Clinical trials: concern over liberal permission

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Special Correspondent

NEW DELHI: Concerned over the Centre's policy to `liberalise' permission for conducting clinical trials by multinational pharmaceutical companies in India by amending the Drugs and Cosmetics Act, Rajya Sabha member Brinda Karat has written to the Union Health and Family Welfare Minister Anbumani Ramadoss expressing the fear that Indian people could be used as "guinea pigs" by these companies.

It is reported that India will earn a large amount of foreign exchange through the outsourcing by pharma companies of clinical trials in India estimated at $1 billion in the next few years. Since around 40 per cent of drug development costs are related to trials, it is felt that India with its vast reservoir of potential recruits at 60 per cent less than the costs in a developed country will hugely benefit the big drug companies.

"It is, therefore, all the more necessary to put in place a set of rules that are more stringent and ensure that the rights of Indian subjects of trials are given full protection," Ms Karat has pointed out in her letter to the Health Minister. On the contrary, the Government has liberalised the procedures for trials by amending Schedule Y of the Drugs and Cosmetics Act, thereby, opening the way for Indians to be used as guinea pigs.

She has pointed out that in the phase-II and phase-III trials, the earlier guarantee of a "phase lag" has been removed through the amendment. The phase-II trials in India were allowed only when phase-II had been completed abroad and phase-III trials had been started. Now phase-II trials in India have no such protection and can be held "concurrently" with trials "overseas." Similarly, phase-III trials in India were allowed only when the drug was being marketed for general use abroad, not experimental. Now these trials have also been made " concurrent."

Pointing out that Mr. Ramadoss had said in a written reply to her question that there are "stringent" measures in place including conditions for "informed consent," Ms. Karat said Schedule Y also mentions the procedure for "illiterate persons" suggesting that an "impartial" person should be present when the form is signed. "You will appreciate that this hardly measures up to `stringent' measures."

"You are also no doubt aware that not a single paisa has ever been given to a single patient who has suffered the adverse consequences of trials," the letter said.



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