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Jan-Mar2004-12(1)
DISCUSSION
A network for the rational and
ethical use of drugs
S Srinivasan
S Srinivasan
Brand-named prescription drugs are called 'ethical
drugs' by the drug industry. Nothing could be more wrong. Many of these ethical
drugs are unscientific and irrational combinations (for example Ampiclox), or
plain harmful (for example Analgin, Nimesulide, etc.), or harmless but cause
wasteful expenditure to patients (for instance, tonics which claim to be
rejuvenators and/or nutrients). Prescribing such unscientific, irrational,
harmful and/or wasteful drugs is unethical; unscientific behaviour by those who
are trained in a particular science must be considered unethical.
For the past 20 years, a group of activists-doctors
and non-doctors-under the banner of the All India Drug Action Network (AIDAN)
have been in the forefront of advocacy for a rational drug policy. Many of the
tenets of a rational drug policy are motivated by a desire to promote ethical
and scientific behaviour in medicine in the interests of people-that is, all of
us.
AIDAN was founded in 1981-82. Before this, members
of the medico friend circle (mfc*) had been expressing concern about the
political economy of the drug industry. AIDAN was the first nationwide network
on the drugs (medicines) issue, seeking to bring together a diverse range of
activists, academicians and even trade unionists.
AIDAN has worked for the propagation of a rational
drug policy. This has meant calling for a restricted list of essential generic
drugs, appropriate price control and elimination of irrational, unscientific and
harmful drugs in India. One of the earliest campaigns launched by AIDAN was on
the banning of EP Forte combination drugs. Subsequently, in a case filed by
DAF-K (Drug Action Forum-Karnataka), AIDAN and others in 1993 in the Supreme
Court, the prayer before the court was for weeding out several categories of
irrational drugs. The case led to a ban of, among others, Baralgan, and the
rationalisation of oral rehydration solution formulations in the country.
AIDAN's other concerns have been the impact of
Trade-Related Intellectual Property Rights (TRIPS), the World Trade Organization
(WTO), patents, etc., on the health of the country. Medicine-the practice in as
much as the production of it-is inextricably interlinked with both politics and
economics. The reluctance of governments and corporations of developed
countries, especially the US government, to make prices of AIDS drugs
affordable, is a case at point. Unfortunately, many of us who are professionally
trained are squeamish about the politics, if not the economics, of
pharmaceuticals and pretend it does not exist. The field is often left clear for
mischief.
Currently AIDAN, LOCOST (Low Cost Standard
Therapeutics, visitwww.locostindia.com), the mfc and JSS (Jan
Swasthya Sahayog, Bilaspur is a group of motivated doctors working in rural
health, visithttp://www.geocities.com/jss_ganiyari/)
are active in a Supreme Court petition related to price control of drugs. AIDAN,
et al. have been consistent with the group's 20-plus-year-old philosophy. Their
prayers include, inter alia:
To issue a writ of mandamus or any other
appropriate order directing the Government of India (respondents in the case)
to:
- ensure that the medicines/drugs set out in the National Essential Medicines List 2003 are available and at affordable prices for the poor by bringing all of them under price control.
- quash the Pharmaceutical Policy 2002 to the extent to which this policy is incompatible with the other reliefs claimed in the petition.
- bring all drugs and formulations under a system of monitoring of their prices and affordability with a view to ensuring that even drugs/medicines not on the National Essential Medicines List are available at reasonable prices.
- ensure that only safe, rational drugs and formulations whose efficacy is scientifically proven, be permitted to be manufactured and marketed in India.
- ban the manufacture, distribution and import and export of all irrational formulations which have no scientific validity, or violate the principles of rational therapeutics or which do not figure in internationally accepted pharmacoepia.
- allow the manufacture and marketing of only those single-ingredient formulations that are referred to in pharmacology textbooks.
- set up a National Drug Authority in accordance with the recommendations of the Drug Policy of 1986 and 1994.
- ensure that both branded and generic medicines in the market are of standard quality and manufactured according to Good Manufacturing Policies (GMP) and Good Laboratory Practices (GLP).
- ensure that all medicines needed for important public health problems such as tuberculosis, malaria, leprosy, diabetes, hypertension, heart care, eye care and the like are marketed only as generic preparations.
- ensure that unbiased and comprehensive information, including the information relating to the comparative costs of medicines and the total treatment regimen, be in the public domain and be made available to prescribers as well as patients.
- set up an independent competent body to ensure that all new drugs introduced in the market from within India or abroad should be allowed in the country only if it meets the criteria of lower costs, better efficacy and less side-effects, and after it undergoes testing in accordance with Schedule Y in the Drugs and Cosmetics Act.
- ensure access to newer, more efficacious and more affordable drugs post 2004, if necessary by using options such as compulsory licensing and parallel imports available under the WTO/TRIPS agreements.
- increase the healthcare budgetary allocations so as to realise the fundamental right to health care for all the people of India.
- pass any other or further orders as may be deemed fit and proper in the circumstances of the case.
- ensure that the medicines/drugs set out in the National Essential Medicines List 2003 are available and at affordable prices for the poor by bringing all of them under price control.
- quash the Pharmaceutical Policy 2002 to the extent to which this policy is incompatible with the other reliefs claimed in the petition.
- bring all drugs and formulations under a system of monitoring of their prices and affordability with a view to ensuring that even drugs/medicines not on the National Essential Medicines List are available at reasonable prices.
- ensure that only safe, rational drugs and formulations whose efficacy is scientifically proven, be permitted to be manufactured and marketed in India.
- ban the manufacture, distribution and import and export of all irrational formulations which have no scientific validity, or violate the principles of rational therapeutics or which do not figure in internationally accepted pharmacoepia.
- allow the manufacture and marketing of only those single-ingredient formulations that are referred to in pharmacology textbooks.
- set up a National Drug Authority in accordance with the recommendations of the Drug Policy of 1986 and 1994.
- ensure that both branded and generic medicines in the market are of standard quality and manufactured according to Good Manufacturing Policies (GMP) and Good Laboratory Practices (GLP).
- ensure that all medicines needed for important public health problems such as tuberculosis, malaria, leprosy, diabetes, hypertension, heart care, eye care and the like are marketed only as generic preparations.
- ensure that unbiased and comprehensive information, including the information relating to the comparative costs of medicines and the total treatment regimen, be in the public domain and be made available to prescribers as well as patients.
- set up an independent competent body to ensure that all new drugs introduced in the market from within India or abroad should be allowed in the country only if it meets the criteria of lower costs, better efficacy and less side-effects, and after it undergoes testing in accordance with Schedule Y in the Drugs and Cosmetics Act.
- ensure access to newer, more efficacious and more affordable drugs post 2004, if necessary by using options such as compulsory licensing and parallel imports available under the WTO/TRIPS agreements.
- increase the healthcare budgetary allocations so as to realise the fundamental right to health care for all the people of India.
- pass any other or further orders as may be deemed fit and proper in the circumstances of the case.
Why should medical professionals bother about
policy issues? 'We are not trained for it,' is often the plaint one hears. It
would be good if medical professionals found time to think about why the
production of more doctors has not led to improvements in people's health. Or
how price control or the lack of it can have a direct repercussion on access to
medical care. At the very least, medical professionals can protest about the
irrational and unscientific medicines in the market and stop using or
prescribing them! That is the least of the many ethically desirable behaviour
expected from those licensed by law to prescribe.
Please join AIDAN or similar efforts. It concerns
us all. E-mail addresses of some active AIDAN members for this case: S
Srinivasan:sahajbrc@icenet.net; Anurag
Bhargav:jss_ganiyari@rediffmail.com; Mira
Shiva:mirashiva@yahoo.com; Anant
Phadke:amol_p@vsnl.comC Sathyamala:sathyamala@yahoo.com
*The mfc, or medico friend circle, is a nationwide
group of socially conscious individuals interested in the health problems of
people of India (visitwww.mfcindia.org)
S SRINIVASAN, 1 Tejas Apartments, 53 Haribhakti
Colony, Old Padra Road, Vadodara 390007, India. e-mail:sahajbrc@icenet.net