject please let me know.
Will keep you informed and with regards,
Yours sincerely,
I .
Dr.
Head, P1
5
MD
ic Policy Dvn.
VOLUNTARY HEALTH ASSOCIATION OF INDIA
I—^-fl
AND
e<| ALL INDIA DRUG ACTION NETWORK
Institutional Area, (Near Qutab Hotel)
South of IIT, New Delhi-110016
—"
PEHAPP-1 (1)
-----
--i
—
November 9, 1990
Dear Friends#
You. must be knowing that Dr# Zafrullah has been one of the
authors of the courageous Bangladesh Drug Policy as well as
the Bangladesh Health Policy© Besides other changes in the
interest of the poor Private Practice by Government doctors
was banned under the new National Health Policy. This has
obviously not been appreciated by the government doctors©
Bangladesh Medical Association has openly protested against
its implementation© The medical doctors had never quite
approved of the Rational Drug Policy of Bangladesh as they
felt it curtailed their clinical freedom as several irrational
and hazardous drugs were removed© The Drug Industry specially
the multinationals have been very angry about the drug policy
anyway because it curtailed their exploitation.
Since Dr. Zafrullah and friends in GK have played such a
critical role# they are at the receiving end from the vested
interestoWhat has been done to the GK office in Dhaka is
really shameful© The enclosed text of Dr. Zafrullah’s fax
gives the detail©
In 1982 it was tremendous support received from the health and
consumer groups in India and outside that had saved the
Bangladesh drug policy from being sabotaged. The increasing
influence of vested interest in policy making is nothing new but acts of violence and victimization of those raisingtheir
voice in the interest of the people is a phenomenon# which
we will see more in the coming years© As supporters of the
National Drug Policy# the new National Health Policy and
GK s efforts we express our concern at this cowardly act and
we hope that such acts are never allowed to happen the
miscreants brought to book.
Please send a letter of solidarity to Dr© r
~
‘ Chowdhury
Zafrullah
and Dr© Quasem Chowdery,> G.K. and also send a letter or
telegram expressing your concern to General Ershad# the
Health Minister*
With regards#
(Ja;a;I k£I$HajA/V
fZ Dr ♦ Mira Shiva MD
Coordinator,ALL INDIA DRUG ACTION NETWORK
Head# PUBLIC POLICY DVN.
encl;
L - ' 'i
< }
ALL INDIA DRUG ACTION NETWORK
October 19, 1990
PEHAPP-1 (1)
Dear Friends,
I am enclosing an essential drug list as formulated by the Health
■’
•1 - ’list of
--c drugs
j--- -in
j-j common
Ministry,
as they
call it the
common use
use ’.
and
the
’
drug
pricing
’
is
left
to
the Chemical
The ’categorization’ <
.
Ministry.
Unfortunately, Diiodo hydroxyquinoly, analgin, oxyphenbutazone
have been included, but it is also a fact that it is for the first
time that the Health Ministry has attempted to formulate an
Essential Drug List.
VZhile congratulating the Health Ministry for at least attempting
to formulate the Essential Drug List, the need to exclude the
controversial drugs must be expressed. The Chemicals Ministry
needs to be questioned as to what it is doing with the Essential
Drug List. The drug debate has got too stuck on drug pricing
with the increase of the petrol and the petro chemicals prices
too will shoot up.
On 10th, 11th is the drug producers workshop in Hyderabad organized
by CHAI. We will be discussing the drug policy aspects. I was
wondering if we should use this opportunity to meet and work out
our action strategy and have an AIDAN Core Group meeting with
it or immediately after it.
This may be important in view of the proposed ban by the Pharmace
uticals Industry, (newspaper articles enclosed).
The next issue of VHAI’s bi-monthly is a soecial issue on drugs
and I am the Guest Editor. In case you have anything eg. ’’quotable
quote” ’’Cartoon”, any news bit that you feel others should know
about, then please do send them. I am hoping that we include
as first hand experience as possible since the Indian Drug Action
efforts are quite unique diverse and yet complementing.
z
..2..
&
5°^
:2:
Since the time is short I am not writing personally. We are inclu
ding a list of drug material produced by the drug groups - if
there is anything that we should include please give the details
of the material, price, contact address, etc.
Hazardous & Substandard Drugs
From November 4th-8th I will be in Barelly, U.P. conducting Women
and Health workshop. A lot of work is required in the area of
Women and Pharmaceuticals as well as Rational Management of Gynaec
ological and other health problems of women.
On 20th September the Net en hearings, were held. Norplant produc
tion and promotion as part of the Family Planning programme will
be taking place shortly. At the Jaipur Workshop in 1982 background
materials on ’’Use of steroids in Pregnancy" had been prepared
by Sathya. Saheli has complied information on Net en for the
litigation case they have filed.
A lot of this information needs updating. The ban on Chlorampheni
col Streptomycin and Steroid combination has still not been imple
mented. No Gazette Notification banning 13 drugs recommended
for being banned by MA Patel committee has been issued as yet.
According to Dr. Sagun Desai an attempt had been made to get these
drugs banned only after further conduction of clinical trials
(obviously sponsored by the manufacturers) to assess their hazar
dous nature. This is obviously a futile exercise and a delaying
technique. The focus of the Drug Policy review needs to be put
back, from ’pricing on to failure of withdrawal of hazardous drugs’
and ’failure of ensuring good quality control. Several vaccination
deaths have occured by Indian Pardiatrics in January. Indian
Paediatrics has raised a protest regarding sending of the vaccines
by normal parcel post. The OBI enquiry regarding the I.V.contamina
tion healths in Delhi is not yet over. We do not know how much
of Lentin Commission Report has been implemented. ACASH and MFC
Bombay will need to update us about that.
In view of all the confusion, corruption, manipulation and moral
degradation all around - it is becoming extremely obvious that
while issues are important, it is much more important to ensure
that all that is the .best within each human being is not merci
lessly allowed to be destroyed.
It is this crisis that is of greater concern because it is linked
up with cooption and corruption of the people as well as the most
..3..
:3:
important words and concepts like 'social justice’, ’people's
participation,’ ’rationalization’,’empowerment’, what is the role
of individuals and groups who have made sacrifices, believed
sincerely in higher ideals and lived out in their personal lives
what they believed inspite of threats and victimization.
There was a time we believed that it was due to lack of information
that the situation was such. After so many years I do not feel
this is the main reason, - something within has died within the
people which is reflected in the widely prevalent corruption on
one hand apathy and indifference on the other, over health issue,
education, drugs, baby food, junk food, liquor, pesticides, pollu
ting industry, child labour, bonded labour, violence against women.
The drug action brought a lot of concerned and committed individual
together who freely pooled in their ideas and efforts, built an
informal network where it was not the money from funding agency,
but a shared concern that was the binding force.
And for the first time in history a challenge was posed to the
vested interest which was earlier limited to drug industry, trade
politicians and some beaurocrats.
It is evident that with time the demands on those struggling for
change will increase so also will the victimization and the
attempts at neutalization , co-option.
It is a difficult phase of the drug campaign, but it must carry
on by the sheer grit of those involve, inspite of all the numerous
constraints. We may need to totally alter our strategy with so
many AIDAN members having developed so much experience and
expertise - specific thrust areas need to be identified and coor
dinated by those best equipped eg. Legal Action, Drug Industry
related monitoring etc.
Wishing you all a Very Happy Diwali,
Yours sincer
y,
Dr. Mira/bhiva MD
Coordinator
All India Drug Action Network
L
..
1
.s
6L
?
A o? JA
r,
By A Staff Reporter
Chemicals
Mr
M.S
For the first time ever Gurupadaswamy.
*. •
< the pharmaceutical In Th4 Join! Council of
Phardustry In the country Is maceutical Industry, comprising,
going on an Indefinite the various national bodies, took
strike . next month in this decision in a.meeting in Bom
retaliation against the bay on Monday where even the,
moderates endorsed the call for’
1 "Inflexible and rigid at the
Bandh which Is an unprece
titude" of the Minister dented step. The bandh is ex
x for ; i Petroleum
and
pected
to coincide
with the winter
\__ ___
_______
_____
sosslon o( Pctfliamont. •
Official sources in the industry
claimed that - the manufacturers
had been plunged in a crisis over
the failure of the Minister to grant
them pricing, approval on the cur
rent price rejzisions as laid out in
the Drug Plice Control Order of
1907.'■
The
crisis • has worsened
(conId. on P.12) '
/
unprocodontod modlcali crisis. A
(
ffl g
.. ,
^.'.spokesman of the Industry, how(contd. from P.1)
' . ■^°ir’clQ'llloff..,hat essential ||(0
i
7
Saving drufjs. would not bo
recent weoks with the Ministry In- s,0PPed-'
'
•
MP,
and|
i
<
;
I.
P
In
oridh next
■■
r
5V
,
■
■
In the absence of any new policy
asPioco^er/of
called vclalms“undo the n
avai|.'' ' '
J,?0
Council consists of the
°
DrlJg Manufacturers As-
■ Mmisteron.Julyai-tocallofHhoIr" nmn^f
Chemists, and
8. Mr Gurupadaswamy had
as
I
I
cording to the Industry,
Industry three
months have lapsed and the Min
Istry has yet to take
tak any steps.
istry
'
i
- While
earlier
it - was •-..the
moderates who prevailed uponA
the hardliners with constant coun<. ■’
sol provided.by bureaucrats at
ohastri Bhawan to avoid the’
Bandh this time the Counsel has/been unanimous In its approach.
The bandh coupled with, the’
prevailing 1 shortage in essential ‘
■ • li e saving drugs, due to stoppago •
of production of severahdrugs on ?
account of unremunerative prices ?
'
')
■/ /
/i
I
i I
Ovei .■ ,< _ .j- es§ . zjg] 12S
listed for health care
l rom Our Bombay Bureau
J
i ; The health BmOnM^-OCtObCr8-
' fe
■
and
/!•
pentamidine
££=? sscjsayftss
a guide-
."fe
tertiary
; health care “A lary and
d tertiary
group ofha^lso
experts
attached to'the Ministry
.... ............ -
me (no specific drugs). 9. Mental
control programme (bEc”tabie“ts)“ n,“ th'- pr08,:llnm« (trif.
3. Leprosy eradication program- fnrfnX"0'
me (rifampicin and clofazimine \Pramine' chlorpromazine,
capsules and
and dapsonc
dapsone tablets)
tablet^ 44 ^a"Pa">. haloperidol and lithium
capsules
Tuberculosis control programme
bo"s,c '?■ Gabeles control pro-
«=«"“jess,
(
'•f
■
t ^commended expansion of the list
I ot diseases covered by the national
• the national health programme adrnmistered by the health ministry
™is W111 consist oi
of me
the fbllowme
followi—
diseases (drugs meant.for each dis:
• •brackets)?
■
t —
ease —
is given~in
“
. 1. Malaria eradication programme
(chloroquine, amediaquine, prima
quine, quinine and syulphadcxine• py. combination tables and quinine
, injection).
T--- (a) Kalazwar (sodium
"T
I
I'1
under this head, including ihose
manufactured
5” Control of blindness program- "?
a.n.l,^.clurc^ in India like
me (silver nitrate solution, vinblastine and vincristine).
worm eradication
eradication proCye -0*ntmenl, 12. Guinea worm
roclortls,ene
onitment; gramme
gramme (no
(no specific
specific drug)
drug). P13
eve dmnT^d rtab m ’ p,?ocarpine D,arrh°eacal diseasei control
control proproeye drops and timelel eye drops). 6. gramme (ords containing the WHO
SupG 7C^tr° n programme <no formula). 14. Maternal and child
eases' LS
hCa,th a"tivilics (immunization
eases (pencililm G injection, vaccines DPT, OPV BCC moadec
intT0 *ne Capsu,es’ nystatin DT and TT and vitamin dcficicnc•y’’
intro-vagmal tablets and formulatins: “ro and folicT
acids
^hlp^T'AinQh ,nl[a-vaginai lab,cls ;3nd vitamin deficiency/ fortablets. 8. AIDS control program- .
Continued on
PaBe 6, col. 1
I
Essential drugs
Continued from page 1, col. 8
desirable effect, drugs generally not
mulations: iron and folic acid abused by an individual and better
tableli.qqd vitamin ^jablcls).,
bio-availability and lesser side efThe rest of the drugs classified ’ fects.' under Mother commonly required
drugs’’'cover, among others, gastro- The report says that categorisation
intestinal diseases, cardiovascular
drugs under 1987 DPCO “has
diseases, allergic disorders, skin dis- generated more heat than light",
cases, blood products and J he apparent contradictions in ex
substitutes,- ophthalmic prepara- *st’ng categorisation arc “possibly
lions,' ''aniidotcs and diagnostic due Io amalgamation of therapeutic
agents;; ;
.
and non-therapeulic parameters,"
' b I.Til'..
„
it -feels. A deliberate ^attempt to
The exports report says the list reduce the, number of drugs comhas been compiled to ensure abun- monly required for the national
i
dam availability of these drugs and health programme to fit- into the
not for price control. Many of them overall objective of “lesser span of
are now. but of price control.
control" has also caused criticism.
criticism,
•Industry,
aav/vTv
however,
▼ V• «
apprehends
VHVi IUO
■*
it nvivu.
notes.
| • tha^ the; health ministry will prcss> The new list has been finalised
some of
1
rfor inclus|on of -------—these
------drugs
-•-©•> a^tcr extensive deliberations
the pijicc controlled lists* It is amongst experts belonging to vari• well knoxvn
knovvn that the ministry is not'
not’ ous disciplines under .the
,thc chairhappyryyiih the existing list of cal- manship of director general of
P cgoryby the “health
services. inu
No cviisiucrauon
consideration
' •l’ -drugs
'---- -------approved
------------ ''J
'-aiui sviviuua.
m I Fl I C I TV/
nJ
I. • L
■
ministry fyf*
ol petroleum Aand
has been given .to .»the number
of
chemicals. Il was minister M. S. manufacturers and production
Gurupadaswamy. who originally status of these drugs. The group of
mooted the idea of compiling an experts was appointed by the
essential list of drugs for manufac- secretary, ministry of health
lure al
at low prices.
“|n India, different hospitals and
The criteria for selection of drugs agencies like CGHS, ESI; Railways
• by'the health ministry panel arc etc. follow their own Jist of drugs
one or more of the following: the for purchase and procurement
practitioner's familiarity with the There is lack of uniformity in the
drug, ibrpad spectrum of action, list and there js room for rationalisnarrow spectrum Ipuf cause-specific ing the, list. >.0
‘"•.t' •***'»,‘***n**».i*.‘i»^
-
,
.....................
...
I
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i
I.
I
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1
70
C\/
•r
Telegram i
f Clipping
X TF 630091
I New Dolhl-65
Telephone i 630091
1 \
PRESS-CMPPUWG SERVECfiO
"Hari Bhari”. C-4S, East of Kailash-I, New D-elhHIOOSS
Name of the Paper
: TUG ECONOMIC TIMES
Published by
I
Dated
, 16 SEP 1930
CALCUTTA
wove
and
From Our Bombay Bureau
.It is well-known that the health small list would facilitate effective
'/r.
•
'■
■
ministry has not been happy
... with
. . the
- - implementation. The health ministry
‘ .^Mhe government has quietly initiat existing category-1 list The
ministry is however keen’to bring a host of antied action? to expand the list of bulk had recommended inclusion of more biotics in this list.
drugs ncoming
under-category-1~ of ^
than
category-1 as
•
an 60 bulk drugs in category-1
Cateeory-l drues now constitnrp
Contt.ro1 i^der fPP,C0)- essential
vital to the implementa- less than 10 per cent of the industry’s
At present, less than. 25 bulk drup^
finn
nf
thA
t
—
i
rum/wor
'h i
• n
drugs tion of the government’s national heal- turnover. This will
< ’
‘
------------ --------------------turnover, inis
substantially
go up
. meant for national health .programmes th programme. •---------------------------- jf
tho,new
move
bears
fruit.
The indusif tho.new
fndus■'■Of the goyernment-come under catego---------------------u
,
a
,„.
However, the department of chemi- try has for long contended that the 75
ry*^’■®nJoy,nS a 75 per cent mark up.
cals
Is and
and petrochemicals,
petrochemicals, then
then part
part of
of per cent mark up. docs not meet the
‘Sq three-member unofficial commit- the. industry ministry, pruned the list average break-even point. When . a
.^teeyhas; been, appointed to identify to less than 25 while formulating the
standing committee with three expen
jn more, drugs, to be included under cate- 1987 DPCO. The depanment wanted
panels has been set up, a backstage
^gory-J.. The.-vcommittee consists of a to'.include only those dru«s which
move to expand the list smacks of dis
ft'representative of the ministry of heal- • were; specific to diseases covered by
trust of the industry. The gulf between
th, an eminent doctor and a representa- the national health programme like
the minister and industry and trade
in ■ &
wi='7o a poin.Tf
\
AY, September 25.
I
I
' file St2reani^atiOnS alSOi
Sagely, the standing- committee
Surprisingly,
consumer groups
<(-.has. not, been, told about the move to ^.appointed by the new government to while decrying the increase in drug pri■ catig^which1^ Tl thlS C0ntr011ed: •■reVew 016 Wl«nentation of the drug - ces, are silent about doctor’s feet and
^category,/, which will amount to .a .policy and DPCO is not associated -.hospital and diagnostic expenses
SJ017’ chan8e‘ ,As- Mr
S. with, the move to expand the catego- : which has been skyrocketing in recent
, Gurupddaswajny is the petroleums ry-1 list, despite the fact that the stand- years. According . to theg 1987-88
■ ..hat thSk
Ster’ ; ■S like# ing COn1minee h3S “ expen thcraPeuCentra? Statical
" be at^Ed
°nS
which ought to have been Organisation, health care expenses
?' a5?0
■ If not.ent™'ed with the form less than three percent oftheave■ kt -ever Vp
a
f
^Bory-1, job
ragc household budget. Of this, cost
; bSE Th new .8°vemmenti
:The-industry ministry, in keeping of medicines account for only about■
appointment of < with . .the - policy of. .progressive. 16 per cent, which works out to less'
•"S Intidn™* g,V“ credence !° the; deconlrol had restricted the category-11 than 50 paise per Rs 100 of household
speculation./.,
. . , hst. to. disease-specific drugs as-a expenditure.
expenditure.
.
• ,,
,:
. • •
_
' . ,
/I
1
V
II
I
I
Telegram i
1
Telephone : 630091
r Clipping
TF 630091
I. Nev/ Dolhi-G5
I
I
I
PRESS-O-■UPPINO STElKVlC
“Hari Bhari”, C-46
, East of Kailash-I, Mew Delhi-110065
Name of the Paper
:
INDIAN EXPRESS
published by
:
BANGALORE
,
?e 11M ■
3 p SEP
(City Edition)
©
?1
d
tre to review drug policy
drugs, we would like to have a
policy which brings about stability
lor a reasonable period, in which
everything is clearly defined, and
applications of which docs not
result in anomalies and con
troversies. However, he ruled out
the possibility of new drug policy
that would replace the existing
one.
Express News Service I
Bombay, Sept. 29: Frequent
changes in the policy generate
unccrnailies regarding investment
decisions and therefore, the Gov
ernment has undertaken ‘to ’re
view the existing drug policy to
make it a realistic one' with the
objective of ensuring faster
growth and in a manner ;that the
consumers.arc' ultimately benifitted, informed Mr. M. S. Gurupadaswamy. Union Minister of Pet
roleum & Chemicals.
Addressing the 24th annual
general meeting of. the Organisa
tion of Pharmaceutical Producers
of India (OPP1) held here on
Wedneday, Mr. Gurupadaswamy
said that as we are answerable to
the Parliament, which .has re
ceived many representations re
garding list of price controlled
1
Name of the Paper
Published by
Mr. Gurupadaswamy also cal
led upon the industry to reduce
the number of proliferating for
mulations which “has no added
thereaputict value and results in
utter confusion in the minds of the
consumers".
In the meantime, the Govern
ment has taken a decision to
discontinue the entire scheme af
ter 1991 and therefore the manu
facture of drugs and Pannaccutic-
I
BUSINESS STANDARD
t
CALCUTTA
als under the loan licence scheme
will be allowed only up to (hat
period.
Mr. Gurupadaswamy
said. The pharmaceutical industry
had been pleading for continua
tion of this scheme as it has
already became an integral part of
the fuijctioning of the industry.
The current political develop
ments in the Gulf region has
aggravated the severe problem of
adverse balance of payment situa
tion of the country. Therefore, in
order to earn more foreign ex
change, Mr. Gurupadaswamy
urged the industry to step up its
exports.' up from Rs. 850 crore.
According to him. there is
“enough potential for this" and it
is expected that the exports of
drugs arid pharmaceuticals would
cross Rs. 1,000 crore, he said,/
» 6 OCT ^90
1 \
i.
(City Edition)
Ilandh planned to protest
e
against govt drug policy
-
X
)
I'
I
FROM OUR STAFF CORRESPONDENT
BOMBAY, OCT 5—The joint solidarity” in the face of snide
In this context, they point out
council of the pharmaceutical trade remarks expressed by “official that the duty on intermediates is as
and
call cfor -a quarters.„”
oori, inctefttry is likely to --ii
hign 1'47 per cent whereas the duty
°ay s bandh to protest against “con- ' Mr Shah told Business Standard on bulk drugs
drugs is
is lower
lower at
at 105
105 per
per
fusing” government statements on that a proposal to file a collective cent. Hence, it is prudent
.
• • t
to import
drug policy.
writ petition by the council on t„".
2.
bulk drugs
than produce them from'
legally as U1C
the ,duty
The council meets here on Mon- behalf of its members, against the the
UiV basicstage
utoIU
on
day.Its chairman, Mr Kishor Shah, Union Petroleum and Chemicals intermediates is very high.
sai^!;
Ministry on the issue of arrears’
ineviteablpnhA had
almKSt ccollection
co,,ec!.ion under the D
™g Price ■‘ The
had also urged ...„
the
Drug
T._ Minister :._2
inevitable because of the ambi- Equalisation1 Account (DPEA) industry
■ •
to step up its R & D
guous statements made by the Un- would also be discussed'
• .
at the efforts. While the earnings, o/ the
ion Minister for Petroleum and . meeting.
- • Though industry sources industry were less than four per
Chemicals, Mr M S Gurupadas rte
on this, there is a cent, the Minister’s call to spend
wamy, on drug policy and 'related likelihood of the- proposal being between eight and 10 per cent on R
issues. •
.
’
accepted..
& D “is ridiculous to say the least.”
Mr Shah indicated that the indusMeanwhile, Mr Gurupadas- thes(;; jour^s say. Further, it is
try and trade would observe a day’s wamy’s appeal for production of P°intcd out. while fixing the price
bandh even though he maintained bulk drugs from basic stage at the
he amount sPen-1 on
that a decision on the matter could recently-concluded annual general
°f a ,nfeW drug *s "P1 la.kcn
be taken only.by the Joint Council, meeting of the Organisation of
account for c°si consideration.
aHdtd tha|tHnkCaSC aibandh w?s Pharmaceutical Producers of India • • To Mr Gurupadaswamy's remark
?a’ dr4L» °U d be or8an,scd only (OPPI) has drawn derisive com- that consumers’ capacity to pay
after Divtfali.
.ments from industry circles.
must be taken into account while
j- “We will prove to the governWhile industry sources agree that fixing prices of drugs, industry
•( ment that we are not paper tigers,” the Minister s concern for produc- sources aver that the Government
. Mr Shah said. He rebutted insinua tion of bulk drugs from basic stage shoUid be pulled up on this account,
tions that the Joint Council ‘‘was is not misplaced,' they wonder.
divided before it awas born and whether this could be possible Taxeslalone constitute 40 per cent
declared that “we <■><11
will proveQur under
underthe
theexisting
existingoolicv
policyregime,
regime, ofofdrug
drugnrices.
prices,thev
theynnint
pointnut
out.
'
I
- Media
RF_DR_10_SUDHA.pdf
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