E-DRUG: India: Nation of inexpensive human guinea pigs?
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The following editorial was published in MIMS (Monthly Index of Medical Specialities, New Delhi, India) in its July 31, 2008 issue.
Testing untested foreign drugs on Indian patients: Sky to be the limit
In a move that could put many poor, illiterate patients in India in grave risk, the government is planning to further "liberalize" rules governing the conduct of clinical trials on foreign untested new drug substances not even tried in their countries of origin. New "drug substances" are new chemical entities not approved as medicines for human use. Thus their safety and efficacy profile is not known.
Some individuals who were administered such substances in the past have
either suffered major injuries or died in the past. Barely three years ago rules were changed to help foreign drug companies try their new drugs in India without waiting for results of similar trials abroad.
A perusal of the draft proposal shows that its language is so loose that new rules when notified can be interpreted the way it suits drug companies and other vested interests both at home and abroad. Let us look at some of the major proposals.
It is proposed that new drug substances can be tried on human subjects in
India if there is "agreement" between the foreign innovator and an "Indian
company" to jointly develop the substance. The nature of such agreement has
not been specified. In practice a foreign drug company can sign an agreement with an Indian company whereby the local entity is paid a small amount of money annually and thus become a "partner" in drug development! Given that there are more than 20,000 small pharmaceutical manufacturers in India, it would not be difficult to arrange a partner merely as a legal fig leaf.
Moreover the "Indian company" has not been defined. Which is an Indian
company? A company registered in India? If so then multinational companies
such as Pfizer, GlaxoSmithKline, Merck, Bayer, just to mention a few are all Indian companies. Does it mean that Pfizer, United States can enter into an agreement with Pfizer Ltd., India and start testing new untested chemical entities on Indian subjects? Or is ownership the yardstick? Since shares of drug companies are traded on the stock exchanges, ownership keeps on changing and foreign investors are free to own such shares. Is Ranbaxy to be treated as an Indian company even though the promoters have sold their controlling shares to the Japanese? None of these issues have been tackled, much less resolved.
Elsewhere the draft proposal requires pharmaceutical manufacturers to disclose the "change in the regulatory status," (such as ban, restrictions etc.), of drugs in other countries. This rule has been part of the Drugs and Cosmetics Rules for decades. The only amendment is that any such change should be notified "within 30 days" to the Drugs Controller General, India (DCGI). This rule has invariably been broken with impunity. For example, has any manufacturer notified the DCGI about the ban on nimesulide in Ireland, Singapore and Nigeria? Moreover no penalties are proposed if the rule is broken. No law ever succeeds if its violation does not result in penal action.
The rule also does not cover the so-called "voluntary withdrawal" of medicines. It is widely known that when a drug is found to be unsafe in western countries, the manufacturers withdraw the same ahead of legal ban and hence the question of formal regulatory action does not arise. Recent cases include the "voluntary withdrawal" of rofecoxib in the United States and other western countries. Such practice is designed to kill two birds with one stone: a formal ban in advanced countries is avoided while unsafe medicines can continue to be sold in developing countries since their laws do not take cognizance of such developments.
Is it not a pity that Indian drug regulator is oblivious to this widely known danger? Drug laws should protect Indian patients, not interests of foreign companies.
Dr. Pankaj Talwar, MD.
Consulting physician,
New Delhi, India
drptalwar@yahoo.co.uk