MEDICAL SERVICE VOL. 42 No. 9 OCTOBER-NOVEMBER-1985
Item
- Title
- MEDICAL SERVICE VOL. 42 No. 9 OCTOBER-NOVEMBER-1985
- extracted text
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COMMUNITY HEALTH C€U
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ch a i as st rpng as i ts m em ber i nst i t ut i o n s • m isuse of a ntib iot ics antimicrobials
• need of a rationaldrug policy < the indiari drug industry and the people's
neec^
* ^ntifi#;^<^tmy"b
counter drugs • rational drug
policy and
vol 42
prirpary
health care—need for understanding;; need for action
no 9
october-november 1985
®^M^BCKBK®fii^^^3^^^NM^N^^PHN3^®NBHKsBI8SB|HBKBBSwBB0wBwR5S5H8B|BBB|J3wBB8B0®3^Bw^^^^;
I
official house journal
of the catholic
hospital association of India
■ medical
I service
■
"the love of christ
urges us" 2 cor 5 :14
vol 42
editorial board
no 9
october-november 1985
contents
dr c m francis
dr ravi narayan
dr prem chandran john
dr daleep mukarji
mr augustin veliyath
fr george lobo sj
prof george joseph
1
editorial
2
2
chai as strong as its member institutions
dr c m francis
3
doctor—do's and don'ts
dr wishvas v rane
8
misuse of antibiotics antimicrobials
u n jajoo
11
need of a rational drug policy
amitava guha
17
the indian drug industry and the people's needs
dr b ekbal
22
scientific scrutiny of some over—the counter drugs
dr a r phadke
30
rational drug policy and primary health care—
need for understanding, need for action
dr mira shiva
43
new drug policy—adding insult to injury!
dr p k sarkar
57
dr paul neelamkavil
fr edwin m j
3
dr prem pais
dr k r antony
j
4
5
editor
fr john vattamattom svd
6
7
cover design
p m isaac bangalore
3
3
published by the catholic
hospital association of india
c b c i centre, goldakkhana
new delhi-110001
printed at kalpana printing
house new delhi-110016
"Articles and statements published in this journal
do not necessarily reflect the policies and views of
the catholic hospital association of india"
EDITORIAL
Health for the Masses
The World Health Organisation (WHO) has put forward a minimum four point formula
for an effective primary health care system.
------ safe water in the home or within fifteen minutes' walking distance, and adequate
sanitary facilities in the home or immediate vicinity;
------ immunisation against diptheria, tetanus, whooping cough measles, poliomyelitis
and tuberculosis ;
------ local health care, including the availability of at least twenty drugs, within one hours
walk or travel;
——trained personnel for attending pregnancy and child birth, and caring for children
up to at least one year of age.
In spite of this, the agonising factor is that these minimum requirements are denied to
millions of people in the developing countries. In our country it is said that there are about
45000 formulations of drugs available in the market. Yet, in many remote villages even theminimum twenty drugs, of which WHO speaks of are not available. At this sorry situation,
what is essential is education of the masses, Environmental deficiencies, poverty and malnu
trition are the real causes of diseases in developing countries. Food must be the first concern
for health work in a community where people are hungry or many children are malnourished.
Then, should come safe and clean drinking water and unpolluted air. Any number of drugs
cannot substitute for these basic elements. Hence, what is essential is to build up awareness
from the part of the common man. Because, ultimately people themselves will have to bring
health to them.
"Primary Health Care" says Zafrullah Choudhury of Bangladesh, "is generally lacking
only when other rights are also being denied.
Usually, it is lacking only where the freed
of some goes unchecked and unrecognized as being the cause. Once primary health is acce
pted as a human right, then the primary health worker becomes, first and foremost, a political
figure, involved in the life of the community in its integrity. With a sensitivity to the villagers,
and the community as a whole, he will be better able to diagnose and prescribe. Basically,
though, he will bring about the health that is the birthright of the community by facing the more
comprehensive political problems of oppression and injustice, ignorance, apathy and misguided
good will".
Our role in the health field, therefore, would be giving this knowledge to the common
man and empowering him to take decisions which are good for himself and to the community
he belongs, and thereby people themselves looking after their health.
CHAI as strong as its member institutions
—Dr. C.M. Francis
The Catholic Hospital Association of India
has chosen wisely to pause and look back
at its past and the present, so that it can take
action to develop further. Development in
cludes growth and direction. Over the years,
the association has grown in its membership
and activities and, hopefully, it will continue
to grow at an even faster pace. The present
assessment should enable the association to
make sure that it is proceeding in the right
direction and, if necessary, make the appro
priate changes in the direction, so that the
desired goals can be achieved, translating
ideals into reality. There is the challenge of
exploring new grounds and of remodelling.
I am sure that, given the vast experience and
talents of the members of the association and
its leadership, it should be possible to meet
the challenges successfully,
being sensi
tive to the changing needs for health care
and health in the country. What might have
been appropriate a decade ago, might have
become inappropriate and obsolete today
and certainly it will become so in the coming
years. The health status of the people con
tinues to be deplorably low, whatever indices
are applied. There is a growing dissatisfac
tion with various aspects of health care: it
does not reach the needy; the quality of care
leaves much to be desired; the cost is prohibi
tive; it is becoming more and more imperso
nal. Rising expectations of the public must be
met.
health care, with particular emphasis on
primary health care and sharing expe
riences.
ii.
Evolving
alternate health strategies
which can be made available to mem
ber institutions for adoption or adap
tation and operational
research for
primary health care.
iii.
Evaluating the member institutions so
that the strengths can be built upon and
weaknesses avoided.
iv.
Training of community health workers
for the member institutions and work
elsewhere.
v.
Providing consultancy services for
community health work.
vi.
Documentation, review and dissemi
nation of the health care activities of
member institutions and of others en
gaged in similar activities.
vii.
Organising placement programmes for
doctors and other health workers in
member institutions and in the rural
health care centres.
viii.
Helping in the formulation and imple
mentation of the
National
Health
Policy.
ix.
Participating with the Government and
voluntary organisations for better
health.
The Catholic Hospital Association must
determine the avenues by which it can serve
the people. There are many such possible
areas:
x.
Acting as a forum for raising health
issues and influencing the Govern
ment to bring forth legislation which
will help in better health.
Helping the member institutions to
develop in providing comprehensive
xi.
Involving directly in situations of ha
zard to health, as in natural disasters
i.
Oct-Nov 1985
3
like earthquakes and cyclones or man
made disasters as in riots and gas
leaks.
xii.
Organising campaigns for better health,
e.g.,
anti-smoking
respect life
rational drug policy.
In order to carry out these activities, the
association must be healthy and strong. An
association is as strong and healthy as its
members. If the members are unhealthy, the
association too would be unhealthy, as each
part contributes to the strength of the whole.
The strength of CHAI being in its member
institutions, it is necessary to see how healthy
the member institutions are.
To repeat a cliche, health has been defined
as a state of complete physical, mental, social
and spiritual wellbeing. This can be applied
to the individual, the community and the insti
tution. Let us apply it to the member insti
tutions of the CHAI.
situation with regards to availability of equip
ments is fairly good (relative to other hospi
tals in the country), though the tendency is to
acquire more. It is necessary to ensure that all
the equipments are in good working order.
Advances in medical technology introduces
more and more sophisticated and costly
patterns of diagnostic and therapeutic pro
cedures. The efficiency of some of these is
doubtful. Newer and more expensive gadgetry
needs highly trained and highly specialised
technical
personnel.
Automated clinical
laboratory testing often brings on more fre
quent testing. All these lead to cost escala
tion. The affluent patients can afford to pay
the higher cost. If their demand is met, the
deficit can be reduced. There is a conscious
or unconscious shift to the care of the rich to
the indirect negation of treatment to the
poor.
Furniture and machinery : Hospital and
common; laundry and other areas.
Learning resources : Books,
journals,
audiovisual aids. Most of the hospitals give
low priority to these. There are however, a few
notable exceptions.
Physical : This would include:
Accommodation : the wards, outpatients,
laboratories,
library,
rooms for seminars,
meetings and conferences, waiting areas. In
many of the member institutions, the accom
modation is good compared to other hospi
tals, though very few are ever satisfied. There
is always a yearning to have more, making the
hospitals more and more unmanageable and
less responsive to the psycho-social needs of
the patients and their families. There is a view
(well accepted in the case of children and
probably true for others also) that members
of the family staying with the patient can have
a highly beneficial aspect. The hospitals have
not catered to this need to any great extent.
Equipments : Laboratory, X-ray, thera
peutic, diagnostic and others. Here again the
4
Pharmacy : with the essential drugs and
formulary.
Many hospitals have far too many brand
drugs (pushed by the manufacturers and their
representatives) and no formulary. It is neces
sary to have a drug policy and reduce the for
mulations to what is needed and not what can
be sold. Some hospitals undertake the pro
duction of intravenous fluids and other formu
lations. Quality control is essential.
Facilities for other activities like nursing
education, training of technicians and other
paramedical programmes.
Supplies of various sorts, including linen
and diet; standbye generators (good quality
small generators are easily available in the
market). Ambulances and other transport.
Medical Service
Staff : adequate in number and quality—
professional, technical, administrative skill
ed and unskilled. Their selection, recruit
ment and development are very important.
Catholic hospitals seem to have very few
catholic doctors. This can be critical in areas
such as Obstetrics and Gynaecology and in
terminal care. In many Catholic hospitals, the
administration is left in the hands of persons
(religious sisters, priests) who have had no
qualifications or
previous
experience in
hospital administration. There is need for
proper training of such administrators in the
principles and practice of hospital and health
administration.
Medical Records : An efficient medical
record library is very useful for follow-up and
better patient care.
Satellite Centres: One way of reaching out
to the periphery is by having satellite centres,
providing primary health care utilising the
manpower and other resources of the main
hospital and using the main hospital as a
referral hospital. This would extend care to
those who have been denied health care faci
lities all their lives. Another. method is the use
of mobile clinics.
Mental: The attitudes of management and
staff should be in consonance with the ob
jectives of the hospital. Are the objectives de
fined? Are all working in the hospital aware
of the objectives? Are the objectives being
followed ? Is there an evaluation system ? Are
the objectives being redefined from time to
time, as the needs change?
Thinking — Creative and constructive. Many
hospitals live on their laurels and past
achievements without making fresh efforts
at innovation, improved management and
better patient care. Everyone (management
and health professionals) should adopt a
problem solving approach. There should be
Oct-Nov 1985
discussions, journal
clubs and bulletins
devoted to improvement in patient outcome.
Planning — Is there a process by which the
planning for service is carried out and involv
ing all the sectors ? Planning should embrace
all aspects, strategic, operational and finan
cial. There should be continuous evaluation,
especially of changes introduced. Contri
butions to improtvement in patient care
and research — Clinical and mortality confe
rences are a must. Attending regional, state
and national conferences would be very use
ful for the professional, technical and ad
ministrative staff. Presenting papers and writ
ing articles in medical and other health
journals will keep the professionals on their
toes. Theie is need for sharing of knowledge
for the common good.
Patient (and relatives) education : Re
cently, I had a letter from a hospital saying
that they have acquired a video cassette pla
yer for patient education and wanted advice
on the purchase of tapes for patient manage
ment and health education. This shows inte
rest in patient education. Education is life
long. Everyone must keep abreast of the deve
lopments. This is particularly true for health
care. The hospital must ensure that their staff
are conversant with what is relevant at that
time. There is need for constant updating
and continuing education of the staff.
Social : How do the management and
staff percieve the role of the institution in
meeting the needs of the community! Are
they responsive to the needs ? An area which
was traditionally agricultural, changed be
cause a few industries were set up in the re
gion. The morbidity pattern changed. The
people's
needs changed but the hospital
continued to provide services according to
the old pattern. We have to identify the newly
emerging health problems brought about by
the rapid changes and respond to them.
5
considering the relevance of the work to the
community and involvement with and by the
community. Most hospitals, while paying lipservice to this idea are reluctant to put it into
practice.
Importance of socio-economic and en
vironmental factors in the causation and per
sistence of illness: Do the hospital staff con
sider these factors when dealing with the
patient? Health economics and cost of
management should come into reckoning.
Are the hospital staff cost-conscious?
Health education — Does it form an integ
ral part of the activities of (all, many, some, a
few) the hospital staff ? Efforts must be made
to inculcate principles and practice of positive
health. Improving the life-style of the com
munity and individuals (e.g. giving up smok
ing) and nutrition education can bring in
great dividends. Effective features can be put
up, counters can be opened where inexpen
sive books and leaflets, printed in local lan
guages are made available to the public.
Prevention of illness : Immunization, well
baby clinics; periodical health check-ups;
involvement in occupational health. Active
participation in the national health prog
rammes, especially in the eradication/control
of such disease as tuberculosis, leprosy and
blindness is necessary.
Outreach progrqmmes : Most hospitals
have outreach programmes, taking health
care services to more and more inaccessible
areas and nearer the homes. This is bound to
have a salutory effect on health, especially
if promotive and
preventive aspects are
emphasized, in addition to the mostly curative
work. Evolving patterns of care for culnerable groups in our society and people with
disabilities and diseases which have a social
dimension.
Spiritual: Catholic hospitals should give
the utmost importance to the spiritual, moral.
6
and ethical values. The management, ad
ministration and staff should show their con
cern for these values in the everyday living. Do
these values permeate every dealing? I am
told that a common practice is to snatch the
doctor from a neighbouring hospital, if he or
she is found to attract a larger clientele. Hos
pitals are, occasionally at least, accused of
being corrupt, mercenary and dehumanised.
Perception of life, death and issues in re
production. This is of special medico-moral
importance to the members of the association.
Discussion on problems in medical ethics:
Does it form a regular feature in the activities
of the hospitals?
Taking a stand on moral and ethical issues:
Catholic hospitals have seldom been known
to take a visible stand on such issues. Hospi
tal chaplaincy is an urgent need of Catholic
Hospitals. This requirement is sadly neglect
ed. The hospitals often have no chaplains or
have some retired priests, who are there more
because they need the hospital services than
their ability to be of service to the staff, pa
tients and others of the hospital community.
There is urgent need for trained, competent,
and committed hospital chaplains who can
attend to the spiritual needs and also provide
guidance and counselling.
The importance of prayer. Are there pra
yers at set times ? Many hospitals start their
daily work with prayers either in one place or,
if the hospital is large, in groups at the place
of work. Some
hospitals have devotional
music at certain times, broadcast (gently)
over the public address system. Are there
prayers at critical times-critical in the life of the
patient, the community, the country, huma
nity or the hospital? The healing ministry
cannot be devoid of prayer and the recogni
tion that we are not alone in this endeavour is
extremely important in giving the needed
strength and courage. Does the life-style and
conduct of the staff show empathy for the
Medical Service
patients, the relatives and the disadvantaged
in the community? Code of conduct : Is
there a written and well-understood code of
conduct for all those involved ? Every patient,
paying or nonpaying, must get the best
quality (not recessarily costly) of care, res
ponding to the Christian calling and ideals,
"I was sick and you took care of me"............
"Whenever you did this for one of the least
important of these brothers of mine, you did
it for me".
An analysis, utilising the above criteria and
others applicable to the particular situation
and particular member institutions, is bound
to help the hospitals see where they are now
and help them to remodel themselves as need
ed. They can reinforce their strengths, remove
their weaknesses and take hold of the oppor
tunities to be of better service. Our hospitals
brought much needed medical relief and help
to large segments of the people when the
health efforts by the Government were rudi
mentary. But we seem to have remained sta
tionary. Our present day activities and style
of functioning are not quite relevant in today's
national context. Do we envisage a new role
for our hospitals as powerful agents of change,
bringing about a different orientation in our
thinking — health versus medical care ? The
Catholic Hospital Association must help the
member institutions to bring about a re-align
Oct-Nov 1985
ment of our priorities, extending basic health
services to the communities and making the
communities, families and individuals res
ponsible for their health. When the individual
member institution becomes better by reach
ing out to the periphery, more conscious of
the need for social justice, cost-conscious
and for the spiritual welfare of the individual
and the community, the combined strength
of the Catholic Hospital Association of India
will become tremendous. The Association
can then be a pace-setter and a great force
for improved health care in the country and
bring about better health for all.
The Christian health care services have re
ceived their mandate to participate in the
Healing Ministry from Jesus Christ, the Healer
and Teacher. The healing work was pointed
out by Jesus Christ to the desciples of John
the Baptist as evidence of being the expect
Messiah. Our Lord Himself was 'reaching out'
to the lowly and the lost. His disciples also
gave great importance to relief of the sick and
suffering fellow beings. The Catholic hos
pitals must have this spirit of healing, per
meating all their activities imbued with a spirit
of dedication and upholding Christian values.
The
Catholic Hospital Association must
be the catalytic agent which helps any
lagging member institution to achieve the
goal.
7
"DOCTOR - DO'S & DON'TS"
— Dr.Wishvas V. Rane
In clinical practice a doctor has to depend
on drugs and diagnostic aids. The consumer
i.e. the patient is normally ingnorant about
the drugs, their effects and side effects. Buy,
borrow or steal, a patient manages to buy any
costly medicine. How-so-ever toxic the drug
may be, he is willing to accept the side effects
on the asking of the doctor. He is normally
ignorant of long term side effects of drugs,
and particularly drug induced carcinogencity
or congenital anomalies that are usually accept
ed by the patient as act of God. But is this
ideal ? If not, how long will it continue and who
should end it? In my opinion, it is the doc
tor who has to end this sorry state of affair.
The day is not far off when patients will
start seeking aid of the courts in getting the
redress from wrong treatment, unjust expen
diture and side effects of the drugs. Though
a doctor is legally permitted to use drugs, he
is not immune to wrong use of drugs. Who
leads the doctor to make wrong use of the
drug? In my opinion, it is the drug manu
facturer who is coaxing the doctor to use the
drugs wrongly. Afterall, the drug manufac
turer is in business and unfortunately our go
vernment machinery is not that vigilant and
earnest in putting adequate restraints on the
manufacturer.
Today the only source of information to a
doctor is the medical representative. This
medical representative is trained to talk only
the positive side of his drug. The most un
fortunate part is that lately the drug firms do
not even leave a detailed literature (data sheet),
but instead only show a visualiser that grossly
highlights indications (and most of these are
immaginary and without any scientific justi
fication) and does not declare the contra
indications or the side effects.
Strangely,
even the composition of the drug is not indi
cated.
Dr. B.C. Mehta, the noted haematogoist
from Bombay has reported that two of his
cases were sensitive to analgin and were suffer
ing agranulocytosis from analgin. The two
cases, one. being a doctor himself, became
worst when their general practitioners used
Baralgan for abdominal pain. On enquiries it
was learnt that the general practitioners were
ignorant of analgin's presence in Baralagan.,
Now for this lapse, who should be held
responsible ? Legally, it is the general practi
tioner who will be held responsible, but strict
ly speaking it is the manufacturing firm that
should be held responsible for not giving the
right information. How can we stop this?
BY ASKING EVERY REPRESENTATIVE to
leave a detailed literature for every product.
This literature need not be on a glossy, multi
coloured, costly literature, but a matter of
fact printed on ordinary paper. Every doctor
should first ask for the composition of the drug,
then side effects of each constituent, and
finally the contra-indications. We should force
the government to screen every advertise
ment material — before it reaches the doctor.
Now that we are on the analgesic and anti
inflammatory agents, please note that analgin
is banned in most of the developed countries
as it causes agranulocytosis and also gastric
bleeding. There is absolutely no reason to use
analgin drops for children and certainly not
as anti-pyrectic (Ultragin). It is advisable to
use aspirin or paracetamol. Never use analgin
containing anti-spasmodics viz Avafortan
*
Baralgan, Codolsic, Spalcin, Spasmolysin,
Spasmizol, Synalgisic etc. Please be aware
Dr. Rane is the Co-editor of Pune Journal of Medical Education.
8
Medical Service
of analgesic and antipyretics containing anal
gin viz Neogine, Novalgin, Pamagin, Promalgin, Sedyn-A forte. Ultragin, Zymalgin-A
etc.
Amongst the anti-inflammatory
agents,
phenylbutazone and oxyphenbutazone is
banned by most of the advanced countries
and even the original manufacturers Ciba
Geigy have withdrawn their brand Tanderil
from the world market. The government of
India has restricted the use of oxyphenubutazone for only two rare indications that are
(1) ankylosing spondylitis and (2) acute
gout. Even for these two indications oxy
phenbutazone is contra-indicated for child
ren under 14 years of age and for senile pa
tients. So please do not use any syrup forms
of oxyphenbutazone: Bestophen, Buta-proxyvon, Esgipyrine, Parazolandin, Zoland in
Alka, and those containing oxyphenbutazone
are : Actimol, Algesin, Butapyringa, FlamarP, Flamar granules, Inflavin, Jagnil, Kilpane,
Oxalgin, Oxytriactin, Paroxy-D, Parvon Forte,
Phenabid, Phenzyn-A, Reparil, Rumatin,
Sioril,
Suganril, Tromagesic, Versalin etc.
Those containing both the toxic drugs viz
as analgin and oxyphenubutazone should
never be used. These are: Esgipyrin, Kilpane,
Oxalgin etc.
Most of the digestive enzymes and parti
cularly the diastases are inactivated in acidic
medium of the stomach and the quantities of
enzymes required is in grams and not miligrams as given in enzyme preparations have
no role to play. The very fact that enzymes are
not stable in liquid forms, most of the liquid
enzymes available in the market are given in
two separate packs. Once mixed and consti
tuted, they cannot be stable for more than 2-3
days. It is advisable not to prescribe liquid
enzymes.
Dose of injectibie tetracycline is 250 mg
to 800 mg intramuscularly daily. Giving 50
mg or 100 mg (because more than 2 ml be
Oct-Nov 1985
comes very painful) by I.M. route is fruitless.
It should not be given to children and to preg
nant ladies. Tetracycline in drops, soluble
tablets or syrup to children should not be
given, as it permanently discolours the teeth
and given during the pregnancy, it is likely to
discolour the teeth of the offspring.
Chloramphenicol should be carefully used
and reserved for it's use in enteric fevers.
Intramuscular chlorampheniol sodium succi
nate is of no use. Chloramphenicol in combi
nation particularly like chlorostrep should not
be used and certainly not for diarrhoeas.
Forte formulations of B complex only in
crease the cost of the treatment. Being water
soluble, these are soon thrown out through
urine. It is advisable to give smaller doses re
peatedly. Combinations of Vit B1, B6, B12,
are of no advantage and are likely to give rise
to anaphylactic shocks. Combinations of
Vitamin B1, B6, B12 with anabolic steroids
(Trinergic, Anabolex 12, Neurobol H, etc)
should not be used as these do not give any
additional advantage. Anabolic drops should
not be used in children (Anabolex 12, Orabolin).
Heparin is an anticoagulant which inhibits
clotting of blood in vitro and in vivo. It has no
effect on a clot in vitro. It's assimilation through
skin is doubtful. It's topical use in haemato
mas, thrombophlebitis is very doubtful. The
preparations are: Beparine, Hirudoid, Thrombophob.
Most of the diarrhoea (atleast 70 to 80 %)
is of viral origin and replacement of water
and salts by ORT suffices. All the anti-diarrhoeats containing clioquinols (iodochloro,
di-iodochloro etc), chloramphenical, strep
tomycin, Kaolin, Pectin, should not be used.
After stool examination if the diarrhoea is due
to amoebiasis either metronidazole and or
diloxanide furoate should be used. If the diar
rhoea is due to giardiasis metronidazole or
9
furazolidone should be used.
Antibiotics
should be used only after the culture study.
Diphenoxylate should not be used for child
ren under six years of age (Lomophen, Lomo
til).
Drugs of doubtful efficacy viz Encephabol,
Normabrain, Piratam Nutropil should not be
used routinely in mentally retarded children or
for treatment of polio.
High dose progesterones viz
Proluton
Depot and Unitprogesterone forte depot do
not prevent abortion. Routine use of high dose
progesterones during pregnancy is contra
indicated. Use of EstrogenProgesterone
combination for pregnancy testing is hazar
dous and should not be used.
Anti-asthamatic combinations with steroids
should not be used. If need, be, sepa
rate steroids be given in acute stages and that
too for a short period, but certainly not in
combination forms.
None of the food products viz Alprovit
(drops), Procasenol, Promolan Protectone,
Protinex, Protinules, Sanatogen, Sue, Horlics, Complan etc offer any advantage over
normal digestible foods excepting that these
cause negative nitrogen balance by depriving
the patients of their hard earned money. Home
made weaning foods are much cheaper and
acceptable to children.
from^/g^g^jg^ pioneers of Ayurvedic research in
* Medical
*
*
Dental
Veterinary fields
nagement of D E NTA L patients
Saf^Simple drugsccurativea^spects
Oral Herbal Haemostatic & Coagulant
in all Bleeding Conditions of Gums, where
the patient needs systemic heamostatic
Pre-operative: as prophylaxis to minimise
bleeding.
Dosage can be adjusted according to the
severity of bleeding (up to 6-12 tabs a day
in divided doses)
etkicoL pnxrcLuxts
for * GUM * DENTAL * ORAL Hygiene
as Gum massage. Dentifrice, Rinse & Gargle
ALARK3
Relief in 2-3 applications
Remarkable improvement in 2-3 days.
in easily crushable tablet form
SOOKTYN
for immediate & lasting results in
• HYPER ACIDITY • ORAL ACIDITY
relief within 5-15 minutes even in severe
cases with 3-6 tabs at a time
Masticating trouble leads to: Indigestion.
Flatulence, Constipation, Hyper-acidity
syndrome (nausea, vomiting ptyalism)
SOOKTYN helps assimilation, degestion.
morning evacuation
GUMS Gingivitis: Bleeding, swollen, spongy, painful Gums
TEETH: Painful, Aching, shaky & Hypersensitive;
prevents plaque formation.
ORAL hygiene : in disease or drug induced conditions.
where oral hygiene has to be improved & corrected.
G32 is an excellent supportive & follow up treatment:
to consolidate the gains of Surgical & Systemic management
of Gum & Teeth conditions and ORAL Hygiene.
DOSE: 2 tabs tds between or after principal
meats.
h^pivipbuiSp^ • Oxyphenbutazone
lor Ax all available in SO & 100 tabs PACKS at Chemists
for Hospitals & Clinics: Supply from factory only
1000 tabs PACKS except G32.
as Anti-inflammatory, Analgesic & Antibacterial
Quicker relief without side effects Complete relief within 5-7 days
in all Inflammatory & Painful conditions of Oral cavity;
after teeth extraction. Trismus. Odontitis. Dental Pulpitis,
Cellulitis, Periapical abscess, T. M. Jt. problems.
DOSE: 2 tablets tds for 7 days.
10
r*'
ton./d^^^sjeatch'da^i.^
TherapexitJ^:lbde»Pr-fc^List S
'' ‘ • e? \Pldsse ytdtd-for- s'£T~u
y
ALARSIN MARKETING P. LTD.
12. K. Dohasb Marg, fort Bombay-400 023.
Medical Service
Misuse of Antibiotics Antimicrobials
Dr. U.N. JAJOO
sounds in chest which are wrongly
interpreted as crepitations and thus
patient is thought to have bron
chopneumonia. Use of antibiotics
now is perfectly justified. It may
be a silly mistake on the part of the
treating doctor that he did not exa
mine after the child is made to
cough, but is a part of the game
which has to be conceded.
A Prescribing Physician
With the time slowly realises that there
are really few diseases where allopathy can
offer a cure. Infective illnesses is one sub-area.
'Antibiotics is the greatest tool that modern
medicine offers today against bacterial infection
However it is a double edged sword, if not
properly utilised not only harms the patient but
also has wide ranging social implications,
evidence of which is ample in the medical lite
rature.
(iii)
A child with severe diarrhoea is
treated with the
combination
of antihelminthic (mebendazole),
anti-protozol (Metronidazole) and
antibiotics to cover up wide range
of diarrhoeal diseases in a setting
where examination facility is not
available, may also be justified if
one keeps in mind that the doctor
will not like to delay the treatment
and risk with child's life.
(iv)
A patient with fever more than 7
days duration who can not afford
to get his blood investigations
(Widal, blood culture, peripheral
smear of parasites) done for a per
fect diagnosis, if is put on Trime
thoprim + sulpha combinations to
cover up resistant malaria, resis
tant typhoid fever, gram negative
septicaemia should also be justi
fied.
Antibiotics account for 20% of drug sale
in India (1976 figures). In a given case, many
times it is difficult to prove that drugs are being
misused or irrationally used, because in majority
of prescriptions, the doctor hardly ever writes
the diagnosis. Even from the hospital records
it is difficult to conclude correctly because
written documents do not mention all that is in
the mind of a treating doctor (It speaks of our
recording quality), say of example:
(i)
A critically ill patient of meningo
encephalitis, where
diagnosis is
uncertain, use of Inj. Chloromycetin,
Inj. Chloroquin, Inj. S/M, INH all
together can be justified to cover
up enteric encephalopathy, cereb
ral malaria, tubercular encephalitis
and pyogenic meningitis. It is a
shot gun therapy, but is justified if
one takes into consideration the se
riousness of the illness and non
availability of investigational sup
port.
(ii)
A child with upper respiratory in
fection may have conducted throat
It all means, that the prescriptions may
vary considerably in the same patient in the
different setting. The pocket of the patient,
Dr. Ullhas Jajoo is a Reader in Medicine in Seva Gram Medical College Wardha and a Core
Group Member of
Medico Friends Circle
Oct-Nov 1985
11
availability of investigative procedure, human
error on the part of the doctor all have their
say. Therefore it is difficult to really rationally
analyse someone else's prescription without
knowing the situation in detail.
But there are indirect means to judge that
doctors do overshoot. Indian literature in this
regards is scarce, however there are studies
available where the prescriber is informed in
advance that his/her
prescription will be
screened for appropriateness of the drug pres
cribed or he/ she is asked to fill up a form
justifying the use of antibiotic use as good as
up to 25% (1,2, 3, 4, 5). Other studies where
physicians have been made to write the diag
nosis over the prescription, it was found that
antibiotics were prescribed without any
evidence of infection in as good as 62% — 90%
prescriptions.6 Thus there is no doubt that
antibiotics are improperly used.
To make things worse, this transmissible
resistance is against series of drugs (multiple
drug resistance). The fact that R factors can
be transferred to every genus of enterobacteiraseae through non pathogenic bacteria like
E coli (normal inhabitants of intestine), has
become a major public health problem. If a
person harbours E. coli with R-factor in the
intestinal tract, they can turn sensitive patho
genic organisms like shigella, salmonella, V.
Cholera to resistant ones. If this continues
further, we may reach a situation when the
future of chemotherapy can appear dubious.
Evidence of this type of resistance in
Indian situation are many. The studies done
on healthy subjects who had not consumed
any antibiotics for atleast one month (Bom
bay; 1977-78) showed 28% of them harbour
ed multiple drug resistant strains of E. coli and
much lower (6%x) of multiple drug resistant
strains among individuals of nearby village.
What harm the inappropriate use of anti
The resistance was predominantly for drugs
biotics can inflict?
like Sulfonamide, Streptomycin, chloram
(i) Adverse reactions
phenicol, ampicillin, Kanamycin, and tetracy
(ii) Huge cost of the prescription (See cline which are most commonly used
antibiotics. The resistance to newer drugs like
appendix)
gentamycin and trimethoprim has also emer
(iii) Resistant bacterial infection.
ged.
Mutation in genes destroys affinity of all
How antibiotics improperly used?
target site for the antibiotics or modifies per
A. Antibiotics use when not indicated e.g.
meability of the cell so that antibiotics can not
enter the cel! and find its target site. This is
(i)
For common cold and all upper
the mechanism for developmet of resistance
respiratory illnesses which are in
in a given patient. However, problem of drug
majority self limiting viral infections.
resistance does not remain limited to 'A' pa
It is estimated that as good as 12%
tient. Drug resistance is a infections organism
prescriptions of
antibiotics are
can be transmitted to other sensitive organisms
given for common cold8.
of the same or different species through so
(ii) For acute diarrhoea in children
called as "Resistant Factor". This drug resis
without any evidence of dehydra
tance is due to ability in the bacteria to modify
tion, dysentry, sereve malnutri
the antibiotics with the help of certain enzymes
tion, septicaemia.
that they can produce. The modified antibio
(iii) For viral infections without any
tics can not recognise their cellular target
evidence of bacterial super-infec
and therefore have no inhibitary effect on
tion.
the cell.
12
Medical Service
B.
Antibiotics use when contraindicated
(i)
A patient of chronic renal failure
gets sulphadrugs, tetracycline, ami
noglycosides (Nephrotoxic).
(ii)
A new born infant gets Chloromy
cetin (grey-baby syndrome).
primary line of drugs, routine use
of this combination is not justified
if one keeps in mind the drug resis
tant tuberculous infection.
e.g.
(vi)
Use of Rifampin 4- Pyrazinamide 4INH in a case of defaulter of tuber
culous treatment who has turned
up for the first time to the hospital.
Majority of these patients still
respond to primary drugs9 and in
our setting shift to costly drugs of
secondary line is not justified.
(vii)
Use of Chloromycetin ear drops
which contain propylene glycol
as preservative which irritates the
ear.
(viii)
Using Chloromycetin 4- streptomycetin combination orally for
cases of acute diarrhoea (strep
tomycin need not be given in short
costing bacterial diarrhoea. The
common organisms are not sensi
tive to this drug).
E.
Defective route of administration:
(i)
Use of Injection
Chloromycetin
when patient can be given oral
drug. (Injectable drug has irratic
absorption).
(fii) A diabetic patient gets sulpha drug
like trimethoprim 4- sulpha com
bination (Papillitis Neuroticane)
(iv)
Inj. streptomycin in a patient of
ear-disease (ototoxicity)
C.
Irrational combinations eg. :-
(i)
Penicillin with tetracycline or Ch
loromycetin (See appendix).
(ii)
Gentamycin 4- Kanamycin
drugs of the same group).
D.
improper selection of drug e.g. :-
(i)
Use of Ampicillin because orga
nisms are thought to be resistant
to penicillin (Ampicillin does not
act against penicillase producing
organisms).
(two
(ii)
Demedocyclin is used when other
tetracyclines which have less to
xicity and equal
effectivity are
available (See appendix).
(iii)
Erythromycin Esteolate (hepatotoxic) is use when other salt of
erythromycin (erythromycin ethy
lsuccinate) which is less toxic and
equally effective is available (Ap
pendix).
(iv)
Use of penicillin G when more acid
stable preparation (Penicillin V)
is available.
(v)
Routine use of Inj. streptopenicillin for bacterial infection. Tuber
culosis being so rampant and stre
ptomycin being one of the cheap
Oct-Nov 1985
F. Inadequate doses :- The possibiities are (i) Doctor prescribes dose for in
adequate duration (ii) The patient does not
have enough money to buy the total course
of antibiotics, thus either reduces the dose or
the duration. The notorious drug misused by
doctors is injection tetramycin which is avail
able in the concentration of 50 mg/ml.
For adequate dose 5 cc of this oily prepara
tion has to be given in an adult which is so
painful that probably patient will not come
back. The most convenient way is to reduce
the dose. It serves two purposes, one that it
reduces cost to the doctor and second it con
13
tinues to give satisfaction to a patient of gett
ing a coloured injection.
Why antibiotics are misused? The pos
sible reasons could be :-
(i)
Poverty of Knowledge of the pres
criber.
(ii)
Shot gun therapy as an easy substi
tute for the careful.
(iii)
Antibiotics are prescribed alsp by
the doctors from other discip
lines of medicine such as Ayurveda,
Homeopathy, Unani etc. i.e. those
who are not supposed to be quali
fied medical practitioners.
(iv)
Persuasive
sales
(vii)
Unaware consumer about the harm
that misuse of antibiotics can in
flict.
Is there a solution to the problem :
—
Refresher course for the health perso
nnel on indication of antibiotics in
infective disorders?
— Availability of antibiotics only by
the prescription from the qualified
health personnel.
— A mandatory justification by a doc
tor for the prescription of antibio
tics?
promotion by
— Abolition of different brand names
and insistence of availability of the
drug by genetic name?
drug pharmaceuticals which are
often the only source of knowledge
for a busy practitioner.
Mass education of the "Consumers"
about the indications of antibiotics
use in common infective illnesses?
(v)
Easy availability of these drugs from
the counter to the public who quite
often practice self-medication.
—
(vi)
Absence of cross-checks on the
prescribing habits of the doctors.
— A cultural revolution uprooting the
marketised value system.
Appendix -1
Please scan through the following table :-
— Commonly used antibiotics and the cost:
per tab./
cap/inj.
cost
Total
cost Rs.
Sr.
No.
Drug
Dose
1.
Sulphadiazine (M & B)
2 tabs 3 times x 5 days
0.30
9.00
2.
Benicillin-V (M and B)
130 mg 6 hrly. x 5 days
0.48
9.60
3.
Tetracycline (Paran)
500 mg 6 hrly. x 5 days
0.34
13.60
4.
Chloramphenicol
500 mg 6 hrly. x 5 days
0.31
12.40
14
Medical Service
5.
Septran (Sruxwell) —. 80 mg
2 tabs, twice a day x
5 days
1.00
20.00
6.
Inj. Gentamycin (Lyka) - 80 mg.
40 mg 8 hrly x 5 days
10.20
76.50
7.
Kanamycin-1 gm
1 -5 gm total 5 days
15.75
133.00
8.
Amoxicillin
1 tab. 3 times a day x
5 days
1.70
25.50
9.
Doxycyclin (US Vit.)
2 stat, 1 O.D. x 4 days
1.80
10.80
Appendix - 2
Mode of action of different antibiotics (10)
Site
Drug
Comment
Cell wall
Penicillin
Cephalosporin
Cycloserine
Bacitracin
Vanoomycin
Require cell wall growth for
their cidal action
Cytoplasmic membrane
Polymyxin
colistin
Streptomycin
Cytoplasm
(Protein & DNA-RNA synthesis)
Gentamycin
Tetracyclin
Chloremphenicol
erythromycin
Hampers normal protein synthesis
Streptomycin
Kanamycin
Protein synthesis continues but
forms a nonsense/abnormal polypeptic
DNA — Naldixic acid
RNA — Rifampin
Comments
Drug like penicillin group,
action of which depends on cell wall growth,
if combined with a drug which retards protein
synthesis
(chloremphenicol/tetracyclines),
will be wasted unnecessarily because now cell
Oct-Nov 1985
does not grow under the influence of protein
synthesis inhibitors. But the combination with
aminoglycosides (streptomycin) is synergistic
because protein synthesis (through abnormal)
continues and cell wall growth is not retarded.
15
Tetracycline
Absorption from Half life
GIT
Chlortetracyclin
Incomplete
Oxytetracycline
//
Protein binding
6-9 hours
Comment
50-70%
20-25%
Tetracycline
hepatotoxin
Least
25-30
Demeclocycline
16 hours
Methacycline
Poor
Doxycycline
Well absorbed
40-50%
Hepatotoxicity more
80%
17-20 hours
17-20 hours
25-30
No
70-75%
No
phototoxicity
but
vestibulotoxic
food does not inter
fere with the absorp
tion
Minocycline
//
Erythromycin
Absorption
Plasma concentration
Erythromycin
base
destroyed by
acid juice
thus adminis
tered in cap
sule made with
acid resistant
coating
Good
4-6 hrs
Erythromycin
stearate
_
Adequate
Good
4-6 hrs.
Erythromycin
Esteolate
Adequate
Best, persists.
longer
Erythromycin
ethylsuccinate
Adequate
Satisfactory
persists longer
nephrotoxicity
Toxicity
Cholestatic
jaundice
(Hypersensitivity)
6.
JAMA, 213; 264,1970.
J. of Amer. Med. Assoc. 2585, 242,1979.
7.
Science Today: Sept, 1981 page. 26.
2.
JAMA 242,1981; 1979 237,2819,1977 ;
227, 1023, 1974; 227, 1048, 1974.
8.
Insult or Injry 1979, published by Social
Audit Charles Medawar. p. 123.
3.
Annals of Int. Med. 76, 537,1972; 79,55,
1974.
9.
WHO Expert Committee on tuberculosis9th refer No. 552, p. 21.
4.
Med. Assoc. J. 116, 253, 1977.
10.
Ann. of Int. Med. 128; 623, 1971.
5.
Lancet: 2,407, 1981, 2,461, 1981; 2,349,
1981.
11.
The pharmacological basis of therapeutics,
5th edition, by Goodman and Gilman.
References :
1.
16
Medical Service
NEED OF A RATIONAL DRUG POLICY
— Amitava Guha
The National Drug and Pharmaceutical
Corporation (NDPDC) formed by the Ministry
of Chemical and Fertilisers constituted three
Working Groups who had studied various as
pects of drugs and pharmaceuticals and sub
mitted their report to NDPDC. The Steering
Committee of the NDPDC had finalised its
reports and recommendations, had submitted
them to the Ministry on 18th August, 1984.
It is expected that the Government of India
would shape its 'Drug Policy' based on this
report.
Chairman of the NDPDC is Shri Ma
hendra Prasad, a Member of the Parliament.
He is also the Managing Director of Aristo
Pharmaceuticals which till date comfortably
sells
Aristopyrin
containing Amidopyrin,
banned by the Govt, and many other irrational
and hazardous drugs. NDPDC has 12 mem
bers which includes two members of the Par
liament from Congress (I), seven are rep
resentatives from the industry and rest are
government bureaucrats. The Council also in
cludes a leader of a central trade union which
has no trade union in the Pharmaceutical In
dustry. Needless to mention, that the Govern
ment did not consider that Non Governmental
Organisations, who were actively working in
the field of health and drugs had any role to
contribution to make in any manner, to such
a vital area like drug policy. It is, therefore,
not very difficult to estimate that the drug
policy prapared by such a combination of ex
perts will serve the interest of the persons other
than the ailing common people of this vast
country.
NDPDC, in its report mentions — "In
India, over 15,000 formulations (to our esti
Oct-Nov 1985
mate it is 40,000) are marketed representing
around 2,500 medicinesinvariousbrands,packs
and dosage. UNIDO and WHO have noted
that the developing countries cannot afford
the luxury of unplaned production of many
different drugs for prevention of same dis
ease. Depending on the public health needs,
disease problems and technoeconomics of
production, UNIDO had recommended that
each country should draw a priority list of
essential drugs which contains the collective
view of international experts. This list con
sists those required for satisfying the health
care needs of the majority of the population.
They should therefore be available at all
times in adequate quantities and in appro
priate dosage forms."
(Summary of the report of NDPDC, P:6)
Therefore the Experts Committee of
NDPDC first selected 121 essential drugs
which includes the following groups :Antibiotics
— 19 drugs.
Anti malaria Is
— 5 drugs.
Anti T.B.
— 4 drugs.
Cardiovasculr
— 22 drugs.
Diuretics
— 11 drugs.
Oral contraceptives
— 10 drugs.
It reflects that cardiovascula r disease and
oral contraceptives are needed much more
in our country than antibiotics, anti T.B. and
anti-malarial drugs. The same is reflected
form the demand estimate exercised by the
Committee.
17
Name of the drugs
Unit
Cardiovascular
Tonnes
29.21
112.45
Anti materials (2 drugs)
Tonnes
440.00
725.00
Anti T.B. (5 drugs)
Tonnes
778.00
1490.00
Phenylbutazone
Tonnes
112.85
220.00
Oxyphenbutazone
Tonnes
110.00
6650.00
lodochlorohydroxyquinoln
136.80
460.00
Di-iodohydroxyquinolin
95.55
160.00
Estimated pro
duction
1984-85
Estimated de
mand
1989-90
(Compiled from Annual Report, Ministry of C & F and Report of the NDPDC).
The above table shows a surprising affi
nity of our Govt, to the demands of Phenylbu
tazone, oxyphenbutazone and clioquinols
which are now considered as dangerous drugs
and being banned in many countries. The
NDPDC, in its 58 pages report had not uttered
anything about withdrawing of banned and
hazardous drugs.
The Industry has successfully convinced
(or pressurised) our Govt. that".... many
companies are in the red because of strict
price control." (NDPDC Report, P : 12) 1978
New Drug Policy revised the Drug Price Cont
rol Order, 1970 which had put a blanket re
striction of profit on all drugs at the rate of 75%
mark up. 1979 Order exempted many drugs
from the restriction but for some life saving
and essential drugs in the categorised items.
This was also unbearable to the industry. As
a result there was sharp fall of production of
life saving and essential drugs and sharp
raise in other drugs of decategorised group.
Profit of the industry remained unabeted.
Analysis from the 1983-84 balance sheet of
some large multinational companies shows.
Rs. in lakhs.
Name of the
Companies
Boots
Parke Devis
Hoechst
Roussel
Searle
Warner Hindusthan
Profit before
tax
Net Worth
502.23
218.71
753.70
*81
190
642.31
316.69
687-37
587.49
277864
444-94
830.00
480.86
Capital
employed
889.28
591.02
3585.63
521.06
916.71
480-86
% of profit
to net worth
73%
37%
27%
43%
80%
66%
% of profit
to capital
employed
56%
37%
21%
37%
70%
66%
(Compiled by Dr. Mira Shiva, VHAI).
18
Medical Service
In a letter addressed to the Minister of
Chemical and Fertilisers dt. 6-12-84, Dr
Y.K. Hamied of CIPL Ltd writes: "During the
meeting, I indicated that subsequent to the
New Drug Policy, 1978 the prices of drugs in
the decontrolled list had risen appreciablly
in a number of cases even up to 200-300 per
cent or more." There is no doubt that the in
dustry is making profit and pressurising for
more allowance from the Government.
There is some amount of price control
on 360 bulk drugs. NDPDC now recommends
that this number should be reduced to 95
drugs and the mark up should be raised
up to 125% which will result not only in im
mediate increase of the prices of all essential
drugs but the prices of all other drugs will
jump simultaneously.
Working Group on Planning and develop
ment set up by the NDPDC was supposed to
study the production pattern of the industry
and prepare recommendations for future plan
ning. The Working Group indeed submitted
their report in time. It was a 18 pages report
out of which 12 pages are attributed to export
orientation of the pharmaceutical industry
It is a novel idea I In India around 22% of the
population use pharmaceuticals. Due to in
crease of prices which will be the inevitable
outcome of the new Drug Policy will further
squeeze the domestic market. If further al
lowances are given to the industry with libe
ralisation of import, the industry will function
in full bloom in the external market. Even be
fore the drug policy is passed the Government
has already opened the flood gates of conces
sions and price enhancement. Bulk manufac
turers of antibiotics have already been allow
ed to increase the prices for three times so far
during the current year. Production of some
bulk durgs were restricted to public sector
and Indian companies. Now the Govt, has
delicenced the production of 94 bulk drugs
which will allow the foreign companies to
Oct-Nov 1985
manufacture the drugs which were so far res
tricted to them. This will render unequal com
petition and pose a danger to the Indian sector
companies.
It needs a rational out look to prepare a
drug policy which of course can not be isolat
ed from the rational health policy. An all
round anarchy is prevailing in the health care
system of our country. A doctor, the moment
he leaves his teaching institution is devoid of
any connection to the developments of the
modern medical world. This task is taken care,
in a very oblique manner by the industry.
Their hoards of sales promotion employees,
tutored to speak for the products of the com
pany, concealing the side effetcts, contraindica
tions, drug interactions, etc. meet the doctors
every day and with the help of these doctors
an artificial demand of non-essential drugs
are generated. Our policy makers never
attempted to arrange for dissimination of drug
informations.
In recent times injectable contraceptives
have been rejected by many countries at the
very onset of trials. German remedies, a multi
national company took advantage of the pecu
liar situation of our country where there is no sy
stem of drug nomincleture and marketing code.
The drug'Net oen'a brand of "Morethidrolone
Enanthate" a progestronal preparation simi
tar to depot provera has not yet been complete
ly field tried in our country. This drug is under
the phase IV of the trial protocol of ICMR
now. At this stage, German Remedies with
the help of a mere six pages cyclostyled note
which consists of few quotations from some
insignificant trials, are convincing the doctors
to indent the drug for actual use
*
In turn, these
indents will be placed by the company to the
Govt, to show that the doctors of our country
are keen to buy them. The company will then
import the drug which is not usedin Germany—
the parent country of the company.
19
Attitude of the multinational companies
are known today. A global opinion is develop
ing against their activities. The Govt, is quite
helpless to their harmful activities. In June,
1983 a feeble attempt was made by the Govt.
to ban certain drugs, most of which have weak
marketability. However, this ban order could
not be given effect as two multinational com
panies—Nicholas Laboratories and Organon
(now Infer) took the issue to Supreme Court.
The Injunctions of the High Courts of Cal
cutta and Bombay has allowed the companies
Name of the
Company
Name of the drug
Hoechst
Baralgon Kitone
Glybenclamide
Pheniramine Maleate
Dexamethasone
Oxyphenbutazone
Merind India
S.G. Pharma
to market harmful drugs. Till the court decides,
the sale of these drugs will continue so will
the injury of the people who would be
consuming these drugs.
The Govt., according to the Drug Price
Control order, 1970 regularly fixes the prices
of bulk drugs. Industry has to furnish all in
formations to the Govt., Department (BlCP)
for approval of prices. It is found that a good
number of companies are not following the
prices fixed by the Govt, and selling them at a
much higher rate. Some of them are :-
Prices fixed
by the Govt.
Selling price
of the
companies
1810.20
2450.00
582.74
51.00
696.72
24,735.38
9,800.00
809.00
92.62
1,002.00
—per kg of
the drugs
% of in
crease
1,267%
300%
39%
83%
44%
(Source : Ministry of Chemical & Fertilisers).
This issue was similarly taken to court and
injunction was issued by the High Court of
Delhi on legal technical matter. Later the Govt.
lost the case and made a leave petition to the
Supreme Court on 9th July *'85 As a result
the industry is continuing the sale of the pro
ducts at a highly inflated rate. Our policy ma
kers had not considered these situations and
the real need of the society had remained ever
ignored.
Whatever have been mentioned here are
only pointers to the seriousness of the situa
tion. The industry led by the multinationals do
not care for the people but for profits. Policy
makers take care of the opinions of the in
dustry only. A study by National Council of
Applied Economic Research, sponsored by
Oct-Nov 1985
the Organisation of the Pharmaceutical Pro
ducers of India (organisation of the multi
national companies) has formed a major back
ground of the NDPDC's report. The issue of
Rational Drug Policy is bound to ignore the
interest of the people.
It is, therefore, the task of the Non Go
vernmental Organisations to take up the issues.
Scientists, medical profession health workers
and other mass organisations need to concen
trate their effort to study the situation, prepare
alternative policy and campaign in support of
their policy so that the vicious cycle of the
Govt, industry metabolising profit out of the
unawareness of the people can be stopped.
Health will then become free from profiteering
and emerge as a right.
21
The Indian Drug Industry and the People’s Needs
— Dr. B. Ekbal
*
The Pharmaceutical Industry is today one
of the most multinational of modern industries.
The firms which dominate it in the developed
countries are to some capacity present almost in
every developing countries. The social im
portance of its products is such that in recent
years it has been subjected to increasing en
quiry and citicism in several countries.
The UNCTAD in a report in 1975 said
that while the huge expenditure by transna
tional drug manufacturers on marketing re
search and development was borne by poor
consumers it contributed little to the real health
needs of the vast majority of the developing
world. Ralf Nadar, in a recent study concluded
that 77% of all drugs approved by FDA of
U.S.A, during a recent 30 month period, were
ineffective or offered little or no advance over
existing products.
In 1975 Dr. Halfdan Mahler, Director
General of WHO made a serious change,
"Drugs not authorised for sale in the country
of origin, — withdrawn from the market for
reasons of safety or lack of efficiency — are
sometimes exported and marketed in develop
ing countries". The third world according to
Mahler is being increasingly used as a testing
ground for new drugs developed by the multi
nationals.
Consumers are captives of drug industry
as in no other commercial venture, and physi
cians are forced to play the role of the pur
chasing agents for consumers. And doctors
often prescribe in darkness partly because
Medical Schools do not provide pharmacologi
cal training after graduation and partly be
cause they succumb to high pressure sales
tactics of drug sales representatives. Ruthless
marketing techniques, and the unrelenting
control of multinationals over bulk chemicals
embodying the latest technology have gua
ranteed the companies windfall profits and a
virtually impregnable market position. And
these multinationals . exploit the third world
market through false advertising, representing
the therapeutic value of drugs whose use have
been severally curtailed or limited in the deve
loped countries.
From all study reports, enquiries and
judgement in India and other countries of the
world it can be concluded that multinational
drug firms produce and sell substandard medi
cine causing death, physical hazards, and de
formation. The multinationals create confusion
by misleading the physicians by misquoting
the trial reports by hiding side effects and to
xicity of drugs.
The multi-national drug companies be
cause of their strong hold over the drug in
dustry have given more priority to the pro
duction and marketing of non essential drugs
rather than giving importance to the essential
life saving drugs. They usualy produce profi
table medicines like tonics cough syrups and
vitamins not life saving drug. The whole pic
ture is one of 'drug colonialism' says Dr.
Halfden Mahler.
The drugs and pharmaceutical industry
in India companies of 110 manufacturing units
in organised sector and about 2500 units in
small scale sector. The organised sector shares
80% of the market. At the end of the 6th five
* Dr. B. Ekbal is presently the President of the Kerala Sastra Sahitya
Parishath coordinating Committee Member
of
AIDAN.
22
Medical Service
year plan in 1982-83 the planned target of
production has been estimated to be Rs. 1900
crores. Pattern of production of the dominating
units is private sector, which consists of multi
nationals.
ed in India for over40 years now, its indigenous
production is inadequate during epidemics
and the production of vaccines against in
fluenza, mumps, measles and poliomyelitis is
"non-existent".
A large part of the total output of these
drugs firms consist of drugs which are nonessential like vitamns, tonics cough syrup
and tranquilizers etc. Sales of vitamins is
65.2, 31.9 and 49.5 of the total turnover in
case of three multinational firms. Manufacturing
of vitamins has led to large scale abuse be
sides draining scarce foreign exchanges.
Despite the fact that excess of vitamins be
yond a certain quantity canot be absorbed by
the body many firms are manufacturing tablets
with higher vitamin contents. At the same time
production of such medicines which can cure
specific diseases is limited. Only 31.5 of the
total drug produced in India are meant to cure
specific diseases.
The production of cholera vaccines in
Indian cannot meet needs in time of epidemics,
eventhough production was started 40 years
ago. Vaccines against polio, mumps, influensa
and measles are not produced in India at ail.
An analysis of 7399 formulations out of
the total of 15,000 formulations being market
ed in India in 1975, by all largescale units (ac
counting for the 85% of total formulations pro
duction) showed that vitamin preparations
accounted for 15% of the total number of
formulations, the largest single groups of
drugs marketed. Tonics, nutrients and defici
ency "drugs (9%) tranquillizers and seda
tives (5%), expectorants (5%) accounted for
another 19% of the total number of finished
products sold. All these items together ac
counting for over 34% of the total, are vigo
rously sold to the rich under popular trade
marks with high pressure advertising and sales
promotion campaigns. Most of the basic in
gredients required for these preparations have
to be imported. For example in the case of
cough syrups and tonics none of the basic
ingredients in these formulations are produced
in India.
In an UNCTAD study, prepared by the
Jawaharlal Nehru University and the Indian
Council of scientific and industrial Research
(ICSIR) on technology transfer in the Indian
pharmaceutical Industry, a comparison of the
patterns of disease and the pattern of drug
production shows the inappropriateness of the
drugs produced in India for catering to the
needs of the masses. Of the 51 drugs marketted in India to combate the 3 major categories
of diseases (infectious, parasitic and respira
tory diseases) 28 have to be imported. AntiMalarials like primaquin and trimethoprim are
not produced at all in India. Further, though
chloroquin is produced in India its, imports
exceed local production although Malaria is
a common disease among the poor. Similarly,
eventhough cholera vaccine is being produc
While anti-infectives and antibiotics
drugs account for 21% of the total, their pro
duction generally falls short of the quantities
required to treat the widely prevalent diseases
cured by them. An analysis of the value of the
drug formulations produced reveals the same
pattern. In 1976, the total value of drug pro
duction in the country was Rs. 700 crores,
vitamins,tonics, health restoratives and enzyme
digestants accounted for 25% of the total
value of drug production, antibiotics 20%,
anti TB drugs 1
*4% and sulphonamides 1.3%.
The study concludes that "In the planning of
drug production in India, the pattern of dis
eases is not given enough attention. Instead,
NMCs have transferred technologies for manu
facture of products that are suited to the disease
pattern of the western world to meet the de
Oct-Nov 1985
23
mand originating from a relatively small sec
tion of well to do consumers in India. This has
occured because their 'patent protected' and
branded products earn a much higher profit
margins than the generic products required
by the poor".
There are about 45000 brand drugs now
on sale in India. It is estimated that 70% of
the 15,000 in circulation are worthless and
atleast 40% of them are harmful or poten
tially harmful. WHO in 1977 suggested that
each country should draw up its own essen
tial drug list which include drugs it consi
dered to be of utmost importance and are
basic, indispensible and necessary for the
health needs of the population. WHO has
published a model list of essential drugs
consisting of 190 drugs. The Hathi Com
mittee (1975) commended that 117 drugs
will meet the health needs of the people in
India.
There is widespread practice of freely
selling irrational and down right harmful
drugs, which are either banned or restricted
in the west, by the MNCs in the third world
countries. Valuable investigative work done
by many individuals and organisations in
different countries round the world has dis
closed the extent to which these companies
can go in their obscessive pursuit of profits.
There is also a growing suspicion that the
people of developing countries are being used
as "guinea pigs" for extensive testing of cer
tain drugs which is now virtually impossible
to do in the developed countries with strict
drug control laws and organised consumer
protection movements.
The banning of the drugs in India or even
their control is a tedious and often impossible
task because of the plethora of control mea
sures. Some of the drugs that have been bannned with a great deal of procrastination over
the years is still furtively available in the mar
ket as are some drugs banned or rigorously
Oct-Nov 1985
controlled abroad. Recently the Drugs Conssultative Committee recommended the weed
ing out of 22 drug formulations. The firms
were asked to stop production by September
1982 and marketing and sales by March 1983.
The Governments procrastination in stopping
the sales of drugs obviously to help the manu
facturers to clear the stocks, has come in for
severe criticism in a recent judgement on drug
issue by the Hon'ble High Court of Kerala.
But the banning of 22 formulations itself
was so much diluted. For eg’ hydroxyquino
line group of drugs are permitted to be ad
ministered for diarrhoeal diseases. The drugs
have been known to cause SMON (Sub
Acute Myelo Optic Neuropathy) in 28 count
ries of which Japan reported 10,000 cases.
They suffer numness and weakness in the legs
and eye damage. A large number became
blind. One firm had to pay out millions of dol
lars as compensation and the drug was subse
quently banned in U.S.A, and U.K.
Depo-provera an injectable contracep
tive banned in America for its potential for
causing cancer and birth defects is being push
ed into millions of women in mostly poor coun
tries including Bangladesh and Pakistan by
some international agencies. The controversy
surrounded the use of depo-provera has taken
a new term following the publication of re
ports that the drug is also being pushed to
U.S. citizens mostly black and Indian women.
The drug may be marketed in India on the
pretext of controlling the population explosion.
The absence of a national stability forum
like the British Safety Committee on Medi
cine in U.K. or FDA in U.S.A, is one of the
reasons for this sorry state of affairs. Only
three out of 22 states in India (Maharashtra,
Gujarat and West Bengal) have machinary
to regulate the manufacture, distribution and
sale of pharmaceuticals. A lot of drug analysis
done at private laboratories barely equipped
for the job.
Some vital measures like the introduction
of essential drugs in mass scale as advocated
by the Hathi Committee and WHO, centralis
ed bulk purchasing of these essential drugs by
national agencies, introduction of generic
names in preference to brand names, cheap
standardized packaging of a limited but suffi
cient number of products need to be imple
mented rigorously in poor countries in order
to provide essential drugs at low prices to a
much larger proportion of their people. But in
almost all countries the large pharmaceutical
firms have consistently opposed such poli
cies. It is a measure of the enormous power
and influence they wield that they have gene
rally been successful in getting rid of all prog
ressive measures taken by some third world
countries like Sri Lanka and Bangladesh.
launch a People's Movement for the formu
lation of a People's Drugs Policy. KSSP is
planning to organise seminars, street meetings,
exhibitions, signature campaigns, slide shows,
art items; publication of pamphlets, books etc.
during the campaign period.
Table 1
PRODUCTION OF VACCINES
Vaccine
Produc
tion (Lac.
doses)
1980-81
Target
(Lac.
doses)
DPT
400
DT
200
145
120
The use of drugs has in any case to be
Tetanus
70
210
put in its proper perspective. In the develop
Polio
20
60
ing countries like India ill health is mostly
caused by a vicious combination of malnutri
Note : 1 Pharmaceutical Enquiry Committee
tion and infectious diseases. Drugs cannot
help unless the very sources of diseases, nu- 4 1952.
tritional and environmental conditions are
"No foreign concerns should be allowed
improved. Latrines to carry away excreta, im
to set up factories unless they undertook
proved housing draining stagnant water and
to manufacture products which were
pipes for clean water are much part of a prog
not manufactured in adequate quanti
ramme to bring health to people as drugs and
ties by other factories, starting from basic
hospitals. A National Drug Policy linked to a
chemical and/or intermediate as near to
heatlh strategy which meet, the real health
the
basic chemicals as possible within a
needs of the people should be formulated.
reasonable time".
The Kerala Sastra Sahitya Parishad has
Hathi Com
already initiated a big campaign exposing the Note : 2 Recommendations of
anti-people and exploitative tactics of the mittee.
multi-national drug companies. The ques
tions of essential versus non-essential and
dangerous drugs, the inadequacy of the drug
safety control measures, the rising prices of
life saving drugs, the non-implementation of
the Hathi Committee recommendations are
being highlighted during the campaign. The
aims of the campaign will be to sensitise the
medical profession on these issues and to
26
1.
Nationalisation of Multinational Drug
Cos.
2.
Establishment
Authority.
3.
Production of 117 essential drugs.
4.
Elimination of irrational drug combi
nations.
of a
National Drug
Medical Service
5.
Abolition of Brand Names and In
troduction of Generic Names.
6.
Revision of India National Formulary.
7.
Quality control of drugs to be stren
gthened.
2.
UNCTAD (1977) Case studies in the
Transfer of Technology, the Pharmaceuti
cal Industry in India, United Nations.
3.
Report of the committee on Drugs and
Pharmaceuticals Industry (1975) The
Hathi Committee, Ministry of Petroleum
and chemicals, Govt, of India.
4.
Mukarram Bhagat (1982) Aspects of
Drug Industry in India. Centre for Edu
cation and Documentation Bombay.
5.
The Drug situation in India (1982) Vo
luntary Health Association of India, New
Delhi.
6.
Lail Sanjay (1974) International Phar
maceutical Industry and less developed
countries' EPW Vol. IX, No. 47, Nov. 23.
7.
Medawar Charles (1919) Insult or In
jury Social Audit, London.
8.
Essential Drug List (1979) WHO Techni
cal Report series 641.
9.
Agarwal Anil (1978) Drugs and Third
World. Earthscan, London.
10.
Patel Aswin (ed.) (1977) In search of diag
nostic MFC, Gujarat.
11.
Diana Melrose (1982)
fans.
12.
Richard Blum (1981)
Pharmaceuticals
and Health Policy, Health Action Inter
national, Penang.
13.
Virginia Beardshaw (1983) Prescription
for change, Health Action International.
14.
Milton Silverman and Philip Lee (1982)
Prescription for Death, University of Cali
fornia, Berkley.
15.
Dr. Tom Heller (1977) Poor Health
Rich Profits, Spokesman Books, Not
tingham.
Note : 3 Hath! Committee 1975.
"Continued presence in this country of
the highly profit motivated multi
national sector can but promote only the
business interests of the sector. Their
presence in India, as a part of their global
effort to capitalise on human suffering
in an organised manner, must therefore
cease as early as possible, we therefore
strongly recommend that the multi
national units in the field of drugs and
pharmaceuticals should be taken over by
the Government. Such take over will
not create any dislocation in the produc
tion or distribution of drugs".
Note : 4 KERALA HIGH COURT JUDGE
MENT O.P. No. 8439-82-L.
"As between the lives of the citizens of
this country on the one hand and the
loss that they may result to the manu
facturers and traders by the immediate
ban on the manufacture and sale on the
other, Government has chosen to view
the later as of more concern".
"The provision of a cut off date for manu facture as well as on sales is an irratio
nal, highly unjust, unfair and amoral
approach adopted as a result of a dis
torted appreciation of values".
References
1.
Dr. Halfden Mahler (1981) Health for all
by the year 2000 World Health Forum
Vol. 2 No. 1 WHO Geneva.
Oct-Nov 1985
Better Pills, Ox
COMMUNITY HEALTH CEIA
326, V Main, I Block
Koramtng^la
Sangalore-560034
IfiOia
27
16.
pharmaceutical
Milton Silverman (1976) The Drugging
of the Americans, University of Califor
nia, Berkley, Los Angels.
Corporations and the
Industry New York.
United Nations Centre on Transnatio
nal Corporation (1979) Transnational
and their Impact on pharmaceutical In
dustry in India, KSSP (under print).
21. UNCTAD (1980) 'Major Issues in India
UNIDO (1978) The Growth of phar
Pharmaceutical Industry, Geneva.
maceutical Industry in Developing coun
22. UNCTAD (1980) "Technology Problems
tries: Problems and prospects.
in the Pharmaceutical, Industry Geneva.
18. Report of the pharmaceutical Enquiry
23. Central Drug Research Institute (1976),
Committee, 1852.
"Country Status Paper of India".
19. Indian Drug statistics, Ministry of Pet
roleum 1978.
24. P. Mohanan Pillai (1984) Multinationals
17.
20.
Planning of New Hospital ?
Expanding Existing Nursing Home ?
Modernising facilities ?
Consider "JANAK" for fine Patient Care Beds such as Inten
sive Care Bed, Recovery Bed, Hi-Low Bed, Modified Fowler's
Bed, Bed with backrest, Emergency & Recovery Trolley, Obste
tric Labour Table 2 Section, Medical Tables, Trollies Wheel
Chair and other Ward furniture
METALBEDS INDIA (in association with Janak Mfg. Works)
Janak House, Opp. Indian oil Corpn Depot,
Sheikh Misry Road, Wadala (East)
Bombay-400037
Tel : 8820171/8820769
Cable : JANAKBED (MT)
Telex : 011-71584 JKMG IN
Oct-Nov 1985
29
Scientific Scrutiny of some over - the Counter Drugs
— Dr
A host of over-the-counter medicines—
medicines which are advertised in the -laypress, media, and can be bought without a
doctor's prescription — are being marketed
by various companies. As of today, there is no
independent expert body to scrutinize these
medicines on scientific grounds as to their
effectivity, safety and price and to advise
the consumers accordingly. Such a body is
necessary for all industrial products used by a
layman. But its necessity is particularly felt
in case of medicines, because, in the field of
medicine there is a lot of scope to include
unnecessary, ineffective ingredients without
the consumer least suspecting it. Moreover
a sick person is less critical about the contents
and the price of the medicine which he/she
buys since he/she is psychologically more
bothered about getting immediate relief, or
improving health. Health is one area where
people are prepared to pay more readily.
Drug companies know this consumer-psy
chology very well and can exploit the situa
tion to their profit oriented aims. The aim of
this paper is precisely to show empirically that
the logic mentioned above in fact operates in
our country in case of over-the-counter me
dicines.
Three types of medical products are di
rectly sold to the laity
1.
Products offering symptomatic re
lief from minor ailments — e.g. Vicks
Vapour Rub, Coldarin, Anacin etc.
A.R. Phadke
2.
Various types of tonics and "health
restoratives" — Phosphomin, Gripe
waters, Incremin etc.
3.
Food substitutes—Complan, Glucon-D
etc.
I have chosen a couple of most widely
used products from each category for a some
what detailed scrutiny as to their exact role,
usefulness compared to their cost and com
pared to the claims made or impressions creat
ed by the producers in their advertisements, I
have confined myself only to the allopathic
medicines since I have no training in other
systems of healthcare. I have selected certain
brands for scrutiny and discussion only for the
sake of illustration and I do not want to selec
tively criticize or favour any particular com
pany. As far as possible I have used non-technical language and have explained some medi
cal points assuming that substantial number
of participants in this seminar are non
medicos.
Pain-Killers, anti-cold
preparations
and
anti-cough
(a) Pain-Killers — A number of anal
gesic-antipyretic (i.e. pain-killing and fever
reducing) preparations are directly sold to
the laity — e.g. Anacin, Aspro etc.
Table 1, gives details of some of them.
Paper presented at the Seminar on THE DRUG INDUSTRY AND THE INDIAN PEOPLE
Organised by DELHI SCIENCE FORUM Held at All India Institute of Medical Sciences,
November 7—8, 1981.
30
Medical Service
Table 1
No.
Name of the product
Contents
Price Per tablet
in paise (Oct.
1985 prices)
1.
Aspirin
Acytyl Salicylic
4 to 5
2.
Aspro
1 Aspirin — 350 mgCaffeine — 20 mg-
** 1
3.
Anacin
Aspirin — 389 mg.
Caffeine — 16.2 mg
Quinine sulfate — 8.1 mg
1?
4.
Avedan plus
Aspirin — 350 mg.
Acetyl-P aminophenol — 125 mg.
Caffeine — 30 mg.
11
Aspirin — 350 mg.
Caffeine — 65 mg.
Codeine — 8 mg.
Salicylamide — 65 mg.
Paracetamol — 65 mg.
23
5. Powerin
Unnecessary Additions
All these preparations contain Aspirin
and in addition one or many other ingredients
to get more analygesia. But standard text
books of Pharmacology tell us that addition
of these other analgesics have no additional
advantage. Thus, for example, the famous
Goodman-Gillman's text book tells us "The
many mixtures of Aspirin with acetaminophen,
or phenacetin and often with caffine and other
drugs are promoted with claims that they
provide more analgesia. None of these claims
withstand critical scrutiny. In most clinical
trials, relief of pain by an analgesic mixture
Oct-Nov 1985
has not been superior to that of Aspirin alone".
(1) It may be argued that by adding other
analgesics to aspirin, we are reducing the dose
and hence the side-effects of aspirin.
But this claim too does not withstand
scientific eivdence "All analgesic antipyretics
alone or in combination, are adequately tole
rated in recommended dosage. Difference in
the incidence of gastro-intestinal distress and
other minor adverse effect are (2) generally
inconsistent and of doubtful practical signi
ficance".
Opinions expressed in standard text
books have to be accepted than the ones ex
31
pressed by individual researchers based on
their individual experience. Addition of other
ingredients merely increases the cost of the
medication for equivalent dosage as can be
easily seen from table No. 1.
Pure Waste — Some of the ingredients in
some of these preparations are a pure waste.
For example—Salicylamide (used in Powerin)
It is "no longer an official drug. Its effects in
man are not reliable, and its use is not recom
mended. The small doses included in "overthe-counter" analgesic and sedative mixtures
are probably ineffective." (3)
Its a pure waste of patient's money and
of national resources to include such products
in analgesic mixtures. Similar is the case with
Caffeine — "In controlled clinical trials anal
gesic mixtures containing Caffeine have not
been found superior to aspirin for relief of hea
dache nor has Caffeine been found to contri
bute other favourable effects". (4)
Quinine Sulfate (which was used in
Anacin until recently) has not even been
mentioned in the list of analgesic drugs, though
like some other drugs it has analgesic proper
ties. Besides, 8 mg, of Quinine Sulfate has
absolutely no value since the appropriate
dose is 300-600 mg. Similarly, addition of a
mere 65 mg. of paracetamol (therapeutic
dose — 500 mg.) or 8 mg. of codeine (therapentic dose — 30 mg.) is also not likely to
be of any help.
Addition of such ingredients in such
dosages helps to confuse the patient, 'justi
fies" a different brand name and increases the
earnings of the companies and the shop
keepers. Yes, even the retail-traders are inte
rested in selling these brands instead of As
pirin since they get very little margin by selling
these brands instead of Aspirin since they get
very little margin by selling a 2 paise-pertablet-drug. It is necessary to stop the pro
duction of all these fancy productsand Aspirin
32
be readily made available as over-the-counter
drug.
(b) Anti-cold
preparations — Scienti
fic treatment. Common cold is a symptomcomplex caused by viral infection of the upper
respiratory tract. Cold is sometimes caused by
an allergic response to changed weather,
dust etc. This "allergic Cold" is characteriz
ed by sudden onset-violent sneezing profuse
watery discharge from nose as well as to some
extent from eyes and by its dramatic response
to antihistaminics (anti-allergic agents).
As is well known, we don't have any
drug to kill the virus of common cold. It is a
self limiting disease and the treatment is es
sentially aimed at relieving symptoms and
helping the body to get rid of the virus. Thus,
the treatment of uncomplicated common cold
is—rest in warm bed, plenty of flu ids and food,
steam inhalation, gargles with warm salted
water. If there is a feeling of blocked nose, a
few crystals of menthol ("Thandai" alias'
"Asman ka tara" used in Masala-pan) can be
added to boiling water to inhale this menthola
ted steam. If headache, body-ache, and/or
fever so demand, one can resort to one or two
tablets of Aspirin three times a day.
Out of all these, ingredients, only men
thol has definitive value, that too, when the
"nose is blocked". At 2% concentration, men
thol can act as a decongestant i.e. it reduces the
excessive blood supply in the nasal tract and
thus alleviates the feeling of " blocked nose'.
However, its combination with Camphor (as
is done in Vicks, Rubex) is "incompatible".
(Remington's Pharmaceutical Sciences,
15th edition 1975).
Camphor, turpentine oil, menthol have
counter-irritant action i.e. they irritate the
local tissue and thereby block the passage of
painful stimuli from that area, thus, reducing
pain. But these actions are hardly relevant in
Medical Service
Role of Vicks Vapo Rub, Rubex etc.
Table No. 2 gives the ingredients of
Vicks and Rubex ointments.
Table 2
Ingredients of Vicks Vapo Rub and Rubex
per 100 gms. of the ointment.
No.
Name of the
ingredient
Rubex
Vicks
Vapo Rub
Quantity
in
gms.
1. Menthol
2.82
2.8
2. Camphor
5.25
5.25
3. Thymol
0.10
0.10
4. Turpentine oil
5.5 ml.
5.6 ml.
5. Eucalyptus oil
1.41 ml
5.5 ml.
6. Nutmeg oil
—
5.5 ml.
7- Paraffin base
to make 100 gms.
common cold because pain in the nose is not
at all the major symptom in common cold.
These counter irritants merely give a psycho
logical satisfaction that some "active" treat
ment is being taken with the help of a "strong
medicine".
supposed to be excellent expectorant. Steam
of a very high relative humidity (above 85%)
liquifies sputum, decreases its viscocity and
affords the patient considerable symptomatic
relief"5. Heat in the steam also gives consi
derable
relief by relaxing the surrounding
tissue. Thus, when we inhale the vapour of
Vicks or Rubex by putting them into boiling
water, it is the steam which is mainly useful.
Eucalyptus oil etc. give only psychological
relief if any. Menthol is useful only when the
nose is blocked.
Thymol has antibacterial and anti-fungal
properties, eucalyptus oil also has antiseptic
properties. But these actions are irrelevant in
the treatment of common cold because com
mon cold is a viral disease.
The five — gram tinned pack of Vicks or
Rubex ointment costs Rs. 2.10 whereas,
the price of equivalent quantity of menthol
crystals in the market is not more than 15
paise. According to Martindale,
"Menthol
with aromatic oils in a soft paraffin base (Vicks
Vapo Rub) provided a higher and more pro
longed concentration of aromatic vapours
from open vessels possible by retention of
the molten basis on the surface of hot water"6.
But one need not spend so much for this.
The same effect can be achieved by adding one
or two crystals of menthol every half a minute
to hot water.
Misleading advertisements
Turpentine oil in low dosage and eucaly
ptus oil have a "Stimulant-expectorant" ac
tion — i.e. they stimulate the output of sec
retions from the mucous membrane thus help
ing the body to throw out the sticky mucus.
But this action is really relevant in the infec
tions of the lower respiratory tract — e.g.
bronchitis. In cold it may increase one's
troubles by increasing the discharge through
nose. Besides, steam is the best for this pur
pose. "Among innalants, steam innalation is
Oct-Nov 1985
Menthol is not necessary is each and
every case of common cold. It is, therefore,
unnecessary to resort to these mentholated
ointments the moment one catches cold. The
advertisement by the concerned companies do
not tell us this. One is less likely to go back to
work or to school (smiling!) the next morning
as is shown in the advertisements, because
common cold, whatever treatment you take,
takes its own time to bid farewell to you. The
33
claim that Vicks ointments can relieve headache
is also misleading. These ointments can re
lieve headache caused only because of block
ed nose and not the one due to toxic subs
tances released in the blood. Medical text
books do not mention "Chest cold symptoms"
which Vicks ointment is supposed to relieve.
Martindale's text book tells us that "it is dan
gerous to apply an ointment containing men
thol to the nostrils of infants, e.g. for the
treatment of catarrh, it may cause instant col
lapse"7. The containers of these preparations
do not give a proper, specific warning that it
is dangerous to apply this ointment to the
nostrils of children below one year. Only a
vague mention is made on the vicks' conta
iner—"Do not swallow or place in nostrils—
Consult Doctor if- illness in very young children.
Nobody is going to "place" the ointment in nostrials, but many do apply it inside the nostrils.
Rubex is produced by "our" Indian Com
pany, an associate of the famous Alembic
Chemicals. This company does not give even
the insufficient warning given by Richardson
Hindustan Ltd. On the contrary it advises to
apply the ontment "inside and outside of nose"
without any qualification. This shows their
concern for the life of infants.
Vicks and Rubex ointment are thus:1 very
costly compared to the benefits they offer
(they may relieve some of the symptoms of
common cold2) promoted by the concerned
companies with misleading claims. The in
creased price is because of some unnecessary,
useless ingredients; advertisements and the
profit motive of the concerned companies.
In 1980, Richardson
Hindustan Ltd., sold
more than Rs. 9 crores of Vicks-range-products
(ointments, tablets, inhalers etc) and earned a
gross profit of a whopping 47% of sales. The
"administrative and general expenses" of this
company, which are the main, expenses on
advertising and sales promotion accounted for
37% of sales. The consumer has to pay
through the nose so to say, all these expenses.
34
I have delt with over-the-counter ana
lgesics and" anti-cold ointments" in some de
tail because they are the most commonly
used over-the counter medical products and
because the irrationality for these products—
especially these ointments—is not well known
even amongst doctors. I will now deal with
other products in a very brief manner.
Role of "anti-cold"
tablets
The content of some of the "anti-cold"
tablets are given in Table No. 3.
These tablets contain analgesics and
some agents supposed to act as nasal decon
gestants and as 'bronchodilators. But as men
tioned above, salicyl-amide.
Phenacetine
(now recently deleted) caffeine (Present in
Action-500) are not the drugs of choice for
relief of pain. Antacids like calcium carbonate,
aluminium hydroxide. Magnesium hydroxide
have been included in these tablets to reduce
the irritation of the stomach caused by Anal
gesics. But as quoted above, analgesics "are
adequately tolerated in the recommended do
sage" and hence, inclusion of these antacids
is unnecessary. Moreover, as seen from table
No. 3 they are present in these preparations in
such low dosage that they are unlikely to play
any useful role.
Phenylephrine
(included in Coldarin)
acts as a nasal decogestant when applied Io-.
cally. But "its absorption from the gut is not
relieable", and hence is not recommended by
mouth.
Ephedrine hydrochloride (included in
Action-500) is a bronchodilator used in the
treatment of asthma or in a certain type of
bronchit's. Its inclusion in an anti-cold tablet
is not at all justified. Moreover the dosage in
which it is used in this tablet is ridiculously
low.
Because of these unnecessary or irrele
vant ingredients and because of advertising.
Medical Service
claim that Vicks ointments can relieve headache
is also misleading. These ointments can re
lieve headache caused only because of block
ed nose and not the one due to toxic subs
tances released in the blood. Medical text
books do not mention "Chest cold symptoms"
which Vicks ointment is supposed to relieve.
Martindale's text book tells us that "it is dan
gerous to apply an ointment containing men
thol to the nostrils of infants, e.g. for the
treatment of catarrh, it may cause instant col
lapse"7. The containers of these preparations
do not give a proper, specific warning that it
is dangerous to apply this ointment to the
nostrils of children below one year. Only a
vague mention is made on the vicks' conta
iner—"Do not swallow or place in nostrils—
Consult Doctor if- illness in very young children.
Nobody is going to "place" the ointment in nostrials, but many do apply it inside the nostrils.
Rubex is produced by "our" Indian Com
pany, an associate of the famous Alembic
Chemicals. This company does not give even
the insufficient warning given by Richardson
Hindustan Ltd. On the contrary it advises to
apply the ontment "inside and outside of nose"
without any qualification. This shows their
concern for the life of infants.
Vicks and Rubex ointment are thus:1 very
costly compared to the benefits they offer
(they may relieve some of the symptoms of
common cold2) promoted by the concerned
companies with misleading claims. The in
creased price is because of some unnecessary,
useless ingredients; advertisements and the
profit motive of the concerned companies.
In 1980, Richardson
Hindustan Ltd., sold
more than Rs. 9 crores of Vicks-range-products
(ointments, tablets, inhalers etc) and earned a
gross profit of a whopping 47% of sales. The
"administrative and general expenses" of this
company, which are the main, expenses on
advertising and sales promotion accounted for
37% of sales. The consumer has to pay
through the nose so to say, all these expenses.
34
I have delt with over-the-counter ana
lgesics and" anti-cold ointments" in some de
tail because they are the most commonly
used over-the counter medical products and
because the irrationality for these products—
especially these ointments—is not well known
even amongst doctors. I will now deal with
other products in a very brief manner.
Role of "anti-cold"
tablets
The content of some of the "anti-cold"
tablets are given in Table No. 3.
These tablets contain analgesics and
some agents supposed to act as nasal decon
gestants and as 'bronchodilators. But as men
tioned above, salicyl-amide.
Phenacetine
(now recently deleted) caffeine (Present in
Action-500) are not the drugs of choice for
relief of pain. Antacids like calcium carbonate,
aluminium hydroxide. Magnesium hydroxide
have been included in these tablets to reduce
the irritation of the stomach caused by Anal
gesics. But as quoted above, analgesics "are
adequately tolerated in the recommended do
sage" and hence, inclusion of these antacids
is unnecessary. Moreover, as seen from table
No. 3 they are present in these preparations in
such low dosage that they are unlikely to play
any useful role.
Phenylephrine
(included in Coldarin)
acts as a nasal decogestant when applied Io-.
cally. But "its absorption from the gut is not
relieable", and hence is not recommended by
mouth.
Ephedrine hydrochloride (included in
Action-500) is a bronchodilator used in the
treatment of asthma or in a certain type of
bronchit's. Its inclusion in an anti-cold tablet
is not at all justified. Moreover the dosage in
which it is used in this tablet is ridiculously
low.
Because of these unnecessary or irrele
vant ingredients and because of advertising.
Medical Service
the price of these tablets is extraordinarily
high, compared to that of Aspirin without
offering any additional therapeutic advantage.
(C) Cough tablets and mixtures
Scientific treatment Cough announces
body's intention to throw away a noxious,
unwanted agent in the respiratory tract. In
a sense it is a protective reflex. But when that
"noxious agent" is the inflamed, pricking
throat, the cough is useless, "unproductive".
When there is accumulated mucus in the
lower respiratory tract, the act of coughing
can throw it-out and the cough in these two
types of cough is therefore different. In un
productive cough, attempts have to be made
to suppress the cough-reflex. In productive
cough, attempts have to be made to bring
out the accumulated sputum.
Unproductive cough can be reduced by
reducing the irritation in the throat. This can
be achieved to a certain extent by warm saline
gargles. Such gargles amongst other things,
wash the irritating agents on the surface of the
throat;
relex the surrounding muscles by
warmth, thus reducing the pain and irritation
in the throat. Irritation can further be reduced
by chewing simple limlet tablet which in
creases salivery secretions from the mouth.
Saliva is an excellent soothening agent. The
"cough-centre" in the brain can be suppress
ed by codeine or similar opioids.
To bring out the sputum from lower
respiratory tract, various expectorants are used.
As quoted above, steam is one of the best
expectorants. Other ones are to be taken
orally.
Unnecessary and irrational .- Recent
additions of Goodman-Gillman's text book
make no mention of the commercial throat
lozenges;
An Indian text book — "Pharmacology
and Pharmacotherapeutics" — spends a few
Oct-Nov 1985
lines on throat lozenges, — "These prepara
tion act by increasing the flow of saliva the
best natural demulcent which produces a
protective and soothing effect" .... "Costly
preparations like lozenges, etc. containing
multiple ingrediants are usually unnecessary
and wasteful"8.
Codeine, which suppresses the cough
centre in the brain is present in some of the
cough-mixtures like Glycodin
and VicksFormula-44 (see table No. 4) But these pre
parations contain some other ingredients
which are useless, or atleast of doubtful
value.
Recent editions
of
standard
text books do not recommend such ingre
dients as Antimony Potassium tartrate or
Terpene Hydrate in the drug therapy of cough
and cold. These ingredients are supposed to
have an expectorant actions. Even if we assume
that they have an expectorant actions even in
the dosage given, combination of a cough
suppresant with expectorants is obviously
not at all justified. Moreover, the dosage in
which these ingredients are added has ab
solutely no scientific basis. As a result of these
irrelevant or ineffective ingredients, the effec
tive cost of codeine in the adult therapeuticde
dose of 15 mg, comes to about 64 paise and
105 paise for Glycodin and Vicks-Formula-44
respectively. Whereas the price of Tab. Codeine
Phosphate-15 mg. is 16 paise.
Waterbury's Compound (Red) is pro
moted for relief from cold and cough and also
as general tonic. Some of the ingredients have
supposedly been included for expectorant
action. Of these, none have been recommend
ed in text-books of Pharmacology because
of doubts about their utility. For example about
creosotes if has been mentioned — "Large
doses of creosotes and guaicols have also
been shown to possess this (expectorant)
action in animals"9. Their role in man has not
been definitively established.
Moreover,
these agents have been included in Water-
35
Table 3
"Anti-cold" preparations
*
No
Brand name
Ingredients
1.
Coldarin
2.
Action 500
Therapeutic dose
Price per
tablet in
ps. (oct85)
Aspirin - 600 mg
300-600 mg
45
Phenylephrine-10 mg
Unreliable absorption.
Caffeine - 300 mg.
60 mg.
Terpene hydrochloride
30 mg.
Not recommended
Calcium Carbonate - 200 mg.
1 gm.
Vitamin-C - 50 mg
(now deleted)
Not necessary
Salicyl-amide-390 gm
Not recommended
Phenacetin-242 mg.
(now recently deleted)
300-600 mg.
(not recommended)
Aluminium hydroxide
gel - 32 mg.
500 mg.
Magnesium hydroxide
— 130 mg.
300 mg.
Caffeine — 32 mg.
60 mg.
8 mg.
30 mg.
Paracetamol - 650 mg.
500 mg.
Ephedrine —
50
(recently added to replace phenacetin)
bury's Compound in ridiculously low amount,
Same is the case with Sodium Salicylate,
This preparation is thus virtually useless for
treatment of cold or cough.
Vicks Vapo Rub is also advertised to
"bring out cough from the chest". As mentioned above, eucalyptus oil and turpentine
36
oil contained in Vicks and Rubex ointments
have expectorant action. But it is impossible
to achieve the kind of dramatic effect in one
night as shown in the Advertisement-Film on
Vicks Vapo Rub. Moreover the way the ointment, when applied to the chest is shown to
act defies all laws of medicine.
Medical Service
Table4
Cough-mixtures
No.
Brand Name
retail price Important ingredients per
per 5 ml. in five ml.
ps.
Therepeutic dose in
treatment of cough
(Oct.1981)
1.
Glycodin Terp
Vasaka
46
Codeine phosphate 11 mg.
Antimony potassium
tartrate — 56 mg.
Terpene hydrate — 11 mg
Methol — 3.75 mg
Tolu syrup 1.25 ml
Vasaka syrup — 47 ml.
15 mg.
Not recommended
—do—
—do—
2.
Vicks-Formula-44
35
Codeine phosphate — 5 mg
Ephedrine — 5 mg.
Sodium Citrate — 250 mg.
15 mg.
30 mg.
Not recommended
3.
Waterbury's Com
pound (Red.)
15
Creosote — .0025 ml.
Guicol — .00012 ml.
Sodium Benzoate — 45 mg.
Not recommended
300 mg. foranalgesoa
Codeine Phosphate —15
15 mg.
4.
Codeine Phosphate 16
tablet
Actually application of this ointment to
the chest is virtually a useless exercise for bring
ing our sputum from lower respiratory tract.
Obviously the ingredients cannot possibly
reach the lungs through the skin. Vapours
of eucalyptus and turpentine oil formed due to
body heat are in such a low concentration
that they , cannot exert any useful effect by
entering through the nose. This particular
piece should be removed from this film.
It is necessary to educate the people
through various media about the causation
and the scientific treatment of cold and minor
cough. Drugs like Aspirin, menthol should be
made easily available as over-the-counter
medicines. Existing over-the counter com
Oct-Nov 1985
mercial preparations should be banned. Only
scientifically sound preparations should be
allowed to be marketed and their advertise
ments should also be monitored to prevent
the misleading of the lay people.
— II —
TONICS
Incremin, Phosphomin and Waterbury's
Compound (Yellow) (Syrups) Vimgran tab
lets and Gripe-Waters are the most widely
advertised and therefore used over-the coun
ter-tonics.
Gripe-Water
Tonic in a wider sense is something which
"Invigorates" the body. Even in this sense.
37
Gripe water is not a tonic. It is not even ad
vertised explicitly as a tonic. But these mix
tures are advertised in such a manner that
an impression has been created amongst semi
literate, illiterate people, that it is a tonic. The
advertisement typically shows a chubby baby
and carries a caption—"For health of the baby"
or "for a growing baby" etc. An illiterate
mother interpretes that Gripe Water is a tonic
for infants. As a result, apart from Anacin,
Gripe-Water is the most commonly used over
the counter-medicine in rural areas and in
slums.
Self-administration of maintenance doses of
Vitamins for a few days after an illness has
some justification. But this is not the case
with iron — since ordinary ailments do not
necessitate extra amount of iron. If a person
develops symptoms of iron-deficiency-anaemia,
none, of these above preparations would be
able to correct the iron deficiency-which re
quires about 200 mg. of elemental iron daily
for months.
A number of companies manufacture
their own Gripe-Water. Typically it contains
Anise-Water, Sugar, Sodium
Bicarbonate
and peppermint. All except sugar have car
minative properties i.e. they help to "expel
gas from the stomach or intestines in the treat
ment of flatulence and in colics". But as claim
ed in the advertisement it is not useful as and
"aid to digestion" or to make the "cricis" due
to teething problems" perfectly mild and free
from danger".
An advertisement of Vimgran shows a
good looking man telling us that he takes
copper with his breakfast. "Consuming Cop
per" is shown as something good for health.
Many laypeople get attracted by this caption
and start taking Vimgran. But it is not neces
sary at all to include copper in any overthe counter
multivitamin
preparation —
"Deficiency of Copper is extremely rare in
Man............ There is no evidence that copper
ever needs to be added to a normal diet, either
prophylactically or therapeutically"10. Its a waste
to add copper to over — the counter tonics.
Similar is the case with salts of sodium, po
tassium, Manganese etc., etc.. Glycerophos
phates included in phosphomin is also a waste"In General
*
the Phosphorus present in ordi
nary foods is an adequate source of this ion.
The use of expensive preparation of organic
phosphates as tonics has no validity"11.
Disproportional Contents :
Misleading Advertisements and Waste
ful ingredients :
Table No. 5 gives the contents of the most
widely used over-the counter-tonics. Vita
mins contained in these preparations are
closer to the values recommended by I.C.M.R.
for daily dietary intake. Recommended daily
intake of iron in adult man is 24 mg. of ele
mental iron. But as seen from the table, the
iron content in Phosphomin-iron, Waterbury's
Compound and Vimgran is such less than this
amount. There is thus a disproportion in these
three preparations as regards their Vitamin
and Iron content leading either to wastage of
Vitamins or an insufficient supply of Iron,
depending upon how much of these prepara
tions are taken daily.
The excessive cost incurred due to the use
of these preparations is not small because
they are very costly compared to the utility
they have. For example, a multivitamin costs
9 paise, whereas these syrups cost from 40
paise in case of incremin to 50 paise in case
of Waterbury's Compound for roughly equi
valent dosage. (Octo. 81).
Basically, the strategy of supplying iron
in such low "Maintenance" doses through
costly preparations is highly questionable.
It is necessary to educate the lay public
through various media, scientific principles
of dietics so that they do not unnecessarily
38
Medical Service
Oct-Nov 1985
Table 5
TONICS
Important Ingredients per 15 ml. in mg.
No. Brand Name
Vit.
B1
Vit.
B2
Vit
B6
Niacin
-amide
Vit.
B12
Mcg.
Vit.
C
Iron
Elemen
tal.
1. Phosphomin
2
1
0.5
15
15
—
—
11% V/V
2. Phosphomin Iron
2
1
0.5
15
15
—
9.3
-do-
3. Tonos - 7
*5
2
2.5
1
25
2.5
23.2
-do-
4. Incremin (Per 5 ml.)
10
—
5
—
25
30
Sorbitol 5 gms.
5. Waterbury's Com
pound (Yellow)
1
1
18
—
—
3
Malt
6. Vi mg ran tablet
3
3
1
20
2
—
50
10
Alcohol
Others
Glycerophosphates of
Na, K, Ca, Mn.
-do-
D-Pantothenol 1 mg.
Na-Salicylate
K-Na, - Salts
Vit. A
I.U.
Vit. D
I.U.
5000
500
Calcium
100 mg.
Iodine
: 0.15 mg
Potassium :
5 mg.
Copper
: 1 mg.
: 1 mg.
Manganese
Zinc
: 1.5 mg
Magnesium
: 6<'mg.
: O.l" mg.
Folic Acid
resort to tonics and rely more on better ma
nagement of their diet. It is also necessary
to ban the production of all these prepara
tions pending their restructuring on scientific
basis. Their advertisements should also be
censored to prevent misleading of the lay
people.
— Ill —
FOOD SUBSTITUTES
Of all the food substitutes, breast-milksubstitutes are the most important — The illeffects of these milk powders are now very
well known and hence there is no need to
repeat these arguments here — I have there
fore decided not to discuss these prepara
tions here.
Pre-cooked foods :
In Maharashtra, the drug-companies are
promoting weaning foods more than milk
powders. These are more pre-cooked balanced
food-powders. Hence, weaning foods like
Farex, Cerelac etc. are not necessary and do
not have any additional nutritional advantage
compared to their price, over home-made
ordinary weaning foods. They are, however,
not hazardous like milk powders which act
as breast-milk-substitutes. Its a waste of mo
ney to spend on such preparations when the
child can and should be gradually induced
from 4th month onwards to normal balanced
diet consumed by the family.
Preparations like Bournvita, Boost, Nutramul, etc. are also pre-cooked but nutri
tionally much less useful products. They
contain cocoa, malt, mi Ik-powder, barley,
sugar etc etc. The exact proportion of these
ingredients are not given in their promotional
literature. They are nutritionally no better
than ordinary balanced diet. It is deplorable
that even producers of Nutramul, a co-operat
ive agency, should resort to completely base
less, misleading advertising gimmicks in the
40
form of projecting the imagery of the "Nutra
mul Dada".
Glucon-D-Powder :
Glucon-D-Powder is used as an "energy
giving" preparations.
Laymen
think that
Glucon-D is a medical, "Powerful" powder
because of the advertising gimmicks and be
cause of the peculiar taste this powder has.
Dissolution of this powder in water (or salvia)
is an endothermic (heat absorbing) reaction.
Hence, this powder has a peculiar "cool"
taste. It is the duty of all medical people to
explain to the laity that powder has absolutely
no special nutritional and/or medical pro
perties : that it is not at all instantly absorbed
from the gut into the blood etc. etc. This pro
duct should not be allowed to be advertised
in the lay-media.
Protein-Powders :
"Proteinex, Protinules, Provitex, Uni
protein are some of the most widely sold overthe counter protein powders. All of them con
tain about 50 to 60% of proteins, and the rest
is made up of carbohydrates minerals, vita
mins. If used in sufficient quantity as a supple
ment to ordinary balanced diet during con
valescence, they can be of help. But as seen
from the cost calculations made by the author
in 1977 (see table No. 6), the cost of proteins
derived from these preparations in much
higher (for equivalent amount of protein)
compared to that of proteins derived even in
the costly form of milk and egg. Egg protein
has the highest biological value of 95%.
"Biological values is per cent of absorbed
nitrogen when food-stuff indicated is the sole
source of nitrogen". It is an indication of the
quality of the protein being consumed. Other
much cheaper sources of proteins given in
table No. 6 have lower biological values. But
the biological value of the proteins in these
commercial powder is also not high. Subs
Medical Service
tantial part of the proteins in these powders
comes from ground-nut whose biological
value is a mere 56-57% (see table No. 6).
The rest come from milk powder. Thus, the
quality of protein in these preparations is
not better than the quality of proteins in ordi
nary foods. Table No. 6 gives biological values
of some grains when used alone. It is now wellknown that foods containing a mixture of
cereals and pulses have a biological value
more than the arithmatic means of their in
dividual biological values. Many Indian dishes
contain mixtures of cereals and pulses.
The only advantage these protein
powders have over ordinary Idli or Urid-wada
etc, is their reduced bulk. But this has to be
weighed against their high price. These pow
ders are generally taken in small amounts 2030 grams a day, not more than 50 gms. a day.
This will give only 30 gms, of proteins. Usual
daily requirement of proteins of an average
Indian is 50 gms. It is much more during convalesence.
Thus these powders provided
much less than half of the protein require
ments during convalensence. These prepara
tions generally give rise to false sense of secu
Table 6
Comparative Costs of proteins from different sources
No.
Name of the Source
Percentage Biological
of the pro Value %
teins
Price per
kg. in Rs.
Cost per 10 gms of
Proteins
Uncooked
Rs.
cooked
Rs.
1.
Buffallow Milk
4
67
2.60
0.58
0.73
2.
Hen's egg.
13
95
5.00
0.77
0.96
3.
Ground Nut
25
57
7.00
0.28
0.35
4.
Proteinex Powder
56 about
60
71.11
—
1.27
5.
Provitex Powder
63
60
71.11
—
1.12
6.
Protenule Powder
50
60
71.11
—
1.42
7.
Uniprotein
50
60
71.11
—
1.42
8.
Bengal gram dhal
17
61
3.00
0.18
0.22
9.
Red gram
22.3
72
4.50
0.20
0.26
10.
Moth-bean
23.6
54
3.00
0.12
0.16
11.
Green gram
24.5
54
4.50
0.18
0.23
80
2.00
0.29
0.37
12.
Rice, Raw milled
Oct-Nov 1985
6.8
41
rity. A person is given only milk with these
powders and relatives get the impression that
the patient's protein requirements are being
fulfilled.
Complan has not been included in the
above list because it is advertised as the "com
plete food" and contains only 20% of proteins.
The rest is made up of 22 (!) other vital foods
like carbohydrates, fats, vitamins and minearls". It has been specially recommended for
young Teenagers by the manufacturers under
the caption "Growing children need complan".
For a non-sick child, having normal appetite,
obviously parents should better spend their
money over many nutritious Indian dishes than
on Complan.
Cost of cooking at home is assumed to be 25 %
of the cost of the grain).
References :
1.
"The Pharmacological basis of therapeu
tics"-Edited by Goodman and Gillman,
5th edition, 1975, P. 349.
2.
Ibid op. Cit. p. 349.
3.
Ibid op. cit. p. 350.
4.
Ibid op. cit. p. 349.
5.
Ibid 2nd edition 1960, page 1068, (Later
editions, do not contain much on the
medicines used in common cold).
6.
Martindale's
"The Extrapharmacoeia"
27th edition, 1977, Page-295.
7.
Ibid op. cit, page. 295.
8.
Pharmacology and
Pharmacotherapeutics-by Satoskar, Kale, Bhandarkar; 6th
edition 1978, page 280.
9.
Satoskar, Bhandarkar, op. cit, Page 280.
10.
Goodman-Gillman,
page 1326.
11.
Ibid op. cit. page 1531.
12.
The nutritive value of Indian Foods and
the Planning of Satisfactory Diets, and
ICMR publications, New Delhi, 1966,
page 51, 52 and 145-147.
Conclusion :
Most of the over—the counter medicines
discussed above are obviously too costly
compared to the benefits they render; some
of them being virtually useless. It is necessary
to scrutinize
exhaustively, in much more
detailed fashion all over-the-counter-drugs
marked in India and to take up a systematic
compaign against their irrational ingredients
and misleading advertising. It is only through
a mass educational movement that these
malpractices can be stopped.
(Note Calculations are based on prices
in September 1977. Protein percentages and
Biological values have been taken from "The
nutritive value of Indian Foods........ "(12).
42
op. cit, 6th editions
Medical Service
Rational Drug Policy and Primary Health Care
Need for understanding, need for action
Dr. Mira Shiva
VHAI, Coordinator
(Peoples Education for Hea
lth Action Division)
The new drug policy for our nation is being
formulated. On the drug policy will depend:
(1)
How great or small will be the drug
shortages of essentia!and life saving
drugs for the poor;
(2)
How many irrational and hazardous
drugs will be sold in our country;
(3)
How many doctors and patients will
be hooked onto prescribing and con
suming irrational and hazardous
drugs;
(4)
How much further marginalized will
become, the other systems of medicine
and of the several reliant low cost effe
ctive alternative methods of treating
trivial problems with home remedies
and herbal medicine.
(5)
How much profits the drug companies
will be allowed to make at the cost
of the people
(6)
How much foreign exchange the
MNC's will be able to take out of our
country.
It is the importance given to medicines that
decides the nature of health care. Greater
drug dependence as is the trend, is a bypro
duct and also a cause of increased pharma ceuticaiization and commercialization of health
care. National drug and health policy decides
where the emphasis will be. A nation's drug
policy influences the role of drugs in health
Oct-Nov 1985
care i.e. whether there will be a large variety
of medicines for the privilaged few at the cost
of basic essential and life saving drugs for the
poor, or essential drugs available for all.
New Drug Policy
Need for Peoples Participation
Unlike the HATH I Committee which sys
tematically reviewed the pros and cons of
various aspects of the drug policy-before
coming out with its recommendations, the
report of the National Drugs and Pharmaceu
tical Council, 1984 is far from conprehensive.
Drug pricing and fiscal benefits seem to be
all that the drug policy seems concerned
about.
All other crucial aspects of a Rational Drug
Policy have been totally neglected.
Our criticism of the National Drug Policy is
for the following reasons :
Gross omission of any attempt at(1)
Selection and adequate production of
essential drugs of good quality at
reasonable price.
(2)
Withdrawal of irrational and hazar
dous drugs.
(3)
Ensuring availability of unbiased drug
information to the health professionals
and consumer caution.
43
(4)
Ensuring effective drug distribution.
(5)
Effective Drug Control and drug legis
lation.
Many of these things have been
stated several years ago-
Hathi Committee, way back in 1975 gave
some of these very recommendations. Accor
ding to Dr. Zafrullah Chaudhry winner of
Magasaysay award and the spirit behind the
Bangladesh Drug Policy, it was the Hathi
Committee Report that inspired the courageous
Bangladesh Drug Policy.
Main Recommendations of Hathi Com
mittee were:
(1)
Nationalization of multinational drug
companies.
(2)
Establishment of a national drug auth
ority.
Priority production of 116 essential
drugs.
(4) Abolition of brand names and intro
duction of generic names.
(5) Revision and updating of Indian Nati
onal formulary.
(6) Strengthening of quality control.
(7) Elimination of irrational drug combi
nation.
(3)
While shortages of essential and life saving
drugs have occured on one hand, even rural
markets have been flooded with costly brands
of absolutely irrational drugs of doubtful
therapeutic value. Market forces have succ
eeded in creating false drug needs. In the abs
ence of unbiased drug information, the drug
prescriptions and the drug consumption pra
ctices reflect the incongruity between real
health needs and drug utilization patterns.
75% of the drugs in the market are unesse
ntial according to Dr. Halfden Mahler. 25%
of our drug market constitutes of Tonics, Vita
mins, Tonic restoratives, enzymes etc. *Tonic
sales in India is 12% as against 3% in deve
loped countries. On the other hand sale
of Vitamin 'A' is mere 3%. Same goes for
Calcium and Vitamin 'D'. In 1977, an UNC
TAD study showed that, 34% of all drugs sold
were tonics, tranquillizers and cough mix
tures. Antimicrobials were mere 2% and
essential vaccines merely 7%. In 1980, the
production of vitamins, tonics and cough
and cold remedies amounted to 23.5% i.e.
137 crores worth of vitamins alone.
Failure of the Drug Policies and Phar
maceutical Industry to meet the Health
needs of the People.
The Hathi Committee in 1975 drew up a
list of 116 essential drugs for India.
*
The
World Health Organization in 1977, recomm
ended around 200 essential drugs.
**
Sweden
has 2000 drugs in the market. India has
30,000 formulations out of which 5000 are
useful and 2500 are of marginal use.
***
68%
of the drugs are classified as obsolete by the
DCC, of these 30% are useless and 70% are
actually harmful.
The drug production, distribution etc. has
not been at all in keeping with the health needs
of our people.
Under these circumstances it is crucial
that a very rational selection of drugs for pro
duction and distribution has to be made.
In India Hathi Committee Report has been
unfortunately gathering dust.
* Hathi Committee Report
** Technical Report-Series 615 updated later 641 & 685 in 1981 & 1983 res-pectively.
*** EP Feb 1985, page 839-Y.H. Gharpure
EASTER PHARMACIST, page 326.
Oct-Nov 1985
Drugs for thesis Vol. XXVII No. 326—THE
45
ing time and again that the Concept of Essen
tial Drugs is as important for the Develop
ground ed Countries as it is for the developing count
ries.
Rationale of Essential Drugs Concept
1.
Medically and therapeutically
choice.
2.
Economically sound so that it prevents
The best private hospitals in U.S. possess
wastage on unessentials by National their own hospital formularies with restricted
governments.
drug lists. U.K. has recently decided to res
3. Socially sound as it responds to the trict the drug list in the National Health Ser
vices at a considerable saving to the nation.
health needs of the people.
WHO has given very clear guidelines re
Economically sound for patients as it
allows best use of their scarce resources. garding selection of essential drugs, it is upto
the different countries to draw up their own,
5. Limits use of irrational and hazardous based on their priority health needs. This
drugs decreasing catrogenesis.
would guide rational drug production, dis
6. Makes it possible for ensuring better tribution, drug information, quality control.
quality control of limited number of Since profit reasons have guided the entire
policy formulation much to our regret not
drugs.
merely is the selection of the essential drug
7. Possible to make adequate drug informa in the list not very rational — but so is the very
tion available for limited number of setting up of the target demands.
drugs.
Previous warped production patterns and
8. Economics of scale increased bringing warped growth rates have been taken as the
down the cost of a larger amounts of criteria. Just as numerous Indians suffer from
essential drugs are produced on priority chronic malnutrition since they do not have
basis.
the purchasing power to buy food while our
buffer stocks increase and the market for junk
While WHO's essential drug list has been food so also the market demands for irratio
considered extremely short and arbitrary by nal drugs do NOT reflect the need, but success
the drug industry as well as out own drug, ful marketing of certain profitable drugs.
control authorities — slashing the essential
drug list under price control from 343 to 95 Antimalarial
does not even indicate a desire at decreasing
the target if not of banning them. In an attempt
Every Indian knows that Malaria is a problem
to decrease the price control basket, to de for children as well as adults in our country
crease the essential drug list, does not make for which we have the National Malaria Era
sense, when similar attempts at decreasing
dication Program for that since several de
hazardous and irrational drugs is totally miss
cades.
ing and their projected targets increasing.
Chloroquin is in the priority drug list, need
Not merely is the number of drugs in market ed for an important National Health Program.
so large and so confusing, but majority are A comparative study of the drug production,
not essential. Attempts to restrict number as compared to the target set, the capacity
of drugs has been made by several hospitals utilization and the drug imports obviously
reflect the real nature of the highly evolved
as well as countries even in the West indicat
4.
46
Medical Service
Chloroquin in Tons
1977-78
78-79
79-80
80-81
81-82
82-83
Production
37.1
42.5
35.2
34.62
5.9
70 est
Targets
—
—
—
72.0
60.0
111.00
Capacity utilized
—
—
19.9%
19.9%
33.5%
—
Imports
—
—
52.8
71.8
166.3
198.2
Source : Statistical Tables 6 pg 246
Tables 7 pg 253
Tables 11 pg 268
— The Indian Pharmaceutical Industry problems and Prospects
(NCAER) National Council of Advanced Economic Research.
Indian drug Industry; of our policy makers
who have allowed such a trend, to continue;
and our medical profession that has never
protested; and mostly it reflects the inability
on the part of the people to recognize and to
react to a worsening situation and efforts
allegedly in their own interest.
Endemic Goitre
India has over 60 million people with ende
mic goitre. Iodine deficiency in pregnant wo
men and children is known to be associated
with birth of deaf, mutes, mentaly subnormal
children. Over 1,000 significantly mentally
deranged children are known to be born in
Terai region alone. In areas with 50% popu
lation with goitre, 2% of all children born are
expected to be abnormal.
**
All this is for
want of Iodized salt. While the required amount
is 7 lakh tonnes, we continue to produce 1
lakh tons from the UNICEF donated plants.
by
P.L.
Narayana,
Non ensuring of adequate production and dis
tribution of iodized salt amounts to criminal
neglect, in a situation such as this, tobe told
that the budgets allocated for the National
Control of Goitre Program and returned unu
tilized would make the blood of any socially
conscious individual boil with anger. Enough
people have to be angry to demand action, to
ensure action and participate in it.
If such large numbers of our next generation
are allowed to be born underweight and allow
ed to develop only to be blinded, maimed or
mentally retarded — with the health and drug
policies failing to change the situation signi
ficantly — even after 38 years of indepen
dence, then the policies which have already
been found to be inappropriate need to be
totally revamped and need relevant restructur
ing.
The problem of Goitre is a health problem,
ensuring availability of iodized salt should be
** Dr. C. Gopalan, Nutrition Foundation of India.
Oct-Nov 1985
47
Health Ministry's problem — but the avail
ability of iodized salt is being handled by ano
ther Ministry and issue of drugs by Chemi
cals and Fertilizer, which after the reshuffle
is put under the Industry Ministry. With this
kind of policy making on one hand and the
status of health services on the other, the po
orest become the worst sufferers. It is known
that" "The imported and inappropriate
model of health service is top heavy, over
centralized heavily curative in its approach,
urban and elite oriented, costly and depen
dency creating”.*
What is becoming extremely unacceptable
is realization that the present medical model
is failing miserably to meet even the curative
care needs of the majority.
Vit. ’A' Shortages
WHO's "point of fact" on Vit. 'A' deficiency
and nutritional blindness states the role of
Vit. 'A' in human growth and immunological
responses, besides Vit. 'A' deficiency is known
to be the "single most" frequent cause of
blindness among pre-school children in deve
loping countries.'*1
It is not merely a question of blindness with
Vit. 'A' deficiency but the recognized associa
tion of increased morbidity and mortality due
to respiratory and gastro intestinal infection.
"Children with mild Vit. 'A' deficiency are at
2-3 times greater risk of infection and at 4-12
times greater risk of dying than children with
normal Vit. 'A' status."2
Xerophthalmia Nutritional blindness, and
death are associated with disasters and we
have had our share of disasters, draughts,
Bhopals, floods etc.
Children who are being weaned, and are
not on breast milk and unable to obtain their
quota of Vit. 'A' from extra milk or food are
the worst sufferers.
Vit. 'A
*
Malnourished children born of malnourish
ed mothers is not a rare phenomenon in India.
All those involved with I CDS or any kind of
community health or under five work are
aware of the extent of the nutritional problems
and Vit. 'A' deficiency, specially during the
weaning period in under fives.1
National Institute of Nutrition, has recom
mended oral ingestion of 200,000 I.U. in Vit.
'A' every 6 months to prevent blindness.2
No one denies there are nutritional alterna
tives to Vit. 'A', but often its the very denial
of this nutritional input that leads to blindness.
According to Sri Yogendra
Makwana
(Minister of State for Health) reply to a Lok
Sabha unstarred question,3 - a scheme to dis
tribute Vit. 'A' solution through PHC's, ICDS
blocks tribal and drought prone areas and
urban slums was set up. The targets are as
follows:
198283
198384
198485
Targets in million 25.00
25.00
27.00
19.09
18.94
21.00
Achievements
* Ministry of Health,
National Health Policy Document, 1981.
1. Kamal S.Jayarao : Vit.'A'Deficiency Aug. 1976; Medico Friends Bulletin.
2. Swasth Hind, pg. 321, Protection against Vit. *A' Deficiency, Nov. 1979.
3. Reply by Sri Yogendra Makwana, Minister of State for Health and Family Welfare.
Unstarred question 5891 in Lok Sabha by Smt. Jayanti Patnaik.
Oct-Nov 1985
49
Production and Targets of Monitored Bulk Drugs1
Unit
1977-78
1978-79
1979-80
1980-81
1981-82
Vit. 'A' MMU
50.2
62.2
58.8
59.8
52.6
On Comparing Production and Targets of Monitored Bulk1-2 Drugs
Unit
1981-82!
1980-81
Vit 'A'
MMU
T
P
66.0
59.8
T
66.6
1983-84
1982-83
PT
52.6
77.0
1984-85
PT
PT
49.90 60.23 105
52.0
P
41.92
(T — Target, P — Production)
Estimated for the year 1984
55.9
Inspite of all these laudable efforts fre
quent shortages of Vit. 'A
* from the field have
been reported and still exist. Inspite of know
ing that our child population is increasing
annually, the target in 1982 and 83 remains
the same, and yet the achievement in pro
duction comes down during that year.
Vit. 'A' Deficiency
As a response to Sri Jaganath Patnaik's
unstarred Lok Sabha question 6371, Mr.
Veerendra Patil said that Vit. 'A' is a centraliz
ed item and main item marketted as Vit. 'A'
Palmitate (oily) and Vit. 'A' Acetate (dry
powder).
M / s Roch e a n d Glaxo are the major pro
ducers of Vit. 'A' and the entire production
of Vit. 'A' in the country during 1982-83
and 1983-84 was from these two com
panies.
1.
Narayana, P.L.; "The Indian Pharmaceutical Industry Problems & Prospects", Table No. 7,
page no. 244—National Council of Advanced Eco. Research, 1981.
2.
Up-dated Ministry of Chemicals, Fertilizers Annual Report 1984-85, page 38.
Reply of Minister, Chemicals & Fertilizeers, Mr. Veerendra
Sabha, Unstarred Question 6371.
50
Patil on 14th May in Lok
Medical Service
Their production in MMU :
198283
198384
198485
Roche
38.24
40.72
37.60
Glaxo
14.25
19.51
16.56
20.346
MMU
12.685
MMU
Total quantity of
Vit. 'A' imported. 12.425
MMU
Anti T.B. Drugs
India has 1 0 million T.B. patients, out of
which 2.5 million are actively infectious and
50,000 die each year because of T.B. We
produce 1/3rd of the minimum requirement
of anti T.B. drugs, according to ICMR —
ICSSR Report.
Shortages of anti T.B. drugs have been re
ported from several places, including primary
health centres and government dispensaries.
The production of basic anti-T.B. drugs has
not been adequate. A situation has arisen
where sales of costlier anti-T.B. drugs like
Ethamtintal and Refampian are being pushed,
false market demands created, which are
tending to form the basis of targets set.
A point to remember is that with the in
crease in population, even when the T.B.
incidence has not decreased, the overall total
number of T.B. patients has.
It should be noted that costlier and the newer
anti T.B. drugs are being pushed and so also
Streptomycin Penicillin combinations which
are considered irrational by medical experts.
specially in countries where T.B. is a signifi
cant problem. In India we have over 10 million
T.B. patients with 2.5 million actively infec
tious. This is so inspite of the National T.B.
Control Programme, T.B. Association of India,
etc. Over the years, the incidence has not
decreased. In fact, with actual increase in our
population, this has obviously meant increase
in the number of T.B. patients. Emergence of
drug resistance to Streptomycin is a reality,
specially with over use of streptomycin penici
llin combination.
In such a social reality, the danger of emerg
ing streptomycin resistance does not warrant
the misuse of this combination for all kinds
of known and unknown infections, lest it be
argued that we have wonderful new drugs
like Rifampicin ethambutal etc. — well these
wonderful new drugs are not given as part of
the National T.B. Control Programme and
those usually suffering from T.B. cannot afford
them and overuse and misuse of drugs when
no effort to prevent default is made is a ha
zardous proposition. Specially after Chingle
Pet trial results on the non-role of B.C.G. in
preventing pulmonary tuberculosis — misuse
of such combinations should not be allowed.
The irony is that this is happening at the cost
of streptomycin availability for T.B. patients.
Shortages for leprosy drugs, anti-epileptic
drugs for gloucoma, for hypertension, even
of anti materials have occurred for prolonged
periods, this continues in contrast to more
and more irrational drugs flooding the market.
Such shortages in a country with such a
developed drug industry and a democratic
form of Govt where peoples representatives
are elected and expected to give priority to the
peoples interest and their needs the existing
silvation does not make sense.
Mira Shiva : The drugs needs of a national health priority Tuberculosis Paper presented at
MFC Annual Convention, 1984 on 'Rational T.B. care'.
Oct-Nov 1935
COMMUNITY HEALTH CBU
326» V
I Block
Koranv ng1 * ?
Bangs iora-b^U034
51
m
S.
No
Name of the Co.
Name of Formutation
Composition
Pack Size
Nos. of the units produced during the year
ended December —
1982
1983
1984
22,37,336
21,77,927
21,25,428
1. M/s Roche Products
Arovit Tabs
Vit 'A' 50,000
10 per tab.
8's
2.
-do-
Arovit Drugs
1,50,000
10 per amp.
7.5 amp
,20,233
11,195
6,686
3.
-do-
Arovit Inj.
1 lakh
10 per amp.
3 amp
2,67,250
2,35,308
1,79,199
4.
-do-
Arovit Forte
3 lakh
10 per amp.
3 amp
1,93,164
1,46,686
1,42,119
5.
-do-
Rovigon Tab
Each tab. con
tains :Vit 'A'
10,000
10 Vit. 'A' 25 inj
8's
17,68,533
14,52,019
13,34,547
Prepaline Caps.
24,000 IV
100's
64,148
42,525
42,965
6. M/s Glaxo Lab.
Medical Service
7.
-do-
Prepaline Inj.
1 ml.
23,790
19,364
4,014
8.
-do-
Prepaline Inj.
(Forte)
1 ml.
4,34,651
3,80,806
28,956
CONTINUED
SALES OF BANNED BANNABLE
AND HAZARDOUS DRUGS
While on one hand shortages of essential
drugs are occurring, irrational and hazardous
drugs continue to be sold.
It is amazing, how with imports of 'high
technology' how rarely are the 'controls' and
'precautions' imported. Bhopal proved it to the
nation and the pharmaceutical sales are another
example.
Technological know-how has come to mean
know-how required for putting up the pro
duction plant. The knowledge of the status
of the product in terms of efficiency, safety,
comparison with other drugs, evaluation stu
dies in other parts of the world are all part of
knowhow.
Numerous unsafe and controversial drugs
continue to be marketted. We expect our drug
control authorities, not to issue licences for
drugs known to be hazardous and banned
elsewhere, we expect them to withdraw licen
ces and also withdraw such drugs from the
market, for which safe alternatives exist.
Thalidomide disaster sums up the problem
of hazardous drugs and the implications of
their indiscriminate sales. Over 16,000 child
ren were born malformed, invalid for life be
cause their mothers consumed Thalidomide —
a drug which was sold to them for morning
sickness and safety alleged. Obviously tests
on effect on foetus was not done.
77?e E.P
*
Drug Story . is a medical crime
story — it received significant press coverage
in 1982 when the national campaign against
EP drugs was launched. Here is just a brief
review:
In 1976 WHO based reports from Austra
lian Medical Association warned all the
member countries not to use high dose
estrogen-progesterone
drugs for preg
nancy test — as it was found to be associat
ed with foetal malformation.
While it was used only for women desirous
of terminating their pregnancies in certain
countries, others switched over to safer
alternatives i.e. urine testing for pregnancy.
In India till 1982 drug marketing literature
advocated the drugs for pregnancy testing.
What was probably most hazardous was the
fact that not merely were these drugs being
prescribed freely by the doctors without any
warning to the mothers, (who had every in
tention of having their babies-healthy babies)
but these products were sold freely over the
counter without warning to anyone for the
asking.
The drugs were consumed not merely for
pregnancy testing but for inducing abortion
and several other gynaecological problems.
Warnings in Medical jargon, warnings in an
alien language, warnings in microscopic let
ters, even if written would not have made any
sense — to the illiterate and ignorant women,
on the 'Women's Day' 8th of March 1982,
the EP campaign was launched. Journalists,
consumers, women activists wrote in the
press, held meetings, discussions and circu
lated information to protest. Refer: "Are hor
monal drugs safe" VHAI handout. On 26.6.85
through DO No. 12-48/79 DC, the production
of these drugs was banned from the 31st
* E.P. is short for high dose estrogen Progesterone Combination.
Oct-Nov 1985
53
of March and their sales banned from the
30th of March '83, Ref: "EP Update" VHAI,
VHAI — handout. The sense of achievement
was short lived. Organan — (now known as
Infar), Unichem and Nicholas went to Cal
cutta and Bombay High Courts and got stay
orders against the ban. Ref: "Review of EP
drugs" VHAI handout.
Today, the drugs are freely sold. Licences
for production of the drugs have been given
for two more years. Issues related to health
and therapeutics are being decided in the
court. Ref: Unifinished EP Campaign — Drug
Action Network.
Money power can buy doctors, bureaucrats,
politicians and even those who are suppos
ed to safeguard the interests of the people.
It may be of interest to know that, Organan,
so concerned about the needs of the Indian
women, does not produce high dose of EP
drugs for Dutch women in Netherlands.
The EP case story indicates that efforts of a
section of public and even action by drug cont
rol authorities (under public pressure) is not
enough to prevent the powerful drug lobby to
continue making its profits at the cost of health
of the people.
Justice Potti's verdict in the Kerala High
Court on the Public litigation case on banned
drugs, makes enlightening reading —
"as between the lives of the citizens of this
country on one hand and the loss that may
result to manufacturers and traders by the
immediate ban on the manufacture and
sale on the other hand, the Govt, has chosen
to view the latter as of more concern."
"The provision of a cut off date for manu
facture as well as on sales is an irrational,
highly unjust, unfair and a immoral approach
adopted as a result of a distorted appreciation
of values" — Dr. Potti, Kerala High Court —
OP No. 8439-82 L.
Disgust and anger has to be expressd at
such drugs, at the drug companies producing
them, at the drug legislations and the autho
rities concerned who formulate these policies
and allow such crimes to continue on the
public.
Antidiarrheals
While 1.5 million Indian children die of diar
rhoea each year, the drug market of antidiarrhoeal is flourishing. Message of ORT is drawnedin the glib sales talk for the galaxy of anti
diarrheals.
Lomotil
Known to have caused several infant deaths
due to its extremely narrow safety margin
continues to be given to children. Social Audit
fought a long drawn out battle jusi to ensure
that the multinational company Searles pro
ducer of Lomotil gave a warning against the
use of lomotil for under 2.
*
Clioquinols-Hydroxyquinolines
form like drugs)
(Mexa-
The crippling and blinding of over 11,000
Japanese with mexaform enterovioform is well
known. Efforts by drug companies involved
and the medical community to associate
SMON Syndrome (subacute Myeio Optic
Neuropathy) with "virus", "genetic" causes
were countered by a group of socially con
scious lawyers, journalists and doctors. The
role of Dr. Olle Hansson who fought as a wit
ness on behalf of the SMON victims is well
known. Not merely did he show the associa
tion of blindness (optic neuritis) with mexa
form and enterovioform he scientifically show
ed that the drugs were absorbed from the gut
*1. "Drugs Diplomacy" by Charles Medawar & Barbara Freexe Social Audit.
2. "Taste of Tears" Health Action Series, by Mira Shiva & Aspi Mistry, VHAI, New Delhi.
3. "Diarrhoea Management" by Dr. S. Datar, MFC.
54
Medical Service
and therefore it could affect the nervous sys
tem. Ciba-Geigy had made several efforts to
deny this and supress the facts which were
available to it. Efforts of Dr. Olle Hansoon
who led a boycott of over 3,000 Swedish
doctors against continued sales of drugs,
efforts of Japanese lawyers and SMON vic
tims to get these drugs withdrawn world wide,
succeeded in forcing Ciba-Geigy to withdraw
Enterovioform and Mexaform from the world
market by March *85.
Irrationality of combinations e.g. chloromycqtin streptomycin and as well accepted
elsewhere and the fear of emerging resistance
against Typhoid (solimonella Typbi) due to
misuse of chloromphenical and its combina
tion are proving tobe genuine fears. Over
20,000 Medicans died in 1975 in a Typhoid
epidemic because resistance had emerged to
chloroquin unrecognized
by the medical
professionals. Several deaths from Kerala and
chlorophenical resistant. Typhoid in endemic
form is being reported from there and spread
ing. Resistance to majority of the commonly
used antibiotics contributed to the deaths of
over 2,000 in 1983 in West Bengal dysentry
epidemic. Besides death and uncontrolled
spread of diseases, resistance due to misuse
of patent antibiotics for trivial problems means,
dependence on costly, unaffordable alterna
tives.
At the Drug Action Network meeting in
August '82 organized jointly by VHAI — MFC
— hazardous drugs were the main focus:
— Paediatric Tetracyclin
— Anabolic steroids
— Aundopyrines
— High dose Estrogen Progesterone drugs
Unit
Oxyphenbutazone
lodochlorohydroxyquinoline
Dilodohydroxyquinolin
Oct-Nov 1985
Tons
Tons
Tons
— Hormonal preparations
— Antidiarrheals — lomotil
— choquinals.
Detailed handouts were prepared on the
above drugs by VHAI.
Since then consumer alerts regarding Oxy
phen butazones have been sent in July '84.
Over 1034 deaths with Tandril have occurred
due to agronulyajtosis according to informa
tion from Ciba-Geigy's internal files, informa
tion which was leaked out following interna
tional pressure from drug action and health
action groups. Forced Ciba-Geigy to de
cide to withdraw, goes to late Dr. Olle Hansson
— friend of the third world. Based on views
of expert committee meeting. Phenyl butazone
could be used only in 2 conditions :
(1) Ankylosing Spondytilis
(2) Gout
tandril is sold under the name of Suganril
and is produced by Suhrid-Geigy. Suhrid
Geigy has alleged that Ciba Geigy's decision
to withdraw Tandril does not bind them in any
way as they are an Indian company now. Sales
continue unaffected white prescribers conti
nue to prescribe and consumers continue to
consume.
For those of you interested to know the
chemicals and Fertilizer
Ministry's future
plans regarding these drugs, see below:
Demand targets for known hazardous and
unsafe drugs for which safer alternatives are
available indicates the total lack of NDPDC
to even seriously consider phasing out these
drugs or at least not planning their growths
e.g.
Estimated
production
1983-84
110.60
136.80
96.55
Estimated
Demand
1989-90
6650.00
460.00
160.00
Growth%
55
DRUG INFORMATION
—Dealing with its scarcity
Nothing can illustrate the situation regarding
Drug Information better, than knowing that
some of the members constituting the Parlia
mentary Drug Consultative Committee had
never heard of WHO's Essential Drug List —
nor of the concept of essential drugs.
For such an important concept, that is basic
to formulation of a rational drug policy and
almost a decade old, for the doctors in medical
colleges, health personnel in Government
and Voluntary sector not to know about it,
indicates total apathy in sharing of drug in
formation by authorities concerned.
Why is it that Hathi Committee's recom
mendations are not taught in Pharmacology?
Why questions of banned drugs, controversy
between Generic Vs. Brands, criteria of ra
tional drug Therapy — based on WHO re
commendations not taught in medical schools,
when some of the major problems related to
warped prescription practices is related to
ignorance about these.
The Health authorities not merely have fail
ed to draw up a comphrehensive essential
drug list for the nation but they have also failed
to pick up the National Drug formulary from
the dusty shelves since 1977 and update it.
VHAI's Drug Action network newsletter
and its handouts drugs and information ser
vices; MFC's Bulletin which has often cover
ed drug issues, their study reports on analysis,
antidiarrheals; several articles and handouts
by All India Drug Action Network members
have contributed significantly to the Drug
Information lacunae. Materials produced by
KSSP, CERC, Drug Action Forum, West
Bengal and others along with the contributions
mentioned earlier are amongst the only drug
information available today.
Locost will be producing Drug Information
sheets on drugs being sold by them, DAF,
West Bengal is planning a Drugs and Therapeuts Bulletin.
It goes without saying that information is
power and that information is for sharing and
information is for action. For any significant
peoples health action we have to educate
ourselves, because no one else will.
Unlike in other forms of exploitation an
aware person can take action by refusing to
prescribe and refusing to buy and consume
drugs that are banned, hazardous or irratio
nal. This is drug action, health action and a
political action.
Failure of the Chemicals and Fertilisers and
Health Ministries to produce the banned brand
drug list — has forced us to bring out the list
initially in a cyclostyled form and now in a
printed form for public education.
Gandhi did it against imported milled cloth
and as a protest against taxation on salt led
the 'Dandi March' and the famous 'Salt Satyagraha'. Consumer groups call it 'Boycott'.
Such actions are needed when no other re
medial action seems forthcoming and when
'irrationality' and'unethical' practices begin
to go unchallenged and start setting the norms.
Drug Bulletin from the PGl, Chandigarh,
Pune Journal of Continuing health education
by 'Arogya Dakshata Mandal' have been
making a brave effort at providing unbiased
drug information to health personnel.
Today not merely growing exploitation,
needless health hazards due to unsafe drugs is
at stake — but the entire concept of rational
health care. No one will help change the situa
tion but us.
56
Medical Service
New drug policy—Adding insult to Injury !
—Dr P.K. Sarkar
Before 1962 there was no control over the
drug prices in India. Thereafter, several orders
have been issued by the Govt, of India (GOI)
to regularise and control the production and
price of drugs (modern scientific drugs; Allo
pathic drugs). The last Drugs Prices Control
Order of 1979 (DPCO, 1979) deserves spe
cial mention. With a view to ensure adequate
production and to keep the price of certain
useful drugs within limits GOI has categorised
different drugs into four categories and fixed
the limits of profits for drugs belonging to
each category as follows.
The idea implicit with the DPCO, 1979 was
that the drug manufacturers would produce
essential and life saving drugs which would
fetch some what lesser (I) profit which they
would make good by selling drugs belonging
to category III & IV and thus the supply of
of essential drugs to the market at a reasonable
price would be ensured. In the following discu
ssion we shall try to analyse the impact
of DPCO, 1979 on the drug scene in
India.
Following
tables will show the
decreasing trend of production of essential
drugs.
Maximum
profit allowed
Category I
Life saving drugs
"
—40%
Category II
Essential but not life saving
"
—55%
Category III
Useful but not belonging to above cate
gories & new drugs
"
— 100%
Others (like Tonics-Vitamins, enzymes,
cough syrups, etc. & new drugs)
Unlimited
Category
IV
Profit margin
Table I
Drugs
Actual Production (April to
Sept. 1980 (in tonnes) 1981
1.
Chloramphenicol (antibiotic for typhoid fever)
46.41
36.16
2.
215.16
122.22
3.
PAS (anti TB drugs)
INH (f
")
69.18
53.70
4.
Piperazine salt (for worm)
6.30
4.20
5.
Dapsone (antileprosy drug)
10.20
10.17
6.
Diethyl carbamazine (antifilaria drug)
10.58
8.42
(Source-Rajya Sabha proceedings, Sept. 1981)
Dr P.K. Sarkar is lecturer in pharmacology & active member of WB Drug action Forum
which is a co-ordinating Committee member of AIDAN. Dr Sarkar will be editing DRUG &
RATIONAL THERAPY.
Oct-Nov 1985
57
Table II
capacity
Actual
1980
production
1981
(Metric
1982
Tonnes)
1983
PAS
110
13.5
13.78
5.7
Nil
INH
80
73.77
54.00
71.5
Nil
Protinex
110
254.86
252.15
278.59
not known
Drug
Lisenced
Data relate to Pfizer, a multinational company.
On the other hand the table II shows
that the production of nutritional supplements
has been stepped up.
know how to manufacture almost all the
drugs in India and there is no need to import
bulk drugs.
Presently about 40% of drug market has
been occupied by these substances (Tonics,
Vitamins, Enzymes, Sleeping Pills, etc). The
drug manufacturers have not only increased
the production of useless drugs, they are also
enhancing the prices of drugs including some
essential drugs almost every year. Follo
wing table III will give us some idea of this
price escalation.
While this unhappy scene continues, there
has been a concerted attempt by the drug
manufacturers to add insult to injury. On the
plea that their business has become unremunerative they are trying their best to change the
existing Drug Policy of the country. Drug
companies have collected favourable data
through a private organisation (NCEAR) in
place of the conventional Bl CP ( a Govt.
organisation) and with the findings of NCEAR
study, they have been pressurising the gover
nment for changes which will be favourable
for them. To appease the drug companies
the government is going to change the Drug
Policy again. National Drugsand Pharmaceu
ticals Development council (NDPDC) had
appointed three working groups for the pur
pose. The reports of the working groups
have subsequently been considered by a
steering committee whose recommendations
have already been submitted. The outstan
ding changes proposed by the committee
may be briefly mentioned here. The existing
DPCO, 1979 is operative on 360 bulk drugs
which means that formulations (finished pro
ducts like Tablets, Syrups, Injections, etc)
made out of these 360 bulk drugs come under
the DPCO and their prices are controlled by
A casual survey of some twenty drugs out of
45-000 drugs sold in the market shows that
the drug manufacturers have enhanced the
price of drugs (between 41 and 614 percent)
over a span of four years only. The list is not
exhaustive and price escalation has left very
few drugs untouched. It is thus apparent
that the DPCO, 1979 like the proviuos one of
1970 has failed to achieve its objectives: A
perpetual shortage of essential drugs for the
treatment of common ailments of the people
of India continues while the drug prices keep
on soaring. It will not be out of place to men
tion that about 30 to 40 per cent of bulk drug
is imported every year, though different expert
committees have repeatedly (Hathi Committee,
1975; UNIDO, 1981) opined that India has
the requisite infrastructure and technological
58
Medical Service
Table III
Name of product Packing
_____ (Manufacturer)_______
Price-June
'81(a)
Rs.
Rs.
Percent
price Sept
rise from (a)
'85
P.
(C)
Rs.
P.
(a)
Dristan (Manners)
4—26
6—90
62
8—12
97
2.
Otrivin (Ciba)
4—75
6—38
34
8—00
68
3.
Antrenyl (Ciba)
1—28
2—33
82
2—50
95
4.
Digiplex-170 m. (Rallis)
5—35
12—55
98
14—84
177
5.
Vitazyme-110ml (East
India)
4—60
8—14
77
9—50
107
6.
Takazyme (P&D)
4—40
8—92
103
11—22
155
7.
Dexorange-200ml
nco-lndian)
10—29
14—50
41
19—00
85
8.
Hepatoglobin-300ml
(Raptakos)
11—14
19—12
72
20—09
80
9.
Protinules-100g (Alem
bic)
9—86
13—22
34
13—91
41
1.
(Fra-
10.
Protinex-225g (Pfizer)
14—50
21—72
50
21—72
50
11.
Syu-300g (AFD)
15—02
16—71
73
28—71
91
12.
Durabolin-25 mg. ml
(Organon)
7—28
10—54
45
12—10
66
13.
Sustanon-1ml (Organon)
20—07
31—21
(10 tab)
56
35—90
(10 tab)
79
14.
Lynoral (20 Tab)
(Organon)
1—05
3—20
515
3—75
614
15.
Menstrogen (20 tabs)
(Organon)
6—00
(20 tab)
4—68
(10 tabs)
56
6—00
(10 tab)
100
3—55
(20 tab)
4—53
(10 tab)
155
5—20
192
5—50
128
6—04
151
70
4
It
P.
Price June percent
'84(b)
Rise (c)
16.
Mixogen (20 tabs)
17.
Aquaviron-B 12-1 ml
(Nicholas)
2—41
18.
Celin 500 (Glaxo)
1—96
3—00
53
3—33
19.
Sukcee (IDPL)
2—02
3—26
61
4—60
128
20.
Stemetil (M&B)
0—88
2—32
164
3—58
307
Source : (from MIMS ‘81)
Oct-Nov 1985
(Actual price printed
on pack)
(Actual price printed
on back)
59
the Govt. In the proposed Drug Policy this
number has been reduced to mere 95. There
will be no price control on the remaining 265
bulk drugs which the Government so long
considered to be life saving and essential. This
is to say as if those drugs will cease to be life
saving and essential once the new policy is
announced. The next change relates to the pro
fit margin of these 95 drugs to be henceforth
considered essential by the government. In the
existing DPCO, depending on the nature of
essentiality the mark up (profit margin) varies
between 40&100 per cent. The manufa
cturers have demaned a uniform mark up of
125 per cent on all the essential drugs. It is
reported that the new drug policy can not be
declared because of lack of unanimity between
the government, IDMA (Indian Drug Manu
facturers Association) and OPPI (Organisa
tion of Pharmaceutical Producers of India, an
MNC lobby) on the extent of this profit margin.
It has also been reported that the government
may agree to a uniform mark up of 75-80 per
cent. Once this issue is settled the new
Drug Policy will be declared which will invari
ably lead to a further increase of the price of
essential and life saving drugs. This is defi
nitely going to deteriorate further the exis
ting drug situation in India;
60
The All India Drug Action Network (AIDAN)
has sharply reacted to the proposed changes
in the new Drug Policy contained in the stearing committee recommendations. AIDAN has
criticised the recommendations almost enti
rely and has submitted the critisissms to the
Minister-in-charge of Chemicals and Ferti
lisers in August 1985. It may also be menti
oned that AIDAN has not only critisied the
Govt. Drug Policy but also formulated an
alternative Drug Policy suitable for the country
which in contrast to the one by the govern
ment is rational and needbased. In their
Drug Policy Govt, only mentions the produc
tion and price of drugs where as the one for
mulated by AIDAN contains such discussions
as estimation of the drug needs, self suffici
ency in production, distribution, quality con
trol, drug price, information dissemiation and
many other topics. The most crucial demand
made by AIDAN is the recognition of a scien
tific definition of DRUG and elimination of
all products from the market which have abso
lutely no medico-scientific basis and falls
outside this definition. These products occupy
the larger share in the production process.
Provided these are eliminated there will be
no dearth of essential drugs if the entire pro
duction capacity is employed for the purpose.
Medical Service
CHAI Executive Director elected Asian Representative
to International Committee of the Federation of
Catholic Hospitals and Health Care Institutions
\
|
The first International Congress of Catholic Hospitals and Health Care Institutions was
held at Vatican, Rome from 29-31 October '85. Fr. Ferdinand Kayavil, President, CHAI and
Fr. John Vattamattom SVD, Executive Director, attended this meeting. The meeting was
organised under the auspices of the newly established Pontifical Commission for the Apostolate of Health Care workers. About 1500 delegates from 40 different countries repre
senting six continents attended the meeting. During the meeting Fr. John Vattamattom SVD,
Executive Director, CHAI, was elected to represent Asia along with Dr. Y.W. BAHK of Korea
in the international committee of the World Federation of Catholic Hospitals and Health
Care Institutions. The need was felt by the Holy Father to have this organisation of health
care institutions to coordinate the works done in the Church throughout the world and to
have a solidarity among these institutions. Holy Father's keen interest in this was evident
when he came to the meeting on the last day and addressed the gathering, with very encour
aging words and imparted his Apostolic Blessings on all the health care personnel and
institutions all over the world.
ACKNOWLEDGEMENT
Dear Reader,
By an editorial oversight the sources of the articles which were reprinted in the July
1985 (Vol. 42 No. 6) issue of Medical Service on Bhopal, were left out. These were recol
lected from a wide range of sources acknowledged below:
Article
Source
2.
Introduction Bhopal a peoples view
of death their right to know and live
Introductory chapter of a book by the same
name Eklavya, Bhopal
3.
The challenge of Bhopal
Editorial, medico friend circle bulletin, 114
June 1985
5.
Medical research in Bhopal
Medico friend circle bulletin 112, April 1985
6.
Mental health introduction
7.
Emotional reaction to stress
Mental Health Care Manual for
Medical Officers, Bhopal, N IM HANS,
April 1985
8.
Industrialization: The darker side
The Indian Express 3rd Feb. 1985 and
Parisara, Bangalore booklet on Bhopal
— Editor
Medico Friend Circle
Regd. Office & Rational Drug Policy Cell
50 LIC Quarters
University Road
Pune 16.
7th February, 1985.
PRESS RELEASE
Only 14 out of 59 analgesic preparations found scientifically justified :
Dr. Jamie Uhrig and Dr. Penny Dawson of Medico Friend Circle have analysed 59 pre
parations listed as analgesics and antipyretics in the July *84 issue of MIMS, India and found
45 of these 59 preparations to be irrational on some ground or the other.
Basing themselves on the latest authentic textbooks. Dr. Uhrig and Dr. Dawson rigoro
usly studied each of these preparations and graded them into the following categories :
A :
Use of the product is justified—14 preparations for example: Plain paracetamol.
Aspirin etc.
B :
The combination is not proven to be superior to single ingredient preparation and
hence not recommended
16 preparations. For example—
Equagesic, Fortagesic, Malidens. Micropyrin, Optalindon
etc.
C :
The combination has been proven to be inferior to single ingredient preparation
and should be withdrawn
11 preparations. For example—
Apidin, Carbutyl, Dolopar Plus, Norgesic, Parvon-N, Parvon-P, Proxyvon, Spasmo-proxyvon, Sudhinol-N C
etc.
D :
The preparation contains analgin and should be banned
18 prepara
tions. For example—Codosic, Dolopar, Novalgin, Ultragin, Sedyn-Aforte, Spasmizol
etc.
Medico Friend Circle appeals to socially conscious medicos to ask for withdrawal of all
the preparations in categories B, C and D.
We congratulate Dr. Uhrig and Dr. Dawson for their spontaneous initiative in conduct
ing this study. This study is available with the Rational Drug-Cell of M.F.C. at a cost-price of
Rs. 3/-. Please write to
Anant Phadke
50, LIC Quarters
University Road
Pune-411016
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