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Clinical trials: Brinda writes to Anbumani

Special Correspondent

NEW DELHI: Brinda Karat, Communist Party of India (Marxist) Polit Bureau member, has said that liberalisation of procedures for granting permission for the conduct of clinical trials was putting at risk the lives and health of the citizens.

In a letter to the Union Health and Family Welfare Minister Anbumani Ramadoss – following reports that 49 infants had died during clinical trials at the All-India Institute of Medical Sciences (AIIMS) since January 2006 – Ms. Karat has asked the government to reconsider the liberalised schedules and protocols, lack of mandatory insurance and compensation as well as poor implementation of the protocols.

Describing as inadequate the enquiry ordered into the deaths by the Health and Family Welfare Ministry, Ms. Karat said she had repeatedly raised in Parliament the issues of liberalisation of Schedule Y of the Drugs and Cosmetics Act regarding the removal of the protective time-lag between the tests of foreign drugs in countries of their origin and India in phase-III trials. As a result of giving permission to pharma companies to make these trials “concurrent” the risk to Indian citizens increases, she said.

It is precisely for these phase-III trials which have a much larger sample that India is now the favoured destination for trials by the multinational companies as it costs 60 per cent less than in their own country where subject protection laws are much more stringent.

The second issue that Ms. Karat has raised is the lack of mandatory insurance or compensation for the subjects and finally the concept of “informed consent” which is a mockery in India as a large majority of subjects are from poor families, most of whom have no access to literacy and unable to give “informed consent.”

More likely the consent is driven by vulnerability due to poverty or sometimes because they believe it is conditional for the treatment for which they went to the hospital. “It is learnt that a new draft for phase 0 and phase-I trials is also in circulation which will give additional benefits for foreign pharma companies to conduct trials in India for foreign drugs,” she said.

“The callous approach of the government on this issue was exemplified by the tax concessions given in last year’s Budget to conduct clinical trials in India which was claimed to be a big incentive for another area of ‘outsourcing.’ I believe it is a matter of shame not pride that India is the favoured destination of the multinational companies to conduct trials on our citizens of foreign drugs most of which can never be used by our citizens because of the prohibitive prices at which these drugs are ultimately sold,” the letter said.

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