Rational Drug Policy Statement by All India Drug Action Network
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- Title
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Rational Drug Policy Statement
by
All India Drug Action Network - extracted text
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Rational Drug Policy Statement
by
All India Drug Action Network
U36
COMMUNITY MEM TH C-: '
'7/1. fPf-H Fleer;- St. Marks Read,
ALL WD1A DRUG ACTION NETWORK
C-14 COMMUNITY CENTRE S. D. A. NEW DELHI 110016
RA i IGNAL DRUG POLICY - STATEMENT
An India Drug Action Network (AIDAN), is a forum, and
coordinating body of organizations,
and individuals
all over the country working towards the adoption and
implement-fion of a people oriented Rational Drug Policy
in India as a part of a Peoples Health Policy. It sets out
the following outline for the Drug Policy :
Majority of the Indians suffer from the diseases of
poverty and ignorance, i.e. communicable diseases,
diseases due to undernutrition etc. Most of these illnesses
are preventable and curable, in addition, distorted pattern
of industrialisation and urbanisation has led to the deve
lopment of so called diseases of industrialisation. What
we need most is adequate nutrition, adequate and safe
water, universal sanitation, development without damaging
environmental balance and primary medical service,
available to all.
Although drugs constitute only a small part of the overall
health care, they are
most urgent, essential and
hence a priority need in the country where incidence
of death and disability from diseases is high. So long
the basic elements of health care are not made available
universally, medical care will continue to be the priority
service to reduce death and disability and in this context,
drugs understandably assume a vital and priority role.
The fact that drugs can save life and relieve sufferings
has been exploited by the drug industry, which is oriented
mainly to profit making, to push all sorts of irrational
druas onto the consumers. The druq industry and the
medical establishment has created a very drug-dependant
health culture which eclipses the much-needed sustainable
solutions to the real health problems. Doctors and non
doctors alike are made to believe that drugs are "cure all"
-:2:~
for all ills. Health is still regarded as basically an indivi
dual or personal responsibility and not a product of
social factors.
It is also believed that freedom from diseases could be
obtained by better an. better and more and more drugs.
Such a belief among educated and illiterate alike, has
led
to a universal craze for drugs and
this DRUG
CULTURE has come to dominate the society. In this
situation it is not surprising that drugs provide an oppor
tunity for unlimited profit-making by the drug industry,
since hardly any consumer asks for the necessity, utility,
rationality,
price-justifiability
and
harmful
effects
of a drug. It is not even asked whether a substance sold
as Drug is actually a Drug at all. As a result, about 60%
of the drugs in the market are unscientific or harmful
or substandard; a large number of these are not actually
drugs; many drugs are consumed by those who do not
need it; people die or are disabled from the effects of
harmful drugs; drugs are sold at fantastically high prices;
and most serious of all life saving and essential drugs
are not available to the majority that need them most.
Even 38 years after independence, multinational corpo
rations continue to dominate the drug industry in India.
Further, the majority of their production consists of
drug formulations and not bulk drugs. Though, according
to UNIDO, India has the capacity to be self sufficient
in bulk drugs, we still import 40% of our bulk-drug
requirement.
Objectives
of the
Rational
drug
policy
We feel that the Rational Drug Policy objectives should
include the following :-
A.
ASSESSING THE DRUG-NEEDS
1)
.2)
To identify the drug needs in consonance with
the health needs of the people, particularly
those required for primary health care; to
prepare a graded essential and priority list of
drugs for different levels of health expertise
inkeeping with actual health needs of the people.
To eliminate
drugs.
irrational,
useless
and
hazardous
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B.
C.
PRODUCTION, PRICE AND QUALITY CONTROL
1)
To make all drugs available at low prices to the
people, particularly the essential & priority drugs.
2)
To ensure quality control of all drugs.
DRUG DISTRIBUTION
To establish a national corporation for the distri
bution of drugs; retailing of drugs through fair
price shops and government's health infrastru
ctures.
D.
E.
F.
DRUG INFORMATION AND ETHICAL MARKETING
1)
To ensure a drug information system for health
personnel and consumers.
2)
To ensure ethical marketing.
3)
To abolish brand names
names for all drugs.
and
introduce
generic
SELF - RELIANCE
develop
self
reliance
in
drug
1)
To
2)
To foster and encourage the growth of the Indian
Sector and to provide a leadership role to the
public sector.
3)
To aim at quick self sufficiency in the output of
drugs with a view to reducing the quantum of
imports.
technology.
RESEARCH AND DEVELOPMENT
To promote research and development for selfreliance and in accordance with the needs of
the Indian people.
G.
LEGISLATION AND ADMINISTRATION
1)
To
provide
comprehensive
drug
legislation
and administrative support to deal effectively
with and implement all the above aims and
objectives.
2)
H.
To ensure smooth Centre-State relations anc
inter-departmentai
coordination
for
effective
and relevant drug production, drug control and
drug supply.
HUMANPOWER DEVELOPMENT
To fulfill the needs of the above Rational Drug
Policy, different type of technical personnel
(e.g. druggists, paramedics, etc.) need to be
adequately and appropriately trained in adequate
numbers.
A.
A
ASSESSING THE DRUG NEEDS
1.
Identification of Drug needs and Prioritized Essential Drug List
i)
The National Drug Formulary should be revised and compiled
by an expert multi-disciplinary committee with suitable repre
sentation from all the sections of health professionals. This
committee should draw up the essential priority drug list,
keeping the following criteria in mind -
*
Medico-social justification should act as a primary
criterion keeping in mind - efficacy, safety, cost, ease of
administration, potential for misuse, indigenous production.
*
Priority for production has to be given to the drugs
required for diseases causing greater mortality (death),
greater morbidity (illness), severe sequelae (after effects).
*
Drugs used in National Programmes e.g. TB, leprosy,
malaria, blindness, goitre control, and immunisation
programmes should get priority.
This list should be revised periodically.
ii)
Selection of the essential and priority drugs would be followed
by preparation of graded drug list for different categories of
health personnel and health institutions. These lists should
form the basic guidelines for bulk purchase procurement and
requisition stocking and dispensing.
A
5
-:5:An appropriate authority (see section G2) should continuously
assess drug needs and drug production and monitor capacity
utilisation in the industry, drug utilisation patterns, health
needs, changing pattern of diseases, drug requirements, new
information on old drugs, introduction of new drugs, efficacy
of the existing policy of production, distribution and use of
drugs.
2.
Withdrawal of hazardous, irrational and therapeutically useless
drugs.
i)
All the drugs in the market should be scrutinised to assess
their rationality on the basis of standard text books of medicine
and pharmacology. All drugs which are not recommended
in these text books should be banned. Those drugs which have
life-threatening or serious side-effects and for which equally
effective alternatives are available should be banned immedia
tely. The rest of these drugs should disappear from the market
within one year.
ii)
No fixed dose combination forms should be allowed to be
manufactured if an alternative single ingredient drug is available
for the purpose, which is therapeutically equivalent and more
cost effective.
iii)
Drug Legislation should be modified to ensure that no stay
order is granted in cases pertaining to banning hazardous
drugs in the interest of public health.
B.
PRODUCTION, PRICE AND QUALITY CONTROL
1.
Production and Price Controls
i)
The priority drug list should be a part of much larger essential
drug list based on WHO recommendations as well as those
of our own National Drugs and Therapeutics Authority. In
this essential drug list, life saving drugs and drugs for primary
health care shall be put as category I termed as priority drug
list and the rest of the list shall be put in category II.
ii)
The production of essential drug formulations shall be a minimum
75% of total formulation turnover of each manufacturer now
and shall be brought up to 90% in five years. The priority
drugs shall constitute 60% of the above essential drugs and
shall be raised to 80% of the essential druos in the next 5
years. The above production quota should,, jpcjude aH dosage
forms of essential and priority druqs.
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iii)
All companies having equity above 26% shall
as foreign companies (as per RBI definition).
iv)
All foreign companies shall produce bulk as to formulation
ratio of 1:5. For other companies the ratio shall be 1:10.
v)
A mechanism should be evolved to provide incentive to those
companies which produce more than the required quota of
essential/priority drugs and deterrent punishment to those
companies which produce less than the required quota as
given above.
vi)
The priority drugs should be made available at low prices.
If required, they may even be subsidized. Before any major
revision in the pricing policy is done, as a policy there should
be an independent study to assess the cost, profitability as
well as availability and price from the point of view of consu
mers. Profit-making should not be the sole basis of the drug
industry. All taxes from priority drugs should be abolished
to reduce the prices of such drugs.
vii)
The trade commission shall be fixed at 20%. However, this
is the total commission which will be paid from the principal
manufacturer to the distributors and the intermediaries. While
the markup under the head of trade commission will be increa
sed, the markup under the head of sales promotion will be
decreased for essential and priority drugs.
viii)
All drugs including nutritional supplements, except that produced
by small scale sector, shall be under price control.
ix)
The small scale sector can be free from price and production
controls. However, the small scale sector will be defined
as those companies whose turnover is less than 20 lakhs and
not linked to large scale and organised sector units through
ownership, financial participation or marketing arrangements.
2.
Proper Drug Registration and Monitoring
be
identified
Registration
1.
All pharmaceutical products, both ethical drugs and over-thecounter (OTC) preparations offered for sale should be duly
registered by a competent authority.
-:7:2.
Commercially sold indigenous medicines should also be registered
and pharmaceutical products which are not registered should
not be allowed to be marketed.
3.
Pharmaceutical manufacturers and traders must provide the
registration authority with a list of all countries in which the
specific product has not been accepted for registration.
4.
Pharmaceutical manufacturers and traders should inform the
registration authority if a pharmaceutical product already
registered in the country has been removed from the register
of any other country together with the reason for its removal.
5.
Pharmaceutical manufacturers and traders, when applying for
registration of a product, must be made to undertake that
subsequent to the product's registration, they will provide
the registration authority and consumers with all new informa
tions they receive about its effects, adverse reactions and
interactions.
6.
Central Drug Control authorities should have an up-to-date
information about the various drug formulations in the market,
their combinations, their date of licensing, drug information
being given with them by the producers and the latest inter
national medical views on the products.
7.
Drugs which have been banned from sale after being marketed
for some time in one country must not be submitted for clinical
trial or marketing in India. The onus of proving why such
a non-essential drug should be introduced or allowed to continue
in the market should be with the manufacturers.
8.
Whenever a new drug is tested on healthy human subjects
or on patients, the clinical trial must be authorised and moni
tored by a local "Ethical Committee" and must be carried
out only with the full informed consent of the people and
patients concerned.
Medical Audit System
It should be introduced to review the medical costs, the prescription
practices, patient complaints of negligence or financial exploitation
and drug misuse. At least minimal medical/clinical record keeping
should be made mandatory. Medical audit systems should be intro
duced in a systematic manner.
-:8:-
Physicians and pharmacists should be answerable to Rational Thera
peutics Committee of Experts. This could be appointed by Medical
Council or any other academic neutral body. Medical experts involved
in primary, secondary and tertiary medical care, chemists and
consumer organisations should be represented.
C.
DRUG DISTRIBUTION
i)
A National Corporation for distribution of drugs and pharma
ceuticals to retail drug outlets, hospitals and dispensaries
should be established.
ii)
National Drugs and Therapeutics Authority (see section G2)
(or its sub-committee) should look into the drug needs of
the peripheral heaith units to identify the bottle-necks and
deal with them as a priority and ensure timely drug supply.
iii)
This corporation should look into
-
requirement estimation of various drugs and their dosage
forms;
-
purchasing effective, safe and quality drugs at most
reasonable costs through bulk purchase and other purchase
procedures;
-
operating an efficient inventory and stock control system;
-
developing an efficient workable system, where drug
needs of the peripheral institutions can be a gauged
and timely drug supplies ensured.
iv)
Adequate drug distribution through the Government's health
service infrastructure should be ensured. Essential drugs in
adequate quantities and at subsidised rates should be available
at PHCs, and their sub-centres.
v)
Quality essential drugs should be made available from Govern
ment fair-price pharmacy shops. These could be handed over
to PHCs and sub-centres.
vi)
Education and relevant material on good pharmacy management
as produced by WHO should be made available to pharmacy
management system.
-:9:-
vii)
D.
Trained and qualified pharmacists should dispense drugs.
DRUG INFORMATION AND ETHICAL MARKETING
1.
Drug Information
i)
It should be the statutory duty of the drug control authorities
to inform health personnel and consumers of the WHO's concept
of essential drugs, India's graded essential drug lists, drug
policies and their rationale regarding banning of drugs. Rational
drug policy as a topic should be included in medical and para
medical education.
ii)
Names of the brands banned for manufacture and sales should
be widely publicized in medical journals, magazines, national
newspapers, giving briefly the explanation and rationale of
the ban.
2.
Ethical Marketing
i)
All sales promotion material including package inserts, medical
data sheets by the drug units should be screened by a permanent
National Drug Information body, which will be part of the
National Drugs and Therapeutics Authority. This body should
be responsible for screening as well as ensuring availability
of unbiased drug information to the health personnel and
consumers.
ii)
Use of audio-visuals for sales promotion on drugs to doctors
in absence of a printed copy (to be kept with the doctor),
of the claims made, should not be allowed.
iii)
All drug promotional literature should contain balanced and
verified scientific information about indication, contra-indications
side effects and drug interaction and antidotes.
iv)
Inadequate and inaccurate information in medical promotional
literature or package insert or worse still of the total commi
ssion of the package insert (as is the trend at present) should
be considered a punishable offence.
v)
Seminars, scientific sessions held by drug companies to present
mainly industry sponsored research studies should be closely
monitored and if need, be restricted as it is associated with
presentation usually only'" of favourable results and tend to
create a sense of obligation in the minds of certain medical
personnel towards drug companies for sponsoring their research.
vi)
Sponsoring of National Conventions of professional medical
and academic societies by drug industry should be discouraged
since consumers have to ultimately indirectly foot the bill
and such sponsorship inevitably introduces bias in favour of
the company and its products. The health ministry should
take up the responsibility for making funds available for such
seminars.
vii)
Advertisement of tonics and food supplements should not
be allowed in the lay-press. OTC sales advertisements making
false or misleading or inaccurate claims should be banned.
Authorities should ensure that adequate consumer caution
is provided to the consumer in regional languages.
viii)
Labelling should be clear. International non-proprietory names
(generic names) should be used. Consumer caution should
be in regional languages.
For food supplements, nutrients, tonics in the consumer caution
in regional languages it should be added that "This is not
a substitute for normal food" and message given pictorially
wherever possible.
ix)
"The International Code for Ethical Marketing" as drafted by
the Health Action International should be adopted by India.
3.
Drug Nomenclature
International non-proprietary names should be used for sales, labelling
and prescription writing. This being so because of several advantages:
i)
Generic drug names are used in under-graduate/postgraduate
medical and pharmaceutical education.
ii)
Generic names are used in medical
medical journals and WHO publications.
iii)
All purchases of medicines from international
international markets are based on generic names.
iv)
Use of generic names also ensure production, sale and dispensing
of more rational single ingredient drugs.
v)
Generic name assures clarity by giving information of the
class of drug and thus avoiding confusion arising out of many
dissimilar brand names of one drug.
text
books,
scientific
tenders
and
^ne
vi)
Drugs of equal quality are usually cheaper when purchased
by their non-proprietary names than when bought using brand
names.
vii)
Use of non-proprietary names is a valuable aid to memory
as health workers have to learn and remember each drug
by one name only.
E.
IE
SELF - RELIANCE
1.
Technological self-reliance
i)
In view of the high importance of achieving the goal of selfreliance in the drug sector, it is imperative that all technology
transfer agreements are made in accordance with the United
Nations Council for Trade and Development draft code.
ii)
Protective mechanisms should be evolved for process that
are being developed in the national laboratories so that techno
logy being developed indigenously does not get aborted as
it has happened in the recent past in case of processes deve
loped at NCL and Central Drug Research Institute.
iii)
While encouraging in house R&D activity through fiscal incen
tives, mechanism should be evolved that the R&D effort
undertaken by different firms is in accordance with the priority
drug needs of the Indian people.
2.
Encouragement to Indian Sector
i)
Make priority drugs, already produced in the country from
basic stage by the public sector and wholly Indian companies,
a reserved category for which companies holding foreign equity
more than 26% should not be allowed any fresh license.
ii)
Stipulate a strict time limit of five years for all
foreign
companies to start production from basic stage for the existing
already licensed production capacities.
iii)
Ensure implementation of the time limit of two years stipu
lated for foreign companies to undertake production from
the basic stage for fresh license.
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iv)
No Carry on Business license or production over the licensed
capacity should be allowed for MRTP, FERA and ex-FERA.
companies.
v)
Loan licenses being used by the small scale sector units linked
through ownership, financial participation and/or marketing
arrangements should be cancelled.
3.
Reduction of Imports
i)
The canalisation of all imports snould be streamlined. Open
general licence system should be abolished. There should be
raw material pool in each State to ensure proper pricing and
availability of raw materials.
ii)
import and excise duties should be fixed in such a way that
the landed cost of imported raw materials and bulk drugs
should not be lower than that of indigenous raw materials
and bulk drug production.
F.
RESEARCH AND DEVELOPMENT
i)
Priorities in research should be guided by the health needs
of the people in India. Drugs required in diseases causing
greater mortality, morbidity, serious sequelae should get
priority. Vaccines should get priority over other drugs.
ii)
Even 38 years after the cessation of British Colonial Rule
in India, research on non-allopathic drugs continues to get
step-motherly treatment. Hence research on these drugs should
be encouraged. None of these drugs, however, should be allowed
to be produced on commercial scale unless their efficacy
and safety has been proved through scientific research.
iii)
Research policy on drugs should be reviewed every ten years
to respond to changing pattern of diseases in India.
iv)
All medical research on human beings must be statutorily
required to conform to the 1975 Helsinki (Mark II) Declaration.
All research proposal must be approved by a central authority
before research is started. This should be strictly adhered
to in case of contraceptive research also.
The present policy of giving priority to research on hormonal
contraceptives rather than to barrier methods must be reversed.
-:13:-
G.
1.
DRUGS LEGISLATION AND ADMINISTRATION
Drug legislation should provide for the following:
a system of registration of all medical products (including
traditional medicines)
enforcement of good manufacturing practice
full control of labelling and advertisement
control of
materials
prices
prescription
drugs
control
of
of
finished
drugs
and
toxic/poisonous
therapeutic
and
habit
summary trial for violations against the drug
manufacturers and traders in special drug courts
raw
forming
policy
by
heavy penalties including confiscation of equipments and
properties for the manufacture and/or selling of spurious
and sub-standard drugs.
The legislation should be reviewed, regularly modified and
updated in the interest of the public and they should not
become bottlenecks for implementation of the national drug
policy.
2.
National Drug and Therapeutics Authority
i)
The greatest need of the moment is greater public accounta
bility and a greater social control over pharmaceutical industry.
For this, setting up an independent machinery such as a National
Drug and Therapeutics Authority is imperative, which can
scrutinize all the drugs currently marketed in India on an
ongoing basis and be held responsible for the nature of drugs
in the market. This permanent body should have representatives
with medical, pharmacy and management expertise. Repre
sentation being from :
1)
drug and health authorities from states
2)
Ministry of Chemicals and Fertilzers and Ministry of Finance
3)
medical professional and medical academic bodies
4)
consumer groups and NGOs involved in health work
5)
Trade Unions related to drug industry
6)
chemists and druggists.
The Government should establish National Drug Authorities
(NDA) at the State level also. The Drug Controllers should
be accountable to NDAs.
ii)
The recommendations of the National Drugs and Therapeutics
Authority should be binding on the drug industry.
iii)
Appropriate powers be delegated to Central Drug Controller
and State Drug Control Authorities for the proper implemen
tation of the recommendations of the Drug and Therapeutics
Authority.
iv)
Relationship of NDA with centre and state drug and health
authorities should be clear'y defined. Its constitution, function
ing and powers should be aimed at proper implementation
of National Drug Policy. Suitable drug legislation support
should be given to this authority so that its decisions are
not unnecessarily challenged in the court.
v)
Drugs should be dealt with by this NDA rather than by Ministry
of Chemicals and Fertilizers, to give greater emphasis to
the therapeutic relevance rather than industrial profits and
Government's revenue.
H.
HUMAN POWER DEVELOPMENT
Not merely medical and pharmacology related manpower development
is required, but also development of drug managers, drug inspectors,
quality control technicians, researchers and scientists willing to
do R and D in areas of grater concern to the health of our people.
The training and development should include training of legal personnel
who will be dealing with Food and Drug Courts.
Exposure and training of policy makers to other dimension of drug
issues as experienced by consumers and health personnel in the
field is also relevant.
Drug control mechanism has to be developed in keeping with the
growth of our drug industry and be proportionate to our drug prod
uction and sales.
THE ALL INDIA DRUG ACTION NETWORK (AIDAN)
COORDINATION COMMITTEE CONSISTS OF
(1)
Arogya Dakshata Mandal, Pune.
(2)
Catholic Hospital Association of India, Delhi.
(3)
Consumer Education & Research Centre, Ahmedabad.
(4)
Consumer Guidance Society of India, Bombay.
(5)
Drug Action Forum West Bengal, Calcutta.
(6)
Delhi Science Forum, Delhi.
(7)
Kerala Sashtra Sahitya Parishad, Kerala.
(8)
Locost, Baroda.
(9)
Lok Vigyan Sangathana, Bombay.
(10)
Medico Friends Circle, Pune.
(11)
Voluntary Health Association of India, Delhi.
»♦*♦***♦♦*****•»****♦«***
AIDAN Coordinator
DR. MIRA SHIVA
c/o VHAI
C-14 Community Centre
S.D.A. New Delhi 110 016.
All India
Drug
tN]@tw©?k
-AIDAN
CM JR DEMANDS
♦
availability of essential and life saving drugs (i.e. adequate
production and streamlined distribution to peripheral areas).
*
withdrawal of hazardous and irrational drugs
*
availability of unbiased drug information to health personnel
and consumers (including updating our National Drug Formu
lary), and provision of therapeutic guidelines as in British
National Formulary; provision for consumer caution in
regional languages for problem drugs
*
adequate quality control and drug control so that every
fifth drug in the market is not sub-standard as in at present
according to Government's own figures
*
drug legislation reform
to prevent drug companies
misusing legalistic loopholes against the people.
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