RF_DR_12_SUDHA.pdf

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extracted text: RF_DR_12_SUDHA

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Phenyl butazone - oxyphenbutazone
HAZARDOUS DRUGS
Prepared for:
Drug Action Network core
group iteeting at Sevagram
30*-. 31 July-1984

IJ. K.:
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ShlVO, WAI
On 6th March 1984
i
, L K. banned phenylbutazone.
On 3rd April. 1984. Ciba Geigy withdrew Oxyphenbutazone 9 a
breakdown product of phenylbutazone from O^arlcet.

In Genaanv C_
65 such drugs have been banned. arid use of another
206 severely restricted^
In Finland
drugs.

manufacturers have been asked to withdraw these

?ri
^ufeXi.c, Citizen Health Research Group has asked the
department of Health and Human Services for an imminent c^n&er
ban.
'
Japan has severely restricted the use of these drugs.
has sent world wide consumer alerts. Norway, Fede ral
Republic of Germany, Italy, Australia, Sw_
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
receiving unbiased authentic information about the extent of
th,e44yel,fe effects related to these drugs, it is our respont0 alcrt 9'fci?erspublic needs to be informed of
their dangers realizing that a significant number of patients
to ouy the drug- over the counter unwarned ?und uninrjxwa10

>Ve are using this as yet another case where, double standards
have existed in the drug- information given to doctors in the
west ana to our own doctors.

The total annual turn-over of the two products of phenyl,
outaz.one and Oxyphenbutazone (BUTaZOLWIN & TANDRII, of liba"
e ■ ^9$ch 200 million Swiss-France ie, £ 65 Eiillion ie.
these drugs have been in the market since
19^2 and I960 respectively and are well known). It is very
^hat, Siba Geigy will withdraw these products from
the.hird world, specially after having already stated their
uecision to witharaw Mexaform(Clioquinol) and Dianabol(Anabolic
w°rld market. Withdrawing Butazolidin and
Tandxia. at tais point would lead to a financial set -back. It is
unlikely that Ciba Geigy will give in very easily toconsumer
pressure- a stand already made clear by the makers of Butazoliam aiU Tardril.
What are these drugs

■used for?

• . -Pkenylbu.tazone and Oxyphenbutazone are non—st eroid al
anwiinflammatory drugs which also have mild anti—nyretic and
analgesic properties. They give only SYMPTOMATIC RELIST1 and
COMMUNITY HEALTH CELL
47/1, (First Floor)St. Marks Road
BANGALORE-560 001

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utAxization of theseclrugs is thoro-

fon+nS"
thS drU€s have been reconmeMed by certain -..nu
Uuer® for nin°r Problems and feeble conditions' Giff-^
-ccordj^'t^Ph^^
MI®S editorial, November 1932 that'
nyreVc^n?"^ n^C01067^co^s "Phenylbutazone as nn nnti~
P^IKut^T'B analgesic larelatj^ly inferior to »B’’irin"
s_an a nt 11nf laLim* t ory
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OXITHBKBUT'^z 0KE?~*

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Bone,anrrow Toxicity:

shut o’oin'wy chT^tS h^?0P?Sa ie* t0tal bone
which is a severe denr-ssiot/Z^
c,af?es’ granulocytosis 9
production - Xtal 2 ^00?%^/ 7 “i*1?0*, granulocyte cell
cancer of bone ^rrtj. ^Xo^.-0?^
which is

ulceration -

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bleedil« or

wse,0acoeaaiioEli?:rliS1'i^S:nl5^aii^3 in 1688 ttaa
Hepatitis usually start- --it Mn
but in 20% cases can bc%tarlt<

-i?y, yy

/“^--Prycllul.nr necrosis,
°f starting treatment

3y

ohlorMu r;?4.tS;\C rt M
hOay ?
plareft volume by ?sPI™jy“?<Oi?h??,yl,JUIaaon»
increase
low an3 oSsX?°l y”luJ,ry<., ?“S sJr’-ir‘iu« OOTilnc functtoric effects
5XXS“»
ee8Sa- »«•>
Iras is oontrnlniloated for use InVeSotJc^SlS^™’ t!la

££g--aeriousness of the probleia:

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Incidence of bone marrow aplasi due to phenylbutazone
and oxyphenbutazbne is assessed as 1 in 55000 to 1 in 99000.
Aplasie anaemia or agranulocytosis were quoted as underlying
oi' contributing causes of death. In 576 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 oxypheribut;azone- Inman W H W,
British Medical Journal 1-1500 (1977). The effect of bone
marrow depression is serious. Drug induced agranulocytocis—
phenylbutazone. Pisciotta A V Drugs 15 152 (1978) Drug induced
bone narrow depression by phenylbutazone, British Medical
Journal 4, 490 (1975).
Ciba Geigy's adverse effects department at its head office
in Basle in one its internal memos in February 1985, gave ii
findings of 1182 reported deaths from these drugs '. A 2724
detailed patient reports of other adverse effects. Well
oyer }2 of these deaths were from bone narrow toxicity inclu
ding 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 1081. 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
®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 dr. s.
Double standards in giving the drug information to tie health
personnel makes, matters worse.

Phenylbutazone and oxyp hentub az one is poorly tolerated by
many patients. Even if diarrhowa, nausea, nervousness, Jnsomnia
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
oiscontinued in their cases. Its use should be limited to
short terra therapy of not more than a week during any one trea
tment 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.
Gosbdinan Gillian? 5th. EidLiticn
Chapter- 17.

According to Martindale : * Although phenylbutazone is
effectavenin almost all rheumatic disorders including ankylo
sing spondylitis, osteo arthritis, rheumatoid arthritis and
reitusdeseas, it is GENERALLY RESERVED FOR USE IN THE TREAT-f
MENP OF RHEUMATIC DISORDERS where less toxic drugs have failed.
- Martindale’ 9 28th Edition

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In 1975, a study was done in U.K. to determine the true
incidence as opposed to the reported inciften^e,f,p.fvqdcaihs due
to aplnsti£ anaemia*;•
pMople using
vrpheh^Hrutazond ;or'oxyphenbutazone. In U.K. even where aid- death
certificated mentioning a drug have to be reported to the
d-overnment Drug Authority, only 1 out of 4 deaths, due t^ drugs
were found to have been reported. It was only because of the
study, that the relationship of the drugs and death could bo
found. According to Oliver Grillie, medical correspondent,
Sunday Times, states ’’In Britain whore the 2 drugs have been
used ccmpnritivcly cautiously, 512 deaths associated with tiom
have been recorded between 1964 and 1980. But, the real total
is probably at least double that world-wide^ ns reported in
the Ciba Geigy internal report (Ref: Dr Hnnssen) 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 But azolidin and Tandr il amongst the
highest death total for any drug*.
Scrip. Mo. 854; Pccefeber 12 9 1983;
pg.18«

In U.K. the death rates ..were found to be 22 deaths per
.•;'m.illion'users of..phonyIbutazdnc, 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 o^’phenbutazon to
estimate the number, of patiehts 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.

with oxyphenbutazone9 about 60 million people expo
sed by 38 deaths per million ie. 2280 doaths. Total=
3930 deaths(ie. 1650+2230)
World wiclo from aplastic anaemia and agranulccytisis; 3930
deaths muofc have secured many of which went unreported. The
internal document shows that aplastic anaemia and agrnnulocylosis 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 19,400 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, 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 Olio Hanssdn another Oiba G-eigy’s internal
nemo
memo has stated in light of
if the ddmers of the'dhjq-1'71^ and ”tlx
presence of many newer equally effcct.Lw
effect
non-sterordal antiinf.lanmatory 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
infl?wiatory and degenerative arthritis as promoted, to see if
such promotions .are justified”.

■•■!>• ■

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^layisia:
of Penang report

sxSS-’HEdsSF: *?»1
the drug from tteJStet for Ibb,??/”08?1^0 Mca11 oi
Malayasian Consumer.
Safety aud health of the
Japan;

ted to3 International^und-ratond
which isf J
a Japanese newspaper dedica hoadllnos on 9th
ooh Sjh0?^611.4116 n0WB 1,1
1 984 • Cib a G- e igy1 sS aatiiitfl^atorpain killing drugs killed’1 ig^in^hf
1__ the world.
INPBRNAL DOCOHEJffs OBTAINED ;

BAN is called EOH

well as in the evfrfrZUy in its morning
The headlines ?n Peb^arv n’ tt +
2 ftron£ editorial,
findings of courts in dX roi±l^
the ^ornnert ig.n;
tions took place about lO^vears n7z^oiD^P^’';n!;ly’1:w0 litigo...
been done, ijsout 15 d-.qthc, in
fstlgatlons should
so far been recorded. '■ "
nh-r-'-c^u+i°i tho80 drUSS hcve
preparations of CibCo" stockir^
Mninichi, February 10 Fohrn
io'+ud .WLtlKira.wnl according to
Side ofAots oSlXa ;evS“^t

is j.osswie for all 4CT6n0££“g'
India;

lett^tolrt^Managing
—t±?n Director
In this issUG noc

37,

of Ciba
against
thei.;
(parasolandin being a combination
of
paracetamol and phenylbutazone)'for
'
‘ indicating it for
like lever.
---- ■ conditions
stro

C E R C;

MS taza«OU8 „-ocombination with amidopyrines ^hc?1^•+
Wphantr.zu ,e
is core
--o serious than the oluntriLAohb.dj SS" 1,1

'

1.

gyer the ooynta^. iri
to believe in the sanctitv th
(falsely contirni ~
2.

3.

and if they bgrthe
,q'',s ?y ^eir doctors
make head „ tall of ths nodical litSSh^ort”“"y

In’ShdffieSblSrtI SZ1t?tfr*S?j’y.‘‘?T» beM available often

^1, dTazepanTTi^Sin Bwith 1 ’ ’ „
’ amlgin, parncstb, dextraprop
oxyphelie
which makes the oombi^ti-m
^rapro£u
^Phelle acet .arc inop he;

Phenyl butazone
'-V

J

and oxyphenbutazone are dangerous drugs

*

VOLUNTARY HEALTH ASSOCIATION OF INDIA

D-9/3?4 (h)
at25.8.82

C- 14 Community Centre>
Safdarjung Development Area»
NEW DELHI - 110 016

USING TETRACYCLINE FOR CHILDREN AND PREGNANT WOMEN

__________
The question of Syp.tetracycline for paediatric
Introductiont
usage is not merely one of discolouration of the teeth. More importantly,
it is the question of SELLING AND PRESCRIBING A POTENTIALLY HARMFUL DRUG
WITHOUT GIVING ADEQUATE!. INFORMATION TO THE PATIENT- It is also a
question of the over use or misuse of a drug in trivial conditions when,
more often than not, it is not required; and of attempting to deal with
childhood infection with pills, while the causes of the infection and
increased susceptibility are allowed to remain untouched.
Looking at the drugs we prescribe or consume makes us realise
the necessity to know more about these drugs - not from the drug repres
entative but from authentic medical literature and the experience of others.
Realization of this discrepancy in the information from the drug companies
and their medical literature enhances our reponsibility in this regard to
the patients.
RATIONAL THERAPEUTICS IS KNOWLEDGEABLE PRESCRIBING OF THE MOST
EFFECTIVE, LEAST COSTLY, MOST NON-T0XIC, EASILY AVAILABLE DRUG in the
RIGHT .QUANTITY, for the RIGHT DURATION and for the RIGHT PROBLEM in the
RIGHT WAY.
IT IS THE RESPONSIBILITY OF HEALTH PERSONNEL TO ENSURE THAT THE
RIGHT DRUGS ARE PRODUCED AND MANE AVAILABLE TO THOSE WHO MOST NEED THEM,
AND THAT HAZARDOUS OR IRRATIONAL DRUGS ARE THROWN OUT OF THE MARKET.

Ensuring that people get at least the minimum required to be
healt^ryis our MAIN CONCERN. We re lize that drugs can play only a small
part in keeping people healtjiy. Therefore, by demolishing some of the
myths surrounding the unquestionable healing properties of all drugs, we
hope more and more individuals will begin to look beyond pills for a
cure for their ills.
The manufacture of Tetracycline for paediatrics is supposed to
be banned from January 1982* The date of the ban on marketing of the
drug has not yet been fixed* The reasons for banning the manufacture are:

1*

DENTAL DISCOLOURATION

"Children receiving long or short term therapy with tetracycline
may develop brown discolouration of the teeth. The larger the dose of the
drug? relative to body weight, the more severe is the deformity, the deeper
the colour, and the more intense the hypoplasia of enamel"* The quantity
received is more important than the duration. Mild darkening of the perman
ent teeth occurred in 3 of 14 children who received 5 courses of the drug,
whereas 4 of 6 who received eight courses had moderate darkening of the
enamel.
(Ref: Grossman,E*R., Walchick,A; Freedman,H.: Tetracycline and
Permanent Teeth: the Relationships between doses and tooth colour:
Paediatrics: 1971, 47, 567-570).

’’The risk of this is highest when the • tetracycline is given to
neonates and babies prior to the first dentition”.
"If given between the ages of 2 months and 5 years - pigmentation
of the permanent teeth may develop.”
The earliest characteristics of this defect is yellow fluores
cence probably due to the foimation of a tetracycline-calcium orthophosphate
complex! with time this progresses to permanent brown pigment.
COMMONH-V HEALTH CEU
• <2/. Mark® Hoad
5S0 001

2 -

D-9/334 (h)
a:25.8.82

2.

CATABOLIC EFFECT

’’Tetracyclines exert a catabolic dffect, perhaps due to a
generalized inhibition of protein synthesis in mammalian cells”.
’’Administration of 2*5 to 3 gms. of Chlortetracyclines given to under
nourished adults results in weight loss, increased urinary nitrogen excret
ion, negative nitrogen balance, and elevated servum non protein nitrogen
concentration.”
(Goodman Gillmans page 1188, 6th Ed)
Goeke, T.M., Jackson, G*'G., Grigsby£•, Love,B.D. Jr, and Finland,M*

’’Some effects of antibiotics on nutrition in man, including studies of
the bacterial flora of the faeces”. Arch. Intem.Med. 1958, 101,476-513.
In India the majority of children who would receive tetracycline are
malnourished or bordering on malnutrition. They would be repeatedly
picking up infection - more often viral but bacterial infections as well.
Additionally, how much of this drug would get pre scribe <fyy different
doctors or consumed anyway, we don’t know.

3.,

BONE GROWTH

According to Goodman, Gillman, 6th Edition (1980), Tetracycline
are deposited in the skeleton of the human foetus and young child. A 40%
depression of bone growth, as determined by the measurements of fibula,
has been demonstrated in premature infants treated'with these agents.
(Cohlan, S.Q., Bevelander, G., and Tiamsic, T. *• Growth Inhibition of
Prematures Receiving Tetracyclines - Clinical and Lab-investigations.
Am. J. Bis. Child 1963, 105, 453-461).

4*
Tetracycline induced diarrhoea is not exactly uncommon and that supra-infection by other organisms may occur sometimes.
5*
’’Tetracycline may cause increased intracranial pressure and
tense bulging of the fontanels (pseudo tumor cerebri) in young infants,
even when given in“usual therapeutic doses”.
(Ref: Goodman, Gillman)
Increased intracranial pressure presents itself with severe
headache, vomiting, loss of function of certain cranial nerves, and limbs
and if severe, even .death. The figures of the common or r^re this entity
is are not available to us right now.

8*
The ingestion of out dated and degraded tetracycline is known
to cause Fanconi Syndrome - a clinical picture characterized by nausea?
vomiting, polyuna (increased passage of urine, polydipsea - increased thirst,
acidosis, protienuria glycosuria and aminoacidune (passage of proteins,
glucose and amino acids in urine) .
Our drug control of sales of hazardous drugs, sales of out
dated products is not exactly good and whether the problems created by
out-dated tetracycline is more than discolouration of the teeth would be
interesting to know.
PREGNANT WOMEN

Liver Damage: According to Gooman,Giiiman: ’Tregnant women appear to be
particularly susceptible to severe, tetracycline-induced hepatic damage”.
Schultz, J.G., Adamson, J.S.,Jri Workman,W.W. ,and Morman,T.D.
Fatal Liver Disease after intra-venous Administration of Tetracycline
in High Dosage. N.Eng.J. Med. 1963: 269, 999-1004.
’’Jaundice appears firs, and azotemia acidosis and irreversible
shock may follow. Although hepatic fat is increased during pregnancy,the
quantity appears to be even greater after-exposure to a tetracycline*

’’Disseminated Intravascular aoagulation has been reported in a
pregnant woman who developed hepatic renal failure after given only 2 doses

P-9/534 (h)
a:25.8.82

3

-----------, Am.J •
Krf'Senonenoh
Gynae. 1973, 115, 585-586). This may be a rare phenomenon.
’’Treatment of pregnant patients with tetracyclines may produce
discolouration of teeth in the offspring. Ingestion of the drug between
to About' 4-8 months of post natal pgriPa is dangerous for
deciduous anterior teeth (temporary front teeth) anAfrom 6 months to
5 years of age for the permanent anterior teeth. Children up to
years
may be susceptible to this complication of tetracycline therapy
(Weyman, J • Tetracycline and Teeth. Practitioner 1965, 195,661-665)

The argument offered for continuing its use is that
Tetracycline is cheap, easily available.
In 1 Australia, the Drug Evaluation Committee has recommended
the banning of all tetracyclines in paediatric formulas.
In Belgium, the Philippines, Italy and the U.S.A.the drug
has been banned from Paediatric formulas. In addition, there is the
compulsory warnings Not to administer in pregnancy and to children
below 8 year^e international Organization of Consumer Unions has listed
Tetracycline as one of the 44 problem drugs, rated as a widespread serious
problem.
Tetracycline is a more expensive drug than penicillinl or
-- many'infections it is
sulphonamides • It is a bacteriostatic drug* For
The
yellowness
of
the
teeth
can
be
seen only months or years
not so good* - •
1-1
_li____ _ —V. 4-Ti^
lifp,
later, and it lasts all through the patient's life.
A mother should not be given tetracycline after four months
■” nor should a child be given the drug if he is helow 7 years,
of pregnancy
unless hfe/is in danger.

-

A, ,

(f 7T

Voluntary Health Association of India
Telegrams : VOLHEALTH

C-14, Community Centre

D~10/540(b)
liGD/ 25.5 484

Safdarjung Development Area.
New Delhi-110016

(A
%

New Delhi-110016
T . ,
668071
Telephones : 668072

Rationality in Banning Fixed Dose Combinations

M C Bindal, t»S
RsS Saxena(Mrs),
Saxena(Mrs) Suman Lata(Mrs) &' B P Jaju
Dent of Pharmacy & Pharmacology,
LLRM Medical College, Meerut.
n oir

/Tl) di 1 I’ll

o//!

cafbe met by only 116 drugs. Howeverover 25,000 drug formu
lations continue to be sold and prescribed in F^entSal basic
thrne formulations are unnecessary variations o± identical a
drSs sold under different brand names ar without any proven
thSneutic 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 loatients but also expose the patients
the/indesirable effects of the unnecessary medicament(s) of
such formulations. Dr H Mahler; The Director General ot
feels that 98 % of the drugs available in the developing w_
al not eSentials hence not required. The Drug Technical Advilorv 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 pl, 1983.

.
1. Fixed dose combination of amidopyrine.
dose
combinations
of
vitamins
w...th
antiinflammatory
2. Fixed
5.
Xoplne
atropine with
with analgesics
analgesics and
and antlpyanTipyreties.
in tonics.
4 Fixed dose combinations of strychinine
----------- -and caffeine
.
.
5. Fixed dose combinations of yohimbine strychnine ana tes
sterone and vitamins.
Flxedcombinations
of iron with strychnine and arsenic
6
and yohimbine.
sOdium bromide/chi oral hydrate
7. Fixed dose combinations of
with other drugs.
8. FL xed dose
(---------combinations of ayurvedic, unani drugs with
modern drugs.
.
9. Fix.' 1 dose
<---------combinations of phenacetin.
with antidiarr10.Fixed dose combinations of antihistaminics
—
hoeals*
11 FiS/dose
combinations of penicillins with sulphonamides,
sulphonamides.

1 ‘ combinations of vitamins with analgesics.
12.Fixed dose
13 Fixed dose combinations of tetracycline with vitamins C..
‘ Fixed dose
’
combinations of hydroxyquinoline
group of drugs
14.
cviuwuxu
v
—v
except preparations
which
are"used
J
for
-the
treatment
of
prsparations
are’uswd'
the
diarthooi addactysentery.
diarthonk
ahdadysentery.
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
17. Fixed dose” combinations of ergot except combinations of its
alkaloid ergotamine with caffeine.
.
18 Fixed dose combinations of prophylactic vitamins with an 1TB drugs except combinations of INH with vitamin Bg #
Lli undesirability of the above said fixed
The rational for the
be
dose combinations can — based on the forthcoming arguments
COMMUNITY HEALTH CELL
andfacts.»
t-

47/1, (First Floor)St. Marks Road
BANGALORE-560 001

1.Fixed Dose Combinations of Amidopyrine:
Fixed dose combinations of amidopyrin^(amidiopyrine) are
irrtional 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 and analgesic properties, its ’’over the counter”
sale'in the ’United States had been prohibited since 1938(Moodbuiy 1970). In view of the recent development of newer and
safr 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 places!os but certainly en
hance the cost of formulationso 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 watte 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 normalCantipyresis).But Atropine is known to cause
hyperpyrexia (ie. it may raise the body temperature). Hence
such combinations is therapeutically antagonistic and is thererfore. 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 CHS 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.Fijdd 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
pressure, 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

!i

...3...
6. Fixed dose Combinations of Iron with Strychnine, Arnica and
Yohimbine:
Strychnine, arnica and yohimbine combinations are used as
stimulant appetizers. In most of the patients (except women)
generally there is no deficiency of iron because iron is adoquatiy 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 dose combinations of Sodium Bromide/Chloral Hydrate with
other drugs:
Fixed dose combinations of sodium bromid/chioralhydrate
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 ijucous membranes,
causes gastritis leading to a variety of GIT symptoms eg.nausea
vomitting 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:
Ta e modern (Allopathic) drugs are well, standardised 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:
Phnacetin is gradually loosing its importance because it
causes kidney damage when used in large amounts or for long
periods. Hence it has no place in routine analgesic, antipyretic
and antiinflammatory therapy. Therefore, fixed dose combinations
of phenacetin 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 Antidaarrhoeals:
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

c

. ..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 sulphonamides 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, 1955)» 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 »
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 long
periods because of their vitamin contents, such combinations
are likely to expose the society to a veriety of undesirable
effects of analgesics.

15.Fixed dose combinations of Tetracyclines with Vitamin Cs
There is no specific therapeutic indication of giving
tetracylines and vitamin 0 together because tetracyclines
does 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 inffective 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 Myefooptic
neuropathy(SMON). 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 these 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

of asthma, since immumological factors play an important role.,
and adrenal steroids cause nonspecific reducat ion of the res
ponse to the antigen antibody reactions, the fixed dose combi
nations of steroids with other drugs in the treatment of
asthma is therapeutically rational and justified.

16.Fixed dosecombinations of Chloramphenicol except with Strepto•myciny
Chloramphenicol 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 as it may cause aplastic anaemia.

17.Fixed dose combinations of ergot except combinations of its
Alkaloid Ergotamine with Caffeine:
Ergot alkaloid, ergotamine is effective in the treatment
of migrains because it is a vasoconstrictor agent and p: events
the rhythmic distension of extracranial arteries.

Caffeine may be allowed in combination also because of its
vasoconstrictor effect on intracranial vessels. However the
combination of ergotamine with other drugs(like paracetamol,
prochlorperazine etc) have no therapeutic advantage and hence
irrational.
18.Fixed dose combination of Prophylactic vitamins with antitubercular 'drugs except combinations of I N H with vitamin Bg,
Fixed anti tubercular drug (except INH) are irrational
becuase in these combinations, the vitamines have on therapeu
tic role to play (of course unless there is a vitamins defi
ciency) and they simply act as placebo and might give some
psychological boost to the patient. However, because INH causes
vitamin B6 deficiency, its combination 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).
These combinations were used for test for pregnancy. The use
of E P hormonal preparations were banned in USA by the Food
and Drug Administration (FDA.) in 1975 because these p.eparaticns were found to seriously damage the foetus.

It is often alleged that drug companies levy a heavy burden
on the common man by charging more and more through their
dubious multiple drug formulations which are their $&rented
products. For example, the real pain killer in most ofthe
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,
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 often aided in order just to put in market
a new formulation and thus increase the price of such a
patented formulation.

...6oaft

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(DThB),Brug Consultative
Committee(ECO) and 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 tur country any longer.
The World Health Organization(VAiO) 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 recommendations of WHO on essential generic
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 adequatelyevaluated for their safety and this again emphasises the need
to exercise strict quality control . This becomes much more
significant in the light 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 from the therapeutic point of view, they are
a boon to therapeutics otherwise a curse to the patient and
the society.

REFERENCES:
I
Woodbury, D M (1970) /jialgesics-Ant ipyret ics, anti inflammatory
agents and inhibitors of uric acid synthesis in The Pharmacolo
gical basis of therapeutics by Goodman, L S and Gilman, IV
Edit ion, The Macmillan Company, Lend on,pp 314-347.

Beaver, WT(1965) Mild analgesics: A review of their clinical
Pt armacology. lun J Med. Sci 250, 577.604.
Jawetz E and Gunnision J B ( 1953) Antibiotic synergism and
.antagonism: an assessment ofthe problem .Pharmacol Rev. 5,1 75-1 92

Laurance, D R(198O) Clinical Pharmacology, Ed fifth y E L B S
Publication, Churchill Livingstons, pp 331, 536,552,617,848
Source: The Eastern Pharmacist-June ’83.

Circulated by the Voluntary Health Association of India
for Drug Action Net Workers for information
and necessary action.

>

J

Voluntry Health Association of India,
C-14, Community Centre,
Safdarjung Development Area,
New Delhi-110016.

b>~1Q/34O(c)
LCD.a.20.7.84

■

HAZARDOUS, BAi^ED BAMABLB AW DUMPED DRUGS
(Prepared for 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.
Resolution.
...
-

It is well known that sales of medical technologles 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# influence over the medical lobby.. Many of the so
called med ical expert s 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 an& sales
sh^W give priority to essential, life saving, drugs over irra
tional and hazardous drugs,. This being, along with WHO’s guide
lines for Essential drug-s programme. The drug industry and it^
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 and advanced'level of medic al e xpe rt i s e ^However, this
same lobby puts India in the category of less developed
countries when_-it comes.-to the issue of banning drugs and drug
controly ciaiming that considei^-^ of hazards over efficacy
are luxuries which we cannot afford!
However, consumers anywhere in the world have a right to expeert
that irrational hazardous drugs are not issued licences and
that licenses of ®uch banned d.rqgs should be withdrawn as soon
as possible, bans implemented, and that all drugs in the market
are quality controlled. Ne 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 HFM 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

...2...

hazardous drugs. The budget allocation for ensuring this, the
J^dlse’ ^echiilcal personnel, quality control labs, qualified

and the consumer.groups, .nothin very nucfe 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.
l.?ffi.er-^.jr.jnre on_Health as a percentage of total1 plan

Programme

Health sub
total to plan

HYP I FYP II PYP HI FYP~IV 'PYP~V'" . PYP^VF”'"
1951-56 1956-61, 1961-66 1969-74 1974-79 1980-85

3.83

3.04

2.79

2.74

1.73

1.87

tV'iS'Tn0? ahwhat is.happening to the health budget is enough
ieli^e Xte
priorities health care is receiving in our
We have 600 drug inspectors in the country (Hathi Committee
has recommended). The required number is one for
< drug
units and ■’ 0 chemist shops. Only Maharashtra, G-u,jurat 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.
x

Our focus will be on what has happened to the drugs reco
mmended for being weeded out in 1980. In 1980 the Drug
221?satiye Commi11ee a statutary body consisting of medical
experus under Section 7 of the Drugs and Cosmetics 'Act (Central
acv 23 of 1940) nominated a. sub special committee to'go into
tne 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.
The criteria Used by the 000^11-10.0 ip

sensible

il Sub Committee of the Drugs Consultative Committee, coin'--'
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:

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
i nd ivid uali zed-.
e) Where a fixed.dose combination would ensure better

. o\3.
patient complianc.e due...to convenience of admini...
. ,
st ration.
x) viu-GTs two. or more drugss 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
hot be permitted under the following circumstances:
.a) Where, adverse int eractions may occur
br VZhen 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 therapeutic doses are used, in the absence
of clinically demonstrable synergism
e ) When pharmacokinetic behaviour of the individual
.agents is grossly different.

Ba”gl”aesh fra' '”““3 ’742 ^uga is
We'44 just look at what was involved in attempts to b^n
a few drugs e^. Jimidopyrines, High dose E P drugs, Paediattic
teTracyclin. oteroid combinations are dealt with later under
ambiguity is. the name; of the game.

„
°ub committee submitted its report, recommended a ban
1
?ru8s.and giving their reasons'for recommend
mg the ban. .16_..categojdesi...of these drugs were recommended for
immed iatweeding and 7. of _the.^categories" t o’be ‘ weeded ^ver”' ''
a sfiecijied time. Over 500 brand dru^TTFmid"Thus”be‘ affUted
Uais list of ? combinations and the reasons are- attached in
the appendix/;. This report was presented, to the DOC at a
special meoting . on 10. TO.later to DT/J3 and Ministry of
Health and Family Welfare' accepted it in i981e The DTAB(Dru^
echnical Advisory Board) a Statutary body under’section 5 of
23 °f' T94O-'lecommended
banning of _T8 jfixea Jose combination (list iffdhhed as appendix
section 23 P of the D-rUgs and OOsmetiq.s act 1940
has had the pov/ers- to issue such
^£e^AQ.ns.J,£.Jlie_St.ate. governments as required to execute
—a^SUUnUS^of„the act. th~'state gJmmmrd.
B§. Had t.P.ow££Lto_^prohioIFmanuf act ure, d ist rib ut i on ^Ud
saJxg Qi drugs by a gazette notification.
~

. i AFSe FF3?'!?7® iand0ffily selected from the Pharmaceuti
cal Guide. Out._ox.JJe§e_350__brands 44 brands were marketed by
sect or,
by public ..ZseJfpFnna- ^8^. private /sector'.
F
is that most of these, drugs were being producod by private Indian companies and not multinationals. This
was to be : inpjinse^ ;_disoo^nt^nuatiorio According' to the
authorities, yhe purpose was to. give time limit to firns vnho
may have already purchased the bulk drugs for manufacturing
t o°the Frug c^paAiesF ^Passion and consideration'shown*

/J4 ID Op YR IKS

' I"1? ?5
ru^of India(DCI) by
by BO
DO No.
No. 1275/77
1273/77 BC
DC
in?iondofhe SJate
Controller to ban the fixed'dose conbtstuJd tri ^opjrrine on effect f^om 3.2.82. Orders were
._ssued to stop manufacture from 1st July ’82 and
hv
ctober 31st '82. This ban was later extended further to 31.3.8;.

h •

The DCI through his DO No. 19013/8/81D dated 22.4.82
directed the State Drug Controllers to ban the manufacture of
t.lx?do^0se combinations from 30.9.82 and their sales from
I- j
‘ Se9ual to V*bSa-n’e panel report government decision to
withdraw 550 unnecessary drugs was taken.
_
When Maharashtra. ID A did ban amidopyrines, the multinah0?art.in?Fc ^?feGted _maWed to Set a stay order on the grounds
that the drug was allowed to be marketed lid other states' by
5heiJ
lri. j.980 33' formulations of amidopyrine nro,.?0 .s.° manufactures were in the market. Multinationals '
a
blS CtrUg houses highly trusted by the public such'
as ouhrscu-eigy, Sandoz, Suhudgeigy, Unichem, Ethnor, Thems,
indon were involved. Most of these drugs were being sold with
out adequate warning.
vp.
A? ?ra?ul Bidwai on 19th August 1980 stated in the
financial limes 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 additional wc.PMing .-.fi.bout; the drugs side effects.

inukaram Bhggat Centro^ for .Rdu’cati on'ard E-ochyentation-;
61
Industry in India’ gives the example of
lc.m.ilnanu government ■ medical list for government hospitals in
Bke amid opyi,ine> phenacetin and' analgin are very
much included even when they were considered harmful and been
ciisaUxoweci.

PgENACETIN AND HOLOGBNATED HYDROXYQUINOLINB:
+ -Dan-0^ <£ix$d dose .combinations of phenacetin' and holoseJn2’—1?e was to-be effective from 1.11.82.
j-he date of-the ban of. fixed' dose combinatibn of amidopyrine
p-henacetin and halogenerated hydroxy quinol Ines was expended
to 3-1.3.83 through DO No. X19013/8/81-D dated 13.8.82,.
In 1979 January the Drug Controller of India had issued
an order to gradually phase out ;amidopyrine as always' 'phased
discontinuation' process was not .meant to be implemented as
there were no specific DE/DLINES.

HIGH DOSE 0? E P DRUGS:
Through another DO Nd. 12-48/79-DC dated 26.6.82 the DOI
directed the State Drug Controllers to ban the manufacture
of high dose estrogen and progest er one combination from
31.3.83 and their sales from 30.6.83.

M/S Unichem Labs Bombay (OP 2927/82 of writ petition
2928/82), M/S Nicholas Labs Bombay and M/S Organon (now known
as Tnfar (India)Ltd Calcutta filed writ petitions in Bombay
and Calcutta high courts against the BCl’s instructions to
ban these drugs, their coniahtthn
that Central government
has no powers to ban the drugs. The high court of Bombay and

r-

■L-

..5..
Calcutta have granted stay orders and these products continue
to be available in the market♦
Even though section 10A and- 261 of. the amedned Drug;; and
Cosmetics Act (April ’82) empower the Central Government to
prohibit import, 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 beer,
included in the gazette, notification of the DCI issued on
23.7.83 banning 22 fixed dose combinations.

5

I’:

3

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 S P drugs from 31.3.83 and 30.6.83) M/S Organon
(INDIA) 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 manu
manufacturing 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 tetracyclin ban too does not figure in the
gazette notification of July 23rd 1983.
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 interest(This was
mentioned in the drug Action Network Newsletter October

Section 3(b)(i) was substituted and section,'"11
were inserted in the act. This came into eff-'^ ±rom 1.2.83.
This means that had our Central Drug
aU^10r-^ies wanted
it, gazette not if icat ions banning t^^ manufacture and sale ot
these drugs could have been unH^-^^aken immediately under the
powers invested in it
section 261 of the abt 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
order against specific bans, making these bans ineffectual and^
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 ’arbitoriness
and discrimination’ ;under article 14 of Constitution of India,

'1

according to Vincent Panikulangara since these drugs would be
dumped in the market, substitutes withheld. With our 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

"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 risk to human beings or
animals or that any drug does not have the thera£ontio value claimed 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,
notification in official gazette prohibit the uianufacture, 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 nutritioh 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 und.er section 18 of bhe act could exercise their
power and prohibit their manufacture and sales by issuing a
gazette notification.•According to Vincent Panikulangara, tho
vP^ug Control authorities- are guilty of not exercising
their power and taking responsibility. They have thus violated
s.gction, 18.,and, ^3of' the Drugs and Cosmetics Act and violated
the fundamental right of the public citizens to health and life
uj3d^_secjtion^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.
"As,
ween .t'he. livens of_ the, citizens of this
As, bet
bj^ween^
country on.the .’.one hand_,.and. loss that may result to
4y-» v> ■> -i -P.-%
4- s -»-»-i- — 2
.. —
x. —
i_ —
4
— _ J 2
—
the«-> manufactures
and traders
by 4-the
inn£diate~ban
.
on the m’anufac*ture
anufac*ture^and
’jind sales on t'he_ other, the
. z.
z-.
i- _ >3
_ i_
_ _—
j_
_
~j! r.
X X _ T_ ....
-7S
government
had
chosen
to view~
the/latter
as o"f
more, concern
h’’'.. It is the’duty'
duty of the state to
protect its citizens from injury,and harm especially

...7...
when the injury is not inevitable"
Acting Chief Justice
P ■ Sub-ramahian Potti and
Justice Paripuran
Kerala High Court, in their dire
ctive to the Union of India to -release
the,list.of brand names of banned drugs

In October 1982 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
uo pass any fresh order as it is considered, necessary in accord
ance with the law after following procedures prescribed by the
government).

Subsequent tp. the Drug__;jnendment .Act coming into force on
1.2.83 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 Commissionor of FDA Maharashtra State(which is suppo
sed to be having the best drug control mechanism) had informed
the DCI thatin the light of^the ruling given by the Bombay
High Court _"it would hot be possible for him to talpe 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).
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 DCI to issue the
gazette notification. . point to note is that dguffs banned ejrlier and at different types make the brand banned list. E p
drugs are not1 included ih-the •gazettqabetifioation. *>
-u •_

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 DCC).
- or the ban was applicable to drugs containing both yohimbine
and strychnine.
- or to y ohimb ine and st ry chnine with test esterone or vitamins
- or ONLY to drugs which contained all 4 ie. yohimbine, '
strychnine, testesterone and vitamins.

Another doubt was regard Ing. criteria 12 ie. whether it
could effectively deal with steroid and antihistamines combi
nation which could be indiented -for allergy as well as .asthma.
First of all DCC had recommendedVa bam.of all steroid combinations. 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 new-a-days say only secondary
t it true tfcat it is mostly used
ancy testing and attempting''abortion, changing' the indication

I

...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 DCC had recommended banning of all fixed dose steroid
combinationx DTAB decided to prohibit manufacture of fixed"
0 e e_b omb mat ion of bronchodilators, antihist.am i n i c s a nd t r a n~
£3±lliS££s«with corticosteroids as early as October 4', 1*980.’”

Dr B Shankaranand, the then DGI-IS, chairing a meeting had
said ”The current medical practice in all the developed count^ios is.to give corticosteroids separately and fixed dose
■O-Qjlb-inations of corticosteroids with other drugs are bein:.
discouraged ”.
'
~
'
Prof. H.^rkishan, Singh of the Department of Pharmaceutical
Sciences Punjab University stated .that 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 Consult,ative Committee comprising of .all state
Drug Controllers entrusted the responsibility of evaluating
34 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 compulsoryintake 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.”.

Dn December 31, 1981, the Drug Technical Advisory Board
c^onstituting 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
- ; Jfp. J February
..... 1982 writing about the ’’san^rsgult on steroids”
says ’’they must have had very extraordinary’ reasdh’tb
a) reverse their own earlier decision
b) ignore the.advise of DCS
c) consider the opinion of the whole battery of eminent and
distinguished medical specialists from research institutions
as inadequate ,so- as to ask further details and wider medical
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
tedious, 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 ”tjo_j2ublisly the
list of trade/brand names and the names.of the manufacturers
of ‘ these '/drugs'. ’ This was*/ in 1 982 .Repeat ed requests for the
same have beenpade to the. Central Drug Controllers office.
Some’ of the Drug Acti on-het workers nave been requested to do
the same at the State lefel.

Excuses were made that the drugs have been licenced end
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 inef -lent that
even toobtaii^ just the list ofF these products has taken more
th|n one year. To ensure their ban'or ’quality controlr would
definitely take,a century.

It shoulci be noted thnt the drug ban will be applicable
for lesser drugs ,than what we had anticipated. Tnsnite of the
presence of irrational .and hazardous ingredients only these
drugs will be banned that contain all the ingredients mentioned
in the various categories eg. under category 5 - on i~y those
□.rugs containing all the following io. yohimbine t strychnine x
Test esterone + Vitamins will be affected.
According to Dr Das Gupta, Asst.Drug Controller the
banned brand list will be ready in about J months. We had oreparel our own black lists of banned or bannable drugs as far
hack as 1982 which have been circulated amongst the health
cafe institutions in the voluntary sector and drug action
networkers. These black lists have been for
hydroxy quinolines ie. mexafom and Co
2) .Amidopyrines - abalgen Ergopyrine
3) Paediatric tetracyclin
4) Diphenexylate - lomotil etc.
5) Anabolic steroids
6) Penicillin and streptomycin
)
In BCC rec 0111.^0 nd at ions
7) Chloramphe-nlc.ol and streptomycin
8) High dose E P drugs
9) Anjilnflammatory 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.
°.n-r esipectations from our drug control authorities_to make
^"L?vailable at least after the Kerala High Court ludgoment
h^L^up f eme“’C'odff~wf it*‘p c^ifldn”— ----- ----------------;~"
ii) The difficulty"in 'oB^alning"fEe:drug list of f ormulations
yn,0P1....the State Dr^- Control authorities.
iii-)The process of reformulation "oT"various drugs taking place
P4? ..h9k...^?Ying))any''ihfo'rui\ntidh ’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 existe<r7rwere "sold
unscrupulously in the market?
c ) Which were the hazardous banned drugs still being manu
factured and sold as such?

Our health and drug conrrol .authorities get extremely upset
when we mention the achievements of Bangladesh in their attempte
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
ylkhdraw these products from the market, to destroy these
pi ofucts.even their export to other countries was st riotly
prohibited. We. on the other hand have failed to implement 'a
recommended ban by our own government commi11ees -'’nd banned
by cur -.own drug controller. The drugs banned were mere~few
hundred, not over a 1000. The time period given was for the

r

4

...10...
i

drug companies to complete the manufacture of their formulation
and sell' off their stocks. The stocks surprisingly-like Medus-io
head never seem to finish'off.

Nepal, Pakistan, kalaysiaf Sri Lahka^and P^angfcdesh feci
that^clioguihol (’hydrqicyqufiioline*) f ormulati ons, have no signi
ficant therapeutic. jv'alueand can haye_mgijor side effect sA? They
have decided _to ban these drugs. Giba Seigy ©aker^^qf jnoxqform
have announced their plans t o withdraw .the drug from_int.erratiGna.1^market. V/e continue to allow them to be sold and pro*mated 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 credos "
problems for our littler neighbours who are attempting to rat
ionalize their drug policies, in the interest of their people.

If our government authorities cannot jiakc all that goes
XijA.nealth7' "^vaiTErbl'e ~ t o"Tt
mfllToh p edp 1 o
it has no business fo allow irrational and hazardous drugs to
Ke~"iriflict'‘ec^', upon Them.
' ‘
....... .. .
"
....... ..
""
¥e will compile our own banned brand list and while the
game playing goes on between the health, drug control .authori
ties of centre arid state < -I theirug industry and the high
courts we will ensure that all these drugs are BOYCOT TIP' by
health personnel as well as consumers.

The DC1 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 make it clear that the issue here J.s not
merely_of^banning a fcwT hazardous and irrational drugs but it
is..t o_ f
'liTTIie mi^“TPTehTth''carcv ;
5$. j.£L.tAAl1?? Ahen'’cah'ses "’of ””111 'TiealtKAie'""elsc~where in^primar^y’7‘‘deHYij^A^
witT ’fEbreA one
'-l)£^AxAig.nliicP^^ chan5e,21B'TieaTth statusAuil ’quality of
There bareAid- eTfecTive ' 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 a 1
inflaunting- and totally unacceptable.

Dr Mira Jhiva
C oord inahor
Low Cost Drugs & Rational.TherapeuticSe

I

Voluntary Health Association of India
D-10/540(b)
LCD/25.5.84

C-14, Community Centre

Az

Safdarjung Development Area
New Delhi-110016

c

%

Telegrams : VOLHEALTH

iz
/o,
/’’/

New Delhi-110016
T , .
668071
Telephones :
668072

Rat tonality in Banning Fixed Dose Combinations
M 0 Bindal, RsS Saxena(Mrs), Suman Lata(Mrs) &'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 Director General of WHO .
feels that 98 % of the drugs available in the developing world
a® 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.

t

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 antipyret ics.
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
TJ
and yohimbine.
C3
O
7. Fixed dose combinations of sodium bromide/chi oral hydrate
ci K
with other drugs.
o
8. Fixed dose combinations of ayurvedic, unani drugs with
o
X
o
modern drugs.
<
9. Fi^d dose combinations of phenacetin.
u
10. Fixed dose combinations of ant ihistaminics with antidiarr- -i.
hoeals.
Jo
11. Fixed dose combinations of penicillins with sulphonamides,
f1?
12. Fixed dose combinations of vitamins with analgesics.
13. Fixed dose combinations of tetracycline with vitamins C.
S iZ '-c
14. Fixed dose combinations'of hydroxyquinoline group of drugs (>
o
except preparations which are’’uswd'for the treatment of
dxarbhoofe ahda&ysentery.
15. Fixed dose combinations of steroids for internal use except

(pa,

■

■r-

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 Bg
The rational for the undesirability of the above said fixed
dos© combinations can be based °n cofcMW ‘MWcai.gum ent s
andfacts.s
C7/1>(First Floor)Si. Marks Hoad
BANGALOaE-560 001

KI t1

1. Fixed Bose Combinations of Amidopyrine:
Fixed dose combinations of amidopyrine(ami<ppyrine) are
irrtional because amidopyrine is an outdated and obsolete drug
as it causes bone marrow depression leading to agranulocytosis
which may be fatal(Beaver 1 965). Even though it has marked
antipyretic and analgesic properties, its ’’over the counter”
sale in the United States had been prohibited since 1938(Moocfbury 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 Bose 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 wa^te of vitamins as well
an unnecessary financial burden f"?ru the patients.
3. Fixed Bose Combinations of Atropine with Analgesics and Anti
pyretics:
Analgesics and antipyretics reduce the raised body temp
erature to ncrmal(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
areunde^irable 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.

S.Fijdd Combinations of Yohimbine, Strychnine with Testosterone
and Vitamins:
Fixed dose c.ombinations 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
pressure, 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/

4

6. Fixed dose Combinations of Iron with Strychnine, Arnica and
Y oh imb in e:
Strychnine, .arnica and yohimbine combinations are used as
stimulant appetizers. In most of the patients (except women)
genera 11 y there is no deficiency of iron because iron is adequatiy 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 ma.y be just
for the purpose of increasing the price of the formulation or
to seek patient rights for the formulations.
7. Fixed dose combinations of Sodium Bromide/Chi oral Hydrate with
other drugs:
Fixed dose combinations of sodium bromid/chi oral hydrate
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 ijucous membranes,
causes gastritis leading to a variety of GH symptoms eg.nausea
vomitting flatulence and epigastric distress. Chloral ^hydrate
can even cause hepatic and or renal damagel 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 © modern (Allopathic) drugs are well, standardised 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:
Fhnacetin is gradually loosing its importance because it
causes kidney damage when used in large amounts or for long
periods. Hence it has no place in routine analgesic, antipyretic
and antiinflammatory therapy. Therefore, fixed dose combinations
of phenacetin 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 Antidaarrhoeals:
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

t

...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 sulphonamides 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 9
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 long
periods 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 C:
There is no specific therapeutic indication of giving
tetracylines and vitamin 0 together because tetracyclines '”d
does 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. Farther, in inffective 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 hydroxyquinoline with some other ant id iarrhoeal arid antidysentery
drugs like enzymes forthe treatment of dyspepsia is undesirable
because hydroxyquinolines may induce Subacute Myelooptic
neuropathy (SMON). 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 these 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 al it is extremely important to adjust the steroid dose
to the minimum that produce! 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;Qxic cumulative effects of these drugs. However, in case

of asthma^ since immumological factors play an important role
and adrenal steroids cause nonspecific reducation of the res
ponse to the antigen antibody reactions? the fixed dose combi
nations of steroids with other drugs in the treatment of
asthma is therapeutically rational and justified.

16.Fixed d os ecomb inat ions of Chloramphenicol except with Streptomyciny
Chloramphenicol 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 as it may cause aplastic anaemia.
17. Fixed dose combinations of ergot except combinations of its
Alkaloid Ergotamine with Caffeine:
Ergot alkaloid, ergotamine is 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 combination also because of its
vasoconstrictor effect on intracranial vessels. However the
combination of ergotamine, with other drugs (like paracetamol,
prochlorperazine etc) have no therapeutic advantage and hence
irrational.
18.Fixed dose combination of Prophylactic vitamins with antitubercular 'drugs except combinations of I M H with vitamin Bgo
Fixed anti tubercular drug (except INH) are irrational
becuase in these combinations., the v it amines have on therapeu
tic role to play (of course unless there is a vitamins defi
ciency) and they simply act as placebo and might give some
psychological boost to the patient. However, because INH causesvitamin B6 deficiency, its combination 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).
These combinations were used, for test for pregnancy. The use
of E P hormonal preparations were banned in U S A by the Food
and Drug Administration (FDA) in 1975 because, these pjeparations were found to seriously damage the foetus.

J I
f I

It is often alleged tha't drug companies levy a heavy burden
on the common man by charging more and more through their
dubious multiple drug formu^ations - which are their ^arented
products. For.example, the ijeal pain Killer in most ofthe
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?
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 . oft en aided in order just to put in market
a new formulation and thus increase the price of such a
pat ent ed formulation.

...6oa#
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) and 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 Organization(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 recommendations of WHO on essential gcxioxxc
preparations. In a developing country like ours, the goalttnust
be to ensure availability oi:' essential drugs to patients and
health education to all about safe water, sanitation and finally
sufficient nutritious food.

However, the major problem lies in the 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 light 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 vrere 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 from the therapeutic point of view, they are
a boon to therapeutics otherwise a curse to the patient and
the society.

REFERENCES:
Woodbury, D M (1970) Analgesics-Antipyretics,
/jialgesics-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, Lcndon,pp 314-347.
Beaver, W T(1965) Mild analgesics: A review of their clinical
P, armacology. Am J Med. Sci 250, 577.604.

Jawetz E and Gunnision J B (1953) Antibiotic synergism and
antagonism: an assessment ofthe problem .Pharmacol Rev.5,175-192
Laurance, D R(198O) Clinical Pharmacology, Ed fifth , E L B S
Publication , Churchill Livingstons, pp 331, 536,552,617,848

Source: The Eastern Pharmacist/June ’83.

Circulated by the Voluntary Health Association of India
for Drug Action Net Workers for information
and necessary ..action.

1

DRUGS COMTAIMING. IRRATIONAL COMBINATIONS OF CHLORAMPHENTCOL
AND STREPTOMYCIN
"
~
•K-

•Jf-

■jc-

*

Basi
BRAND
Basiplon
Basiplon Suspension
Chlorostrep Kapseals
Chlorostrep ' Suspension
Enterostrep
Enterostrcp 1C*
Enterostrep Suspension
Ifistrep
Ifistrep Suspension
Heofin
Reto strep with leomycin
S t repto-P araxin
Strepto-Paraxin Pediatric
Streptophenic el
Streptophenicol S^rup

IRUG HOUSE
Khandelwal
Khandelwal
Parke-Davis
Parke-Davis
Dey1 s
Dey^s
Dey’s
Unique
Unique
Rallis
Retort
Boehrnger- knoll
Bo eh ring e^knoM
Mercury
vercury

Dec

P-lCf

Drugs containing —nicillins and Strepteycins
Bi st re pen
Bistrepen Forte
Dicrysticih’-S'
Dicrysticin-S ’SOO’
Dierysticin-S Forte
Hanacillin-S
Munomycin
Omnamycin
Penicillin Streptomycin
Penmyn
P ens t rep

/ilembic
Alembic
Sarabhai
Sarabhai
Sarabhai
SP LTD
Glaxo
Hoechst
TDPL
S arabh ai
MSD

VCC - /?-/6

Combiotjc - £L
Injection: Each J? gm contains StEptomycin sulhre 0.5 gm. 4
Procaine nencillin G 300,000 units. Sod.’bncillin G 100,ODO units

Combi tic porte
Injection: Each 1 gm contains Streptomycin Sulfate 1 gm.
Procaine penicillin G 3^0,000 units. Sod Pencillin G 100,000 lac units

(The drugs containing Penicillin and Streptomycin have been
taken from the Phannaceutical Guide 1981)

DRUGS CONTAINING ANALGIN

MS-cb/D-10.340/
26.8.1982
BRAND

#
#
Vc

•JJ■&

#
#
#
#
#
#

*

•jj-

*

DRUG HOUSE

An ad ex
Baralgan
Benalgis
Corrib igesic
Cemizol Inj
Cimalgin Compos it urn
Cona\il
Do lag in +
Eucrasix
Eucrasi 5
Eucrasil Forte
Fargosic
Fargesic S up
Maxigesic
Medalgin
Medalgin SyruA
Neogene
\
Novalgin
\
Novalgin Inject!
Promalgin
Sedyn-A-Forte
Spasmizol
Spasmizol Drops
Spasmizol Inj.
Ultragin
Ultragin Syrup
Ultragin Inj
Zim algin

*

MPAS APRIL 19S2

#

CIMS

MAY

Concept'
Hoechst
Franco-Indian
Unloids
IDPL
Ciba-Geigy
Citadel
Ph armed Gujarat
Eisen
Eisen
Eisen
PharEast
PharEast
Ethico
Medoz
Medoz
Anglo-French
Hoechst
Hoechst
Uniloids
M M Labs
IDPL
IDPL
IDPL
Manners
IDPL
IDPL
Rallis

fjca- A 7

19S2

DRUGS CONTAININt PHEN ACET IN

#

*

C aph eriri
Do lop ar
lelviran
Treupel
Veganin

HIMS
CIMS

APRIL 1982
MAY
1982

MercuryMicro
Bayer
German Remedies
Warner

Dec P '/3

////

fxr ftvl,

MS-cb/D-10.340/
26.8.1982

#

#
#
*-

#
#
#
#
#
#
#
J*.

^4.

•?(-

\

ERUGS CONTAINING AN/iLGIN

BRAND

DRUG HOUSE

An ad ex
Baralgan
Benalgis
Combigesic
Cemizol Inj
Cib algin Compos it urn
Conaril
Do lag in +
Eucrasil
Eucrasil-5
Eucrasil ^orte
Fargosic
Fargesic Syrup
Maxigesic
Medalgin
Medalgin Syrup
Neogene
Novalgin
Novalgin Injection
Promalgin
S edyn-A-Fo rt e
Spasmizol
Spasmizol Drops
Spasmizol Inj.
Ultragin
Ultragin Syrup
Ultragin Inj
Zim algin

Concept
Hoechst
Franco-Indian
Unloids
IDPL
Ciba-Geigy
Citadel
Pharmed Gujarat
Eisen
Eisen
Eisen
PharEast
PharEast
Ethico
Medoz
Medoz
Anglo-French
Hoechst
Hoechst
Uniloids
M M Labs
IDPL
IDPL
IDPL
Manners
IDPL
IDPL
Rallis

•K-

MIMS ?PRIL 1982

#

CIMS

MAY

1982

ERU(/ CONTAINING
•?(-

#

*
#

C aph erin
Dolopar
3clviran
Treupel
V eganin

MIMS
CIMS

Merc^ •y
Micro

BaWr
Geiman Remedies
Warner

PRIL 1982
AY

1982

DRUGS COMAINING IRRATIONAL COMBINATIONS OF. STEROIDS AND ANTI II^FWMATORY AGENTS

MS-cb/D-10.340/
25.8.1982

.-4

’i

BRAND & DRUG *
HOUSE

INGREDIENTS

COST

* Butacort
(PCI)

Prednisolone 1.5mg
Phenylbutazone
100mg

100064.80

* Butapred
(Biochem)

CONTRAINDICATIONS & SPL, PRECAUTIONS

Rheumatoid arthritis, osteoarthritis,
ankylosing spondylitis

Oedema or hypertension where there is danger
of cardiac decompensation, renal-and hepatic
disease, peptic ulceration, blood dyscrasias.
May potentiate coumarin-type anticoagulants,
oral hypoglycarmics and sulphonamieds. Check
blood regularly, (See Sec. 50)

Prednisolone 2mg
10-4.40
phenylbutazone
500-142.47
tOOmg, salicylamide
300mg, dried alum,
hydrox gel 20mg

Rheumatoid arthritis, ankylosing
spondylitis, gout and superficial
vein thrombosis. Extra articular
rheumatism fibrositis, tensoynovitis,
bursitis, painful shoulder and acute
arthritis of any joint,
osteoarthritis.

(As above)

# Deltaflamar
(Indoco)

Dexamethasone 0.25mg 1C-5.50
oxyphcnbutazone 75mg
dried alum,hydrox
l50mg, mag trisilicate
100mg

Rheumatic and allied conditions.

(As above)

* Ingapred
- (Inga)

Phenylbutazone 50mg 10-1.23
prednisolone 1.25mg

Rheumatoid arthritis. Still’s disease
gout, ankylosing spondylitis,^
osteoarthritis.

(As above)

*

1 -l

IbDICATICNS

10-2.09

MIMS
ScOj^C
Corticosteroids are contra-indicated in tuberculosis, local or-systemic infections unless controlled by chemotherapy, active
peptic ulcer, psychoses, osteoporosis, renal dysfunction, diabetes mellitus, glaucoma, hypertension, myasthenia gravis, thrombo-embolic
disorders, congestive heart failure and pregnancy.

4
2 -

MS-cb/D-1O.34O/
25.&.19B2

uauos

IIUREDIENTS

COST

INDICATIONS

CONTPuJNDICATIGNS & SFL. PRECAUTIONS

Phenylbutazone 125mg
dexamethasone O.37mg
mag. tri sillicate 150mg

10-2.64
500-99.17
10-2.64

Rheumatoid arthritis, osteoarthritis,
spondylosis, myositis, fascitis,
tendinitis, gout

Peptic ulcer, blood dyscrasias, cardiac/
renal/bepatic insufficiency.
(See Sec 5C)

Triactin
(Pharmed)

Prednisolone 1.75mg
mag. tri si lli c ate 150mg
phenylbutazone 0.1g

10-2,80

Rheumatoid osteoarthritis3ankylosing
spondylitis, osteoarthritis, gout,
painful joints.

Oedema or hypertension viherc there is danger
of cardiac disease, peptic ulceration,
blood dyscrasias. May potentiate coumarin
typo anticoagulants, oral hypoglycaemics
and sulphonamides. Check b!6od regularly.
(Seo Sec. 5C)

•A

Triactin-D
(Pharmed)

Dexamethsone 0.25mg
phenylbutazone 100mg
mag. tri si Hie at e 150mg

10-2.80

(Same as above)

(Same as above)

J

# Arumin
(MPI)

Paracetamol 0.15g
dexamethasone 0.25mg
phenylbutazone 0.1g
chloroquine phos.25mg

10-6.65
10 x IQ66. 50

di

brand
HOUSE

Thilozone-P
(Unique)
i.

■f.

666
*

'I

MS

T
........ .. .

•

.....................

’

: ‘

# CIMS
Sec 5C:-Corticosteroids arc contra-indicated in tuberculosis, local or systemic infections unless controlled by chemotherapy, active peptic
ulcer, psychoses, osteoporosis, renal cysfunction, diabetes mellitus, dlauccma, hypertension, myasthenia gravis, thrombo-embolic disorders
congestive heart failure and pregnancy.

t;

I

MS-cb/D-10,340/
25.3.1932

BRANDS CONTAINING DIPHENOXYLATE (LOMOTIL)

Antidiarrhoeals
.I'

Lomotil
(Searle)

•i

Diphenoxylate hcl 2.5 .10- 1.84
mg, atropine sulph.

Symptomatic relief of
diarrhoea

O.O25mg

Lomotil
Liquid(Searle)

Diphenoxylate hcl 2.5 20ml-2.22
mg, atropine sulph.
60ml-6.59
0.025mg, alcohol 0.79
ml/5ml

Lomofen
(Searle)

Di ph enoxylate' h c l 2. 5i
mg, atropine sulphO.25mg, furazolidone
50mg

10- 1.97

Lcmofen Susp.

Diphenoxylate hcl 2.5
mg, atropine sulph.
0.025mg, furazolidone
50mg

60ml-6.75

# Lcmcmycin
(Searle)
(Searle)

Diphenoxylate hcl 2.5
mg, atropine sulph.
0.025mg> neomycin
sulph. 250mg

10- 5.50

# Lcmcmycin
Liquid( Searle)

Diphenoxylate hcl 2.5
mg, atropine sulph.
O.O25mg, neomycin
sulph. 250mg

60ml-10

ji
IT

(Searle)

11

MIMS
CIMS
<

Children above 2 yrs
O.25mg of diphenoxy
late hcl/kg body-wt
daily in divided
doses

Atropine intolerance and janndice>
hypersensitivity to diphenoxylate hcl,
diarrhoea associated with pseudo
membraneous enterocolitis

(Same as above)

Bacterial diarrhoea
with gastro-enturitis
or food poisoning

(Same as above)

Hypersensitivity to active irg redials
ingredients, entero-colitis. Hepatic
disease, ulcerative colitis and
patients on narcotics, addicting drugs
or MAOls alcoholic beverages,
G-6PD def.
(Same as above)

Children above 2yrs
Corresponds to 0.25
mg, diphenoxylate
hcl/kg body wt. in
divided doses

(Same as above)

Diarrhoea ■’.•of
bacterial origin
associated with
gas tro-enteritis.

(Same as above)

(Same as above)

(Same as above)

4

MS^b/D-10,340/
25.3.1982

BRANDS CONTAINIDE TETRACYCLINE

V

1
i

J
•F
1

ANTIBIOTICS
BRAND & DRUG
HOUSE
Ificyclin Paed.
drops (Unique)

Tetracycline lOOmg/
ml

5ml- 1.81
10ml- 3.35

Ificyclin Syrup
(Unique)

Tetracycline lOOmg
per 5ml

25ml- 2.44
50ml- 4,39
A50ml-32.24

•ianemett Syrup
(Mercury)

Tetracycline 125mg
per 5ml

30ml- 3.18
60ml- 5.37

333mg -1g 8-12 hourly.
Children: 20mg/kg body-vrt in
divided doses daily.

Renal failure. Prescribed with caution to children
under 6 years.-H-( See Sec. 7A)

4&upicyclin Syrup
(Lupin)

Tetracycline 125ng

30ml -4.60
60ml- 3.13
500ml-41.17

250mg 6 hourly. •
Children: ’20-40mg/kg body-wt
in divided doses.

++(See Sec.?A)

*Mysteclin-V
Paed.Drops
(Sarabhai)

Tetracycline hcl
100mg5 amphotericin
B 20mg/ml

10ml- 2.91

*Sandocycline
Snsp. (Sandoz)

Tetracycline 125mg,
60ml- 6.05
broxyquinoline 200mg<?
brobenzoxaldine 40mg/

INGREDIENTS

COST

■ t

t

■ {DOSAGE

............

^NWNDICATIONg & SPL. PRECAUITONS

In childhood it can cause permanent discolouratLo^pf
the child1 s teeth and therefore prolonged use' should
be avoided.

+4-(See Sec. 7 A)

2.5-10ml 6 hourly according
to age. See lit.

Kenai disease. Concurrent
C
admin, of other
hepatotoxic drugs.j ++(See Sec. 7A)

5ml
>> -

4

(MDiS),
++Sec TA : Tetracyclines
'
■'
should not be used m the latter half of pregnancy or in children unto 12
caution in impaired renal
- ■ or hepatic function; dosage should be reduced accordinelv
The
2
containing salts of calciua, magnesium or iron should be avoided

2/nr

aSe' Use ’KLth exfcrcme
simultaneous administration of milk supplements
f

I-

►
--^^asapsan-,

. r'
»?•

MS-cb/D-10.340
25.8.1982

■i.

•r

■•’I.

*

BRAND & DRUG
HOUSE

INGREDIENTS

COST

Subamycin Paed.
S5TUP (Dey’s)

Tetracycline 125mg/
5ml

40ml- 4,9j

12.5-25mg/kg body-wt daily in 4
divided doses

*n Subamycin Paed Tetracycline lOOrng/
DropsCDey’s)
ml - • -

5ml- 2.71
10ml- 3.47

(

25 -3.15

Children: 20mg/kg body wt in
equally divided doses every
6 hourly

*# Terramycin
Syrup(Pfizer)

Oxytetracycline 125
mg/5ml

30ml-3.70
60ml-6.32

2O-55ing/kg body wt daily in 4
divided doses.

Terramycin
Oxytct racycline 100
■ Paed Drops(Pfizer) mg/ml

5ml- 2.58
10ml-3.59

Oxytetracyclire 50mg 50mg:2ml125mg/ml
1-,06;
125mg/ml
10ml-3.59
12Jmg:2ml1.J7

* Terramycin I V Oxytetracycline
Inj. (Pfizer)

*
/>

Trycin (MSD)

M- 2.90

Tetracycline hcl ?50mg *-2.20

"H~(Sog Sec 7A)

.i'

Oxytetracyclire hcl.
50mg; •

*# Terramycin
■ I M Inj.(Pfizer)

I

^2Z®^©icattons _ & otUprecaution^77 :

Terramycin
Soluble Tabs ■
(Pfizer)

.

>

DOSAGE

I!

fl

II

II

200-400rng daily in divided doses
every 6-12 hrs. Children: 7-10mg/
kg body wt daily.

25O-5OOmg 12 hourly. Maximum 250mg
6 hrly. Children: 10-20 mg/kg body
wt. daily in 2 divided doses. Maxi
mum 30mg/kg body wt. daily in 3-4
divided doses.
250mg 6 hrly.

Children:

II

n

25-60mg/kg

bodfeft wt, daily, in $ divided doses.

I CIMS .
* MIMS
v++ SEC 7A : Tetracyclines should not be usd in the latter half of pregnancy, or in children upto 12 years of age.j Use with extreme
■’ or hepatic functin: dosage should be reduced accordingly. The
T simultaneous administration of milk supplements
caution in impaired renal
■£££« 7a£TS"oalk-, WMi* « u. should
folded.
■

n

MS-cb/D-10.340
’ 25.S.1982

I-

i
I

BRAND & DRUG
;
HOUSE

INGREDIENTS

COuT

# Alcyclin Paed.
: S Drops(Alembic)

Tetracycline hcl
lOOmg/ml

5ml- 2.2?
IOml-3.05

.d

(approx 20 drops)
#

Alcyclin-0
(Alembic)

i

’ #
•i •

CIMS

“

Oxytetracycline sjuiv* 25Cmg:
to anhydrous oxytet- 10 x’2mlracycline 50mg,
13.94
lidocaine 2% per ml
vial and 250mg per
2ml with lidocaine 2$

DOSAGE

CCITOAINDICATI ONS & SPL. PRECAUTIONS

Prolonged and frequent use in children
10-30 mg per kg body wt. daily
in 4 equally divided doses
according to severity of infection
Children a^d infants: 10~15mg per
kg body wt per day in 2-3 equal
divided doses i.m. 250mg:lamp
deep i.m. every 9-12 hrs

0^
STATEMENT SHOWING THE CATEGORIES OF FIXED-DOSE
COMBINATIONS RECCMMENDED BY THE SUB-COMMITTEE
OF THE DRUGS CONSULTATIVE COMMITTEE FOR. BEING
WEEDED OUT

A.

Categories of fixed-dose combinations to beweeded out
immediately,
reasons FOR WEEDING 0U1 •
CATEGORY
Fixed dose combinations of
1Fixed dose combinations
Steroids
with any other category
of Steroids
of drugs should not be allowed
as they are considered harmful
for the following reasonss-

2* Fixed Dose Combinations
of Ami-dopynine

(a) The adrenal suppression
accompanying steroid therapy
leads to symptoms and signs
of adrenal insufficiency, if
the steroid is abruptly
withdrawn.
(b) It is difficult to titrate
the dose of the.steroid
when it is present in fixed
dose combinations with other
drugs.
Ami-dnpyrine is considered toxic
because:(a) It causes high -incidence of
agranulocyto si s.
(b) In some individuals, it may
cause a sharp fall of total
leucocyte count associated
with chill, fever, headache
and pain in muscles and
joints following the admin
istration of drug.

3. Fixed Dose Combinations
of Chloramphenicol

j
f

Fixed Dose combinations of
Chloramphenicol with any other
category of drug is considered
harmful for the following
reasons and should not be
allowed (a) Chloramphenicol is the
commonest drug which causes
pancytopenia and peripheral
. blood changes including
Leucopenia, Thrombocytopenia
and aplasia of the bone
marrow. This reaction is
not related to dose and
when done, marrow aplasia
is complete; the fatality
rate is almost 100%.
(b) Patients receiving
chloramphenicol must be
checked repeatedly for blood
studies which is however
generally done in the case
of patients receiving fixed
dose combinations of
Chloramphenicol,

...2A

i

I

2

4 • Fixed Dose combinations
of Ergot

Fixed dose combinations of Ergot
estradial,etc.
with Quinine, Jthinyl
:
Sn«ah
should not be allowed,
considered
harmful
combinations are <-------for the following reasons:
(a) They may cause uncontrollable
bleeding and nay lead to
serious consequences.
(b) They may cause many harmful
side effects.

5- Fixed Dose combinations
of Vits. with anti
inflammatory' Agents &
Trang uili zers.

Fixed dose combinations of Vits.
with anti-inflammatory agents and
tranquilizers should not be allowed.
Such combinations are considered
irrational for the following reasons:

(a) There isi no definite role of
Vitamins in the management of
inflammatory disorders and.
therefore a fixed dose addition
of Vitamins in such preparation
will be irrational.
(b) Similarly there is ixO rationale
for adding Vitamins to
tranquilizers.
6. Fixed Dose combinations
of Atropine in Analgesic
Anti-pyr' tics.

Fixed dose combinations of atropine
in analgesic antipyretic should not
e allowed as atropine may reduce
efficacy of antipyretics by block
ing sweating response.

7. Fixed Dose combinations
of Analgin

Fixed dose combinations of any
category of drug with analgin in
oral dosage form are considered
generally harmful as analgin is
potentially a toxic drug and may
cause agranulocytosis except for
some combinations which may.have
therapeutic rationale, e.g.with
ne.urovitamins.
However, fixed dose
combinations with analgin in
injectable form may be continued to
be allowed, as these are generally
meant to combat an acute attack of
pain, and injectables are less
likely to be misused.
Fixed dose combinations of
Yohimbine and Strychnine in a form
ula containing Testosterone and
Vit.B.12 should not be allowed. Such
combinations are considered harmful
and irrational for the following
reasons:
(a) Yohimbine easily penetrates the
OUS and can cause central
excitation including rise of
BF.P. and heart rate, hyper
excitability and tremour.

/•

8. Fixed Dose combination^
of Yohiebine and
Strychnine with
Testosterone and Vitani ns

3 (b)

There is no convincing evidence
regarding the aphrodisiac
effect of Yohimbine and the
drug has no proven therapeutic
value. •

(c)

There is no rational basis for
the use of strychnine in
therapy and therefore no just
ification for the use of it in
any proprietary medicine.

(a)

There is a very narrow margin
between the therapeutic dose,
and.Ahe^.--toocLc -dose of stry
chnine .

' 9* Fixed dose combinations of
Iron with Strychnine,
Arsenic. Yohimbine

Fixed dose combinations of Iron
with Strychnine, Arsenic and
Yohimbine should not be allowed -as.,
there is no rationale of such
combinations and such a combination
can cause harmful side effects.

. Fixed do.se combination of
Sodium Bromide/Chloral
Hydrate with other drugs

Fixed dose combinations of sodium
Bromide/Chloral Hydrate with any
category of drug,are.considered
irrational and harmful for the
following reasons:
Use of both Sodium Bromide and
Chloral Hydrate have become
bsolete, as th re safer hypnotic
drugs available today and their,
therapeutic concentration in bbod'
is very close to their toxic
levels.

• Fixed dose combinations of
Tetracycline,Analgin with
Vitamin C

Fixed d.ose combinations of Tetra
cycline, Analgin,' etc. withVit.C
should not be. allowed as there is
no rationale of such combinations.

12• Fixed dose combinations of
Ayurvedic drugs with
modern drugs

Fixed dose combinations of Ayur
vedic drugs and potent allopathic
drugs like Stilboestrol could be
very harmful and there is no
adequate evidence of safety of the
interaction of drugs of these two
systems of medicine.

13 • Fixed dose combination of
Phenacetin

Fixed dose combinations of any
_jcategory of .drugs- with Phenacetin
should not be allowed, as the
question of banning Phenacetin
because' of its potential toxicity
(nephropathy, methemoglobinemea,
hemolytic anenn.a as a consequence
of chronic over dosage) is under
active consideration of the
G-overmpent.

4 -

14.

Fixed dose combinations of
Chloramphenicol with
Streptonycln

Fixed dose combinations of
Chloramphenicol with Streptomycin
should not be allowed as Chloram
phenicol being potentially a
toxic drug its use should be kept
restricted to enteric fever only.

15. Fixed dose combination of

Fixed dose combination of
penicillin with streptomycin should
not be allowed.

16. Fixed dose combinations of

Fixed dose combinations of more
than one anti-histaminics in oral
dosage form should not be allowed
as the differences between their
action i s but marginal.

Penicillin with Streptomy c i n

more than one anti-histaminics

B.

Categories of fixed dose combinations to be weeded out
over a specified Vine.. ...

Category

1. Fixed lose combinations of
Anti-histaminics in antidiarrhoeals.

Reasons for weeding out
Fixed dose combinations of sedat
ive anti-histaminics in antidiarrhoeal preparations may be
permitted provided all ingredients
are in adequate therapeutic doses.

2. ________________________________
Fixed doso conbinations of
Fixed dose combinations of
Penicillin with Sulphonamides penicillin with sulphonamides are
irrational for the following
reasons:
(a) The combination of penicillin
bactericidal drug and sulphon
amide, a bacteriostatic drug
may cause antagonism.
(la) There is risk of development of
bacterial resistance to both
the drugs.
5.' Fixed dose combinations of
anti-histaminic with
tranquilizer.

Fixed dose combinations of antihistaminics having patent sedative
preparations (for example,diphenhy-dramine dimenhydrinate, tripelennamines, pyrelamine, Antazolin
methapyrilline,etc). with tranquil
izers are considered irrational for
the following reasons:
Such combinations may cause
enhanced sedation, which may
interfere with the patient’s day
time act.i vi ty and dull the mind
and. slow the reflex ae.fxviiy.

I

»

t

- 5 -

4• Fixed dose combinations of
tranquilizers, AntiHist aminics and Analgesics

Fixed dose combinations of Tran
quilizers with anti-histaminics
and analgesics in oral dosage form
are considered irrational for the
following reasons:(a) Such combinations may cause a
lot of unwanted sedation , will ch
may interfere with the
patient’s day t~me activity
and dull the mind and slow
reflexes.
(b) There may not be many clinical
situations which would need
a fixed dose combination of
these 3 categories of drugs and
there will be unnecessary drug
ging. However, fixed dose
combinations of these drugs in
injectable form may be allowed
as injectables are not likely
to be misused.

5* Fixed dose combinations of
Vitamins with Analgesics

Fixed dose combinations of high
dose Vitamins with analgesics
should not be allowed unless there
is adequate evidence in support
of the rationale of such combinat
ion.

6• Fixed dose combinations of
Paracetamol with Antihistaminics and tranquil
izers.

Fixed dose combinations of Paracutamol with anti-histaminics and
tranquilizers should not be allowed
as there is hardly any clinical
situation which should demand a
fixed dose combination of anti
pyretic,an anti-histaminic and
tranquilizer. However, fixed dose
comb nations of paracetamol with
anti-nistaminics and paracetamol
with tranquilizers may be allowed
provided the formula contains an
adequate dose of such ingredient.

7. Fixed dose combinations
of prophylactic Vitamins
in anti-TB Drugs.

Fixed dose combinations of
Vitamins in prophylactic doses in
anti-TB drugs should not be allowed
as such combinations lack rationale.
However, combinations having a
therapeutic rationale such as INH +
B6 may be allowed.

I

Voluntary Health Association of India
--^^,''Ga^nwntIy"r?entre, *
'
Safdarjans Development Area,
New Delhi-111016.

STATEMENT SHOWING THE C/dTEGORIES--^^
CQIffillUlIONS^lEX^^
BY THE SUB-^^miTTEE
OF THE DRUGS CONSULTATIVE COMMITTEE FOR BEING
.
WEEDED OUT

.. --

■?

•j

-Categories of jfi^ed*>dose combinations to beweeded out.
Immediately. 1 '
REASONS FOR WEEDING OUT
CATEGORY
Fixed dose combinations’ of
1• Fixed dose combinations
Steroids
with any other
pf Steroid.9
of drugs should not,be allowed
as they are Considered harmful
for the following reasons-:
. (a) The - adrenal s upp re s si pn
accompanying-oteroidathfireqpsrleads to symptoms and signs
of adrenal insufficiency, if
the steroid is abruptly
withdrawn.
(b) It is difficult -to' titrate
the dose of the steroid
when it is present-in-fixeddose combinations with other
drugs.
Suffixed Dosj, Combiiiatlong., . . Am—dnpyrine is considered toxic
because
of ^mj-dopyrine
(a) It causes high incidence of
agranuloey to si s.
(b) In some individuals, it may
cause a sharp fall of total
leueocyte count associated
with chill, fever, headache
and pain in muscles’ and
joints fallowing the admin^istration
of drug.
*

3. Fixed Doge Combinations
of Chloramphenicol

Fixed Dose combinations of
Chloramphenieol with any other
category of drug is considered
harmful for the following
reasons and should not be
allowed ■>
(a) Chloramphenicol is the
commonest drug which causes
‘pancytopenia and peripheral
blood changes including
Leucopenia, Thrombocytopenia •
and aplasia of the bone •
marrow. This reaction is
not related to dose and
when done, marrow aplasia
is complette; the fatality
rate is almost 100^.
(b) Patients reeeivirg
chloramphenicol must be
checked repeatedly for blood
studies which is however
generally done in the case
of patients reoeiying_Xi±e<l_
dose combinations of
^UTh 1 pyrrmp
rsiitl hftn i

'■

I

d

I

“1
L

r

1-,.
!•

I

!

♦

i

.

i

i
A

J-

I

■<

; J

- 2 -

4> Fixed Dose combinations
of Ergot
~
\
\
\

5^ Jixed D o s e b ombi nalji ons
o i Vxt s ♦ with .antluw
inflammatory Agents &
Tranquilizers>

Fixed dose combinations of Ergot
jj±th-~Qu ini nar Fth iny l - ^erbraiiaX^to .
should not be allowed. Sn«h
combinations are considered harmful
for the following reasons:
(a) They may cause unpontrollablebleeding-and may lead to
serious consequences.
(b) They may cause many harmful
side effects.

Fixed dose combinations of Vits.
with anti-inflammatoxy agents and
tranquilizers should not -be allowed^
Such combinations are considered
irrational for the following reasons:

t

1

(a) There is no definite rale—of— Vitamins in the management of
inflammatory disorders and
therefore a fixed dose addition
of Vitamins in sunh’'prreparai±TTs:
will be irrational.
(bl Similarly there is no rationale
for adding Vitamins to
tranquilizers.
:

~ _ i iogibiiiationei
4. Fixed Doge
U
I ^4.
V -U '-' J-Z -K. ** v | 'in .^naXges^t
of
Atropine
Antj-py retie s~»
Antl-pyretil

7. Fixed Dose combinations
of Analgin r.«

8.- Fixed Dose combination^
of Yohimbine and
Strychnine with
Testosterone-^ and Vit
amins

-•

• —■

" • “I
...

’>

Fixed dose combinations of atropi hpin analg esi c antipyretic- * sb on-1 d no t
be allowed as atropine may reduce
efficacy of antipyretics by blocKing sweating response.
Fixed dose combinations of any
category of drug with analgin in
oral dosage form are considered
generally harmful as analgin is
potentially a toxic drug and may
cause agranulocytosis except'for
some combinations' which may have
therapeutic"rationale e.g.with
neurovitamins. However, fixed dose
combinations with analgin in
injectable form may be continued to
be allowed as these are generally
meant to combat an acute attack of
pain, and injectables are less
likely to be misused.
Fixed dose combinations of
Yohimbine and Strychnine in a form
ula containing Testosterone and
Vit.B.12 should not be allowed. Suah
combinations are considered harmful
and irrational for the following
reasons:
(a) Yohimbine easily penetrates-the
ONS and can cause central
excitation including rise of
K.P. and heart rate, hyperexcitahility and tremour.

i

3

(c)

(d)

There is no. convincing evidence
regarding the -aphrodisiac
effect of Yohimbine and the
drug has no proven therapeutic
value.
There is no rational basis for
the use of strychnine in
therapy and therefore no Jasti
fication for the use-of it in
any proprietory medicine.
There is a very narrow -margin
be-tween the therapeutic dose
and the toxic dose of
strychnine.

9^

F ixed dos e c omb in a t i ons o f
iron wiih Strychnine',
ArsenioYoh jmbjjne'

Fixed dose combinations of Iron
wi th S trychn ine /' A rs en ic and “"
Yohimbine should not be allowed as
there is no rationale of such combi
nations and suclra combination can
cause harmful side effects.

10< -

apse combination of
Sodium Bromide/^ChloraT1
Hydrate with other drugs

Fixed dose combinations of sodium
Bromide/Chloral Hydrate with any
category of drug are considered
irrational and harmful for the
following reasons:
Use of both Sodium Bromide and
Chloral Hydrate have become obsolete,
as there safer hypnotic drugs available today and their therapeutic
concentration in blood is very close
to their toxic levels.

11.

Fixed dose combinations of
Tetracycline, Analgin with
Vitamin C

Fixed dose combinations of Tetra
cycline, Analgin, etc. with Vit. C
should not be allowed as there is
no rationale of such combinations.

12,

Fixed dose combinations of
Ayurvedic drugs with
modem drugs

Fixed dose combinations of
Ayurvedic drugs and potent allo
pathic drugs like Stilboestrol
could be very harmful and there-is
no adequate evidence of safety of
the interaction of drugs of these
two systems of medicine.

13.

Fixed dose combinations
of Phenacetin

Fixed dose combinations of any
category of drugs with Phenacetin
should not be allowed, as the
question of banning Phenacetin
because of its potential toxicity
(nephropathy, methemoglobinemea,
hemolytic anemia as a consequence
of chronic over dosage) is under
active consideration of the
Government.

- 4 14.

£i^;ed_dose combination^ of
g^loramp.heniqol yith
Strejtomyctn

15. Fixed dose combination of
Penicillin with Strep to*- ■
mycin

’~

16. Fixed dose combinations of
more than one anti-his^am ini cs

B.

Fixed
Fixed dose
dose combinatjons
combinations of
of
Chloramphenlcod with Streptomycin
should not be allowed as Chloram
phenicol being potentially a 't
toxic drug its use should be-keptrestricted to enteric fever only.

Fixed dose combination, of
p e nicilli n wi th str ep tomycin. should. _
not be allowed.
Fixed dose combinations of more
than one anti-histaninics in oral
dosage form should not be allowed
as the differences between their
action i s but marginal.
"

Categories of fixed dose combinations to be weeded ouir
over a specified Vlneu
-

Category
1. Fixed dose combinations of
Anti-histaminics in antidiarrhoealg.

- -. -

••

■

-'■■■-

•

Reasons for weeding out
Fixed dose combinatio\s of sedat
ive anti-histaminics in'antidiarrhoeal preparations may be
permitted provided
all ngredients
"
are in adequate therape ttdc doses.

i

2. Fixed dose combinations of
: Fixed dose combinations >
Penicillin with Sulphonamidg penicillin with- suiphona:mudes are
irrational for the following
reasons:
(a) The combination of penicillin, a
bactericidal drug and sulphon
amide, a bacteriostatic drug
may cause antagonism.
\
(h) There is risk of devalapment ai-----T
bacterial resistance to both
the drugs.

j

3. Fixed dose combinations of
anti-histaminic with
tranquili zer.

Fixed dose combinations of^anti^.
histaminics having patent sedative
preparations (for example,diphen
hydramine dimenhydrinate, tripel-c
ennamines, pyrelamine. Antazolin "
methapyrilline,etc). with tranquilizers are considered irrational for
the following reasons:
Such combinations may cause
enhanced sedation, which may
interfere with the patient’s day
/time--ac4djgit_v ard dull the mi nd
and slow the Yef:===

- 5 4. Fixed dose combinations, of
tranquilizers," AntiHistaminics and Analgesias

fl

5-. .Fixed dose fombinatipn.8, of
Vitamins with Analgesi»g

6. Fixed dose combinations of
Paracetamol with Antihist&minics and tranquil
izers .

7. Fixed dose combinations
of prophylactic Vitamins
in anti-TB Drugs.

Fixed dose combinations of Trantquilizers- with anti-histaminics
and analgesics in oral dosage form
are considered irrational for the
following reasons
(a) Such, combinations may cause a
lot of unwanted sedation , which
may interfere with the
patient’s day feme activity
and dull the mind and slow
reflexes.
(b) There may not be many clinical
sit* .at io ns which would need
a fixed dose combination of
these 3 categories of drugs and
there will be unnecessary drug-,
ging. However, fixed dose
combinations of these drugs in
injectable form may be allowed
as injectables are not likely
to be misused.

Fixed dose combinations of high
dose Vitamins with analgesics
should not be allowed unless there
is adequate evidence in support
of the rationale of such combinat
ion.
Fixed dose combinations of Para
cetamol with anti-histaminics and
tranquilizers should not be allowed
as there is hardly any clinical
situation which should demand a
fixed dose combination of anti
pyretic, an anti-histaminic and
tranquilizer. However, fixed dose
comb, lations of paracetamol with
anti-nistaminics and paracetamol
with tranquilizers may be allowed
provided the formula contains an
adequate dose of such ingredient.

I
ii

Fixed dose combinations of
Vitamins in prophylactic doses in
anti-TB drugs should not be.allowed
as such combinations lack rationale.
However, combinations having a
therapeutic rationale- such as INH +
B6 may be allowed.

I.

MS-cb/D-10,340/
25.S.19B2

ANABOLIC STEROIDS FOR GROWTH
1•
■Z

l:

BRAND & DRUG
HOUSE

v

INGREDIENTS

COST

INDICATIONS

DOSAGE

'?•

CONTRAINDICATIONS & SPL^PRECAUTIONS

* Adroyd
(Parke-Davis)

Oxymetho lone Jmg

15-9.04

Underweight or asthenic patients Occassionally 20-30mg
convalescence fran acute infec
daily may be required.
tious diseases!# major surgical
Usually for 10-21 days
procedures-pre-and post-operative- but not more than 90
ly, chronic debilitating illness; days. Ped. dosage:
osteoporosis, fractures and
see lit.
decubitus ulcers, severe burns

Prostatic carcinoma. Although Adroyd .
has a low degree of androgenicity, veipyoung and preadolescent individuals arcusually sensitive to the masculinising
effects of- androgens. Duo to this,
they • should be under • medical- supervision
during therapy’and-the- drug - withdrawn
if-masculinising effect .devel^
,
Adroyd should be used- with- cah .
caution.in cardiac disease, hepatic
dysfunctionT -nephritis and nephrosis.

Anabolex B12
(Cipla)

Methandieiiorie- <mg
Vit B12 50mcg
ferric amm, cit
50mg/mL - - -

5ml-6.23

Loss. of. appetite and vjeig.' t loss
with anaemia. Growth disorders
in children

Continuous-treatment- shoulbe <
limited to a max. of'4 weeks with
intervals of 1-2 months between courses.

Dianabol
(Ciba-Gelgy)

Meth andi e n one
25mg

lml-5.70

jnl-i.t® weekly.
psctcirf malnutrition, convales
For intensive therapy
cence, wasting diseases,
1ml on alt mate days
osteoporosis, growth retardation,
aplastic anaemia, red-cell
aplasia.

Ji
IT

15-10 drops daily
for 4-6 weeks

MIMS
CIMS
t

#

I

Prostatic cancer, severe liver *
insufficiency, severe nephrosis ,
pregnancy and lactation. Should not
be given continuously for persons
periods exceeding 4 weeks. High
doses in women may produce menstrual
cycle disorders, hirutism, deepening
of voice. In children, premature
ossification of epiphyses and
virilisation may occui

2

MS-cb/D-10.340/
25.3.1982

\

BRAND & DRUG
HOUSE

d —-------------------

• i!

INGRISIENTS

^ir Dianabol
I'
"
Methandienone
Img
Tabs(Ciba-Geig^) and 5mg

Durabolin
• (Organon)

lmg<:2f^
^.53
5mg: 106.02

INDICATIONS

DOSAGE

CONTRAINDI CATIONS & SFLfc PRgl Ainrrnwg

(Same as Dianabol)

Male:5mg daily.Maint. therapy: 2.5mg
daily. See lit.
Female:2.5mg daily.
Maint:1-2mg daily.
See Lit.

(Same as Dianabol)

(

Children: 0.010.04mg/
kg body wt for riot
more than 4 weeks

(

i

4LJZ
7T7/.

Dianabol Drops
(Ciba-Geigy)

COST

Methandienone Img
per ml

5ml-5.5O

f!

)

Nandrclone phenyl »0mg-13. fProtein
’
loss following surgery
propionate; lOmg
25mg21.35
trauma,
burns
J, infectious
-1)
and 25mg
diseases or following pr ..longed corticosteroid therapy, uraemia
due to acute and chronic renal
failure, general debility,
osteoporosis, aplastic anaemia,,,
>•
inoperable mammary ^arcincma,
under weight chi ldren and
fractures.
# Deca Durabolin Nandrolone deca10mg:1amp 1 ,m. 25mg every 3 weeks. In
A
noate 10mg and
-9.28
acute renal failure upto 50mg
25mg
25mg:1amp weekly and in chronic renal
8.53
insufficiency upto 10mg every
3 weeks. Children: 10mg,
every 3 weeks

\

MIMS
# CIMS

25ug' cvq$3

JKl acutes

ok.
Jure

tgjAc 5Cs^-«.
in chronic renal in
sufficiency upto 50mg
tvdcp weekly.
Children: 10mg every
week

Dianabol has been deleted from the- June issue ofMIMS and is idthdrawn by Ciba-Geigy.

J!

(See lit)

)

JMS-cb/D-10.340/
! 25.8.1932

3

BRAND & DRUG
■11 . HOUSE

INGREDIENTS

COST

TAXATIONS

. 1
Evabolin
1 (Concept)

Nandrolone phenyl
propionate 25mg
Vit.E 100mg/2ml

2nil-7.O6

Convalescence, to promote
2ml-Aml i.m. oncO-'
growth in undernoursihed children weekly
adjuvant to steroid therapy.

DOSAGE

CONTRAINDICATIONS & gPL^PREGAUTTON^

-------

J

Carcinoma of prostate, pregnancy,
male breast carcinoma.

Osteoporosis, hypoproteinaemia.
Haemolytic anaemias.

, * Neurabol tf(Cadila)

Vit Bl 60mg
B6 27.5mg
Hydr oxy c obalami n
100m§g, nandrolone
ph enylprepi onate
2ml

2ml-4.42 General debility, osteoporosis, ' 2ml i.m. every week
weight loss, refractory anaemias,
neuritis, neuralgias.

Prostatic carcinoma, pregnancy,
B1 sensitive patients.

Orabolin
(Organon)

Ethylestronol 2nig;

20-13.34 Osteoporosis, weight loss;,
debility, anorexia, burns
during steroid therapy

1 tab t’jice daily.
In serious conditions
dosage may be
increased

Pregnancy, prostatic carcinoma,
male breast carcinoma. Severe
liver dysfunction.

Orabolin
Drops(Organon)

Ethylostrencl 2mg
per ml

5ml-6.56

Body wu upto 1Okg

Body--.rt upto 10kg:
10-20 drops.
10-20kg: 20-40 drops
20-30kg:40-50 drops
More than 30kg:
50-60 drops. All
daily

: I'

'A

■A

* Trinergic
) (Unich'SEi)

Methandionone 5mg' 20-12.71
:
Vit Bl lOmg, B6 10mg;
Bl 2 30mcg

Malnutritpn and unde? nutrition
convalescence, old age anorexia'
nervosa, neurological disorders,
extensive burns, severe
injuries

* Trinergic
’ Inj.(Unichem)

Methandionone 25mg
Vit B12 500mcg/ml

(Same as above)

-I

■w IOS

# U1MS

1ml-2.96

»

Continuous treatment should be
limited to a max# of 4 weeks
with intervals of 1-2 months
between courses.
1ml once or twice

. weekly.

(Same as above)

MS-cb/D-10.340/
V

25.8.1962

- 4 -

I

I-

BRAND & DRUG
HOUSE

• INGnSDBKPS

COST

Unabol
(Unichem)

Nandralpne phenyl
propionate 25mg/
ml

1ml-7.0l Negative nitrogen-balance, old
age, osteoporosis, bone frac
tures, during prolonged corti
costeroid therapy^ to promote
weight gain

Winstrol
(Cosme Parma)

Stanozolol 2mg

20-12.46

Poor protein anabolism, osteopow- 2-4mg thrice daily
rosisj convalescence, aplastic
just before or with
anaemia. 3 during corticosteroid .meals. Children 3-6
therapy
years: Img twice
daily; 6-12yrs:
2mg thrice daily

# Aquaviron Bl 2
(Nicholos)

Free’ testosterone
251^711612 500mcg
per ml

1ml-4.75

Depressed debilitated male
patients

^Aquaviron Inj

Free testosterone
25mg/ml

1ml-2.5O Male: hypogonadism, - organic
impotence, eunuchism, delayed
puberty, premature senility
Female: metropathia haemorrhagica menorrhagia, frigidity,
inoperable breast carcinoma,

INDICATIONS

DOSAGE

WTWWCAWNS, &

25mg weekly

£ Carcincma of prostate, pregnancy^
male breast carcinoma

I

r

I’

r

jl

mis
CIMS

7

Iril i.m. twice
weekly for about
6 weeksj diminish
frequency as
conditions improves

Male: 1-2ml every 1—2
weeks diminishing the
doseas patient improves
Female: 1-2ml daily
until bleeding stops.
Not more than 200mg
in one month

Pregnancy, carcinoma'of prostate,
severe liver disease. Pro-pubertal
children where it may lead to
stunting of growth. Use lower
dosage in young females to minimise
androgenic side-effects. Impaired
cardiac and renal function.
Prostatic carcinana

MS-cb/D-10:343/
\

Information on some of the unwanted drugs

Drug Banned

Brands

Reason for Banning

Clioquinol

Mexaform
Enteroquinol

Blindness
Sub acute myelo optic neuropathy
10,000 - 30,000 afflicted in
Japan presenting with pain,
paralysis blindness and in
extreme cases death
Until banned in Japan in 1970
WHO - Risks of treatment out
weigh benefits
• paralytic
leading to inacurate
assessment of fluid
loss and toxemia if
assiciated gut
infections

Lomotil for infants

C5 p *

Is '

£o o’ si:
v,
■' i
CT F -

r

2 ?: p

* Banned Abroad1

C

< %

'o A,
O,>

(Dumped in the Third World)

Countries in which banned

US, UK, Japan, New Zealand

( see dear doctor series
of social audit )

MS-cb/D-10:343/

2

-

Some of the unwanted/dumped drugs

Generic Drug

Brands and Preparation

Reason for Banning

' Countried in which bamed

Analgin Dip Dipyone

90 brands sold in India

Fatal agronulocytisis
blood dyscreaseas

Analgin market in India
FIVE SHORES ANNUALLY.

Labels for Di pyrone in
US should be restricted
for its antipyretic
effects in serious life
threatening situations.

American Medical Association
’’Because «£ Dipyrone (analgin) may
/produce fatal Agranulocytosis and
other blood dyscrasias its use as
a general analgesic antiarthritic
antipyretic cannot be condoned.
Permissable only for febrile
convulsions where parential
preparations needed and in Hodgkins
when fever cannot be controlled,”
Dr Satoskar -’50$ of aplastic
anemia here is due to this drug.’
In India Hoechst claims Novalgin to
be ’patent, non salycilate, analgesic,
antipyreitc, antispasmodic, anti
inflammatory, anti rheumatic agent
for all kinds of pain, rheumatic fever,
rheumatoid arthritis, relief of colics.
Literature enclosed says although danger
of agranulocytosis is remote, it has to
be borne in mind and a white cell count
should be done if patients condition so
warrants. r>

...3/-

r
J.

&

MS-cb/D-10:343/

Drug banned

3
Brands and Preparation

Reas on for Banning■

Countries in which banned

Amidopyrine

incriminated with stcmach cancer
and bone marrow suppression

Phenacetin

Renal damage converted to paracetamol
for painkilling action - other by
products cause toxicity so why got use
PARACETAMOL

Tetracyclin
(Paediatric drops)

For pregnant mothers and for children
upto eight years - discolouration
of teeth, their early decay, the
incorporation of drug in the bones
causing disorders
Several antibiotic syrups decompose
rapidly with time and arc therefore
sold exclusively as granules to be
rocohstitjited before use, but in third
world ready to use syrup preparations
freely available.

Banned in most countries
Market in India of
Tetracyclin drops
Rs. five crores.

Pregnancy tests in which
estrogen progestrone mixtures
are administered

Associated faetal malformation

US,UK, Sweden, Finland,
Singapore

.1

Alpha Hydroxy, Progestrone
Caproate

Prolution Depot
Foetal malformation specially spinal
being advocated for
cord defect
prevention and treatment
©f abortion, prolonged
treatment with adequate
dosage recommended to
maintain pregnancy

U.S.A.(banned in 1938)
U.K., Germany, Japan,
Switzerland.

US(Banned in 1973)
UK
According to Dr Satoskar
’’proof of prevention of
abortion unclear but most
shocking is its use as
long term contraceptive.

...21.. .

t

Nos used in Category Name of the .Drug House Content S ou rc e Aval, a
blc . :
Drug
BCC/ETxW/G-a- Banned
the
zette Noti
ma - - ■
fication res
or
pectively
________
Nectrine
Nandril
ICC
Neoril
Alkem (
Nennygin
Medo uhem
Neurodin
Beckcem
Neurogesic
(KLaxy
Neuroxy
Veniy on
Neurovon
Nib in
Nib idril
Onalpam
Khandelwal
Cifiss
OPE
Bombay Tablet
Ophen
Artic hem
01g in
Nib in
Oxalpam
Nutri Thera
Oxam ol
Cadila
Oxalgin
Dia Pharma
Oxal
Lark
Oxylar
Healer
Oxydon
By namic
Oxydril
Ent od
Oxy t od
Thio Pharma
Oxypyron
Cadila
Oxymide
Eros
Oxybutal
Gy p er
Oxypam
Eros
Oxypam Plus
Pharmed
Oxy-Triattin
Oxyrin
Themis
Tablets
Oxyryl Pius
it
Oxidine
Simis
Oxypose
Rank
Oxone-A
• Pl azma
Oxydrex
Oasis
Oxidigin
Mi n
Oxigin
Monokem
Oxypyrin
Axar
Oxin
Bio Med
Oxym ol
B P Labs
Oxyphen
Oxyphe nbut az one Acron,Acila,Alma,Arora,B P Labs,
Belco, Bombay Drug,Chemical &
Pharma,C oop er,Gyp er,Beepharma,
Fa ird e al,0anes h,Ind i c a,Kanp ha,
•KSEP,Kent,Lark,Lupin
Art ichem
Paramin
Albert David
Parazine
Artichem
Prrin
Penta
Pent oxy
IDPL
Phenabid
Pasteur
Phenzyn-A
Lupin
Placidin
Prim
Primoxyphen
Mercury
Prolyn
Syntheco
Prestigesic
Stade hem
Prestigen
Primoxyphen
Prim
Unique
Red uc in
Mac Mohan
Referin

...22.o.

V

Nod used in Category Name of the lirug House
Drug
DCCplT.W/Ga- Banned,
setts Noti
<ficat ion res
pecitively_____
Reparil
Eairdeal
Rilifon
, Shree
Lanept
Roxypam.
Sanoxymol
1 Sa nitex
Sidril
?' Sims
Suganril
S G- i’harma
Tendasone
Cxystal
Thio Kof
Thiodril
-Trigger
Trigerzin
Tromalgin
-La. Pharma
Tromin
Rays
Tromagesic
Themis
Venco Oxypainol Vefiiyon
^.Vikrant
Vikrapyrin
v Virgo X ‘ .
Vi rgonalgin
Medoz J
‘ ’
Zeroxyl
Zonalgin

Anabolic Steroids:
Ad royd
Anabolex B12

Di a nab ol
Dianabol Tabs
Dianabol Drops
Durabclin

..

tt

Organon
0 one ept

Neurabol H

Cadila

Grabolin
Orabolin Drops
Tri nergic

Organon

Winstrol

Aquaviron B12
Aquaviron Inj

Source
bli

the
mar
or

X

iC

’'m

Parke Lavis -Oxymetholone MIMS
-M e t hand i e n on e ”
Cipla"
Vit B12,Eerric ama ci
Methandi©none- Both
Ciba C-eigy

Leea lurabolin
Bvab oli n

Trinergic Inj.
Unabol

Co nt ent

n

it

tt

tt

u

Hand rolone
CIMS
phenylpropronate
-Handrolone decanote! ”
-Handrolone phenyl b ot
propionate,Vit E
-Bit B1,Bo,Hydroxycoba
lamin, nandrolone p.heny propionate
MIMS
Ethyl estrenol
both
it

n

-Methandienone, MIMS
Vit B1,B6,B12
tt
Methandienone,Vit B12
it
-Nandralone phenyl b ct
propionate
Cosme Farma-Stanozolol
”
Nicholas
-Free testosterone,Vj^gU
-Free testosterone
”
Unichem

CLASS VI

Irrational combinations of Tonics, cough syrups etc.
Vitamin B Complex,Liver extract and iron
” ”
, Vitamin C
"
” etc.
(Would like to get your views and help from you)

Mm

<MS-cb/D-1O.34Q/ '
25.6,1982 <

DRUGS CONTAINING IRRATIONAL COMBINATIONS OF STEROIDS AW AM Il^LAMMATCRY AGENTS^

. BRAIW & DRUG *
HOUSE

INGREDIENTS

COST

* Butacort
(PCI)

Prednisolone 1.5mg
Phenylbutazone
100mg

10-2.09

i

INDICATIONS

•

1000-

64.80

Rheumatoid arthritis, osteoarthritis,
ankylosing spondylitis

OedCma
Oed&na or hypertension where
’Aero there is danger
M.
of cardiac decompensation, • renal and hepatic
disease, peptic ulceration, blood dyscrasias.
May potentiate coumarin-type anticoagulants,' '■ij
oral hypoglycarmics and sulphonamieds. Check -'i
'i
blood regularly, (See Sec. $C)

•4

4

) .
0

I

CONTRAINDICATIONS & SPUPREQAIHIONa
\

. t.

*

t

'* Butapred
/(Biochon)

Prednisolone 2mg
10-4.40
phenylbutazone
500-142.47
ftOOmgj salicylamide
300mg, dried alum,
hycjrox gel 20mg

Rheumatoid arthritis, ankylosing
spondylitis, gout and superficial
vein thrombosis. Extra articular
rheumatism fibrositis, tensoynovitis,
bursitis, painful shoulder and acute
arthritis of any joint,
osteoarthritis.

(As above)

* Deltaflamar
(indoco)

Dexamethasone 0.25mg 1C-5.5O
ozxyphenbutazone 75mg
dried alum,hydrox
l50mg^ mag tri si lie ate
lOOmg

Rheumatic and allied conditions.

(As above)

* Ingapred
- (Inga)

Fhenylbutasone 50mg 10-1.23
prednisolone 1,25mg

£3

• k-'--

•

4.

Rheumatoid arthritis. Still’s disease
gout, ankylosing spondylitis.^
osteoarthritis.

H •

(As above)

’•

* MIMS
i
.Sec. $C
' Corti^^fieroids
in tuberculosis iocal or-systanie infections unless controlled by chemotherapy, active
peptic ulcer., ps^ch,^Gs, vosteoporosis,
-%«+s are contra-indicated
renal dysfunction, diabetes mellitus,
di s orderg , ’
- glaucoma
hypertension, myasthenia gravis, thrombo-embolic
■art
failure and pregnancy,
.S’M
*
i

.. .

i

. J

COMMUNITY HIALTH CELL
47/L(r-irst Fioor)3t. Marks Road
BANGALORE-560 G01

•A."

<5^

>

X

• s.

v.

|

MS-cb/D-lQ,340/
25.S.T9S2 '

.Il

BRAND & DRinS
HOUSE

I INGREDIENTS

Thilozone-P
(Unique)

Phenylbutazone 125mg
dexamethasone Ot37ing
mag.trisillicate 150mg

I-

1

j
■■.,1

I

2 a

INDICATIONS

10-2.64

Rheumatoid arthritis, osteoarthritis^peptic ulcer, blood dyscrasias, cardiac/

500-99.17
10-2.64

Prednisolone 1.75mg
mag. tri si 111 c ate 150mg
phenylbutazone 0.1 g

10-2.80

Rh.cixiatoid osteoarthritis,ankylosing
spondylitis, osteoarthritis, gout,
painful joints.

Triactin-D
(Pharms^

Dexamethsone 0.25m^
phenylbutazone 100iag
liag.trisillicate l50mg

10-2.80

(Same''as. above)

# Arumin

Paracetamol 0.15g
dexamethasone 0.25mg
ph enyIbutaz one 0.1g
chloroquine phcs.?5mg

10-6.65
10 x 10-

't

CONTRAINDICATIONS & SrL.PREGAUm»JS^. /;

Triactin
(Pharmed)

(m)

j

■ f;

■

COST

Z

•
-S‘
r.s
~
Oedema
or hypertension where. tliere is danger
of cardiac disease, peptic-ulceration, Bp •:'A?
blood dyscrasias. May-potentiate coumarin-- . Ttype anticoagulants, oral hypoglycaemies
and sulphonamides. Check bJAod regularly.
(Seo Sec. 5C)
J

(Same as above)

\
\
\

>

66.50

666 :

* MIMS

T

- ------------------------- ------------ —------------------------------

# oiks

A

£ec_5C:-Corticosteroids are contra-in1!cated in tuberculosis, local
meilituAB^^
0
Unless controlled by chemotherapy, active nenfi?
ulcer, psychoses, osteoporosis, renal dysfunction, diabetes
-’
dlauccma,
hyper
tens!
ys
cuion,
diabetes
mellitus,
dlaucana,
hypertension,
myasthenia grevis, thrembo-ambolie disorders
congestive heart failure and pregiiancy.
••■

4

•J

A
\

1

1

I

/
/

z

/

DRUGS COMTAIMING IRRATIONAL COMBINATIONS OF CHLORAMPHENICOL
AND STREPTOMYCIN
-K-

*
*

4?•K■te
■fr

Basi
BRAND
Basiplon
Basiplon Suspension
Chlorostrep Kapseals
Chlorostrep ’ Suspension
Enterostrep
Enterostrcp ’C1
Enterostrep Suspension
Ifi strep
Ifistrep Suspension
Reofin
Reto strep with isomycin
Strepto-P araxin
Strepto-Paraxin Pediatric
Stroptophenicel
Streptophenicol S^Tup

Drugs containing
Bi st re pen
Bistrepen Forte
DicrysticirT-S ’
Dicrysticin-S ’FOO’
Dicrysticin-S Forte
Hsnacillin-S
Munomycin
Omnamycin
Penicillin Streptomycin
Penmyn
P ens t rep

DRUG HOUSE
Khandelwal
Khandelwal
Parke-Davis
Parke-Davis
Dey’s
Dey^s
Dey’s
Unique
Unique
Rallis
Retort
Boehrnger-knoll
Bo eh ring e^-kno'M
M ercury
vercury

nicillins and Streptmycins
Alembic
Alembic
Sarabhai
Sarabhai
Sarabhai
SP LTD
Glaxo
Hoechst
TEFL
Sarabhai
MSD

Combiotjc - CL
Injection: Each i gm contains StiQytomycin sidfere 0.5 gm.
Procaine n encillin G 300,000 units. Sod.’bncillin G 100,000 units

Combi tic ^orte
Injection: Each 1 gm contains Streptomycin Sulfate 1 gm.
Procaine penicillin G 300,000 units. Sod Pen ci Ilin G 100,000 lac units

(The drugs containing Penicillin and Streptomycin have been
taken from the Pharmaceutical Guide 1931)

MS-cb/D-1O.34O/
26.8.1982
BRAND

#
#
#
-X-

#
#
//
#
#
#

#

-X-X-

DRUGS CONTAINING ANALGIN
DRUG HOUSE

An ad ex
Baralgan
Benalgis
Combigesic
Cemizol Inj
Cibalgin Compositurn
Conaril
Do lag in +
Eucrasil
Eucrasil-5
Eucrasil ^nrte
Fargosic
Fargesic Syrup
Maxigesic
Medalgin
Medalgin Syrup
Neogene
Novalgin
Novalgin Injection
Promalgin
Sedyn-A- Forte
Spasmizol
Spasmizol Drops
Spasmizol Inj.
Ultragin
Ultragin Syrup
Ultragin Inj
Zim algin

Concept
Hoechst
Eranco-Indi an
Unloids
IDPL
Ciba-Geigy
Citadel
Ph armed Gujarat
Eisen
Eisen
Eisen
PharEast
PharEast
Ethico
Medoz
Medoz
Anglo-French
Hoechst
Hoechst
Uniloids
M M Labs
IDPL
IDPL
IDPL
Manners
IDPL
IDPL
Rallis

MIMS WIL 19S2
#

CIMS

MAY

19S2

DRUGS CONTAINING PH W AC ETIN
■?(-

#

#

C aph erin
Dolopar
Holviran
Treupel
V eganin

MIMS
CIMS

MercuryMicro
Bayer
Ge man Remedies
Warner

APRIL 1982
MAY
1982

CO.-

,0^-^

I
I

< >

I

MS-cb/D-10.340/
27.8.1982

ERUGS CONTAINING HYDROXYOUINOLINE

BRAND

r

Amb act in-4
Amo eb indon
Aldiamycin
Aldiamycin Suspension
Alliquin
Amebys
Ambilan
Amoechin
Antidar
Bioxy 1
Ch lo rambin
Colon
Davoquin
Dequinol
Dependal
Dy sen ch lor
Digichlor
Diodoquin
Di-Iodobydroxyquin
Di-Iodohydr axyquino lin e
Di-Iodohydroxyquino line
Di-Iodohydroxyquinoline
Di-Iodohydroxyqunoline
Dinochlor
Dinoquin
Diorcin
Dy strin don
Dysen^al
Dysentol
Dysentriad
Ehteroton
Entro Iodochlor
Embaquin
Entrokin
Entroquinol
Ent ero-vioform
Intestopan-In
Faircolin
Fairdiquin
Floraquin
Furoquinol
Histoquin
Idosulpain
Indoquin
Intestopan-Q
Intestopan Suspension
Labrody
Lumigyl Caplets
Mebinol Complex
Mexaform
Neoquin
Moebagym
Phenipan

I

ERUG HOUSE

B C P W
Indon
Aik on
Aiken
Standard Pharmaceuticals
Napha
Swastik Pharmaceuticals
Universal Drug House
Dextromed
Bio-Drug
Anglo-French
Em sons
Albert David
Dey’s Medical Stores

I
i
I

I
3

sk &r

J

S G Chemicals
T H P
Searle
Senit
T H P
Fairdeal
Usan
Baropham
Bengal Immunity
Bengal Immunity
Cos Pharma
Indon
Quality Pharmaceuticals
Bronkal Pvt Ltd
GDA Chemicals
I N D C
Bombay Tablet
M & B
Bengal Chonicals
Indo-Pharma Lab
Ciba-Geigy
S andoz
Fairdeal
Fairdeal
S earle
Chogule
Zandu
Indo Pharma
Indoco
Sandqz
Sandoz
Labrbs Chemicals
Ethico
MAC Labs
Ciba-Geigy
S unways
Ebers
Sandoz

3

i

1
I

■

' I

■ f

[.
t’

i•
'i

t
7
•f

J

I,

2

BRAND
Quinifonn
Quinogel Compound
Stadmed Entrozyme
Sul^aquinol
S ulphaquino-B ael
Sulphazyme
Uni-Eiys
Yodchin Sulpha

ERUG HOUSE

Albert David
Acilla
Stamed
Comteck
Standar Pharmaceuticals
INDC
Unichen
Duphar, Navaratna

\

■

1

f

L-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.

Glass I: Drugs banned under gazette Notification of 23rd July 1983.
Class II: Drugs that should have got banned under the same notification 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
—‘strychnine or test esterone in tonics is just as irrational
as a drug containing all the 4(obviously the number of dru<; 3
affected this way are much less.

Class IE : 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 recommendatici.

Class /: 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 indicate DCC/DTAB/Gazette Notification to
facilitate cross checking. If there are any errors they are uni nt er .-1.
You are requested to review the list, add/substract/modify
according to most recent information. T her§ is notmachinary for
sharing unbiased drug information omaeas health personnel and con
sumers would not have to spend time on this. If this list makes some
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 canmake it.
Note: - It is possible that some brands have been reformuia ted,
eg. Some APCs may now contain Paracetamol instead of Phenacetin whi i
drug companies have actually done so and withdrawn their earlier AP'ls
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 been
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 cai,
share the information with others. Information and knowledge are
powerful tools for action.
YOU ARB 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 ^>rug Action Networkers and VHAI members
with help from Dr Rane and Dr Anil Pilagaonkar of Arogya Dakshata
Mandal. Late Mr Agacy, CCynthia Brown have helped with the earlier
'Black Lists'. For the final
—- version
L—i we owe our thanks to Alphonse.
In solidarity,

L

Dr Mira Shiva
Coordinator
'-K’N.yy .A'ALTh C v Low Cost Drugs & Rational Therap*^(FirstF(c
.
ioor)3
(.
. L'
tics, Vr. ..
'--IE-560 00J

-

D-9/33O(c)
LCD.a. 20. 9.84
BANKED BRAND DRUG LIST

Note:

Banned drug list is being divided into 6 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
pectively.
1980/82/83
CLASS I
2/1/1

Name of the
Drugs.

Drug House

Content

Amidopyrine and its
combinations.
Adysmene
Ethnor
Alergin
Cipla
Aristapyrin Aristo
Gajiar1s
Arthrex
Biochem
Biopyri n
Bipipyrin
B P Labs
Bitapyrin
Bombay Tablet
Butapyrin
Inga
Butarin
Themis
Cibalgin
Ciba
Ind on
Dolorindon
Eropyrin
Eros
Esgipyrin
S G Chemicals
Mercury
Meparin
Naphapyrin
Napha
Nectarin
Nectapyrin
Ne o- Sp asm ind on-1 nd on
Optalidon
Sandoz
Oripyrin
Indo Pharma Labs
Phenorin
Jagson Pal
Phenylbutazone & AmidopyrinPharmakab
Predapyfin
Eros
Ind on
Pyrindon
Rumipyrine
Uniloids
Spasmerin
Mercury
Spasmindon
Indon
Spasmo Cibalgin-Ciba
Theraphen
Therapeutic

Source Availah

PharmalS1
H

s°
^'3

£p$

§
P « c?

s&

Sss

M IMS’83

I

Dolviran
C od opy n
Apidin
Trevpel

Bayer
Stadimed
IDPL
German Remedies

it

eras ’83

f

.. .2. ..

Nos used in Cat eg or
DCd/DTiS/G-a- Banned,
zette Hoti
fixation res
pectively_____________
5/2/2

1'lane of the
Drug.

Drug House

Cont ent

Source

Ava iT"
ble in
the or- •
ket . r
not.

Fixed dose combinations of Vitamins with anti inflammatoiy
agents and tranquillisers:

Placid in
Lupin
Spasms Proxyvon-Wockhardt

Licyc 1 onine HCL, b ©xh oproxhphene HCL,Acetaminophen,
Cloriazephoxide
Sudhinol-M-C c.ompuund-Ranbaxy-Eexnopropoxyhene, Hapeylat
Paraxetamol diazepham
Tylenol wj.th codeine -Ethnor-Acetaminophen,Corcintamoktroprophyhen,Paracetamol,
diazephem
Cater
Wallace
Walagesic
Analg in, C oed ine, ph as
~ Citadel
Conaril
", Ponacetalol,diazepam
TTR Pharma
Paranal
■ . , 4
Sedyn-A-Fort e
Wy^th
Equagesic
Meclozine HCp,Hie otinlet
Uni-UCB
Liligan
acid-Hydroxizine HCL
O.<j:

6/3/3

?

Fixed dose combinations of Atropine in Analgesics,
And Ant ipyretic s:
Ejrthel morphine nec
St ad med
Ant ispasmin
Phenolphtha lein. Phenobar
bit one. Amidopyrin,
MMS’<At rophine mothonit rate„
P arac et am ol,Hy oscyan in e,
Eskaylab
pryd onnal
scopolamine HBr,Phenobarb
At r op in sulph.
Analgin, At ropin methonitrat,
Standard
Spasmolysin
Papaverine HCL9Liazepam.

...J...

NOs Used ih Categofy
DCC/DTAB/Ga- Banned,
zette Noti
fication res
pectively
1 980/82/93

Name of the
Drug.

Brug House

U6nt ent

aouce

7

0/4/4

Fixed dose combinations 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 9
Arsenic and Yohimbine.

10/7/7

13/9/8

1/10/9

Avalble i\
the m r
ket
not,

Fixed dose combinations of Sodium Bromide
Chloral hydrate with other drugs.
Gy nod ex
Retort
Ext. alet^is, Ext. Viburtum
Ext. hyoscyamus, Ext. of
ovary, Ext.of placenta,
Sodium bromide.
Phenacetin and its combinations:
Pharma183
Anti spam
Cooper
Asthimindon
Ind on
Bellaspin
Nibin
Cyperdine
Cyper
Dolviran
Bayer
Espico
Kirti
Influenza Tabs Bey’s, Acila
Phenacin
Kirti
Qinarsol
Cipla
Ind on
Spasmindon
Spasmon
Semit
Vencospasmin
Veniyon
Capherin
Mercury
MIMS ’82
Dolopar
Micro
CIMS 82
Treupel
G-erman Remedies
Both
Veganin
Warner
(Continued on Page. 12)
Fixed dose combinations of anti histaminics with
anti diarrhoeal^.
AFD
Clorambin
Light AaMin, Pect in,
meomycinsulph,di iodohydroxyquinyline belladonay
Chloraphenaramin,mebate.

2/11/10-/Fixed__________
dose combinations of Pencillin and
Sulphonamides.

^rystastrep
Ley’s
Penitriad
M & B
Penivoral Trisulfas- Franso Indian
Pentid-Sulfas Sarabhai
Sipromide V
Al emb ic
SP Ltd.
Stanpen-S
5/12/11

Fixed dose combinations of vitamins with Analgesics:
Micropyrin
Nicholas
Acetysalicylic acid,Vit.C
Phenabid
ILPL
Oxyphenbutazone,Vit . C.

Nos used in Category
DCC/L'TAB/Ga- Banned,
zette Noti
fication res
pictively.
1 980/82/83

Name of the
Drug.

L-rug House

Content

Source

Aval'
ble
.
the
mark
or n. .

0/13/12

Fixed dose combinations of Tetracycline
with Vitamin C.

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 combination of steroids with other
drugs for the treatment of Asthma.
Cortihist
Ingo
Prednesolone, chlorpheneamino
Maleate
Perideca
Merck Sharp & Dohme - Bexame theone,

cyproheptadine.
Aquivorn B12
Mixogen

testosterone,vit.B
vit.B1
Nicholas
Free testosterone
122
Infar India- Ethinyl oestradiol,testostOestradiol monobenzoate 9 er or ■
’’ phyenylpropionate.
Testosterone propionate
" phenylpropionat e, isocap;: ;
Pasuma 1 Strong*-Merck
Methyl testosterone,vit.E,‘
Caffeine, recephedrine HCL(t b
Testosterone, Vit.E(inj)
Test iob ion
Merck
” , vit.E,B6, B12.
bisecron Forte Nicholas. Progestrone,Oestradiol,
benzoate
(a)Senso
Vilco
Methylt est ost erone,Vit.E,

Caffeine
(b )Theragran-Cr£

Sarahhai

Ethnyl oestradiol,Methyl
testosterone,Vit.A,B1,B12,
Vit.L, E,
(c)Geriatone
Wyeth
Ethinylestradiol,methyl testostrone, Vit B1,B12,folic
ac id, c,dried ferrous sulf.
(d )Trinergic
Unichem
Methandienone , Vit B1,b6,
B12(capsule)
Methandienone,Vit B1,B6,B12(.' j
Other oral(contraceptives) are combinations of
2 or more steroid^.
Dexabolin
Infar India - Pexamethozone,ethynloestrend.
it
Docabolin
Nandrolone phenylpropionate,
desoxycorticosterone phenylpropronate.
((Duoluton
German Remedies
E P Forte
Umlchem
Menstrogen
Infar India
Norlestrin
Parke bavis
Orasecron Forte-Nicholas
Orgalutin
Infar India
Osterone
Iyka
Ovral
Wyeth

...5...

Nos used in Category
DCC/DTAB/Ga- Banned,
zette Noti
fication res
pectively.
1980/82/83______

Name of the Drug House
Drug.

Content

Source

Aval
ble
the
ker
not

a
I

ar
r

•Ovulen
Searle
Lyndiol
Infar India
Minivlar ED -German India
Norcyclin
Ciba GeigyOrlest-28
Parke Davis
Ortho Novin -Ethnor
Ovral L
Wyeth
Primovrar
German Remedies))

3/16/15^/

gixed dose combinations of chloramphenicol for
internal use except combination of chloramphenic<31
and st reptomycin;

Chloramphenicol & Sulphonamides:
Diastrep
Sunways
Enteromycetin Sulfa - Dey&s
Kemisulfan "Carlo Erba
4/17/16

4X6& dose combinations of Ergot:

Ergatap
Oafergot
Erg ophen

Merc ury
Sand oz
Inga

Ingagen
Ingag en^-l1}
Migranil

Inga
Inga

Migril

Welcome

Vasograin

Cadilia

ii

Ergot prep.
Ergotamine tartrate, Caffe Ln?
Ergotamine tart erate,
Belladonna dry#ect, hence-Md
Erg/?tamine tart erat
Methyl ergotamine maleate
Ergotamine t art erat e, Bell ;dona dry ext. Paracetamol
Ergotamine tart erate,
cyclizine HCL,caffeine
Ergotamine tart erate,
caffeine,paracetamol,pro
chlorperazine ,maleate.

7/18/17 y Fixed dose combinations of Vitamins with
anti TB drugs except combination of Isoniazide
with Pyridoxine Hydrochloride(Vit.B6):

Antic ox 450 -Unichem

Rifampcin,INH,B6

Cadilla

Rifampicin,INH,B6

Antic ox 600

0/0/18

Pencillin skin/eye ointment:

0/0/19 v/Tetracycline liquid oral preparations:
Ificyclin Paed.drops -Unique -Tetracycline
Ificyclin syrup
-Unique”
Linemett syrup
-M e rc ury
”
M IMS
Dupicyclin syrup -Lupin
”
n
Mysteclin-V Paed drops-Sarahhi-T, amphotericin”
Sandocycline susp. -Sandoz
”, broxyquinoline,
Subamycin Paed syrup -Dey’s
Md robenz oxaid ine

.. .6...

Nos used in Category
DCC/DTAB/Ga- Banned,
zette Noti
fication res
pectively.
1980/82/83_____________

Name of the
Drug.

Drug House

Content

Source

Avbl. 1X
thmax ot
or •t

Tetracycline CMS &
MIMS
Terramycin soluble Tabs- Pfizer Oxytetracycline”
Tersamycin syrup
H
n
n
Terramycin Paed drops _
II
—
11
”
T e r ramy c in M In j
It
terramycin IV Inj
t MSB Tetracycline
MIMS
irrycin^.
'
CMS
”
Alcyclin Paed S drops -Alembic
- ”
Oxytetracycline I!
Alcyclin-0
lid ocaine,anhydrous
oxyt et racy cline.
Subamycin Paed drops -Dey’s

0/0/20

Nialamide:
Niamid

0/0/21

Pract olol:

0/0/22

Methapyriiiene, its salts.
Capqu
Roc

Pfizer

Pharma-179

Pharma ’83

...17)...
CLASS II

Nos used in Category
DCC/DTAB/Ga- Banned,
zette Notif
ication respect ively.
1980/82/83

Kame -of the
-Drug.

Drug House

Cent ent

0/0/0

Amidopyrine

5/2/2

Fixed dose combinations of (vitamins)
anti inflammatory agents and tranquillisers:

Source

zp.-

b2.
th.
m
■ or

Wockhardt
Ind oc o
Ethico
Nool
Drugs containing Vitamins and anti inflammatory agents:

Butaproxyron
Fkamar P
Maxigesic
Rumat in

Ra nodine
Mjicropyrin
Phenab id

Ranbaxy
Nicholas
ILPL

0/0/0

Fixed dose combinations of Atropine in Analgesics
and Antipyretics.

0/0/4

Fixed dose combinations of strychnine and Caffeine
in tonics:
Ciltone
Buphar
Merck
Orheptal
Sant evini
Sandoz
'•^enophos
Rallis
Toniazol
Boehringer Knoll
Aminovin Tonic -Smith Stanstreet
Eunova
German Remedies
Mynberrys
Juggat Pharma
Ranbaxy ’ s t onic-Ranbaxy
Acelyisalic acid -Aleid -Bengal Immunity
Antiflu
SP Ltd.
APC
-Boots, CPL, Dey»s, JDPlj,Opil, Kemp
Khandelmal, Nectarine, Pharmakab,
Semit, Swastik.

8/5/5

Fixed dose combinations of Yohimbine and
Strychnine with testosterone and vitamins:
Qavert
Gavarine
PMT
Cadila
Vilco
Sensa
Vigotab
Jagson Pal
Yohimbine
Atul
Yohimbine & Strychnine
Nectarine Peatles-Nectarine
E Marek
Pasuma Strong
Emetine & Strychnine
St remb in
Usan

Pharma !85

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.

..a
r.
t
A

...18..,

Nos used in Category Name of the Drug House
Drug.
DCC/DTAB/^a Banned,
zette Noti
fication res
p actively
1980/82/83_____________
Phenacetinland its_combi nations:
13/9/8

Cont ent

Source
bL
th
mr

1/10/9

Fixed dose combinations of anti histaminics with
anti diarrhoeals.

2/11/10

Fixed dose combinations of penicillin with sulphonamides

5/12/11

Fixed dose combinations of vitamins with analgesics.
Mitacin
Nicholas.

6/13/12

Fixed dose combinations of tetracycline with vitamin C.

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 combination of steroids with other drugs for the
treatment of asthma.

3/16/15

Fixed dose combinations of chloramphenicol for internal
use except combination of chloramphenicol and streptomycin.

4/17/16

Fixed dose combinations of Ergot.

7/18/17

Fixed dose combinations of vitamins with anti TB drugs
except combination of Isoniaaide with pyridoxine
hydrochloride (Vit. B6).

0/0/18

Pencillin skin/eye ointmaet.

0/0/1 9

Tetracycline liquid oral preparations.

0/0/ 20

Nialamide

0/0/21

Practolol

0/0/22

Met hapyrilene, its salts.

.r

;t
t

Nos used in Cat egory
DCC/BTAB/Ga- Banned
' zette Noti
fication res
pectively.
1980/82/85
13/9/8

Name of the
Drug.

Drug House

Content

Source

Avsj -a
bio ' n
th..
mar? t
or . . t

Phenacetin and its c ombinati ons
Acetylsalicylic Acad, caffeine &Phenaceti_n:
Ale id
Bengal Immunity
Pharma183
Antalgin
Medinex
...
Antiflu
SP Ltd
APC
Acila, Alma, Arora, Belco,
Bengal Immunity,B.ombay
Drug House,BP Labs,Chemical
& Pharma,Deep^arma,Cooper,
Ley1s,Eros, Forstar,Hima,
Ganesh,H Jules, IDPL,Inga,
Gyp er Pharma, Kanp ha Labs,
Nectarine, Nymph,. Panacea,
Phamakab, Sanitex, Sarvodjaya,
Semit,Stamac,Tablets,Teecee,
Apidin
IDPL .
Apihist,’’
Bombay Tablet
Apocine
Mediproducts
Aselgin
Gavert
.. ..
Bodryl
Parke Lavis
Capherin
Mercury
Gapramin
Glaxo
Gapsin
.
BC,
Godral
Burroughs Wellcome
Golithan CPA- Faildeal
Dolorin
Cal Chem
Dristan
Whitehall
Flucut
Emkay
ICC
Histacap
Influenza Tabs-Panac.eaIngacin
Inga
Nylacin
Nymph
Painkill
Paras
Panalate
Forstar -

Prolene Comp.65- Stadmed
Relaxin..
Franklin
Salurin Forte Alma
Supacin
Nymph
Veganin
Warner Hindustan
VeraPen
Pharmakab
Verind on
Ind on
Wescogesic • Wesco
Acetylsalicylic Acid,codeine & phenacetin:
Ant
’ ' ad- one
SPLtd
Coc odin
Cooper

Cod od on
God op in
Codophene
Codopyrine
C od ot ab
Cod ral
bardona
polorin

Nectarine
St filmed
G-avert
Glaxo
Jagson Pal
Burroughs Wellcome
Baidyanath

V aganm

H omb
Warner?

Wh“
tains
Thio Kof
urg
Treupel

. .10. o . .

CLASS III
Nos used, in Cat egory
LCC/DTfxB/Ga Banned.
zette Notifv
ication res
pectively.
1 980/82/83

7/0/0

1 5/0/0

Name of the
Drug.

Drug House

Clit one:

Dupari

Orheptal:

Merck

Pencillin & Streptomycin
Bistrepen
Alembic
Bistrepen Forte-Alembic
Dicrysticin-S -Sarabhai
Licrysticin-S800- ”'
”
g Forte- H
SP Ltd
Hemacillin-S
Munomycin
Glaxo
Hoechst
Omnamycin
Penicillin St rept omycin- IDPL
Penmyn
Sarahhai
MSB
. Penstrep
Campleillin C Cadila
Carbelin
Ly la
Sarahhai
Crys-4
Z.halgin :
Aarelgin
Adgesic
Ad ol
Algesin-0
Algiril
Alp ox
Anae et
Anadex
Analog
Analgin

Source

Aval1 ble 1
the
mark c
or Nc

Vit.B,Nicotinamide,
Penthenol,Sodglycer^ pho'.
mangsulph,caffeine,!
liver fraction with B12,o:/
Nic ot inamid e, Cal. pant hothenali,cupicichl,qunine ,
he 1, sod glycereo, caffeine .
alcohol, mang chi

. Crystapen & Granules - Glaxo.
7/0/0

Content

MIMS
*83
ii
II

II

Pharma183
Ramsons
Ethico
Acila
Alembic
P & B Labs
.. Alps
Semit
Concept
A TaCC
Acila,Acron,Alembic,Alkem,
Alma,Apex,L TaCC,Arora,Arya,
Associated Product s,B eng al
Health,Belco,Bombay Drug
House,BP Labs,Biochem,Carewell,
Chemical & Pharma,Comet^Cooper,
Cyper Pharma,Beepharma,BWD,
•^mcee. Fairdeal, Forst ar,Govert,
Ganesh,Haffkine,Hima,H Jules,
IDPL,Ifiunik,INDC,Ind ic a,Inga,
Indian, Inventa, ICCO,Kanpjia,
KSDP, Lark,Med inex,Med irose,
Medisearch, Nulif e, Nymph,Paam,
Nectarine,Panacea,PCI,Pharmakab 9
P rakash, P ulymar, Ranb axy, Ray s,
Remedies(I),Sanitex,Sarvodaya,
Semit,SlRi,Smith,Stamac,Tablets,
Tarachem,Teecee,Veniy on,Vidarbha.

.. .1*1...

Nos used in Category
DCC/DTAB/Ga- Banned,
zette Noti
fication res
pect ively.
1980/82/83

c

Name of- the
Drug.

Drug House

Analpar
Thio-Kof
Anamol
Heiko
Roc
Anapiron
Medirose
Anmol
West Coast
Anoxy
Tharachem
Avalgin
Belco
Belgin
Franco Indian
Benalgis
Bio-Med
Biogin
Bitalgin
Bombay Tablet
Butac ort incbon-Indon
Butagin
Aikem,Tablets
Butaphen Plus-Biochem
West Coast
Butaster
U
S Vitamin
Canapar
Capagin
Kon test
Cartagin
IndoJhem
Veco
Celgal
Cemizole
idpl
Cetalgin-D , Optho
Dadhalgin
Dadha
Dexabut algin -Monoekem
Dexabutazone -Stadchem
Diapar
Navil
- DCI
Dicigesic-N
Dicolgin
Kanpha
PCI
Dipralgin
(Franklin
Dizalgin
Dolagin
Pharmed
Dolo- Neurob in -E Merck
Indic©
Doloril-A
Dolotril
Saima
Doloxan
Shree
B P Labs
D-Pyrone
Sanderson
Duogesic
Dublactin
Tab lets
P & B Labs
Dypalgin
Ebejlam
Eb ers
Bp agin
Kon Test
Eisen
Eucrasil
Phar-East
Eargesic
Eevozone
Alpha
Excel
Elunil
G avert
G- avalgin
Geecoprin
Paam
G-inol
Nib in
Histarin
La Pharma
ICCO
Iccalgin
Ind us
Indalgin
Ind o- Amalgin-1 nd oc hem
Inflagin
Kanpha
Inflar
Navil
Jemjesic
J ems
Kent
Kanamol
Kanopar
Kanpha

Cont ent

Source

Availhie i .
the
mark.
or n<

.. J2...

Nos used, in . Category Name of the
DCC/DTAB/G-a^- Banned# ■ Drug,
z et t e Not i
fication res
nectively.
1980/82/83

Drug House

Co nt ent

Kapaxgin
^Kaptab
Kelgin
Kee Pharma
Kepoxgin
Kanpha
La-Pyrin
La Pharma
Largesic
Lark
Medalgin
Med oz
Supreme
. Met abut ad ec
Met oxy 1
' Acron
Wesco
Micron Plus
Molgin
Dia Pharma
Monokem
Monalgin
Myalgin
Shree
Mylogin
Chemical & Pharma
Neorin
Themis
Hivelgin
Nictarine .
Febro
Novapam
Nurolgit
hulife
Nycin
Nymph
Amee
OAD
Orphalgin
Biddle Sawyer
Oxal
Dia Pharma
Oxalgin
Cadila
Oxidigin
Oasis
Oxigin
Min
Dynamic
Oxydril-DS
Oxymol
Bio Med
Euphoric
Oxynal
Oxypose
Sims
Oxypyron
Thio Pharma
Oxy z ol
Medirose
Palgin
Chemo Pharma
Pamagin
Alkem
Pamolgin
Paarn
Panalgin
Carewell
Parageic
Radicals
Paralgenol
Veco
Paralgicin
Stade hem
Paralgin
Emcee
Paralgin
God am a
Paralgin
Stamac
Par Analgin.
Bombay Tablet
‘Paranalgin
Gavert
Eourt s
Parladim
Parazoll
G-anesh
Penalfine
La Pharma
Penalgin
Tarachem
P et rag in
Thio Pharma
Medi
PPI
PEC
Alkem
Predniphenol-6-G-avert
Prim
Primdril
Pyragesic
Jamsons
Synthiko
Quikalgin
Referin
Mac Mohan
Repalgin
Rays
Resin
Assam iharma

Source

Availa
hie i
the
m .ark
or r

'13.

? Nos used in Category Name of the Drug House 0 ont ent
DCC/DTAB/Ga- Banned,
Lrug.
zette Notifi
cation res
pectively.
1980/82/83
_______
Ricofast
Plazma
Rumalgin
Shree
Rumasol
Excel
Selectagesic
Supreme
Rupalgin
Rup
Shormetal-D
Themis
Spalcin
Martel Hammer
Spanil
Grosons
Spasaron
Kon Test
Spasmatac
A^TaC^
Spasmat e
Terce
Spasm o
Enkay
Sp a sm o- Am id o z on e Sup r ac h em
Spasmolyrin
Standard
Spasmog in
Ind ochem
Spasmlan
. Ad or
Sterpose A N
Sterfil
Sunalgin
Medinex
Sup ralgin
Sarvodaya
Synalgesic
Geoffery Manners
Trialgin-D
Osseisule
Trigerzin
Trigger
Trigin
Biox
Tromalgin
La Pharma
i
Trypin
Healer
Uniprox
Unicure
V espanil
Veco
Virgo
Virgonalgin
Wespalgin
West Coast
TOE
Zinalgin
Zonalgin
Eebro

14/0/0

Source

Avail.ble in
the
market
or not.

Chloramphenicol with Streptomycin:
Basiplon
Khandelwal
Bichlorfenin
Medinex
Caristrep
Carewell
Cemistrep
Suprachem
Cilast rep
Acila

Chloramphenic o St rept omycin-Sarvodaya,HA,Tablets
Chlorocin Strep Jagson Pal
Chlorostrep Kapseals -Parke n avis
Chlorostreptoseal INDC
Chlorosulf
Ranbaxy
Chlorosoin
Dolphin
Cooperstrep
Cooper
Conti Strep
Cont inental
Dee Strep
Deepharma
Dye os
Dynamic
Glue ostrep
Gluconate
Glycostrep
Glyco Remedies
Gravostrep
La Grand el
If istrep
Unique
Intest ostrep
East India
Li st rep
Lister

...-u..
Nos used in Category
DCC/DTAB/G-a- Banned
zette Noti
fication res
nectively.
X1 980/82/85

M

Name of the Drug House
Drug

Medistreps
Medirose
Med ost rep
Med oz
Monost rep
Monokem
Niscostrep
Nishikam
0-St rep
Opt ho
Paam Strep
Paam
Pharaastrep
Pharmakab
PCI
Phenistrep
Phenistrep
Usan
Phermceostrep
Pharma Medico
Prom
Buff
Ranstrepcol
Ranbaxy
Red st rep
Duff
Rhof in
Rallis
St repc ol
New Life
Strephenic ol
H Jules
St rept ac hl or
Forstar
Strept ok ep'
Remedies(I)
St reptochlor
Mac f
Streptophenicol Mercury
St reptosain
Sain
Vilco
Streptovil
Sunstrep
Sunchem
Vec o
V ecost rep
Vinystrep
Healer
Wilostrep
Dadha.

Content

Source

Availble ir
the
mark.?
or no4'

V

...15.

CLASS IV

Kos used in Category Name of the Drug House Content - SourceAva.i- .
bje > .
DCC/DTAB/Ga- Banned. _
Drug...
\ .
Tfrlte :zette Noti.......
markt. .
fication res
.
•
or no;.'
pectively.
1980/82/83
Those, drugs that were. banned separately 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
of hydroxyquinoline group of drugs except preparations
which are used for the treatment of diarrhoea and dysentery.
E P Drugs:
E P Forte

Unichem

Hydroxyprogest- CIMS ‘83
erone, ac et ete,
et h ni-ny lest rad i ol,
hydroxyzine hcl

Cumority
Secrodyl
Allenbury^
Lut-Estron Forte- Mac Progesterone, CIMS n
oestradiol dipropion
Menstrogen Fortv-Organon-Estradiol benzoate tt
Progest ert one
G-estaplon
Khandelwal- progesterone, IMIMS‘83
estradiol benzoate
Orasecron Forte-^icholas-Ethisterone,
CIMS n
Ethinyl ostradiol
Disecron Forte-Nicholas-Progesterone,Oestradiol
benzoate
H

D.i-Iod ohydToxyauinoli.be
aj
____
Pfizer
Amebiotic
Pharma'83
Excel
Amecure
Griffon
Amidine
Amidochlor
Therapeutic
Amidys
Sarvodaya
Trigger
Ami trig
Am oc id ol
Saima
Amoebin
Penta
Ind on
Ameobindon
Stade hem
Bi oquin
C hl o rambin
AFD
Colon
Emsons
Usan
Comtiasis
Albert David
Davoquin
Diazole
G-odama
THP
Digichlor
Di noquin
Bengal Immunity
Searle
Diodoquin
Cadila
Diodys
Di-i od ohyd r oxy quin-Semit
Di- iod ohyd r oxy quin oli ne- Alma
Di-i od ohyd r oxy quinoli ne- Apex, Arora, As s oc iat ed
Products,Belco,BP Labs,Bombay,
Cadila, Cooper,Cyper,Haffkine,
H Jules,ICCO,Ifinnik,Indica,
Indian Research,Indon,Ganesh,
Kanpha,KSDP,Nectrine, Nymph,
Paam,Pharmakab,Pharma Products,
Sarvodaya,Stamac,Tablets,Teecee,

.o.16„..

Nos used in Cat egory Name of the Drug House C ont e nt
Drug.
DCC/DTAB/Ga- Banned,
zette Noti
fication res
uectively
_______ _
Supreme
Li-Met razole
Eros
Eroquin
tt
ErOquin-F
.i
Phar East
Farnid
Searle
Floraquin
Revers
Furaquin
Saima
Furogil
Gluconate
Glucoline
Zandu
Histoquin
Indo Pharma
Indosulpain
Nishkam
Int estren
Smith
lod ocycline
Indoco
lodoquin Comp.
J ems
J emeob ic
Max & Kent
Kentizole
Kent
Kentroquin
Kee Pharma
KequinsaM
Plazma
Lumigyl
Vita Nova
Met r oquin
Ebers
Moebagyl
Kanpha
Mexogil
Medix
Mexogyl
T e rc e e
Nid
M & B
Nivemb in
P & B Lab s ■
Novonidagyl
Cipla
Nut rozyne
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
INDO
SuIphazyme
Thio
Kof
Thiozyme
Medinex
Trie odys
Ramson
Tryquin
Unichem
Uni Dys
Cifiss
Vagiquin
Veniy on
V eniquin
Pulymar
Zolaquin
, I od oc hl orhyd r oxy quinoline z
Alliquin
Ambarid
Ambiquinol
Am eb ide TC
'Ambizyme Forte
• Amo echin
Amygil Plus
Andocin
Ant idys
Aremzyme

SP Ltd
N I Pharma
Emcee
fiotrerts
Emcee
UDH
Emcee
Angel Pharma
Remedies(I)
Roberts

Source 'Avri
b1e .
the
■ mar1'

Pharma ’ 83

...17...

Nos used in Category
DCC/DTAB/Ga- Banned,
zette Not!
fication res
pectively____________

Name of the
Drug.

Drug House

Content

Source

Avails •
hie if
the
market

/Daidyaaath Eczema Malham-Baidyanath
Baidyanath Isabhael
"
B rad ex-Vi of orm
Cib a
Chloropectidin
Cal Chem
ulogil
M R Labs
Corto Quinol
East India
Cosmezem
Jos Pharma
Curogyl
Shree
Darmadar
Stamac
Davoquin
Albert David
Deaquin
Cadila
Depedal
Eskay
permo Quinal
East India
equinol
Dey’s
Diacheck
New Life
piarzole
Monopax
Digichlor
THP
Diogyl
Searle
Dysentol
Quality
Dysentol
Bronkol
Enapec
A TaCC
entakon
Non Test
Entrobael
INDC
Entero Quinol
East India
Ent ero-Vi of orm
Ciba
Enterotone
INDC
Entromin
Panacea
Entroquin
Indo Pharma
Entrozyme
Stadmed
Entrozyvit
Amava
Forquin
Medirose
Fungrin P
Saico
Gestro Quinol
Prakash
Gquin
Grosons
I odochlorhydroxyquin -Alaji, Associated Products,
Arora,Cooper,ICC,Haffkine,
Nymph,Panacea,Semit,Stamac,
Tablets, Unit ed , Apex, ICC,
Kanpha,Deepharma
lod ocortindon
Ind on
Indoc hl or a HOD
Paam
Idofur
Nymph
I of ur
Apex
Metroquin
Rays
Mexaform
Ciba
Wudy’s Comp.
NuLife
Ompect ol
Ramsons
Pectocin
Thio Pharma
PCI
Prot oquit
Prot ozide
India Health
Quinidochlor
NCPW
Quinid ochlor
Amava, AtaCC
Quinimole
Min
Quinod oc hl or
Forstar
Quinoform
Albert David
Stamaquin
Stamac

...18. . .

Name of the B^g House
No(s used in Category
'Drug
DCC/DCW^a- Banned
zette Noti
fjJcation res
pectively
_________ __ ___________ ____ —;—
Stomazole
Kanpha
Sulpha quina Bael -SP Ltd
Sterfil
Tolnacomb
Unichem
Uni Dys
n
Uni Enzyme
V eniyon
Vencosarin SN
Therapeutic
Viod ochlor
Vilco
Vilco 12-21C
Vioform
Ciba
West Coast.
Wesco -^ys

Content

S ourc e

Av • • ’

bl . ... n
th .
Mar
'
or
,t

CLASS V:

Problem drugs that should be severely restricted if not banned,
eg. Butazolidines,Anabolic steroids for children etc.

Phenylbutazone:

Acetazohe
Act inol
Acapyrin

IRI .
Pharmed
Usan
Alembic
Alfeesin
PCI
Amphiyrin
Aquapyrine
Vidarbha
Alkem
Arc on
NuLife
Arc u. re
Ar-ogopyrin
Arora
Ari st o
Arist opyrin
Arthozolin
Remedies
Sanitex
Baripyrine
Enk ay
Beesopyride
BP
Labs
Bipipyrin
Bombay
Tablet
Bitapyrine
Osler
Butadol
PCI
Butacort
Cadila
Butadez
Angel LabsyG-anesh
But am ol
THP
Butanyl
Inga
Butapyringa
Franklin
Butasule
G-anesh
But ascarbi sone
Biochem
Butapred
Themis
Butarin
West Coast
But aster
Indoc hem
Cartagin
Veco
Celgal-P
Chemical & Pharma
Cepyrin
PtSTI
Coirtazolin
Badhapyrin Tabs Dadha
Delta Pharma
Decapyrine
Delta Jagozolodin-Jagsonpal
Themis
Dexabutarin
ft.c;.:
St ad c hem
D exabut az one
Monokem
Dexabutalgin
Dexaphenalgin
Sims

Pharma ’83

...19...

Nos Used in Category lane of the
DCC/DTAB/Ga- Banned.? Drug.... zette Noti
fication res
pectively__________
Dexapyrin-D
Dexapyrin ’
Dicipyrin
Ebeflam
Erobut ol
Esgipyrin
Gavazone
Gee opyrine
Gravodine
Inapyrin
Intasolone
Gagopyrine
Jagzolodin
Kebutacine
Medic opyrine
Med opyrin
Qmdex
Oripyrine
Ort hod ex
Pamapyrin
Pancy
Parazone
Parazolandin
Phem ol-D
Phenamide
Phenid opyrin
Phenorin
Phenopyrine
Phenylbutazone
Phenylbutazone
PhenyIbut az one

Drug House

Content Source

4V ■; ’

ble . n
.the
mar> t
or .. A

T—------------------

Sarvodaya
Ganesh
DCI
Ebers
Eros
SG Pharma
Gavert
Paam
La Grande
INDC
ICC
Jagson Pal
if

Kee Pharma
Medi
Med oz
Ramsons
Indo Pharma
Saima
Galpha
Lister
New Life
SG Pharma
Pharmakab
Nib in
Sterling
Jagson Pal
Cooper
Acila
Albert David
Apex, Bleco,B P Labs,Bombay Drug,
Cyper,Cooper,Chemical & Pharma,
Deepharma,Ganesh,Inga,Indica,
Kanpha,Nectarine,Nishkam,Nymph,
PCI,Sain,Sarvodaya,Semit yStamac,
Tablet s,Veniy on
Phenylbutazone& Amid opyrine- Cooper,Cyper,Deepharmr
Ganesh,Pharmakab,Albert David
Navil
Prenovil
Gavert
P red niphenol-6
Pulymar
Pulrheuma
ICC 0, Cyper,Deepharma
Pyrine
Albert David
Remaitl
ICCO
Rib opyrine
Shree
Rumalgin
Rhumalport
G^lpha
Stamac
Rhumagon
Carewell
Rumatril
Robert
Rum a rem
Siri
Rumatison
INDC
Rumicort
n
Rumin
Sanitex
Sanipyrine
Teraphen
T&e rap eutic
Thilopyrin
Unique
ii
Thiozone
Thio Kof
Thiopyrin

. ..20...

Nos used in
'DCC/DTAB/Gazeiite Noti
fiCation res
peetively

Category
Banned.

Name of the
Drug

Triactin
Triactin-D
Trigxyl
Udypyrine
Venoogegic
Oxyphenbutazone:
Actgesic
Algiril
Alophen
Amid ozone
Anox
Anoxy
Arden
Arodil
Best ophen
Broxyl
Butac ortindon
But ad ex
Butagin
Butanil
Butaphen
Buta Proxyvon
Cetazone-D
Coxin
Cypadril
Dafenoxyn
Delta Plamar
Dexopam
Diazeril
Disflam
.Doloflam
Doloril-A
Doloxam
Feb rogesic
Flamar
G-Oxyl
Inflandril
Inflar
Inf lad ol.
Inflamak
Inflarid
Inflagin
Infla Proxycap
Inflavan
I not imee.
I nt aryl
Jagril
Jamril
KapfLam
Kapoxgin
Kentigesic
Largesic
Maxigesic
Met rozole
Metrozole-F
Monoril

Drug House

Content

Source'

Av'\
a bi’

in
tlic

_____ gg§
Pharmed
ti

Trigger
HUH
Veniyon
Thio Pharma
P & B Labs
Alpha
Suprachem
Shanberg
West Coast
Ad on is
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
¥ilco
Indica
Shree, Healer
Pebro
Indoco
Grosons
Medzix
Navil
Nishkam
Novus
Radicals
Kanpha
Kanpha
Kandelwal
Keepharma
Ge no
ICC
damsons
Kaptab
ii

Max & Keht
Lark
Ethico
Supreme ..
n

Monokem

Pharma ’ 8;

3t

^mumty Hr:
V Main, /B/ocfc
^Oram^gala

a
CELL

Zx<<y

7’9a'ore-560034
VOLUNTARr’^gAXTH ASSOCIATION OF INDIA
C - 14 Community Centre,
S. D. A.
New Delhi 110 016

D-9/gg4-(a,l)
19.8.1982s a

BACKGROUND PAPER PREPARED by. VHAI FOR DRUG-INFOmATTOTUSHA RTTmTO PREPARE FOR ACTION
"

---

THE CLIOQUINOL CONTROVERSY
Remanding its bar. A Just Demand* Or, Just
a Demand?
We are grateful to our friends in IOCU,Penang, Social Audit me
for some valuable information they sent to“f.
Audit,UK,

Historical Background
Hydro^ygruinaiin^.,^ introdueed into the Swiss phamaoopea

1900 as ja jppical and antiseptic
of interest when
itsj potential asagent;* In the SO’s it became a focus
----------an intestinal amoebicide was investigated.
It was around 1932 that• classical animal studies
established the
"therapeutic potential of the :halogenated hydroxyquinolines
—
1 as lumen al
amoebicides n.

i) Refs Leake, C.D. (19g2) Chemotherapy of Amoebdasis.
oi American Medical Association - 98. 195-199.

J oumal

U.S.A. 2ei^g!ial Cli21ical trial of elioquinol was conducted in the
muVim’ N'A’’ Johnstone, H.G., Reed, A.C., Leake, C.D
The Treatment of Amoebiasis with todochlorhydroxy-auinoLinZ

Since then
popularly used for

1
»2r tres,,““t of moebio dysentery and: simple diarrhoea,
teoaiis est^SU

absorbable chelate and it was replaced by zSc

P^LgNSTIcgF1^
s

7

0Mllne 811

ABOUT
i

ciba
urst
rter ■
doctors in Argentina describing exactly thf same sife ef?ects°as
Japanese cases in the 60-s and 70's <Bft- reived. by^CIBA-Fr®m internal documents in 19g9, from Switzerland nnd

U
L

I
■ J

• • 2/-

'y

i

W-9/334 (a-1)
as 19.8.82

- 2 -

reteriD“d»> roportea to
twated with Satew-

CIB4 CEIG? Sat’S
vlofom had Uod, £ XSo”».

(e p- dtn°OT,d+?S4-t2i.;Dr,01e Hansen "attempts to hide facts, deny facts'"
noVto
S
6 <1TOe ±S a’bsorVed) ®d attempts to convince doctors

s p”“f
,
Cases of optic atrophy were'observed in s
-a small
of
children receiving the treatment for acroderaatitis
< •proportion
’ *
------3 enteropathica - this
was prolonged
high dosage treatment. Since earlier, children
-----------survived without treatment, optic atrophy al
earller’. chll
^enx never
a
late
manifestation
of the
disease could not be excluded.
out of Inni9-4\^eV^Sitle
unusual gait changes
noted in 20
out of 4000 institutionalized patients on long tenn were
treatment.

RefS SnnU L:M”
W-L-(1964)! Prophylaxis and Therapy of
Amoebiasis and Shigellosis with lodochlorhydroxyquin.
American Journal of Tropical Medicine and Hygiene.13,396-401).

19'69 pnd°?r^iOnS4.in dab0rat0I'y mice on high dosages was reported in
domestic dogs and cats treated for diarrhoea
in veterinary
pid/U l/JLCtz •

A reversible confusional state had been described following acute
dosage in man.
clionuirnT” ,perd^nal ohsotvations of "transient global amnesia after

and Basel

the’RfSt

DGpartment °f Neurology, University of Berne

casee
'!mo'3 Drug Information: Jan-March 1978, though sporadic
oT„“e of
"y9 roportod, It
Japan that SMOH w n 1
,treateient end prophylaxis of diarrhoea in
f recognized as a distinct clinical entity in 1964
ATsubaki, T., Toyokura, Y., TSU Kagoshi, H. (1965). Sub-acute Myelo "
Studv N®Ur0pTat^ following abdominal symptoms - A clinical and pathological
otudy, ?apanS Journal of Medicine; 4, .181-184).
P
logical

i

-i

HOW USEFUL IS CLIOQUINOL?
Vr,Th?rS *S+n° \\idence to sugges that clioquinol is effective in the
prophylaxis of travellers diarrhoea.

British National Formulary, 1981
+

.

TxS 21Wa for 'fche value of clioquinol in the prevention and
^arrhoea^' do not withstand

1

i

I

4

The Lancet (197?)
relatin^to^^Jpof “koines,UK) has reviewed the data
S “u?! efficacy of clioquinol in the treatment of diarrhoea and
iders that rhere is inadequate evidence to support the claim".

Pharmaceutical Journal (30.7.77)
page 597.
3/-

D-.9/334 (a.l)
a: 19.8.82

3 -

cohvenedhind197/fo exC1Udei fro® consideration by a WHO expert committee
convened in liW 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). .

e^t0riai in'the Journal of American Medical Association
10th April 1972, page 273 stated:
/

"••....in the 40 years that clioquinol has been available
on y one study which is not entirely convincing, has shown
it to be effective in preventing travellers’ diarrhoe/ 7
whereas one other prospective study has shown it to be no
more effective than" a placebo... ”
/ j
Hydioxyquinolines are active only on organisms present
^ithin 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
certainty fevQn
ev^n in
in
patients with asymptomatic amoebiasis”.

PDT/jDl/78• 1 TOOsLrug Information.
Jan-March 1978
■

ti»ss

“a —•••toain - “■

+
.
"^he S01entific evidence for the value of clioquinol in the
treatment of prevention of traveller's diarrhoea is scanty".
;
the Pha7C7dcne 7Dr:-?• c* 0andiya of Jaipur, then President 7
he Pharmacy Council of India. "The Indian brand of Mexaform contains
2 more drugs (besides Iodo chloro hydroxyquinoline the basic drug phanquone and oxyphenonuin - and has“come to be used'not only fob

‘

4

STS aSuSSK* ”lt 41“rh“a Of.‘U

inolpajj that

sraem r,7th
relief is due to oxyphenonuim which reduces the
pasm.oi the.intestines and bowel movements and thus markedly reduces
abdominal pain and discomfort”.
. '
nf'oqh 7^
Co™^ttee had included clioquinol ’in the analogous list
4. n +me7lala7U?’
to lts low cost' in'relationship to alternative
SMON^th-311^
eZenar<i t0 th6 PaucitJ of documented evidence of
oMON within the country”.
. nnfla Hyd^xyquiholines 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 g-astro-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
Pl^tar responses a sensory level nn the tmnk and sphincter
disturbances could also occur and the combination of exaggerated
patellar reflexes and absent ankle jerks was considered to ba
a characteristic finding*

..4/-

D-9/334 (a.l)
a:19.8.82

4 -

«« ”«* ’""•Uy

an

substanuL^In^g^11 the “™ber of 381011 cases reported annually was
went 5
"
03368 Were rePorted
1969 the number
(PBT/Dl/77.4 page 10): WHO Drug Information. 197?
Mzyh r. "P6EI/eS
elderly were particularly vulnerable and formed
a
n °f Patlents wh° also suffered from serious chronic

(Ref. Sobur, I., Ando, K., (1969)
(1969) - Review and Comment on Myelo 24UrO?^9oy A™pani0d by Abdominal Symptoms, Paisnin Igakn

More reports were received in summer -

”A correlation between the use
clioquinol and the occurrence
of SMON in a series of 171 patients ■wasoffirst
reported in 1971".
T
/'(Refs au&aki T. Honma^ Hoshi, ivi.
M.(1971): Neurological Syndrome
Associated with Clioquinols
1’ Lancet 1, 696 - 697.
This was following the discovery of a green compound - later
identified as an iron chelate of clioquinol on •the tongue of some patients
and m the urine and faeces of others by Professor Tsubaki of Sigata,J
. rapan.
Regarding the effects of SMON which, according to some elioauinol
sjanpathisers, have allegedly been due to idiosyncrotlc causes the relatLnship between SMON and Clioquinol has unequivocally.been shown.
According to the WHO report ^e fact that some 15$ of the victims

Cli0^n°l

t ^htA?Zn y

merely renect

difficulty

.' .
ing precise drug histories from patients; alternatively, it mav
or^hateSM0N exlste*ce °f other factors in the etiology'of the disease,
or that SMON may not always b^- readily distinguishable on clinical
grmmds-'from other neuropathies.

/

ber?re

Pharmaceutical Journal
30.7.77: page 597

taring <leteote<‘ 1083 ””ber of eases
- 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:
1

"Bad information means bad medjcine" has this to say about

’’Clioquinol has caused thousands of cases of SMON a condition
involving continuous Apain, paralysis,
--- v-- f blindness and* in
extreme cases, death. TIn Japan,
’
cases of SMON re ached-epidemic
proportions - affecting an estimated 10,000
the drug was banned there in 1970".
P P

The casual relationship between clioquinol and SMON has even been
accepted by the Japanese courts.
i •

D-9/334 (a.l)
a: 19.8.82

5 -

WHAT IS THE INCIDENCE OF SMON OUTSIDE JAPAN?
0
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”.
■ -i

r 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, Denmatk, the Netherlands^ and the USA,
have described patient's who developed neurological symptoms while taking
these compounds.
The clinical symptoms of these patients were like the one that
characterized. 5iviojn,t4
Journal of the American Medical Association
23rd July, 1973: Page. 296

According to an international suryey-'On recent reports concerning
intoxications, with halogenated oxyppino'lines derivatives - ”A survey
of the literature has proved .Jbhart'86 cases were reported as SMON or
intoxication of halo^ena^edT' oxy quinoline derivatives (including duspected
cases in 47 articles published outside Japan from January 1970 to
^February 1977).
According to Dr. N. H. Wadia in his article: ’’Some Obs-ervations'’"
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 19^7-71 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 CIBA-GEIGY).

i

^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

1

Hydroxyquinolines are sold in more than 100 countries, In some,
there is a ban 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, HCQ was accepted for treatment of acrodermatitis
6

D-9/534 (a)
a:19.8.82

6 -

enteropatbica. Later, however, Sweden totally withdrew it and replaced
it by zinc .alts, which is considered safer and.more efficacious.

In the summer of 1976, Dp. Ole Hansen proposed that all CIBA GEIGY
or promote ?heir^odS^of StSvJofo^^d^Z^^
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.
anks 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
™ n™1 Ual
CIBA GEIGY lost
of their
in S*eden.
CIBA GEIGY is said to have lost 75 million Swedish Kroner during the
Jn 1980, this was equivalent to the total turnover of
vinA GEIGY kSweden)•
The boycott by the Swedish doctors and the public was their'way
to the developing countries, fulfilling their responsibility towards all peoples in preventing drug suffering.

38 individuals afflicted with serious side effects by taking
Mexaform, sued CIBA. GEIGY for damages in Sweden. CIBA GEIGY arid Nraco
agreed to pay 1.8.million Swedish Kroner as damages in an out of ±ourt
settlement according to the Economic Times of the 14th April 1982.

rJ—k T
muAh0Ut 10,000 persons are reported to be suffering from
SMON in Japan- 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
damage^suit
companies (CIBA GEIGY . jap£UI -Takeda Chemicals
Tanabe Selyakulo)
for the Tokyo district court to reach two decisions:decisions
1 C1ioquinol causes SMON
2 CIBA GEIGY et al. were liable in failing to pass
oh information
about the dangers of clioquinol.
Regarding the demand for appropriate instructions and a warning
for doctors and patients, the company has argueds
"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".

(Dr.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
using part
of their money to fight against needless drug induced suffering.
_ According to Michiko Kinoshita, a SMON
SHORT victim from Japan, in an interview
wittr the New Internationalist, Januaiy 1981:

nWe 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..helpedassistance foy
thalidomide victims in Japan”.
)

-4

\

(

V

D-9/334 (a)
a:19.8.82

- .7 -

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, 1982, 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 to restrict the sale of HOQ.
However, in 1977, it was felt that oral clioquinol should be/vailable
only on prescription.

. (Ref: Pharmaceutical Journal 1977: 106,219)
In 1977, the Lancet had said:

~

w

’’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 prescript
ion only, they have just disappeared fro# the market in England.
(The role of the press and Government Health Mini Rtry needs to
be noted and appreciated).

A point to note:
The Medical authorities in Britain had said:
’’This (SMON) is no
problem in Britain”. F
'
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 the consumers.
Therefore, banning of dangerous drugs is the only solution in the absence of
adequate control.

TUR

PLAIT

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

- 8 D-9/334 (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

- 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.

Demand that a cheaper alternative be made available.

8.

Letters to MIMS, CIMS,

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.

IMA.JOHRNAL.

References ?
1.

2.
3.

4.

5.
6.
7.
8.
9.
10-

11.

*An international Survey on Recent Reports concerning
Intoxication with Halogenated Oxyquinoline derivatives
and regulations against their use and supplement”
Kiyohiko Kalthaira, Ph.D, Tokyo Medical and Dental
University. Medical Research Institute.
Supplement of the above.
Bad Information means Bad Medicine: Clioquinol Pamphlet by
Social Audit, London.
Transient 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 Nei
-n
-r
. .
Surgery & Psychiat
WHO Drug Information:
&
Jan-March, 1978. PDT/DI/78.1 Page 9-11.
WHO Drug Information-. PDT/DI.77.4 Page 10-15
The SMON Syndrome:
Utusan Konsumer' March 1982
Some Observations onSMON from Bombay:
N.H.Wadia, Department of Neurology, J .J ^Hospital ,By cull a.
SMON Victims Plaintiffs Make Compromise Accordi
Japan Times "Sunday (Sept. 16. 1979)
Journal of Neurology, Neurosurgery and Psychiatry, 1977,
40 - 268-275
Goodman Gillman

- O/::

- 9 -

9/334 (a.l)
ai’ 23-8.82

ALTEWATiraS
Mfoonidazoles,

like Metronidazole (iNN)
Finidazole (iNN)

PROS
" have amoebiciclal action in the tissues as well as

in the intestinal contents.

■y- they are fairly well tolerated by the majority,
therefore Metronidazole can be used for amoebic
dysentery -as well as hepatic amoebiasis.
CO1TS
Occasional reports of neuropathy and. putopenic ■an.
carcinogenic potential in animal models (of uncertain
relevance to man), has led to statutory requi’temnts
for warning labelling in the USA and India-

i

- Metronidazole is relatively costly.
/Since

/ Metronidazole —
is extensively
——— tw-uj absorbed in the sua-vl
intestines and hence for greater and adqi/ate action
in addition
--------- ^n a lumenal amoebicide/should /be routinesly
prescribed^

/it

Diloxanide furoate
I
■
/ ■ i
PROS
- .is highly effective against nonsymptotiatic carriers.
in 95^ cases eradication of organisms has/ been reported
• ;

'

■

.:

/

•

I

- regarding its use in acute amoebic dysen-ieiy divergent
results have been obtained - concurrent7 use of tissue
amoebic!de whenever possible is re/omEi'ended.

Paromnmycine

toinoglycoside
Am in o gl yc o s i d e

/
Antibiotic - Is effective both foif .symptom less causes and
acute amoebic dysen^ry.- i
'/ \

p

CONS
High cost

■

■)/"

•

/

Troublesome diarrhoea

Carbasone arsenical and Glycobiafc
£sol gave unimpressive
performance - isolated fatalities attributed/uo carbasone~ occasionally — evidence of cumulative tbricity.
- the choice of lumenal amoebae ide shou^k/be 'based on its
effectiveness.
/
// /
// /
'/ (
I1

/

10 -

D-9/334 (a.l)
26.8.82: a

References continued:

Ashworth,B. (1975) Neuro-ophthalmology, In recent Advances in~Clinical
eurology, p.101. Edited by W.B.Mathews, Churchill Livingstone,London.

-rta
Wadia, N.H.
am’

,'e"rolo81“1 e>™dro”e a»oolaM
Is there SMON in India? Necrology India,21,95-103
Sut,acute myelo-optic neuropathy. Journal of the

Kono, R. (1971) Subacute i
Tnyelo-optico-neuropathy, a new neurological
disease prevailing in Japan, Japanese Journal
--------- of Medical Science and
Biology, 24, 195-216.
Le Quesne, R.M. (1975) Neurotoxic substances. In Modem Trends in
V
7 6,pp.91-93.Edited by D.Williams, Butterworths; London.
Meade,^T.W.(1975). Subacute myelo-optip- 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

i

Lt

"i

Mt

Pallis.C.A.(1976) Proceedings Honolulu Symposium on '^idemiological
issues m reported drug-induced illness. SMON and other examples',
McMaster University Press, Hamilton (Ontario).
Pallis,C.A. and Lewis, P.D.(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 Industry (1975),
Ministry of Petroleum & Chemicals, Govt.of India, Chapter X pp.251-261
1
Subacute myelo-optic neuropathy in. Australia!*Lancet
1,123-125.
Selby, G. (1973) Subacute myelo-optic neuropathy (SMON),Neurotoxicity of
9 1p3Ui^°1S’ Proceedin£s of the Australian Association of Neurologists;?
H (1973)’ Neuropathology of subacute myelo-optic-neuropathy,
SMON, Neurology India, 20, Supplement, 3, 395-419.
;mdo’Kl Li<ia M‘ Takayanagi,T! Yamamyra,Ys and MatsuokaiYs
UUYi;, Myelo-neuropathy with abdominal disorders in Japan,Neurology
(.Minneapolis) 21, 168-173.
^ldo’K: Lida,Ms Takayanagi,T: Makoyama M: and Matusoka,Y:
kl
bubacute myelo-optica-neuropathy in Japan; Neurology India 20
supplement 3, 420-425.

J.-

IS A PATIENT A CONSUMER ?
>

R.C. GOYAL

Introduction
Till rreriHly. if anv dlapulr t rgai i Hi »g tirgllgfin r <>n
the port ol the doctors or hospitals was raised In
a Court of Law. it was either filed under the Law
of Torts to claim damages, or under Sections 304
A. 336, 337 and 338 of the Indian Penal Code to
get the negligent punished. However, after the
. introduction of the Consumer Protection Act. 1986.
a drastic change has taken place. We find a
number of complaints being filed by patients and
their heirs in the District Forum, and State/
N
mal Commissions created under the
Consumer Protection Act. 1986, against individual
doctors and hospitals for negligence of one sort or
another.

Negative Impact on Consumers and the
Medical Profession

On the other hand, there are many good reasons
for excluding medical services from the Consumer
Protection Act. These are:
♦

♦

It will hamper doctors from giving their best
out of fear c: mishaps, unwanted litigation,
huge compensation claims etc.

♦

In every area of medicine, junior doctors need
to be trainee and all senior doctors need to
extend their expertise. This introduces
specific risks and raises distinct ethical issues.
Senior surgeons may well be the best of
surgeons bin the nature of medical care and
the need to .rain surgeons for the future
means that .he former must allow their juniors
to perform some of the procedures for which
they arc responsible. The delegation of these
duties is based on an assessment of the ability
of the juniors to perform the operations
concerned. As a result even if a junior doctor's
work is supen’ised. it will leave the senior
doctor's Judgement of the clinical problem or
the junior s ability open to criticism.

There can be a number of reasons for this change,
but the main reasons are :
♦

Increasing knowledge of ones rights as a
patient:

♦

Doctors and hospitals are no more held in high
esteem as before:

♦

No cost is involved if a complaint is filed in
the District Forum or Slale/National
Commission, since a patient can make out his
case and argue it himself:

♦

A complaint is decided within a short span of
♦hree to four months under the Consumer
Protection act while it usually takes years in
the Civil/Criminal Courts.

Benefits to Consumer
There are a few reasons for keeping medical
services under the purview of the Consumer
■protection Act. These are:
♦

♦

There are cases of medical practitioners dealing
casually with their patients because these do
ctors are negligent and callous by nature. The
Act may serve as a deterrent to these doctors.
The Act provides speedy, easy and cheap
remedy to aggrieved patients against negligent
doctors, enabling them to claim compensation.

In dc< ide.
h iIu i .i p.iiK iii i*. .i < iiii .imid hi
not, one sh-.l havr to give iniportaucc not to
the letter of he law but to the spirit behind it.
Otherwise, by extending the definition of the
term ‘consumer’ to users of hospitals, nursing
homes and private practitioners, one will invite
a Hood of irresponsible litigation, especially
since the serrices of the Commissions are
available free of costs to .ill complainants.

♦

Doctors will cease to rely on their own
clinical diagnosis and will resort to practising
defensive meaicine. To reduce the risk of
litigation, they will put patients through
different tests - radlolo.gy. pathology, etc.
which will prove expensive to the patients.
The patient who comes in with a headache
of one day's duration may be advised X-ray
views of the skull, to seek the opinion from
an Opthalmc.ogist. a C.T. Scan and an M.R.I.
scan, lest the doctors miss a brain tumour.
He has Io have a series of test results to
justify his - irse of action and pass the buck
if things go .rong and he finds himsell
dragged to . consumer <'ouii.

I

£
I

r

*

<;

Health for the millions

e

save tlv mother
liH l u i iHii

Tes.7. AAI 1 Kt A
ill ?

winnwwTTwL^H^
SrTV*s of tests — No clhical or nu-tlical inslificalion.

Pioneering surgeons use techniques that others
would not attempt. Because of the nature of
their work, these surgeons are vulnerable to
emotive appeals about the use of patients as
guinea pigs. Though they treat their patients
with respect, care and expi rlise, yet their
actions can be painted in a bad light before
the general public.

♦

There are certain specialist doctors who work

in high risk areas such as neurosurgery,
traumasurgery or heart surgery and who
regularly have fatalities. However, this is
merely a reflection of the risk of the surgery
they are prepared to undertake. Now they may
think twice about working In these high-risk
areas because of the Consumer Protection Act
being applicable to them.

♦

The learned members of the District/Stale
National Commission are likely to commit
errors in their orders while granting
compenstion/award in the cases of hospitals/
nursing homes/doctors due to lack of medical
knowledge in general and in particular with
regard to instant decisions which are
frequently taken by doctors during emergency
treatment and at the time of an operation.

Example: When an obstetrician conducts a
delivery in a labour room, she has to take
many instant decisions, such as during foetus
distress. At that time, her prime duty is to
26

in

h i

in

devote her entire energy in saving
either the mother or the foetus,
whichever is more viable.
Similarly, she has to decide
instantly whether to conduct a
normal delivery’, forceps delivery'
or caesarean keeping in view the
condition of the mother as well
as of the loci us. In most cases,
patients and their family
members misunderstand the
whole issue due to lack of
medical knowledge. Not to talk of
the patient and his family
members, if the decision taken by
the obstetrician is discussed with
a doctor of any speciality other
than obstetrics, even he may not
be able to justify the decision of
the concerned obstetrician. Such
an issue was rightly appreciated
in appeal by the Tamil Nadu
Stale Commission against the order of the
Thanjavur District Porum. In this case, the
obstetrician was directed to pay Its,.r>0.000/- as
a line for taking a wrong decision by the
District Forum. However the Stale Commission
scl aside I he order because one of I he
members of the Stale Commission was also an
obstetrician and could understand the difficult
situations in which an obstetrician has to take
instant decisions when two lives are at stake.

Kiocf-f

♦

wt II a1-’ llw

>iiiin 1111ii

♦

Patients usually go to doctors with implicit
faith and doctors generally respond with a
feeling of responsibility. Treating this service as
a purely commercial one will do more harm
than good. Even if II is assumed that this
profession has become commercial, it still
cannot be tenned as a trade or commerce.

♦

Insurance companies have increased their
premiums on the premise that medical
professionals are subject to a large number of
claims under the Consumer Protection Act.
Naturally, doctors have started charging more
from their patients to cover the enhanced
insurance premium.

♦

I

F
There is no comparison between a doctor and
a trader. The consumer law is meant to protect |
consumers from those traders whose intention
is to defraud. In all doctors-patient cases, the
doctor intends to cure and at times fails to
cure. The intention of the doctor is never
I
malafide and when something does go wrong.
Ih.ilili lor ih<‘ mllllonM

compensation m Civil Courts. 11 the Civil
Courts are over-burdened with cases, as tiie\(dearly arc. the government (’an constitute
separate Civil Courts io hear medical cases lot

it is never intentional or preplanned.
♦

A doctor’s professional reputation is one of his
most valuable assets, as dear to him as his
professional skill. The consumer court may
111 I

il It

cl | I I Cl *' t

I I l< 1 I H >■ I

Illi

I ■ I I ■ I' I I I . I i I I I II.'

-1 I II I

the doctor may opt to settle out ol court. Thus
the Act can be held as a weapon to blackmail
an honest doctor. It will encourage
unscrupulous operators and waste valuable
time and energy of professionals.
♦

It is an admitted fact that allopathic medicines
are generally useful but at the same time they
are also harmful as they may also have side
effects. Thus while curing one illness, the use
of some medicines causes another illness
through no fault of the treating physician.

♦

In most cases which lead to litigation under
the Consumer Protection Act there is lack of
communication between doctors and their
patients. Doctors often do not realise that
patients and their family members arc anxious
to know about the nature of the illness and
line of treatment, and seek assurance of full
rccovcrx’. Sometimes doctors do not find time
to explain the situation to them because of
their busy schedule.

The points discussed above will ultimately lead to
a situation of ‘patient selection’ by doctors. They
will select and treat only those patients who would
^^t create a legal problem for them. In other

11 .isi ii r .

I .« ili<

:ii.

•

I' -I

I- l

l

■

To discourage false complainants, there should
be a provision in the Act to deposit 10 percent
of the claimed amount as securily in the
government treasury at the time of filing a
complaint before the Consumer Forum. If he
wins, he gets back his deposit otherwise he
loses it.

♦

When a patient files his claim before the
Consumer Forum, he must give an undertaking
that if-his application is found frivolous and is
dismissed, he will pay lor the entire expenses
incurred in defending the claim, compensation
for time lost, damages for loss ol fcpiilatioh
and mental torture and agony undergone by
the defending doctors and hospitals. At the
same time the Consumer Forum should be
liberal in awarding costs while dismissing the
complaint so that false complainants do not
get undersired encouragement under the Act.

♦

If, because of pressure from the consumer
associations or for any other reason, the
government is not willing to make drastic
changes in the Act such as keeping patients
out of the pundew of the Act or constituting
separate Civil Courts for dealing with the
grievances of patients, the government can
make slight modifications in the Act. They
should nominate a medical person with the
same specialisation as the doctor in the case.

Recommendations

Aggrieved patients could file suits for

i

The President and Members of the District
Stalc/Nalional forums arc not conveisanl
with the medical profession and its
intricacies. Therefore they can easily
commit a mistake in concluding whether
there is any negligence involved or not. II
separately constituted Civil Courts were to
hear such medical cases again and again,
they would soon begin to understand the
medical intricacies involved.

/ds they would treat only ‘clean’ cases. Thus

The Parliament should reconsider the
previsions of the Act in the interest of one and
all and redefine ‘consumer’ and ’service’ so that
doctors and hospital authorities do not become
subject to frivolous litigation. Urgent
intervention in this connection is required by
the Medical Council of India and the Indian
Medical Association. More than a hundred
cases have been filed against doctors and they
have been asked to pay damages amounting to
as much as Rs. one lakh to ten lakhs.

Illi

Under the Consumer Protection Act. 1986.
one can file a complaint against a doctor of
a hospital in the District/Siaie/Nalional
Consumer Forum without making any
payment. If people had to file their cases in
the Civil Courts under the Law of Torts,
they would have to pay Court fees at the
time of filing a suit and will think twice
before filing frivolous cases.

the ultimate sufferers will be tfie patients.

♦

ilicp-. : il

ill.Hl i

When a person goes to a hospital for
treatment, there is always some risk. Eveiyr
surgical operation involves risks. It would be
wrong and indeed bad law to say that simply
because a misadventure or mishap occured.
the hospital and the doctors are liable.

♦

♦

<|ili> I

Health for the millions

27

A

AM.

a J*

7'^

■f

as an ad-hoc member of the Consumer Forum.
Or. before registering a complaint in the
Consumer Forum, a show-cause notice should
be issued to the other party, i.e.. the hospital
or the doctor or both as the case may be. and
then refer the complaint as well as the reply to
a team of medical experts. On I heir advice,
the complaint may be either rejected or
entertained for trial.
♦

fe

Members of the various Consumer Forums
should look into complaints against doctors/
hospitals sympathetically as they do not inten
tionally provide deficient service to patients.

♦

Advocates should discourage patients who
come to them to file frivolous complaints.

♦

Patients should give serious thought before
entering into litigation against doctors. They
should carefully consider whether they were
really given deficient service or whether it was
the only alternative remedy available to their
doctor.

$
♦

I

♦

The press should not give undesired, exagera
ted publicity to doctor-patient matters because
it will further harm the relationship. If any
news of deficient service is brought to the
knowledge of the public, it’s coverage should
be objective.

The government should issue a notification to
exclude patients from the definition of the word
’consumer’ and medical ‘.rivlrca houi the wold
‘service’ as given in the Consumer I’rot vet ion
Act. keeping in view the pros and cons of the
application of the Act on them.

Conclusion

I

'

If there are still occasional lacunae in treatment.
The remedy is not in demoralising those providing
the requisite services nor in diverting their atten
tion from the provision ol such sendees to dealing
with a spate of irresponsible litigation - which will
certainly result from the wider and more flexible
interpretation of the terms ’consumer’, ‘sendee’ and
‘hiring for a consideration’ in Hie Consumer
Protection Act. This type of interpretation would
become counter-productive and would defeat the
very purpose of the legislation.

In a case of demonstrable ‘negligence’, it is not
that a patient would be deprived from seeking
justice. Recourse is always available to him in a
Civil Court where suitable compensation can be
provided to the aggrieved and also in a Criminal
Court where the negligent ('.an be punished.
28

References

Books
1. Banerjee. Awasthi A.K. & S.K.; Digest on Consumer
Protection Laws: Ashok I^iw House. Allahabad. 1992.
2. Mukherjee. K.N.: The Consumer iYotection Act: Book
N Trade. Calcutta. 1991.
3. Singh Dr. G.; Law of Consumer Protection; Bharat
Law Publications. Jaipur. 1990.

Newspapers
1. Tire Hindustan Times (Delhi) August 27. 1991. Pg. 3
2. Tire Hindustan Times (Delhi) February 27. 1992. Pg.5
3. Tire Hindustan Times (Delhi) March 17. 1991. Pg. 5
4. The Hindustan Times Sunday Magazine (Delhi) May
24. 1992, Pg. 10
5. The Hindu (Gurgaon) June 16. 1992, Pg. 17

6. Tie Economic Times (Delhi) July 1992 Pg. II

Journals
1. Consumer Protection Judgements: .January 1991 to
July 1992.
/)/?. li.C. G oyai. lias been tunlinq recjnlai,^ on a ixiru tii <>/ issues
lungiiui frotn Is a ll(itieni a Consunyr to Hole oj Counselling in
Managenu'm and bird Ham as a Counsc.or.' Dr. Goi/al is
presenthi leotkinq until Hohj Famili) llosp.ial. Netv Delhi.

URGENT

DOCTOR REQUIRED
Department of Health (DoH). Central Tibetan
Administration invites application from dedicated
doctors (M.B.B.S.) to work .n a 45 bedded
hospital. Mundgod. Karnataka State, on contract
basis for 1 to 2 years. The candidate should
be willing to work in a rural Tibetan Community
of about 10,000 people.

The Department will provide free accomodation.
Pay scale Rs. 4000-5000 per month. Interested
applicant should respond immediately to DoH
with complete bio-data and relevant certificates.
Retired doctors may also apc:y. Last date for
the receipt of application 20th February, 1993.

Health Secretary, Department of Health, CTA.
Dharamsala-176215 District Kangra (HP)

Ic.dih !■ >r ihe milhor,

t

I

4

-•• a..;.

1

/

Ji
f

,rT^HANKS to Consumer Protection
I Act, two recent cases filed in the
1. Delhi and Maharashtra Conliner Redressal Fora against hospitals
nr adminiitarlng contaminated-blood
Inrini treatment, has brought to fore
he safety of blood supplies by blood
• hiik* across the country
The tirct nice reiltM to a D-lh*
: hi- '..-eXifc/flidu Rahl who weJ ad
iiittec to Safdarjung Clinic in August
119 for delivery of a child. As she re
in ired a ceasanan operation, she was
isked to
arrange for blood,
"nfnrrunately. blood was procured by
I private blood banr. which made all
the difference. Three months later,
vdien she comp la med of fever and
vomitting. her blood test showed that
the was HB and AG positive as a result
I receiving contaminated blood.
On appeal by the patient, the Delhi
Consumer Redressai Forum held the
Sunil Blood Bank and Transfusion
Centre (which supplied the blood)
I'Uilty of supplying infected blood and
was asked to pay Rs.20000 as damages
io the complainant While it is easy for
a blood bank to pay damages and ab
solve its responsibility, it will not be
•o for the patient who has to suffer till
her death.
Blood banks which are supposed to
save human lives are fast turning to be
death traps. Despite the fact that blood
banks, whether public, voluntary or
private have been screening blood, in
creasing instances c: supplying infect
ed blood has raised doubts about the
safety norms followed in these banks.
The reports of more and more people
contracting malana. jaundice, syphilis
and even AIDS due to transfusion of
unsafe blood, is an indication of the
murky business that goes on in blood
hanks.
While a few diseases arising due to
administering contaminated blood is
curable, what is of great concern is get
ting infected by that dreaded disease
AIDS, as it happened in the case of
Sunita Heganavar (25) ofKohlapur. She
was given four units (bottles) of blood
.is pan of a surgical operation. AU the
inits were supplied by the blood bank
maintained by Miraj Medical Centre,
which is authorised by the
Maharashtra Food and Drug Adminis
tration (FDA).

Out of four units of blood, three were
screened and found safe. However, the
fourth was not subjected to regular
tests. Before the hospital administra
tion could find that the fourth unit of
blood was contaminated, the damage
had been done Now Sunita. her hus
band. hei daughter (bom after the operatioi'i ell irv infected with the virus
. . . mat rouses AIDS. Sh? nos appeal
ed to the Maharashtra Consumer
Recressal Forum claiming Rs 10 lakh
as damages plus medical treatment.
The final verdict is awaited.
'•Vhat is alarming is that a number
of instances of administering blood
wr_-.out screening have been hushed
up or have gone unnoticed.
The increasing number of diseases
due to transfusion of contaminated
blood may be attributed to several rea
sons One to the ever increasing de
mand for blood and secondly, as a re
sult of this, a mushrooming in blood
banks that pay scant regard to safety
aspects.
To date, there is no accurate statis
tics about blood business in the country. According to one estur.ate. the
country requires nearly 50 lakh units
of blood per year
Out of this, 19 lakh bottles is obtain
ed from volunteers Bv WHO norms. In
dia requires 42 lakh units of blood
against the availability of 20 lakh. For
the rest, patients have to depend on
prcressional donors. Obviously the de
mand and supply doesn't match —
guaranteeing a market for those who
seii blood as their only means of survivaL
Poverty coupled with unemployment
leading to migration to cities in search
of jobs, has led young men taking to
selling blood for their survival. Most
blood banks have touts, who prey on
poor, desperate villagers and offer
them money in exchange of blood.
Even in the case of donors, reliable
stanstics are not available.
However. World AIDS (July 92) re
ports that there are nearly 30.000 pro
fessional blood donors in India. Each
donor sells roughly 15 units (one unit
is 350 ml) of blood a month from Rs.25
to Rs.500 depending upon the category
of blood. The Professional Blood Do
nors Welfare Association claims that

All blood banks are also required to
send samples of every unit of blood col
lected to one of the Government Sur
veillance Centres. This is done the
same day that the blood is drawn and
the results are back within 24 hours.
There are 180 zonal blood testing
centres spread in 112 cities. In Bangathere are two zonal, centres ar4
,•.<0 surveillance centres.
The conditions of licensed private
blood banks are not encouraging. Many
blood banks use domestic refrigerators
for storage which cannot ensure the
standard of four degree centigrade tem
perature. as prescribed by the drugs
and cosmetics rules. They often take up
to five units of blvod a day from a
single professional donor, but use five
different names in order to evade regu
lations which limit donors from giving
no more than one unit every 12 weeks
Blood banks seldom check the do
nor’s Haemoglobin count. Medical stan
dards stipulate that the donors count
should not be below 12.5 gm. While
such persons could be at risk by giving
blood, the receipient would hardly
benefit. I: is not surprising that the Pro
ject Director of Nauonal AIDS Control
Organisation.
monitoring
blood
supplies termed these blood banks as
5 'money spinnig rackets- whose aim is
5 to supply as many bottles as possible
< from as few donors as possible.
2 The government has drawn up a plan
to clean up the 1018 blood banks
through a senes of measures. The
tors, weighing machines, disposable
NACO will set up 30 blood component
plastic packs, blood collection bottles,
emergency equipments etc.. More im separation units in major cities. A cen
tral legislation to control the blood
portantly, blood banks should ensure
banks, standardising the quantity of
that blood supplied confines to the
standards laid down in the curren; edi blood in commercial banks, total ban
tion of Indian Pharmecopoeia.
on tapping professional blood donors in
all government hospitals and fixing a
According to FDA regulations every
unit of blood has to be tested for four standard selling price of blood under
the Drug Price Control Order, are some
diseases — malana. hepatitis, syphilis
and HIV — before being released for of the steps to be taken to control blood
business
use. It should be remembered that no
Despite ail these plans, the fact re
blood transfusion is completely free
from infection and there is no test com mains that demand for blood can be
pletely reliable. While the shelf life of met only by encouraging voluntary do
nations. As of now, there is no strong
whole blood is between 21-30 days,
effort either by the government or so
there is what is called 'window period'
of 45-90 days when the incubating virus cial organisations to promote or cam
does not reveal its presence in the test.
paign for voluntary blood donations.
- So it is possible, for a person to give There is an urgen' need to create an
blood up to 45 days after exposure to awareness among tin people about the
HTV. without the virus being detected.
need for blood donation. Mat^y miscon

Blood or death banks ?

Despite the fact that blood banks, whether public, voluntary or
private have been screening blood, increasing instances of
;pp;ying infected btood haib laised doubts ai.cuL the safety norms
followed in these banks, writes Y G MURALIDHARAN

R

they cater to 80 per cent of the coun
try's needs.
But the sung lies in the fact that
many of these professional donors are
carriers of HIV.
According to the Nauonal Aids Con
trol Organisation (NACO) statistics
14.87 per cent of the country's estimat
ed 15 lakh HIV infected cases are pro
fessional blood donors. Another cat
egory of blood donors who sell plasma
to blood products manufacturers are
also responsible for getting and spread
ing HTV.
In order to bring down instances of
H."V infected blood being given to pa
tients. professional blood donors were
extensively tested for HTV in 1985.
Though none of them were found HIX’
positive, the situation is not so in 1994.
Despite the fact that blood busmess

in the country is playing havoc with
the lives of the innocent patients, no
thing has been done to stop this men
ace. Four years ago. Ms. A.F. Ferguson
and Co., carried a survey and found
that there were 1018 blood banks in the
country. Of these. 378 do not have a
mandatory licence from the govern
ment Again 326 out of 378 uniicenced
blood banks are the ones owned by the
government itself. The committee also
found that half the banks it sun-eyed
were not carrying out all the critical
tests against blood infections.
Elaborate rules which runs to seven
pages have been framed under the
Drugs and Cosmetics Act for establish
ing and maintenance of blood banks.
These provisions include minimum
area of 100 square metres, equipments
like sphygmomanometers, refngera-

ceptions exist about blood bank> and
thanks to ignorance. India wuh a popu
lation of 850 million people collect just
20 lakh units, whereas Japan with a
population of 120 million collects 80
lakh units a year And only 10 to 15
per cent of blood comes from centres
that have proper AIDS testing faciiit-

Anoiher reason for shortage of blood
is that blood is not used judiciously.
In many of the cam, where blood
transfusion is needed it is only a part
of the blood that is to be transfused.
Whole blood transfusiort is needed only
in case of heavy loss of blood as in ac
cidents For instance, anaemics just
need red blood corpuscles, haemophili
acs Factor 8 and bum victims need
plasma. Unfortunately, all these, pa
tients are given whole blood as we do
not have adequate facilities to break
down blood
.Another way to minimise HIX’ infec
tion as also the menace of professional
donors, is to go in for 'autologus
transfusion- wherein one's own blood
is drawn and administered. Under this
system one or two units of blood is tak
en from the patient before surgery and
replaced with the same after or dunng
surgery. Of course this is subject to
other medical conditions.
Very recently, the National Plasma
Fractionation Centre at Bombay mtroduced,
what
is
called
the
"Fractionation system", a unique way
of multiplying the benefits of one blood
unit Under this system, plasma is
fractionated into three products Le.
albumin of five and 20 per cent. Factor
DC and immunoglobulin. While
albumin is used as a volume expander.
Factor DC is used for bleeding disorders
and immunoglobulin is used to raise
the level of antibodies in the treatment
of Hepatitis A. The equipment costing
Rs.3 5 crore is presently available only
in this centre in the whole of South
East Asia.
The need of the hour is to make
blood banks more responsible and ac
countable. Licence should not be grunt
ed unless all the requirements are com
piled with.AU said and done, the one
debate that remains undecided is that
should untested blood be given to a pa
tient in case of emergency? Over to you
dear doctors.

PRESCRIBING^DRUGS

Questions t( ask yourself before writing a prescription.

1.

2.

Need

:

Is this drug really necessary

:

Is it being given to make the patient
feel that something is being done?

:

’What aim is to be achieved by/this drug?
What disorder of function is to be
corrected?
What symptom/s have to be relieved?

Aim

:

3.

KnowledCj.-

: What is the approved or generic name?
: What class does it belong to?
: What are its characteristics?
: Do I have the requisite experience or
knowledge to use it?
: Have I weighed the potential toxic
effects against the benefit?

4.

Route ani Dosage

: By what route, in what dose and at what
intervals is the drug to be given and
• why? In what form/s dees the drug come?

5.

Alternat i ves

: Have I selected the best agent availablefor this particular purpose?
What other remedies might have been
chosen?
How do these compare in effecacy, safety,
cost?

Duration

: For what period of time, days weeks or
months will it be advisable to continue
'therapy?

When and how could a decision be made
to stop?

7. Observations

: What observations can be made to judge
whether the aim has been achieved?
When should they be made and by whom?
What laboratory investigation if any
would help in this assessment?

6.

: How is the drug eliminated?

►- 1 4 rn •? n □ + ■? .

r>

v -l. * i | j

Will the patients illness change the
usal pattern of distribution, effects
or elimination «f the drug?

9. Unwanted
eff ects

: What are the side effects or toxic
effects of the drug?
Are they acceptable?
How frequent are they?
1 .How carfc they by modified/managed?

IO.

:Have I checked for the following:
a. Passible allergic risks
b. Pvssible idiosyncratic reactions
c. Patients drug diet which may interfere
with the drug

What precautions can I take to ensure
continuation of ther^

.
.•I
- 2

: Are there any conditions in which
this drug is contraindicated?
Are these ’absolute’ or ’relative’?
Are there any drugs which should
be avoided when the/patient takes
this treatment? ' vVhich and why?

11, Contraindications

i
i

12. Patient poit|t of view

13. Patient reliability

; Does his relative need additional
information?
Is the patient reliable for this
type of therapy?
Will he need/get proper supervision
by relatives or attendants?

: Is the drug the cheapest drug of
that type?
If not could a cheaper drug do the
job as well?

14. Cost
li

15.

: What does the patient believe about
the drug?
What has he been told about it? and
What has he remebered?
Does he need additional information?

Finally ib there anything else I need to know about this
drug?

Adapted from;’

i. A Herxhe|mer : The Lancet II 1186-1187, 27th Nov.1976
ii. Formular* and Therapeutic guide-Kurji Holy Family
Hospital^
Hi. 7
Prescribing drugs -• MNAMS Handeut, Dept of Pharmacology,
St.John’* Medical College, Bangalore.
o •

-

■

••

•

1 •------- ■’

•c

* -X- -K- -X- * * * * -if- * * * *

I

St

X

♦

ADVANTAGES OF ESSENTIAL DRUGS
ON FINGERTIPS

i

Preparing a rational list of essential/restricted drugs has
several advantages: medical, economic, social and administrative.

Medical advantages

* It is medically, therapeutically and scientifically soumd,
and it ensures rational use of drugs.
z
* It limits the use of irrational and hazardous drugs and
illness)decreases the risks of iatrogenesis. (Doctor-induced
(
Economic advantages

* It is economically beneficial to the nation because it
prevents wastage of scarce resources on non-essentials.
* The economics of scale achieved in the larger production
of priority drugs brings down their prices.
* It curtails the aggressive marketing of non-essential
formulations.

* It is economically beneficial to the patient because it
prevents wastage on irrational and non-essentials.
Social advantages
*

It responds to the real health needs of the people.

* It facilitates the dissemination of correct information
about the drugs to health personnel, medical practitioners
and consumers in general.

* It makes it imperative to draw up priorities to meet the
most urgent needs of the people for essential health care.
Administrative advantages

* It is organizationally sound because it makes quality
control easier because of the limited number of drugs to
be mentioned.
*
5

* It facilitates the streamlining of production, storage
and distribution of drugs, because of the smaller number
of drugs involved.
It helps in the clear identification of the drugs.
•
i as well as the
* It facilitates the fixing of' prices
revision/withdrawal of excise duties, sales tax, etc.

*

Source: AIDAN

1

MARKETING OF PHARMACEUTICALS

Dr.ARUN BAL,

ACASH

Even in the remotest part of the world t
_! people consume
drugs.These drugs are part of the armamentorium
of thezmedical
practioners and healers
u at
every level and are universally
perceived to have powerful effects.!5
--- Drugs are treated quite differently from othar consumer
consumer items
in all
all the
items in
the societies
soc«iCties.
. It
It is
quite common in the most
most advanced
advanced soceities
also
to
see
that
the
soceities also
consumers, though otherwise well informed and aware of his\her
rights, purchase and consume the drugs without even a routine
enquiry about its price,quality and necessity.Another aspect of
the drugs marketing which is specific only for the drugs is that
the consumer usually has no choice
Of the selection.This is
partly because of the technical nature of the sub- -ct.However
the marketing of the drugs affects
_j the consumer financially,and
many a times physically also,The gap in per capita drug
consumption between the developed and the developing countries
is considerable.In
considerable.In India we have
approximately 60 000 drug
formulations while WHO essential drug
list mentions only 277
drugs.Approximately
55%
drugs
in
the
market
are
either
irrational,inessential or hazardous .The i
total turnover of the
drug industry is Rs.5500 crores which is
slated to increase to
Rs.16000 crdres at the end of 8th five year plan.This enormous
increase in the production of the drugs over the years has not
been able to improve the availability
of the drugs for the
common man.The availabilty of the
drugs for the common man
continues to be as low as 20-30% of the population.A number of
publications have
discussed at length the inappropriateness of
the expensive and often ineffective products consumed in
the
developing
country.The
resources
of
the
developing
vital
countries are being used for products that are
are not essential at
a time when the large section of the population is without
access to even most basic drugs.Under the National Tuberculosis
Control Programme the anti tuberciular drugs, which are of
category one
one as
as per the DDPCo of 1986, are suppuosed to be
available to all
registered patients at the District and Taluka
1 O V.r I
TI 1K O r 1 i 1
r. -i
control centers.In a recent personal experi
n two taluka level centres, it war, found that the number
ence iin
of registered tuberculosis patients was 250 and 210 while the
doses available were only 2 and 4 respectively which were taken
awa_. iv t e staff of the centres . This forces the poor patients
to buy the drugs from the market.WHO estimates that some 500
million dollars have been mobilised to support national drug
policies m the developing countries but this amount is only 5%
or the.amount being spent by the industry on the drug promotion
worldwide.In India we have 20000 drug manufacturing units.Indian
armaceutical
industry is
categorised
as
category IV by
—

-

■

- —

- X-.

A

O ± O

UNIDO.This
means
the
technologically
most
advanced
pharmaceutical industry.This obvious contrast of technologically
advanced industry with the ever increasing drug production with
poor availability of the essential drugs is
perplexing at
first.However when one goes in the deetails of the situation it
is obvious that
some other factors are at play which have made
situation so difficult.
/

Over the last few years we have winesoed number of ttagedies
causing deaths due to the substandard, spurious and hazardous
drugs beuing marketed in the country.In spite of all the policy
decisions, seemingly people oriented, the spate of tragedies has
not abated. Is this an aberration or a d£*p rooted problem?It is
obvious that the wrong kind of the drugs are being maketed.For
years the industry has justified the high prices of the drugs
with the argument th t this is necessary for the research and
developement of the new drugs for the various diseases.However
over the last decade even the people connected with the industry
have admitted that the marketing departmenrt of the companies
and not the reseaerch departments, decide the production and
marketing patterns of the companies.On the avarage 5-10% of the
turnover is spent on on the R&D while 15 to 20% spent on the
marketing of the drugs.Of the 348 new drugs from 25 largest US
drug companies bedtween 1981 and 1988 the FDA said that at the
time of introduction only 3% made imporatant contribution to the
existing therapies,13% made modest potential contribution while
84% made little or no potential contribution.Glaxo advertising
in UK of Fortum (Ceftizidime) ,a powerful antibiotic, mentions
that the drug may be used when there is no time to wait for the
sensitivity test. In case of powerful antibiotic like Fortum is
it ehical to allow and promote the marketing
which may cause
indiscriminate use?Similarly newer forms of advertising are
dificult to monitor.These include Video ads which are circulated
through TV stations.In 1991 US FDA warned Ciba Geigy Ltd
regarding its product Actigall which was claimed to avoid gall
stone surgery.Many a time^ the
slides about certain products
prepared by the company but used for scientific discussions are
prepared with the specific purpose of promoting the product than
the scientifin enquiry.WHO essential drug list has received poor
response from the industry.Head ofUS Pharmaceutical Manufaturers
Association said that it would be poor buisiness practice
to
support essential drug list. The vice president of International
Federation of Pharmaceutical Manufacturer's Association remarked
you cant expect us to support the policies which run counter
to our own interestsIndian goverment is signatory to various
international agreements regarding adoption of essential drugs
list of WHO.Inspite of these agrements the correct application
and execution of essential drug list remains to be a distant
dream.There are number of instances of mercenary attitude
adopted by the industry while marketing the drugs in various

2

countries.These instances are well documented and need no
recounting.However it would be wotrh while to narrate some of
the instances of the marketing in Indian context.

High Doee Oestrogen Progestrone Drugs

f

This group of drugs were being marketed in India for many
years.These drugs, were used mainly to diagnose pregnancy and to
delay the onset of the menstrual period. However over the years
the drugs were proved hazaerdous and were banned in the
developed countries and many of the developing countiree.In
India the sale of these drugs was about 7-tt crores rupees per
year.These drugs were known to cause foetal ananmolies.On orders
from Supreme Court the drug controller of India was forced to
hold the public enquiry in four metropolitan cities in India to
collect the public evidance about the hazardous nature of the
drug.The overwhelming evidance about the hazardous nature of
these drugs forced the government to ban these drugs.This was
the first instance of a drug banned after public enquiry in
India.The industry perceived this as an adverse trend for the
future of the industry. The campaign for ban on High Dose
Oestrogen Prcgestrone drugs did not end after the ban order was
issued by the government.The injections of these drugs were used
more than the tablets.The industry was marketing agressively the
injections relying on the fascination for the injections in the
soceity.The ban gezette notification mantioned ban on only the
tablets.The voluntary organisations were
we r e again forced to move
the court to secure the corredct ban order.Here also the
industry and government nexus was obvious.The counsel of the
drug controller was not breifed by the government and the task
was left to the voluntary oraganisations .

Anabolic Steroids

Anabolic steroids are synthetic androgenic hormones.The primary
use of androgens is to deal with impaired functioning of testis
known as hypogonadism.However androgen have significant effects
on muscle mass and body weight.When administered to patients
with hypogonadism,it was assumed but never proved that the
androgen in pharmacological doses could promote growth of muscle
mass above normal levels.This was based on a wrong assumption
that anabolic and androgenic actions are different.A standard
texbook of Pharmacology by Satoskar states that various studies
have shown that there is no lack of anabolic drive in patients
recovering from the illness The use of anabolic drugs in such
condition is highly quest ionable.In India anabolic steroids are
being marketed by the industry for many indications which are
highly
irrational.Infar
(India)
ltd.
a
subsidiary
of
multinational
Organon
Ltd.
markets
Anabolic
steroids
in
India.This company used to hold CME programmes in collaboration
with Indian Medical Association.These programmes were being held

3

in five star hotels accompanied by lunch\dinner.The company used
these programmes to promote the irrational product instead of
scientific discussion.The enclosures to this paper details one
such incident.This company used to pay even some doctors to spy
on the voluntary organisations.

ANALGINYPIEYRQNE
Analgin\Dipyrone is an analgesic or painkiller.One of the widely
used analgesic in India, this drug is banned all over the de
veloped world and whereever it is available its use is highly
restricted.In India one of the main manufaturers of this drug is
Hoechst Ltd.In 1988 this compoany started marketing the drug for
treatment of fever in children and the company booklet claimed
that
analgin has direct smooth muscle relaxing action.As the
enclosures to this paper would reveal the company on
enquiries could produce some papers which were of 1950 s and did
not
sunstantiate
the
claims
made
by
the
company.Analgin
continues to be used in India on large scale and such false
cliams many a times go unnoticed .

Gl&xo (India) ltd and thg recent conxt cases
In October 1993 FDA,Maharashtra issued orders for Glaxo to close
its plant in Worli,Bombay for ten days for grossi violation of
provisions of Drugs and Cosmeticsi Act.The violations found by
of grave nature.The rejects from the assembly line in
FDA were <
Glaxo's Worli plant were beina only dumped in refuge dump in the
factory premises.These were then being
being lifted by the scrap
dealer employed by the company and sold in the market.The FDA
officials found that the code numbers asi well as the labels of
Glaxo Ltd. in possession ^of the scrap dealer.Subsequent to the
order of the FDA, Glaxo ‘ Ltd filed an appeal with the Health
Minister which was rejected.However the company went into appeal
in possession
to High Court which was also rejected.The papers
of ACASH reveal that the abovementioned offence was not the
solitary instance.FDA had found that Glaxo Ltd was indulging
into many gross violations of the* provisions of Drugs and
Cosmetic Act.Some of these were:
f or
Inadequet check of raw material industrial gelatine used
knovm to
making blank capsules.The industrial Gelatine is known
like
zinc,
lead,
arsenic
ect.The
zinc
,
lead,arsenic
contain
many
impurities
this violation is that in JJ Hospital glycerol
significance of I--- ----noticed and the
i
tragedy similar violation
violation of
of rules
rules was not
used
for
glycerine
was
allowed
to
be
used
for medicinal
industrial glycerine was allowed to
patients
.Salbutomol
purpose leading to the deaths of many
treatmert
of
Asthama
is
Inhaler marketed by Glaxo Ltd for
Salbutomol
.
However
the
supposed to contain 100 microgrammes of
FDA analysis showed that the particular batch which had pasased
quality control* contained only 4 microgranunee of
the company's
(Ceftazidime)
is
a
costly antibiotic
Salbutamol.Inj.Fortum

4

marketed by Glaxo Ltd.FDA enquiry found that the company was not
conducting Pyrogen test for this antibiotic.Susequently ACSH
wrote to the parent company in UK but received an ambigous
reply.The British Medical assaociation took up the matter with
the parent company in UK but also received similar reply.FDA
also found many violations of Drugs and Cosmetics Act by other
companies
namely Boots (India ) Ltd and German Remedies.These
companies were using the raw * material which had already
expired.The Glaxo Ltd has atlast realised the futility of
pursuing legal cases and has closed down its Worli plant for ten
days.

These are not isolated instances to shrugged off as an abberrations
of
othereise
perfect
system
of
drug
productiop,distribution and use.There is no denying that the
pharmaceutical industry has made important contribution to the
public health over the last r0 years through the developement of
many life saving drugs. The performance of the industry
is
usually measured in terms of profit and production.However the
pharmaceutical industry is different from the other consumer
industries.Its performance also needs to be measured ln*<the
terms of social accountability and the benefit\risk retio of its
products.Its products affect lives of millions of consumers.If
the performance of Indian Pharmaceutical industry is measured
against these parametrs
it would appear to be dismal.lt has
always discliamed the responsibility for marketing hazardous
products while taking credit for technological acheivement.lt
always blames the goverment for allowing the marketing of
dangerous drugs while fconvieniently forgetting the sinister role
played by its lobbyist to influence the policy makers.The
deafening silence of the medical profession regarding marketing
of hazardous drugs and the marketing strategies of the industry
encourages the industry to continue to market these drugs.lt
would be worthwhile to point out here that in case of Glaxo Ltd.
none of the professional associations
of Medical profession in
India raised their voice while British Medical Association took
up the matter with the parent company of Glaxo in UK.
Marketing of Pharmaceuticals is an important aspect of the
healthcare in context of developing countries.Vital resources of
the poor people are being spent on irrational inesential drugs
instead on the necessities like food and clothing.Consumer
activists,media,medical profession need to join the hands to
correct the situation in the larger interest of the national
health .Unless this is done on priority basis the oft repeated
slogan of Indian Government ' Health for All by 2000 AD
is
likely to turn into 'Wealth for Few by 2000 AD.

5

■'Z

vix
DRUG INFORMATION AND ETHICAL MAR KET1NG

Perhaps the most crucial component of

a rational drug policy

is to
to ensure
ensure that accurate and unbiased information about drugs is
available to consumers and to medical practitioners.
The manufac
making

luch information

available in respect of the drugs produced by them.

This is the area

the primary

have

turers

responsibility

wnere there is maximum confusion.

of

There is ample evidence to show

that drug producers as a rule either suppress vital information relating
to their products, or deliberately provide wrong information.

The situation prevailing in India in this regard is truly incompre

A glaring example is provided by the rec. it case ol

hensible.

the

lodgement of the Kerala High Court on writ petition No. OP 8439/19S2
in which the

Court directed the

Central and State

Drug Control

Authorities "to publish the list of

trade/brand names and the names

of

drugs"

the

manufacturers

of

(these)

(which

have been banned).

Tms directive has not been complied with ,on the excuse that the

drugs have been licenced and registered with State health authorities
and the Centre has no clue about the various formulations and brand

involved.
The current practice is to notify the banning of a drug through

a Gazette Notification,
tne generic

Surprisingly, the Gazette Notification indicates

the drug whichare being banned, whereas the

name
name of
of

products are all marketed under trade names.

tions are generally
normally

impossible

couched

in such

to gather

Moreover, the notifica

ambiguous

whether

language that it is

the ban becomes applicable

if any one of the drugs in the general category is present in a combi-

nation, or whether all the drugs have to be present in combination
for the ban to become applicable.

Similar ambiguities are created

by not clarifying — -g; whether steriod combinations means only non-sex
steroids or sex-steroids

also.

Ban of all steroid combinations except for asthma saw

no drugs being banned in reality - just a change of indications
on paper. (See Table 8.1).

Such ambiguities favour only the drug trade.

91

i

.>•

It should be the responsibility of the Drug Control Authorities
to :

screen

all

literature

promotional

for

false

information

(e.g. recommending Lomotil for children under two years

age),
monitor

i

prescription

guides

which

are

used

by

doctors

(e.g. MIMS & CIMS) to ensure that information contained

in these guides is accurate.

inform health personnel and consumers of the WHO'

s

recommendations for an essential drugs list.

provide

information

which are

banned

to

the

abroad

general

public

about

drugs

- giving the reasons for their

being banned or restricted.
ensure that proper cautions about side-effects and contra

indications

are

provided

along

with

the

products

in the

names

(generic

appropriate local language.
ensure that labelling ol products are clear.
ensure

that

international

non-proprietory

names) are *used on all products.

92

I
double STANDARDS

A growing phenomenon, which is r
assuming menacing proportions
IS the manufacture, import, distribution and sale <rf
drugs in India

XC,rhird

have either been

rx z""" h"viiy r'!,ric,M

in the
Company.
•or <hb b.„ ^,0.0. th. Company no.
Company not only continues
in India, but makes false claims
about its safety.

main

The

the

reason

weakness of

for

such

legislation

a strong administrati

in

unethical marketing practices is
India
and the practical absence of

machinery.

The menacing proportions of
drugs in developing

a Resolution (see

the problem of

dumping banned

countries caused the Non-aligned Summit to adopt

Tab 2 3 ) at its meeting in Colombo in 1976.

conferences, SEMINARS,

ETC

«s well known by now that Pharmaceut.cal Compan.es
to

defray

the

expenses

of

national

seminars and scientific sessions.

an<J

They host these

most lavish sett.ngs and shower the participants w.th

a

meetings in the

extravaganzas are eventually
poor consumers who have to

products.

°n

conferences,

expensive gifts,

Obviously, the burden of these frightful

horne by the

agree

internatlonal

less

visible

pay higher prices for dubious

level,

pharmaceutical companies vie with
one another to bribe doctors and chemists to
promote their products.

sponsorships to, ■■storty .oo.,-

.ho ..tae ol

or even

straight cash incentives.

The
become a

giving

of

free

according

samples

'*1 ine practice.

93

and

occasional

“give-aways”

has

*

In contrast to this system adopted by the Government
of India,
British Government sends individual
notifications to all health

the

and

institutions

about

the

market.

medical |practitioners, and gives detailed

a

reasons for

particular

being

drug

inforjnation

withdrawn from

the

(See Table 8.1)

UNETHICAL MARKETING PR A CT 1C ES

In the absence of coherent policies, and the even
absence of adequate monitoring and control machinery,

a

wide-open

is fierce.

market

for

pharmaceutical

products.

The profit-making objective is over-:
over-:

more glaring

India provides

The competition
ng.

Industry has

no inclination or time to consider ethical alternatives.

at some of

A close look
the practices indulged in by the pharmaceutical industry

will suffice

to show that ethics is the first casualty of competition.

Examples can be adduced by the thousands, but a few are given

here only by way of being indicative :

Glaxo Laboratories cited the authority of
its sales of

B-12,

<>>tocalcium

even

Lancet'
'Lancet'

to
to promote

though there was no such

endorsement of the product in Lancet.

Boehringer- Knoll

quoted

UNICEF

and used their logo to promote

the use of streptomycin-chloramphemcol combination for diarrhoea
treatment,

whereas

UNICEF

promotes

actually

simple

ora!

re-hydration therapy for most common diarrhoeas.

Franco-Indiani

to promote

Laboratories • misquoted
thpir

tonic
- - • .7

> ivl

Goodman

V*1111111411
• T ->
. r*

and

UIIq-S

Q
I
L-J’" 1 Z.

Gilman

no role in

ordinary anaemia.

S.G. Chemicals misquoted Goodman and Gilman

to promote

a combination of

oxyphenbutazone,

whereas,

in

and Martinadale

two dangerous drugs analgin and
fact,

the

texts

warn

>
|
>

against

the use of this dangerous combination-

►

______________

■f

Banned in letter,
not in spirit
The high dose EP combination drugs case offers a classic
example of how medicines with proven negative effects on
the foetus can remain indefinitely on the market, even after
being banned. It also shows the six longyears of effort made
by concerned individual^ and groups to get the stay order obtained
on the ban by drug manufacturers vacated More recent cases of
banned drugs,fixed dose Chloramphenicol Streptomycin
combinations and combination steroids offer gnm testimony
to an ongoing struggle

he high dose estrogen-^ togesterI one (EP) combination drugs case
is a fascinating story of how India’s drug
consumer movement matured over six

around their association with congenitai malformations of the foetus in women
who had used them in the early stages
of pregnancy.

trying years in Its struggle to get a oncebanned drug re-banned - and against all The use of synthetic female hormones
odds. Not only does this story refiectthe in pregnancy testing is based on a
powerful resistance put up by the drug simple principle - a woman who misses
industry in collusion with a galaxy of her period due to reasons other than
gynecologists but'alsoraise J the dis- pregnancy would menstruate if injected
' 1
with the female hormones. When the
couraging question of the lacunae in
drug legislation rendering impossibie Australian Department of Health withthe implementing of a ban order in the drew from the market a number of
virtual absence of a drug monitoring hormone pregnancy test (HPT) prepanetwork and a communication link rations both fortheir questionable safety
reaching out to chemists, doctors and and increasing availability of reliable
alternatives, WHO informed all govern
unsuspecting consumers.
ments of this action. As consequence,
E.P. combination drugs are synthetic thegovernment of India banned the use
female hormone preparation^ which, in of these drugs as pregnancy tests,
the absence of other substitutes, were making It obligatory for the manufacturpropagated for use in the diagnosis and ers to print a caution on the packaging
treatment of gynecologicaf disorders in 1976.
during the 40s and 50s. Its issue was
raised seriously for the first t^ne in India Born with defects
in 1975 after a number of countries had
already banned such hi^h dosage In 1979, a furore resulted when a study
combinations completely or had conducted by Dr. B. Paianiappan, Pro
banned their use in pregnaqcy testing, fessorof obstetrics and gynaecology at
The controversy then had centred ^Kilpauk Medical College, Madras, high-

16 HEALTH for the Milligiis December 1990

ji_____________ ■

-

f

lighted the fact that high dose EP drug
combinations were being taken by
women in the mistaken belief that they
could terminate an unwanted preg
nancy. Of 52 mothers who had given
birth to babies with congenital defects,
31 per cent had taken hormonal prepa
rations during early pregnancy, often
with a view to terminating it. The issue
was re-examined by the government in
consultation ' with concerned depart
mentsand professionals but the drugs
remained on the market, albeit with a
strong caution against use in pregnancy
testing.

i

In practice, however, most manufactur
ers ignored this directive, and these
drugs were readily sold by chemists
over-the-counter for pregnancy tests
and also as abortifacients. Such mass
scale misuse of the drugs led a number ;
of women and health groups to reopen
this issue as one directly affecting
women and a campaign spearheaded |
by Voluntary Health Association of india, Medico Friend Circle and Arogya ;■
Dakshata Mandai was launched on i■
March Sth, 1982. Various groups pressed |
f°r various strictures ranging from rigid I
implementation of the “warning” rule to
a complete ban of such drugs. As result i
of the campaign, the issue was reo
pened at the governmental level. On
18th March, 1982, the Drugs Controller i
first issued a directive for strengthening j
the warning on the packages and later I
directed that al! EP formulations (other ?
than oral contraceptives in low doses)
would be banned for manufacture with
effect from 31 st December, 1982 and for •
sale from 30th June, 1983.
Where profits rule

To allow the manufacture of a hazard
ous drug for almost another one year,
before effecting its ban was to ignore
the urgency of the lives at stake. Not 1
surprisingly, the drug industry took .
advantage of this callous laxity to keep i
this profit-earning drug, with an annual |
sales of Rs 7 crores, well entrenched in j
the market. Aware that its market lay
essentially in pregnancy testing and
abortion Induction and only marginally

i

i

»

I

1
I

I

I

i

f

I
i-

I:

I

in treating gynaecological disorders
such as secondary amenorrhoea (Ipng
delay in menses), it sought and ob
tained stay orders against the ban in the
Calcutta and Bombay High Courts on
the technical grounds that the ban could
be effective until the Drugs and Cosmet
ics Act itself was amended.
The ban order was effected on the ex
tremely grave charge that high dos$ EP
drug combinations could result in the
birth of deformed babies if consumed
by pregnant women. Yet. a stay lasting
several years, was obtained on mere
technical grounds permitting a haz
ardous drug to circulate in a free and
open market comprising iargeiy qf an
illiterate and ignorant public. The moral
dHen^a.deepenswhenweaddtOfcoillInformed public a large number of un
qualified or ignorant prescribers and
dispensers, a weak drug control infra
structure and drug manufacturers who
have consistently failed to warn consumers in regional languages against
its use during pregnancy, knowing full
well the real dangers involved in^elfprescription. The extent of the risk involved can be seen from the fact that
roughly 6-12 lakh mothers could b$ affected by this exposure.
Campaigners who worked for the ban
were hard put to establish that what
was recommended was not a bag on
all hormone preparations, a premise
used by the drug representatives to
mislead the consumers. High dosQ estrogen-progesterone fixed combina
tions were not to be confused with low
dose combinations used for contracep
tion. Once propagated for use in India in
the 40s and 50s in the treatment of
gynaecological disorders, the utje of
high dose EP drugs was no longer ra
tional when only a small percentage of
patients required hormonal prepara
tions In the treatment of amenorrhoea,
the major causes being directly trace
able to malnutrition, anemia, tuberyulosis and psychological stress. The Issue
that needed to beiunderscored was that
under the guise of treating secondary
amenorrhoea
requiring
feipale
normones, high dose EP drugs contm-

ued to be used mainly in pregnancy
testing where the chunk of the profit lay.

In an obvious bid to counter the risks
alleged and get the ban order■ rej
~
scinded, Jhe Organisation
of Pharmaceutical Producers of India (OPPI) put
forth the following argument to the Drug
Controller in a letter dated August 4,
'1982
—
' defending
: "We are by no means

erapeutic
erapeutic agents
agents or
or as
as diagnostic
diagnostic tests,
tests.
The epidemiologies1 evidence demon

strating the risks of EP preparations are
substantial; ‘proof Aixid require a pro
r _ _ _______________
t___
spective
randomised study
which would
be quite unethical to perform”.
Dr. Stephen Franks, Senior lecturer in
reproductive endooinoiogy, St Mary's

Hospital Medical Scnooi, London:” I feel
the use of such drugs for pregnancy strongly that there s no justification for
tests, but reiterating that if -— a few the use of these drugs amenorrhoea,
uninformed individuals do use them for menstrual irregulartiesand other gynae
this purpose, the risk involved does not disorders. If menstrual regulation is
call for a total banonthesedrugs.” That required in patients aw have irregular
the magnitude of risk is large can be or no periods then the treatment of
seen from the categorical condemna- choice is either the conventional low
tion of these drugs in pregnancy testing dose oestrogen-progesterone or proby authoritative sources all over the gesteronesalone. I might add that there
world. Besides foetal malformations, 's very little literature in the most reputhese drugs have given false positive table journals of gynaecology on the
results in one out of five cases with 10 use of the high dose pill for amenorper cent cases resulting in unwanted rhoea or other gynaecological prob
abortions.
lems. The reason is obvious : there
i
seems little point in conducting trials on
Views from foreign experts
preparations containing high doses of
steroids (with well recognised spec
Specific responses sought from ex trum of side effects^ when low doses of
perts from other countries proved re the same drugs or alternative agents
vealing. Quoted below are some letters are effective and widely available.”
received on the Issue:
If the above responses are not suffi
Prof. M.D. Rawlins, Professor of clinical
cient to counter OPPI’s second claim fa
pharjnacology, Uniyersity of Newcast
vouring high dose EP drugs for treating
upoA Type: "It is mAiew.... that there is yaridui menstrual disorders in the atZ
no place for high dose oestrogen-pro- sence of substitutes in India, ICMR in
gesterone combinations either as th- 1982 had made the foilowing recom-

December 1990 HEALTH for the Millions 17

I

I

I

manufacturers. Neither were any orders

=

I

ing and sabotaging the ban

manufacturers and the drug control---------authorities have to be held responsible.
An unenforced drug ban is as bad as no
even for the treatment of secondary ardousdrug would c^inL,e '< a o2?
amenorrhoea as other substijptes are time even after the ban had been ef- ban at all. If this could happen to a
watertight case like high dose EP, one
available for its management!'
fected.
shudders at the effects of other hazardPermitting the manufacture and sale of ous drugs doinp4heir round in an unTo ban afresh
high dose EP drugs as single ingredi- controlled market
In 1984, Vincent Panikular jara, an ents In the same dose would be ridiculadvocate, filed a public Interest litigation
in the Supreme Court challenging the
continuation of the production and sale
of EP drugs in the country. >Vhen the
matter came up for hearing It) Novem
ber 1986, the judges expressed surprise
over the stay orders passed by the High
Courts and came down heayjly on the
Drug Controller for delay arid inaction
on a matter concerning public health.
The Drug Controller was greeted to
hold an inquiry on the issue through a
public hearing soliciting th$ views of
Drugs Consultative Committee review
interested individuals, expertsand con
ing 34 combination drugs in 1986 had
sumer groups. The Drug Controller’s
recommended that these two combina
opinion and the report of the hearing
tions be immediately weeded out is
were to be submitted within §jx months.
now history. This fact would never had
been known if it weren’t forthe diligence
Public notices for the he^ings were
of rational drug campaigners.
inconspicuously inserted in newspa

£

When ban orders
are stayed

pers and failed to state in $lear terms
that they were being held to decide
whether or not to ban hiejb dose EP
drugs. The drug companies yvere shrewd
enough to use professional bodies like
the Federation of Obstetric^ Gynaecol
ogy Society of lndia(FOG§l) to act as
their spokesman. Till th^ very end,
FOGSI supported the stand of the drug
manufacturers in stating tliat the drug
was essential and absolutely safe. The
statements of many eminent gynae
cologists appeared based on personal
anecdotal experience unsubstantiated

Several attempts were made to dilute
these recommendations. From the origi
nal decision to weed out “all steroid
combinations,” the Drug Technical i
Advisory Board In 1982 watered it down
to “all steroid combinations except for ?
bronchial asthma”. Full use was made
of this loop hole. All products containing
steroid combinations continued to sell
and be used and misused for all kinds of
senseless indications eg. Insect bites,
vague allergies, food poisoning etc. The
»of hazard*"'* *s and irrational chemists and doctors were not warned
r

lishing statistical scientific evidence.
to be an extremely difficult task. The
*
; story of combinations of steroids and
After a delay of several months follow- j Chloramphenicol-Streptorpycin are yet
ingthefourpublichearingj, abanorder more cases in point. Sincethe formula-

the reasons for the change. In other
words, most doctors and chemists were
not even aware of the Gazette notifica_ ecame clear that notifica-

r’KTWS’S’S ^.ssuedty.h.drogcon.-o.a^.
released on 15th July, J988. But no
move was made to inform the chemists,
medical professionals ^pd ignorant

Gazette Notifications were issued by
the Drug Controller of India, banning
them on 3rd November, 1988.

ties and alterations made in the product
literature by some manufacturers aimed
to ensure “legal coverage” but not
necessariy the “warning and stoppage
01-^N.^doo.er^^

18 HEALTH for the Melons December 1990

j

'

5*"

been prescribing a product for several
years feels the need to read the pack
Withdrawal of irrational drugs from the market
age insert each time unless the warning
has proven extremely difficult
Is printed outside. Moreover, most duc
tors dont even get to see the medicines
Unless considered life saving, sys- zuela, Italy, Australia, Belgium, Greece,
they prescribe as these are dispensed
tenrtic administration of corticosteroids Norway, New Zealand, Singapore,
by the chemiss or the hospital pt#ris contra indicated (use not recom- Thailand, USA, India, Nepal etc. have
macy.
V
mended) in patients with peptic ulcers, either banned, withdrawn or severely
brittle bones, psychoses or severe restricted these fixed dose combinaSteroids
psychoneurosis. They should also be tions of steroids. /
Since doctors prescribe drugs unjer used with great caution when patients
brand names, many are unaware of the suffer from congestive heart failure, On 3rd November 1988, after much
cogent and dosage of the various In diabetes, infectious diseases, chronic rethinking; these fixed dose combinagredients i.e. even the presence of renal failure, uremia (high levels of tiqn drugs were ultimately banned eight
steroid in a combination is sometimes urea in blood) or are elderly. Use of cor- years after they were initially recomnot known. The tragedy becomes evi ticosteroids may mask the symptoms to mended for “immediate weeding out" in
dent when one considers that many of such an extent that a true diagnosis 1980.
the cond itions for which these drugs ure becomes extremely difficult to make.
administered are . chronic conditions Many chronic asthmatic patients, unfor Ironically, history has repeated itself.
requiring treatment for long periods. tunately, are not even aware of the dif The manufacturers have gone to court
Prolonged use of steroids, according to ference between a bronchodilator (air and obtained stay orders against the
ban. Two years after the ban order,
therapeutic guidelines, should be pref
passage dilator) alone and a bron
fixed
dose combinations of steroids
erably avoided because of the many
chodilator in combination with a steroid.
continue
to be freely sold and there
associated side effects. Some of the Steroids do give relief in asthma and
appear
no
signs of any attempt to get
known side effects are suppression of can be life saving in acute cases but
these
stay
orders
revoked.
pituitary and adrenal gland functioning, creating dependency on them for mild
high blood sugar and a predisposition
attacks when more effective and safer Since many old stocks continue to be
to diabetes. Due to the suppression of
alternatives exist is medical malprac- sold in smaller towns and villages, a list
the immune system, there is also a pie tice and drug misuse.
*
J ■J" J
of some formulations of fixed dose
disposition to infections such as tuber
combinations of steroids is given below
culosis, a thinrwng of bones leading to
Several countries eg. Bangladesh, Tur- even though some manufacturers have
fractures, pepbc ulceration, myopathy
key, Denmark, Saudi Arabia, Vene- decide to stop their production:
(muscle weakness), fluid and salt reten
tion leading tc hypertension, central
obesity with “moon face" and “buffalo
hump", behavioral disturbance, "ster
oid psychosis’ , (hair growth on the face
in women, acne etc. Besides the above,
danger also lies in an abrupt stoppage
of steroids since the suppressed adrenal gland fails to take up its normal
functions immediately, leading to an
abrupt fall in blood pressure and a sud
den collapse wnich could prove fatal.
Steroid doses have to be therefore
administered according to need which
may not be possible in fixed dose com
binations. Also it is crucial that stop
page of sterocs following prolonged
treatment be done gradually. M^ny
patientstaking steroid combination* tor
years for the tre^ment of asthma, aru iri
tis, allergies etc. are often not aware ifiat
they are taking steroids, as no spetaa;
warnings are gr*«en.

Brand Name

Content

Manufacturer

Betaklor

Betamethasone
Chlorpheneramine

Velcb

Betneton

Betamethazone
Chlorpheneramine

Glaxo

Cortina

Dexamethasone
Chlorpheneramine
amine

Lupin

Cortophen

Prednisolone
Chlorpheneramine

Uniloids

Histacort

Chlorpheneramine
Prednisolone

SIRIS

Histapred

Prednisolone
Chlorpheneramlne

Wyeth

Kenamina

Triamcinolone

Sarabhai

1

1

December 1990 HEALTH for the Millions 19

-

Chloramphenicol-Streptomycin

'1
For consumers, however, doubts lo Jtn large about the
economy, safety and ejficacy of these drugs.

The story of CMoramphenicoi-Stryptomycln is another woeful tale, vyh’de
Chloramphenicol is meant for typlioid
and Streptomycin for tuberculosis, a
combination of these two has 4?een
promoted and sold for diarrhoea Be
cause the majority of diarrhoea^ are
viral based, antibiotics have no r$e to
play in their treatment. An irrational drug
combination only detracts froip the
main line
treatment which is oral
rehydration. Besides being an’ eco
nomic waste, it also has a dangerous
potential for causing fatal toxicity i.e.
agranulocytosis in which the while cell
count falls, making a person prone to
infection, a condition which could prove
fatal.
The emergence of drug resistance is
yet another alarming problem. If Chlo
ramphenicol is used for trival infec
tions such as diarrhoea, a patjupt can
become resistant to its effectiveness

in the cure of typhoid for whiph it is
actually meant. Not surprisingly, resis
tance of typhoid to Chloramphenicol
has been reported from several parts
of India. In the dysentery epidemic in
West Bengal a few years age, some
2000 children died as the- bacteria,
shigella, became resistant to Chlo
ramphenicol as well as to many other
drugs, ironically, this drug is SjJd in an
irrational combination with Streptomy
cin, rendering the latter unavailable for
the treatment of tuberculosis which af
fects 10 million people in our country.
The Chloramphenicol Streptomycin
combination along with Stety'd com
binations were banned on 3rd Novem
ber, 1988. Together, they remain on the
market due to stay orders obtained
by the manufacturers. On tijy subject
of the continued role of banned drugs
which came up for public litigation as
early as 1982, while pronouncing his
judgement. Justice Potti said : " As
between the profits of the manufac
turers and the health of the consumers,
the government has considered the
former of greater importance/’

What has been the fate of oilier drugs
20

HEALTH for the Millions

I

recommended for elimination since
1986? The Drug Price Control Order of
1986 only made prices more remu
nerative for the manufacturers.

banned drugs, it is difficult to envisage
action on other hazardous drugs be
ginning with identification and then a
painfully prolonged historical process
of battling for their ban.

For consumers, however, doubt?,
loom large about the economy, safety
and efficacy of these drugs. If stay
orders can be obtained recurrently on

A -list of banned ChloramphenicolStreptomycin combination drugs is
given below :

Manufacturer

Brand

1.

Basiplon

Khandelwal

2.

Bichlorphenin

Medinex

3.

Chemistrep

Suprachem

4.

CHLOROSTREP
SUSPENSION

Parke Davis

5.

Chlorocinstrep

Jagson Pal

6.

Chlorostrep
Kapseals

Parke Davis

Chlorostreptoseal

INDC

8.

Chlorsoin

Dolphin

9.

Cilastrep

Acila

j
i

■

i_

10. Contistrep-j.

Continental

11. Cooperstrep

Cooper

12. Chloramphenicol *
Pharma and Streptomycin

Indiana

13. Chloramphenicol
and Streptomycin

Sarvodaya

14. Chloramphenicol
and Streptomycin

H.A.

15. Cyperstrep

Cyper Pharma

!

Sunways

16. Diastrep

December 1990

t

i

VT
HAZARDOUS AND IRRATIONAL DRUGS

1
3

There are about 8,000 pharmaceutical units in India, which are producing

r

60,000 drug formulations.

approximately

many

of

these formulations are

known to be irrational and even hazardous.

MOST DRUG COMBINATIONS ARE IRRATIONAL

*

they increase cost unnecessarily

30

they increase chances of drug interaction

ncwrc;

they make quality control difficult

1

they make drug pricing and price control difficult
J

■*

they make monitoring of adverse drug reactions difficult

they confuse consumers and medical practitioners alike.
i

300
: intervals)

The WHO List of Essential Drugs which consists of

only seven combinations.(Technical Report

250 drugs contains

Series 722,

1965)

In 1980, the Drug Consultative Committee, a statutory body constituted
under Section 7 of the Drugs and Cosmetics Act (Act 23 of 1940), nominated
a

sub-committee

fixed
300
.jG

the

‘ 'aisi

dose

of

experts to study

combination drugs.

This

the

sub-committee

of

was

34

categories

of

to recommend to

DCC whether these combination drugs should be allowed or withdrawn.

The sub-committee formulated norms

f results)

rationality

to allow combinations of

drugs.

These were :

1

a)

if there is synergistic action

b)

where there is corrective action

c)

when

two

or

more

drugs

are

normally

prescribed

together 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

compliance due to convenience of admirastralior

57

better

patient

f)

where two or

more drugs, prescribed separately may

lead

to

non-mgestton <* one <* the drugs, thus adversely affecting the

to ob

health of the patient

Conversely,

norms for

NOT

allowing fixed dose

formulated as follows :

combinations were

extrac

a)

where adverse interactions may occur

b)

when one

of

the

combined drugs becomes

toxic
or

use

c)

when abruspt withdrawal

Of one of the drugs

symptoms

d)

if

sub-therapeutic

doses

are used

demonstrable synergism

e)

when pharmacokinetic behaviour
different.

and on

2 No.

the basis

prolonged

may cause withdrawal

in the absence of clinically

of the individual agents is grossly

T
of

34 categories of combination f
drugs were evaluated
these

to know

criteria, the sub-committee
------- j recommended a
ban on 23 combination drugs and
gave reasons for
recommending the ban.
Sixtten categories erf these
drugs were
recommended
to be weeded out
immediately, while 7 erf
the categories
were recommended to be weeded
out over a specified period.

he list of 23 combinations to be weeded

torfhcon

RECOMf
and th
#

out is given on pg.

The sub-committee submitted ,ts report to the Dr... r
.
Commi-,.ee on the 10 October 1981
it
8
onsultative
cai Ad
a
WaS alS° Presented to the Drug Techni. .
..sory oaro, and to the Ministry of Health and Family Welfare which

recommended

to prohibit the
UildlOTSd'tt
antihistaminics
October 1980.

--.J

-

™-roids as early

some mcompreher^e logic, the Drug Technical

as

Advisory board

consists of exactly the same members reversed .ts d
31, 1981 and allowed the sale of the
'
ts decision on December
O the sale erf the products which it had earlier cons.dered

58

. .

to be dangerous.

At this point of time, it claimed that it was necessary

to obtain wider medical opinion.

The Editor of MIMS in his editorial in the issued February 1982 (Voi.
2 No.3) on the ’’somersault on steroids” said that ’’they must have had very
extraordinary reason to

reverse their own earlier decision
ignore the advice of the Drug Consultative Committee
consider the opinion of the whole battery of eminent and distin

guished medical specialists from research institutions as inadequate

so as to ask for further details and wider medical opinion.”

The consumer
to know

1
a

who is exposed to these hazardous drugs is entitled

for the

the reason/s

This

volte-face.

has, however, not been

< or thcoming.

K I.COMMENDATIONS

FOR

OF

WITHDRAWAL

HAZARDOUS,

IRRATIONAL

jt

AND THERAPEUTICALLY USELESS DRUGS

?d

All existing drugs available in the Indian market should be screened
by an appropriate, impartial authority, such as the National Drug

Authority recommended by the Hathi Committee.

ve

Those drugs which have life-threatening or serious side-effects,

ni-

and for which safe alternatives are available should be banned

ich

with immediate effect.

ory
ics

Jgsho-

*

No fixed dose combinations should be allowed if an alternative

single

ingredient drug

is

available,

except

in accordance with

the norms laid down by WHO.

as
Information

regarding

the

action

taken

by

other

countries to

ban hazardous and irrational drugs, and their reasons for Going
ard,

so (together

nber

be made available t^ rhe public.

with

supporting

medical/research evidence) should

ered
59

i

The criteria for the withdrawal of

hazardous and/or irrational

drugs which have an unacceptably* high risk factor, which are
prepared

in

sub-therapeutic do^es,

or

which

are

marketed

in

!

irrational combinations, should be widely publicized for the benefit
of

medical practitioners and the general public.

The criteria

used by the Scandinavian countries,Sri Lanka.Bangladesh,Mozambique

?

etc. can be used as guidelines (see Appendix)
*

Once a decision is made that a particular drug or drug combination

is hazardous or irrational or useless, immediate steps must be
taken to destroy all existing stocks and-to stop further production

immediately.
♦

Legislation

c

be

should

suitably

modified

to ensure

that

Courts

do not grant stay orders against decisions to destroy existing

stocks of hazardous drugs, or to stop further production of such
drugs forthwith.

After screening by the proposed National
those

drugs

which

the Government.
the

market,

S

This is necessary in the interest of public health.

are

All

approved,

Drug Authority, only

should be

re-registered

with

other products should be withdrawn from

and further production banned.

In line

♦

<

with the

practice followed by other countries, it should be made mandatory

for all drugs to be re-registered periodically e.g. every five years.

i

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4

Laws that protect
Various laws exist for tfie protection ofpublic health. But a lack of knowledge or a neglect of
theirprovisions. fien results in drug induced ill health. Dr S.G. KABRA describes
some of the a^es that suffer due to a neglect or a non implementation of the
law aiid the efforts made to bring breaches before law courts.

■p
I

here are several laws, the ly ovisionsofwhicharemeanttortjgu-

late health care facilities for the benefit
of the public. Indifference to oj negleet of these legal provision^ en
genders a tact nexus between offend
ers and the authorities. It is therefore
necessary to identify these legal provisions to create awareness arid to
evolve a strategy to ensure that the
authorities entrusted with the enforcement of these provisions do in fa^i do
so. Enumerated below are several laws
with a direct bearing on public health.

Drugs and Maeic Remedies
(Objectionable Advertisement)
Act,1954
Its statement or objects and reasons :
“In recent years there has be:jn a
great increase in the number of objec
tionable advertisements in newspapers
or magazines or otherwise relating to
alleged cures of venereal diseases,
sexual stimulants and alleged cure;, for
diseases and conditions peculiar to
women. These advertisements tend to
cause the ignorant and the unwaiy to
resort to self-medication with hai/nful
drugs and appliances or to resdtf to
quacks who indulge in such advertise
ments for treatments which cause neat
harm. It is necessary in the public Interestjo put a stop to such undesirably advertisements. This bill is intended for

this purpose.”
Taking into account specific provisions, Section 3 of the Act states :

"Subject to the provisions of this Act, no
person shall take part in the publication
of any advertisement referring to any
drug in terms which suggest or are calculated to lead to the use of that drug
for:
a) promoting miscarriage in women or
prevention of conception in women;
or
b) the maintenance or improvement of
the capacity of human beings for
sexqal pleasure; or*
c) the correction of menstrual disorder
in women; or
•d) the diagnosis, cure, mitigation, treat
ment or prevention of any disease,
disorder or condition specified in the
Schedule,*' or any other disease,
disorder or condition (by whatsoever
name called) which may be specified
in the rules made under this Act.

(* The Schedule appended to the Act
lists 54 diseases, disorders and conditions which cannot be advertised.)
Section 4 of the Act states :

Subject to the provisions of this Act, no
person shall take any part In the publication of any advertisement relating to a

drug if the advertisement contains mat
ter which : a) directly or indirectly gives
a false impression regarding the true
character of the drug; or b) makes a
false claim for the drug; or c) is otherwise false or misleading.

No person carrying on or purporting to
carry on the profession of administering
magic remedies shall take any part in
the publication of any advertisement
referring to any magic remedy which
directly or indirectly claims to be efficacious for any of the purposes in Section
3. Under Section 9A of this Act, an offence punishable under this Act is a
cognizable one.
A test case

Offending advertisements are a very
common feature in the print media in
India. To invoke the provisions of this
Act.
initiated a test case in a magistrate’s court in Ajmer against the then
Editor and Publisher of The Hindustan
Times, Delhi (Khushwant Singh and Dr
Hans Raj respectively) for an advertisement by Dr Sablok which appeared in
the newspaper. The case was registered only after letters written to the
editor, drawing attention to the provi
sions of the Act went unheeded, the
advertisements appearing unchecked.
v the case was
_ ________
Though
ultimately dismissed through default, it did succeed

in ensuring that all three defendants

December 1990

HEALTH for the Millions

21

i

.1

——

■

i

■ ■■

"

•

appear in court whenever required
through the execution of a bond arid
surety. The case also succeeded ip
establishing the following :

‘

leading lawyer of Rajasthan, agreed to
file a writ petition which was decided on
September 1989. The Hon’ble Mr. Justice SN Bhargava issued a directive to
the inspector General of Police, Rajasthan, to establish a special cell to monitor such advertisements in the print
media and initiate prompt action
against the offenders. Some cases
have been registered by the police,
Some
Some of
of the
the newspapers
newspapers have
have stopped
stopped
carrying such advertisements. Much
still remains to be done to fully get the
court’s order implemented.

‘

tion of its provisions throughout the
country.

Despite its existence, precious little has
been done to implement its provisions.
A case in point is drug induced blind
* The offence is cognisable. Any court
ness. Eye drops and ointments with
in whose jurisdiction a newspaper pr
magazine
is
sold
or
circulated
has
steroidcontentarewidelyusedforallermagazine is sold or circulated has
jurisdiction in the case if the offe;Je
gicconjunctivitis..Due to prolonged use
is deemed to be committed locally
of eye drops, I have known several
and the cause of action local
cases
casesturn
turnblind
blindthrough
throughdrug
druginduced
induced
glaucoma and cataract. Though every
text book of medicine and pharmacol* The editor and publisher along yjth
the advertizer are all equally liably to
ogy mentions that steroids should not
offence
be used for prolonged periods, no
warning to this effect is written on prepa
Drugs and Cosmetics Act
rations. The implications are specie'ly
Efforts at implementation
This Act provides for the control and ominous when one considers the fact
After my deputation to SDM Hosj jtal, regulation of safe production, distribu- that self medication is a very common
Jaipur, I wrote letters to the Director, tion and sale of drugs and cosmetics, phenomena. Even well meaning parHealth Services, Inspector Genet ai‘ off Powers to enforce the provisions of the ents regularly administer eye drops to
Police and Health Secretary of Rujast- Act are vested in the State Drugs Con- children, oblivious of the dangers. The
han, drawing their attention to the provi trollers whose activities are coordi- six year old son of a compounder first
sions of the law and its breach. There nated by the Drug Controller of India put me on the trail which led me to
was no response. Marudhar Mridul, a who in turn ensures the uniform applica- compile over 18 cases of blindness in

I

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1

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22

HEALTH for the Million*

December 1990

one year due to prolonged use of uerold - containing eye drops. None pad
been warned.

iwas •Issued- by the Drugs Controller
against the prolongedI use of steroidr
-------containing
eye drops. Partially imple-

mented, the court order has not been
Letters were written to apprise the D| ug followed In true spirit.
Controllers of Rajasthan and Indi^ of
the cases In point Articles were written Banned and bannable drugs
In the lay press, giving case histories of
the patients
to highlight
the dangerj of According
to V...»
,
.
’
writ petition■ filed Ml
under
ln_^ye medlCineS' ?ne Such the Dru9s and Cosmetics Act,
the deci-•
- ----------article which appeared in Rajastnan sions of the Drugs Consultative ComPatrika, a Jaipur daily, attracted thy at mittee and the Drugs Technical Advi
been filed in the High Court with notices
tention of the local government A sory Board, the highest technical bodissued to the central and concerned
committee of experts was appointed to jes under the Act/i
once accepted and State government.
investigate the facts and to submit their
communicated by the government, are
report.
y
binding on all health authorities and The Indian Medical Council Act and
government doctors. A drug that has the Medical Degrees Act
The committee recommended that all been declared harmful or irrational by
steroid
warningeye
.hotpreparations
th
a- - should
•
,cai i y a the technical b°dies cannot be pur- Provisions of these two Acts have been
warning that the medicine s prolonged chased or prescribed by any govern- invoked to prevent advertisements and
use may lead to blindness due to cata- ment authority. This is irrespective of
unethical practices, professional mis
ract, glaucoma or fungal infection. J he the fact that government orders prohibconduct and the use of unrecognised or
State government forwarded the rec- iting manufacture and sale of the drug fake degrees by doctors'
. The State
ommendations to the State Drugs Gon- might have been stayed by a court ProMedical Council must be made to do its
troller, who in turn, instead of acting hibitlng the manufacture and sale of a
duty to regulate and supervise the pro
.U2^Llhu fr^IS,<LnS of ^he ,aw‘JDr’ drug and directing all government fessional conduct of the doctors regiswarded it to the Drugs Controller of doctors not to prescribe a drug found tered with it and to ensure ethical stanIndia. The Central Drugs Controller re to be harmful are two different conse- dards of medical practice,
turned it to the State Drugs Controller, quencesjthat flow from the decisions of
agreeing with the recommendation^* of the two technical bodies.
The Insecticides Act.
the Committee. The State Drugs Con
troller still did not act. Even the repci t of
An interesting observation made by the The provisions
this Act have been
the Committee was not made publl^.
court during the hearing was that a stay invoked to prevent the availability of the
----------------- CT

I

a

I

I.

state government machinery exists to
_________
ensure that
these safety provisions are
followed. The_ --result
----- :: no x-ray units fol
low them. With commercialisation of
diagnostic x-rays and their rapid prolif
eration, there is grave danger to the
population. After having written to all
authorities bringing to their notice the
mandatory provisions and having failed
1 persuade them to fulfill their responsT
to
bilities under the Act, a writ petition has

A wrt petition was then filed in the tijgh
Court on 20th January 1989. Hobble
Mr. Justice
Mahendra
and
Mr
lifQtiro
i q Bhushan
iero • h- Sharma
♦ u
~
h Justice I.S. Isram directedthe
Drugs Controller of Rajasthan to ensure
the printing of the necessary warning oh
all steroid-containlng eyp preparations.
Their lordships quoted extensively the
specific rules under which the State
Drugs Controller had the power to Im
plement the provisions so as to allay
any impression to the contrary.

T.
u
.
Though a number of steroid prep,rations now carry a warning, many stiji do
not. Despite a large number of caaes
brought to his notice, no public warping

I

■aik.VJ

IM Cl

order by one High Court is not automatically binding on the other High court,

deadly pesticide aluminium ohosohide
in the open market Numerous articles

Evidence of banned drugs still being
Purchased’ Prescribed and reimbursed
by health authorities was produced
Ibefore^the
*
court. The case is still pending before it.

have been written to bring to light a large
number of deaths that result every year
from aluminium phosphide. All tte con-

Atomic Energy Act, 1962

cerned authorities have been warned.
Questions have been raised and an
swered In parliament. Though there are
widespread assertions on the illegality
of open market sale of aluminium
phosphide, nothing has been done to
prevent it. A writ petition, it is felt, should
now be filed to prevent thousands of
deaths due to this deadly pesticide A

The Atomic Energy Regulation Board
constituted by the Central Government
under the provisions of the Act have
codified the mandatory safety provisions for diagnostic x-ray units. The
safety code details
the mandatory '* S-G' f^bra is a Processor ofAnatomy, a trained
measures
measures r.eccoo
necessary to prevent unnec- surgeon, a medicaljoumalist who has also done law
essary exposure
J to radiation. Yet no and written extensively cm medical - legal i^uer
December 1990

HEALTH for the Millions

23

Ill
CONCEPT OF ESSENTIAL DRUGS
Confusion abounds in the minds of the consumers, health personnel and policy
makers as regards drug demands and wants created by market forces as opposed

to genuine drug needs.

essential drugs aims at providing much

needed help in this

selection process and in the way out of the 'pill jungle',

There is an urgent

The concept of

need for a clear understanding for what

is meant by rational, essential and

priority drugs.

The WHO Expert Committee on Essent.al Drugs attempted to provide guidelines

to niember countries to help them draw up a list of essential drugs:

"It is clear

that for the optimal use of

limited financial

resources

the available drugs must be restricted to those proven to be therapeuti

cally effective, to have acceptable safety and to satisfy the health
needs of the population.

drugs,

indicating

that

The selected drugs are here called 'essential'

they are of

the utmost

importance,

and

are

basic, indispensable and necessary for the health needs of the population".

"Drugs included in such a list would differ from country to country
depending on many conditions, such as the pattern of prevalent diseases,

the type of health personnel available, financial resources and genetic,
demographic and environmental factors". (See Annexure 3.1).

It is evident, therefore, that the key elements in the concept of essential drugs
are that, that they be

RATIONAL

SCIENTIFICALLY PROVEN
THERAPEUTICALLY EFFECTIVE
ECONOMICAL

and

SOCIALLY ACCEPTABLE

51.

Drugs have a definite role in health care.

They are meant to help people and

not to serve economic interest.

According to Health Action Internation (HAD an international pressure group
cy

working towards rational drug policies and rational drug use, all drugs must:

-ed

1.

MEET REAL MEDICAL NEED

This means that their use is likely to improve the quality or extent

his

erf medical care.

?nt
»nd

2.

HAVE SIGNIFICANT THERAPEUTIC VALUE

This means that they

must do what

is claimed for them,

and that

patients will benefit from that.

nes

3.

BE ACCEPTABLY SAFE
This means that their likely benefits must far outweigh risks.

ces

utialih

4.

OFFER SATISFACTORY VALUE FOR MONEY

ual’

This favours

are

as other medicines, but cost less.

the introduction

and

use

of

drugs which work as well

ion”.
AIDAN
fniry

ases,
letiCj

reiterates the above and

it feels that the Selection at

Drugs from

amongst the different therapeutic categories should be based on
MEDICO SOCIAL JUSTIFICATION:
it should keep in mind -

drugb

THERAPEUTIC EFFICACY
SAFETY

COST

OF

TOTAL

COURSE

r\r

UNIT COST OF A DRUG
EASE OF ADMINISTRATION

LIMITED POTENTIAL FOR MISUSE
INDIGENOUS PRODUCTION

EASE OF TRANSPORT. STORAGE
LONG SHELF LIFE

52.

rxn i i z—
LJCK <_'kJ

TREATMENT

NOT

MERELY

ESSENTIAL DRUGS RELATED DEFlNmONS

In drawing up the essential drug programme, it will be helpful to bear in mind
the following concepts ;

RATIONAL DRUGS

are those drugs which are accepted
world-wide and included in the standard
text books of medicine and pharmacology.

ESSENTIAL DRUGS

are those selected by each country
according to health needs to its people.
The 'Criteria of selection of essential
drugs' suggested by WHO have been
accepted by over 80 countries.
In
addition to these criteria,
Norway
has based the selection of essential
drugs
on "efficacy".
"safety"
and
"medical need",
This medical need
clause
precludes
the registration
of any new drug which is not ’’more
effective" than one that is already
in use, and which is not safer and
cheaper than drugs currently used.

PRIORITY DRUG LIST

are drawn from among the essential
drug list to give priority to drug
production, distribution and availability
for use in diseases having
- greater mortality (death)
- greater morbidity (illness)
- severe sequelae (after effects)
- communicability (T.B,Leprosy)

and for use in national programme
such as T.B. and Malaria eradication,
Blindness»
control,
Goitre control,
Immunization, etc.

GRADED ESSENTIAL DRUG LIST

drugs are needed for different levels
of health personnel and health institut
ions.
Bangladesh prepared such a
graded list of essential drugs which
indicated 12 drugs for use at village
level; an additional 33 drugs for use
at "thana" level; and 105 drugs for
restricted and specialized use. (See
Annexure 3.3).

33.

......

ADVANTAGES OF THE CONCEPT OF ESSENTIAL DRUGS

Preparing

a

rational

list of

i

essential/restricted drugs has several

s

advantages^ medical, economic, social and administrative.

i

MEDICAL ADVANTAGES
§

§

It

is medically, therapeutically and scientifically sound,

rational

use of drugs.

It limits

the use of

and it ensures

in ational and hazardous drugs and decreases the

risks of iatrogenesis.
§

It improves the possibility of monitoring adverse drug reactions in patient^.
ECONOMIC ADVANTAGES

§

It is economically beneficial to the nation because it prevents wastage

of scarce resources on non-essentials.
§

The economies of

scale achieved in the larger production of

priority

drugs brings down their prices.
§

It curtails the aggressive marketing of non-essential formulations.
It is economically beneficial to the patient because it prevents wastage
on irrational and non-essentials.

SOCIAL ADVANTAGES
§

It responds to the real health needs of the people.

§

It facilitates the dissemination of correct irrformation about the drugs

to

$

health

personnel,

medical

practitioners

and

consumers

It makes it imperative to draw up priorities to meet the

in

general.

most urgent

needs of the people for essential health care.

ADMINISTRATIVE ADVANTAGES
§

It is organizationally sound because it makes quality control easier because

cf the limited number of drugs to be monitored.

■’-i*»<*>'<A*.4‘Mifr ailMUiirt.-.

i

It facilitates the streamlining of production, storage and

cf drugs, because of the smaller number of drugs involved.
§

It helps in the clean identification cf the drugs.

§

It facilitates the fixing cf prices

distribution

as well as the revision/withdrawal of

excise duties, sales tax etc.

36.

■

■>

.

I.

RATIONAL DRUG QSE
Drugs are the hallmark of Modern Medicine. The ’healing
professions’ throughout the ages have always used ’natural’
or ’synthetic’ products for their medicinal value, to
treat various ^ommon ailments of people. Drugs, however,
have never in the past dominated the medical scene as
they have done in the second half of this century. Today,
the ’pill for ^very ill’ culture is well established.' It
has ensured that we are probably the most ’drugged
generation” of all times. Not a very healthy thouqht!
thought!
Throughout the centuries, philosophers, social activists and
concerned doctors have warned against the dangers and
problems of overuse or misuse of drugs by doctors and the
people.

The Indian Situation

The Indian Council of Medical Research and the Indian
Council of Social Sciences Research set up a joint study
group to study the health situation in India and evolve
an alternative strategy for our commitment to ’Health for
All by 2000 AD?. This high powered expert committee had
some very interesting things to say about the present
situation of drugs and prescribing practices, in their

Report published in 1981.(l)

"One of the most distressing aspects of the present health
situation in India is the habit of doctors to over prescribe
glamorous and costly drugs with limited medical potential.
It is also unfortunate that the drug producers always try
to push doctors into using their products by all means - fair
or foul. These basic tacts are more responsible for
distortions in drug production and consumption than anything
else.”

Irrational Druq Use — Some dimensions

To understand the principles of Rational Drug Use, one needs to
first identity and appreciate ttie elements of irrationality in
the present situation. A spate of reports appearing in our
newspapers and periodicals high-light these elements. Of all
of them, however, the report of the recent ’Lentin Commission’
and its shocking findings are the most telling.
Irrationality ^n drug use arises out of three sets of factors:

A.

Irrationality in drug production, marketing and
availability.
'>

B.

■

irrationality in prescribing practices of doctors and
health workers.
Irrationality in drug use by the consumber public.

All these takep together result in the situation we find
ourselves today.

A.

Irrationality in drug 'production, marketing and availability.

* Industrial Policy

Drug policy continues to be part of the industrial policy and
not part of the-health policy. Industrial growth and profit
margins determine the policy and not health needs of the
people.
* Over abundance

j

/

There is a plethora of drugs produced in the country. The
The
Hath! Committee recommended 116 as essential and the WHO
says 200 are necessary. At present there are over 70,000
formulations in the country.
* Quality of drygs

Twenty percent yf the drugs available in the country are
substandard andtspurious. Many are adulterated. Many are
old and being spld atter the ex;iry dates are over.

Turmeric powder in tetracycline and poor quality intravenous
fluids have been reported. The substandard ’glycerol’ in
J.J.Hospital highlighted by the Lentin report is another
example.
?
* Unwanted drug^

The formulation^ available include the following:
i.

Banned drug^; Drugs which have been banned in many
countries sych as Lomotil and Clioquinol.

ii. Irrational combinations:
Formulations which :have combinations that are antagonistic
or irrational. Thd1 Hath! Committee had suggested weeding
out of atle^st 23 such groups of preparations. These were
finally banned by a gazette notification in July 1983 but
continue tobe available.

iii. Hazardous or Bannable drugs: .Hazardous drugs which should
not be available without prescription or adequate medical
supervision. Preparations containing analgin, oxyphenbuta
zone and cqrtico-steroids are the commonest examples
(Refer A to 2 of Drug use - page 31)
iv. Drugs promoted for indications that are not clinically
proven or a^’e potentially dangerous, eg., promotion of
EP Forte conibinations for pregnancy testing and induction
of abortion?even when there is well documented evidence
that risk of foetal deformity is increased by the use of
these preparations.
(now banned since 1988 June 30)
v.

Costly Drugs: Drugs which are inflated in cost by
inclusion of.costly, additional, often unnecessary ingredients
or by cosmetic embellishments in manufacture and packaging.
Ionics and rjj.gh protein foods especially baby fodds are
good examples.

- 3 -

* Wrong Priori!*es
There is over-production of unimportant drugs or drugs for
the rich while drugs for some common health problems are in
short supply. Tonics, vitamins, horomne preparations and
high protein substitutes are being produced in wasteful/
abundance while drugs for leprosy and tuberculosis (tv*o
major public health problems) are produced at one third and
one fourth of actual requirements. Similarly Vitamin A and
many vaccines urgently required for child care programmes
are frequently |n short supply.
*

^ver-the-counler sales

Sale of drugs oyer-the-counter without doctor’s prescriptions
or the necessary statutory checks are not at all uncommon.
This results frgm inadequate drug legislation and even more
inadequate drug controls. Over-the-counter unauthorised sales
of prescription drugs which now-a-days do not even have the
precautionary product information make the situation even more
hazardous.
* Escalating Prices

Price control policies have been both inadequate and ineffective
and hence the cost of drugs has been constantly escalating.
With liberalization policies of the present government this is
bound to increase further. The purchasing power of majority of
our patients is limited. With increasing prices, patients are
forced to buy ^nly pafct of a prescription or go in for sub
standard alternatives promoted by the (drug shops.

B.

Irrational Qruq Prescribing

Doctors, nurses and health workers often prescribe or administer
drugs irrationally. The types of irrational drug prescribing
has been classified as follows: (4)

Type of irrational drug use
Extravagant prescribing

Occurs if a drug is prescribed
when:
A less expensive drug would provide
comparable efficacy and safety
Symptomatic treatment of mild
conditions divert funds from
treating serious illness

I

A brand name is used where less
expensive equivalents are available.

2. Overprescribing

The drug is not needed
The dose is too large
The treatment period is too long
The quantity dispensed is too
great for the current course of
treatment

I

- .4
*

Occurs if a drug is prescribeo
when:

Type of irraiional drug use
3* Incorrect prescribing

The drug is given tor an incorrect
diagnosis
The wrong drug is selected for
the indication
/'

The prescription is prepared
improperly
Adjustments are not made for
co-existing medical, genetic,
environmental or other factors.

4. Multiple prescribing

Two or more medications are used
when one or two would achieve
virtually the same effect.
Several related conditions are
treated when treatment of the
primary condition will improve
for cure the other conditions.

Under prescribing

Needed medications are not
prescribed
Dosage is inadequate
Length of treatment is too brief.

1

There are many background factors which lead to such prescribing
practices.

a. Inadequate training

Doctors, nurses, pharmacists and health workers may be inadequately
trained in the use of drugs. The training may be theoretical and
not geared ty the practice of prescribing in the real life situa
tion. Technical minutiae may be stressed at the cost of informa
tion on cost', social context and hazard.
b. Inadequate continuing education
The doctor, pharmacist, nurse or health workers in field practice
are inadequately supported by a process of continuing education
by their professional associations and training institutions.
Once graduation is over, there is little opportunity to refresh
one’s knowledge of drugs and medical matters through unbiased
sources of information.

c. Unethical medical advertising

Medical advertising of drugs has been more often than not,
found to be full of unproven claims of efficacy. In addition,
promotional literature all over the world by the same company
for the same^drug has been found to be vastly different. Facts
are withheld or modified. Statistics are used in a biased manner.
Drug company sponsored misinformation is not uncommon.

- 5
d* Prescribing for prestiqe/power
Doctors especially often prescribe extravagantly as a sign of
•prestige’ apd ’power’. In India people often consider a good
doctor to be one who gives a long, costly prescription, in
keeping with his list of degrees. Many doctors succumb to
this cultural status symbol. A vicious cycle is maintained
thereby.
e* Busy outpatients
z
Many of our institutions are understaffed especially those,
run by the government. The queues at the out-patient clinic
are long and there is a heavy rush. Lack of time to make a
good clinical judgement often results in an irrational
prescription including drugs for all eventualities.

f. Inducements by medical companies
Misintormatiqn is not the only method by which doctors are made
to prescribe irrationally by medical companies, bales promotion
includes a host of practices-such as unethical trade discounts,
bribes, gifts, sponsorship for conferences and travel. The
commercial proposition induces many doctors to prescribe
unethically.
g. Unauthorised prescribing
Health workers and practitioners of other non-allopathis systems
of medicine are often by virtue of their training unauthorised
to prescribe all the drugs in the medical armamentarium. Health
workers may be trained to prescribe only a few drugs. Too often
they get a larger number of arugs and dispense them to get the
community’s approval and get greater prestige. Many traditional
medicine practitioners, dispense allopathic drugs with little
background training or knowledge.

h<, Drugs as a substitute for caring
Drugs have become a symbol of the new medical culture, where
treatment is primarily drug oriented and all other aspects of
’caring* and pursing of the patient are relegated to the back
ground. Whep simple home remedies like hot water gargles and
nursing procedures can provide reliet to many symptoms of the
patients, doctors prefer tb prescribe symptomatic drugs
instead, thus increasing drug consumption irrationally.

j

i« Drug use by Consumer Public-irrational dimensions

i. Self-medication.
Medication by patients themselves is not an uncommon problem.
Either they are too poor to consult doctors or because of the
easy availability of urugs they medicate themselves, encouraged
by the pharmacists, advertisements, peer group information or
advice of family members. A survey conducted by the National
Institute pf Nutrition in the twin cities of Hyderabad and
Secunderabad covering 10 percent of the 330 retail Pharmaceuti
cal shops showed that self-medication rate was an alarming

46 percent.
i

ii. Use of unutilized drugs*

It is a vei / common habit among the consumer public to take
a medicine, not as the doctor has directed by just enough to
feel better* This is often the case with antibiotics and
particularly tor children. Unused medicine is kept in the
home pharmacy and given to one or other of the children or
family member who gets the same symptoms, next. Unused or
unutilized portion of prescribed medicine is often kept
beyond expiry date. If proper storage precautions are not
taken, it jnay also get denatured. Use of such medicines
is a major cause of untoward reactions.
iiiQ Inadequate labelling or storage of medicine.

Medicines prescribed by doctors are often inadequately
labelled by the dispensing pharmacist. Storage instructions
are not very clearly explained to the- patient. The medicine
cupboard is often a source of irrational drug use. Children
may k.ave jjccess to it and this may lead to accidential
poisoning;
iv> Peer group exchange

Consumers of drugs often advise relatives, friends and
neighbours about the benefits a particular prescribed drug
has given them. They are advised to take these drugs for
what is thought to be a similar complaint or disease. This
peer group exchange is often the cause of much irrational
drug use by the lay public.
vo Status symbol drugs

Capsulesa injections and tonics have become status symbol
drugs. Ihey are thought to be more effective and also
being co&tilier are considered to be of greater prestige
value, patients often demand or pressurise their doctors
to prescribe one or more of these and doctors often comply
with the request to retain the patient and family in their
practice.
vl. Multiple consultations
Patient^ often go to many doctors seeking quick relief of
their symptoms. The doctors are not often aware that
consultation with them is one of many such concurrent
events. Ceneralists and Specialists may both be consulted.
Practitioners of different systems may be consulted
simultaneously. Different medicines given by different
’are then consumed with the hope of getting relief,
hen relief does occur it is not easy to decide which
medicine brought it about.

Multiple prescriptions then become a way of life when
symptoms recur. Many drugs may potentiate one another.
Others way work at cross purposes. When the consultation
is of plural systems the contusion is worse.

- 7

vii. Inadequate Consumer Awareness

absent in India

Consumer education is next to

Dua

educational system and the sAlal SCe age^ciei0"’ the

wsk
prescribed !drugs is'not cJnsidereS U Ce CO”“>nl>'

a-d

further p2?oblem for consumer education, an adequately
Hpha - I 1-4.--The problem is
further compounded by a ?large
illiterate population and
the need of such efforts to be m multiple languages when
they do get organized.
Rational Drug Use

* Means practice of socially
■
‘ '
conscious, relevant and
scientifically sound medicine.
*

Emphasises the selective

use of orugs based on

- Essentiality
- Efficacy
- Safety
- Easy availability
- low cost
- £ase of administration
- Adequate quality
- Preferably; ot indigenous production

^Recognises the non-role of drugs in c '
conoitions and the
role of alternative systems of medicinecertain
in
- -i some other conditions.
haJa^ntS 3 c°uScious decision not to r-are ^aUyXded"!131'
banned
USeuse^certain
811 others drugs which are
----- ; only when they

* Means prescription with a--awareness, to avoid as far as possible
iatrogenesis which includes
- drug induced problems
- crug interactions,
- adverse drug reactions and
- emerging drug resistance.

medlca! ceivl«?tinUG tO P18y their

They
meaningful
movement must ensure that
J but useful role in

J*

- 8
And it will only be if
- The public;
Governments;
drug industries;
planners;
health professionals;
medical colleges;
pharmacy college^;
nursing colleges;
drug controllers;
pharmacists;
journalists and ^iedia persons;
and
teachers and educators;

i

/

3•*

Commit themselve^ to promoting a Rational Drug Use.

Hef erences:
1.

ICMR/ICSSR (1981)
health for A|1 Analternative Strategy

2.

VHAI (1986)
Banned and B^innable drugs

3.

Shiva Mira (1985)
Rational Drug Therapy
Medical Service, Vol. 42, No.1, January 1985

4.

Management Sciences for Health (1982)
Managing Drug Supply, Boston, Masachusetts, USA

5.

Narayan Ravi (1984)
Consumer Ale^t - Consumer Action
Medical Service, Vol. 41, No.9 October-November 1984

6.

Werner David & Bower Bill (1982)
Helping Health Worker's Learn Hesperian Foundation, USA.

■!.

ZQj JNTARY HEALTH ASSOCIATION OF KARNATAKA

"RATIONAL DRUG THERAPY”

What is Rational Drug Therapy?
Rational Drug Therapy is the art and science of prescribing the
best suited d}.ugs to individuals who need them, net to those
who merely waijt them.
/

The Drugs usea will be
* Efficient
* Safe (With low incidence of side effects)
-K- Low Cost
* Easy to administer

z

The person whg prescribes will have knowledge, skill and concern
for the patient, Rational Drug Therapy requires firstly accurate
diagnosis.
Are a number uf 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 lii;e an'over crowded O.P.D. Accurate diagnosis is
only possible 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 choice.
Use more expensive ones, for those who do not respond to the
first drug or’those who develop adverse reactions to it.
Consider all aspects together
oor patient can afford only a less powerful drug.
Some times a j,«,oor
In a life threatening situation cost will not be the main
cons ideration f
t

Remember these
Most potent d,.ugs are not necessarily the best.
The most -rational drug therapy in a given situation is not
always the ideal.
When do doctors become .^irrational in their use of drugs?
According to WHO, therd are 75 w^ys doctors misuse drugs,
commonezt is overuse of drugs. They prescribe^
* Too large quantities
* For too loijg duration
-KEntirely unnecessary' drugs
* Too many dtugs at the same time for the same problems
What happens when patients overuse drugs?
The following are the results of overuse of drugs:
* Waste of drugs
* Wastage of money
Increased chances of adverse reaction due to
toxicity ang drug interaction •
-KConfusion ig the minds ..of patient.

The

. . . .2

. - 2
Why do some doctors over prescribe?
Doctors over pzascribe when they do not have enough time and
facilities to
a proper diagnosis. They try to make the
patients happy by . over; pr-escribing.
Sometimes doctors do not have enough knowledge of drugs ^nd their
prescribing principles, due to lack of continuing education.
At other times it is the patients who pressurize dostors into
overprescribing. Because many patients believe tj^at a good
doctor gives h^avy prescriptions. z
.
Very often advertising ahd sales promotion techniques used by
the drug companies influence the doctors. They ofxen receive
incomplete information and excessive amount of samples.
By prescribing a drug where none is needed doctors try to retain
the patient’s c,pod will.
Some doctors prescribe the latest drugs just to, prove that
they are update.
Often tie ups qxist between local chemists, shops and doctors
Accordingly, dqctors advise you to go to a particular chemist
or prescribe a-particular product more often.
Are there times when doctors also underprescribe drugs?
Yes,'Doctors sqinetimes do fail to prescribe sufficient of the
right kind of utedicines. This is because:
* The medicines are too costly for.the patient
* The.doctors do not have enough information on the drugs
-K- Non-availability of drugs (Anti T.B.,Leprosy drugs)
Drugs are being rapidly added. Medical information therefore
is radically changed every ten years.

From where do the doctors get their information on drugs?
As WHO says "Drug advertising and contacts with representatives
of pharmaceutical firms are often the main sources of information
for a physiciarj on drugs and some time the only ones. Such
information is always influenced by commercial interest. The
basic theme of promotional material is that a drug will provide
the answer to ^distressing clinical problem. Little attention
is given in aiding the physician io use his clinical judgement.
Unfavourable aspects and complications ofj such treatment rarely
receive sufficient attention”.
In developed countries, there is one drug representative for
every 30 doctors and in developing countries eg.Tanzania, one
for' every 4 doctors. No wonder most of the profits made by
drug companies ’is from third world countries. According to
Tom' Heller in Ppor Health, Hich Profits some of the multina
tionals have been comfortably overpricing their products
anywhere 20% to 6000%.

Drug companies Iso try to influence the doctors through gifts,
calendars and posters, They usually fund medical conventions,
dinners and so ^n.

I:

Do you mean to ay that doctors do not receive impartial infor
mation on drugs'^
Yes unfortunately there has been no organised attempt to give
doctors imparti'al
impartial information. Any information on drugs become
all the more difficult to get in rural areas.

Information on drugs is certainly available in the pharmaco
logical text boo^s. However, brand names of these drugs and
the comparative'impartial analysis of the brand named drugs
are not available to the prescriber.

3

What about the training the doctors receive? Does it not
help doctors to tyiake the right choice of drugs?
Unfortunately medical training does not train the future
physician to judge a preparation critically.
Encyclopaedic
knowledge of pharmacology does NOT include rational .drug ztherapy"(where cupt is an important criterion)
/

NOR does it include conscious ’’immunization against the half
truths of persuasive industrial advertising'’’.
/

NOR does it give due importance to non drug therapies, and is
not open to other simple and effective form of therapy.

There are 30,000 orand or trade named drugs in India, many of
them are "me too’’ drugs i.e. being very similar, to the ones
they are supposed to have replaced. Many are combination drugs.
The various doses of the drugs combined are very different from
recommended doses in the pharmacology books and therefore very
irrational. Sin^e most doctors do not have time to open the
pharmacology books, they accept what the drug representative or
•the accompanying-literature has to say about the drugs. Even
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 sreps need to be taken.
1. Elimination o; imitative drugs for which adequate therapies
already exist in the market which are cheap as well as
ef f ective.
2. Elimination O| ineffective drugs-those having irrational
combinations «)nd drugs of unproven efficacy.
3. Elimination oj drugs fdr which the toxic effects are un
acceptably high and the use of which needs to be more
severely limited than is actually the case.

Such an approach called
ratiobalfzed rather than an essential
drug list allocates different'priorities to different kinds of
drugs based on therapeutic need, efficacy, cost and available
resources. The cjrugs easily obtainable within the country .
should be grouped into three categories according to priority.
What are these tt)j?ee categories?
•i

First line main drugs needed by primary health care units
of the country. These products would be relevant to the
diseases of wide prevalence and would include pharmaceutical
care. Such drugs should number 50 to 60 and meet 80 to 90%
of the total health needs of the developing country.

2. Second line drugs would be available at district and regional
hospitals and yvould be needed for cases not responding to
first line drugs, or that are so severe that second line drugs
should be usea immediately. ^hey would also be needed for
less prevalent conditions. This list may be longer than the
first but quaupities needed would be. much less.

3. Finally the thjlrd line drugs would be available only for
specialised tertiary care. What is meant by basic drugs
refers to first line drugs while all the drugs taken
together may bu called the rationalised list of drugs.
4

i

I
- 4 -

•i

How do patients use their drugs?

A WHO working group report on Rational Drug Therapy, 1975,
lists following reasons for patients failing to take drjdgs
properly:
?
-* Failure to pbrain 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
* Self medication with potent drugs

What can a doctor do in such situations?
The prescribe}' needs to keep in mind the drug-taking be
haviour of the population; their attitude towards
prescription ’of drugs; their simplicity; illiteracy and
gullibility tg believe anything the doctor says.

The doctors ijj turn has by force of habit come to believe
everything tljj? smooth taking drug rcpresenhatives and drug
firms claim. This too is irrational. Merely Writing a
prescription t.-ven if it is medically sound is not rational
drug therapy.r The dori-m ** l
Li lity does not end
there. The patient has to be given clear instructions and
explanations as required.
The patient needs motivation,
reassurance a^d follow up if need be. The role of non drug
therapies also needs to be learnt by the doctor, and
use conveyed t'o the people. The doctor’s role is of an
educator and liberator# The doctor needs to liberate the
patient from drugs and ^diseaseiarid not encourage slavish
dependency on^either the drugs or the doctor.
-

SOI IRCF

•’HuALTH FOR THE MILLIONS”
A-.

.April

- June

1981.

f

-IX I

CONTENTS

1.

Drug situation in India

2.

Pharmaceutical scene : an overview

3.

Rational .drug therapy

4<

Concept of essential drugs

5.

Spurious and sub-standard drugs

6<

Blood or death banks..?

7.

Laws that protect

8.

Hazardous and irrational drugs

9.

F

10.

Drug information and marketing

11.

Marketing of pharaaceuticals

12.

Medical ethics

13.

Consumer action

14.

Is patient a consumer

ned drugs

«

!

i

.DRUG.SITUATION IN.JNDIA
^GERWS.PRO^

MY IDEA OF A BETTER ORDERED
WORLD IS ONE IN WHICH MEDICAL
DISCOVERIES WOJLD BE FREE OF
PATENTS AND THERE WOULD BE NO
PROFITEERING FROM LIFE OR DEAT1J” •
- Indira*Gandhi
World
Health Assembly (1981)
at

The pioneer
in
L_.._
in establishing
establishing the drug industry in the country
wereVc.Rav
and T.K.Gujjar.
P.C.Ray and
T.K.Gujjar. At the time of Independence,
the total pharmaceuticals sale was Rs.10 crore.
Over the yeurs, the multinationals have gained strong roots
in the Indian Drug Industry and repatriate huge amounts out
of this country. On the whole, the contribution of.these
drug manufacturing units towards producing ^^-^ving and
essential drugs ha.s been very little, The Indian orug
industry floods the market with about 70 000 formulations,
yet 40,000 children go blind every year because o
Vitamin A Deficiency.
Most of dru.is produced are unessential and many of them
have been banned in developed countries.

Unlike othe, commodities in the market for which the market
is open and common'fchrough t^ mass media, the drug
main conceri> are doctors, wholesalers and retail chemists.

It is obvious that the drug, companies use high pressure
marketing techniques, and thus non-essential drugs are sold.
An analysis shows that 52 multinationals_Jji_12Z8^7.9-^pent
Rs:'1~~56',crore on re~^arch, but Rs/15.34 d?ore was spent
f or marketing.
(
Though the drug companies approach the doctors through
medical representatives, they extensively advertise in
professional medical journals also.The Indian Council of Medical Research and the Indian
■Council of Social Sciences Research set up a jpint study
group to study the health situation in India and m the
?epo?t have'rightly said, -Eternal vigilance is required
to ensure that the health care system does not get
medicalised that the doctor-drug producer axis does not
exploit the people and that the abundance of drugs does
not become ,1 vested interest in ill-health1.
Regarding ine drug-pushing strategy of drug companies,
the ICMR^aRd ICSSR study states. "It is unfortunate
that the drug producers always try to push doctors
into using 'their products by all means - fair or foul.
These basic facts are more responsible for distortions
in drug production and consumption than anything else .

After having known about banned drugs, bannable drugs,
unessential drugs and the promotional techniques of.
....2/-

a

or, let us see what our drug
The’folinwxug ooservations are worth noting.

dr'jg cc~/:2:.

11-lC

ffe.v.

1.
Tne
drug f.'i'J.X'yy
policy of our
country
is prepared by the Ministry
■ .
A1JC UJLUJ
J
.i
of Petroleum and Chemicals, and the Health Ministry is in
no way involved.
2.

The policy announced as on January 3, 1986, -did make* a
brief mention about, banning of drugs.» TBut no thought had
been giv^n to the loopholes in the ban orders.

3„ No attempt has been made by the policy about abolition of
brand names and introducing generic names.
| > c was
Wdb made
nidUe to
LU make d
± Uyb .
4. No attempt
a lib
listL UofL cbbtllbldl
essential U
drugs/

5.. The 1986.drug policy increases the cost of essential drugs.
The increase in price is even one hundred percent for some
products'.

6

The policy encourages more formulations by delicensing
certain jlrugs and also its formulations.

7. The drug-''pot.i cy makes no meuhi on about -ro*.t r j ctions . tb«^t
.
to be pul on the pvoin. >T.i
1 iH'iborinl of ditij «_ *»uq •••t*.-;
In short, tpe drug pbl-ioy
pblioy is njnre
more a pricing policy than making
it a people's policy.
J

A committee set up under the oindanco <>t Jaisukhlal Hathi made
certain useiul
.'uunond.H Ions. None of these has been fully
implemented
Ine following are the highlights of the recommen
dations .
1. All multiuational companies should be nationalised.

2. Generic names should be used, instead of using trade names,
brand na»pes.
3. Product!‘ii of single drugs.
4. Elimination of irrational drug combinations
5. Indian National Formulory must be revised in order to keep
the medjcal profession will informed.
6. Pistvibution of drugs being an important factor, a National
Drug Authority of India (NDA) should be set up.

A list

117 essential drugs were drawn up by the committee.

8. The Indian sector of drug industry should be helped to
obtain ^elf-sufficiency.
Former judge of the Supreme Courpt Justice Krishna Iyer is on
record as stating. ’’Government is allergic to the Hathi
committee report and dithers, delays, shies and even retreats,
allowing the hefty drug industrialists to hold to ransom
people’s health. Pharmaceutical imperialism practised by
covert and overt disinformation, trade terrorism and brain
washed professionalism is a menace to a patriotic drug policy”.
In the context of the entire drug issue, a lesson has to be
learnt from a small neighbour, Bangladesh. In fact, the country
took up th! entire idea of a drug policy from the Hathi committee.

The Indian drug industry should cease to exist as a profit making industry and the concern should be for health of the
people. ^vuqs have a role to play in the health carp svs+nm

'4

MEjgCATION.AS.A^SUBSTITUTE, FOR CARING
s

Perhaps the biggest reason f*r overuse of medicines, however,
is that docoturs and health workers often find it easier to
hand out medicine than to give the time and personal /
a

attention t.hai people need.

About 4 eut o| 5 illnesses are self limiting..

This means

people get well whether they take medicine or not. Most
health problems can be better managed without medication.
What often will help people most is friendly adivce and
understanding support.

However, many doctors and health workers get into the habit
of giving eveiyone medicine for any and every problem they
have. The lesj? curable the problem, the more medicines
they gi>/e.

il

At the same time, people have come to expect medicine

every time they visit a doctor or health worker.
They like
to believe that "there is a medicine for everything”. They
are disappointed if the doctor or health worker does not
give them any, even when medicines will do no good and the
health worker ^arefully explains why.

So a ’Vicious Circle' results in which the doctor always
gives medicine because the ’patient’ always expects
(or demands) il, because the-doctor always gives it. The
prescribing of a medicine becomes both the symbol and the
This problem especially
substitute for human caring,
common in places whore doctors nurses, and health workers
are over worked, The result is not only a costly overuse'of
medicine, but 0 failure to meet human needs on human terms.

- Helping Health Workers Learn
David Werner and Bill Bower.

"The physician who sets about to treat a disease without
knowing anything about it is to be punished even if he is
a qualified physician; if he does not give proper treatment,
he is to be punished more severely, and if by his treatment
the vital functions of the patient are impaired, he must be

punished most severely".
- Koutilya Arthashastra.

r

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