Indian Journal of Medical Ethics

DISCUSSION

A network for the rational and ethical use of drugs

S Srinivasan

DOI: https://doi.org/10.20529/IJME.2004.005


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, visit www.locostindia.com), the mfc and JSS (Jan Swasthya Sahayog, Bilaspur is a group of motivated doctors working in rural health, visit http://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.

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.com C 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 (visit www.mfcindia.org)