Dr Vasantha Muthuswamy, called the Queen of Bioethics. head of basic medical sciences at the Indian Council of Medical Research, was responsible for coordinating the ICMR’s guidelines for biomedical research, finalised in 2000. Dr Muthuswamy was a keynote speaker at Indian Journal of Medical Ethics’ National Bioethics Conference held in Mumbai in the last week of November. Excerpts from the interview:
ICMR is a research organisation and have issued guidelines: Ethical guidelines for biomedical research on human subjects, 2000. But ICMR is not a policing authority and have no legal authority to take any action against anybody. Even if the guidelines become law, there has to be someone to implement the law, and this authority may or may not be the ICMR.
But there are laws governing research in India. Under the Drugs and Cosmetics Act all trials in India should follow the ICMR guidelines of 2000. The Medical Council of India (MCI) Act, amended in 2002, states that all research in India carried out by physicians has to follow the ICMR guidelines. So there is indirect power to enforce our guidelines.
The Drugs Controller General is the regulatory authority for clinical trials. Schedule Y of the Drugs and Cosmetics Act applies to trials of new drugs, but permission must be sought from the DCGI for other trials as well, of drugs which have received approval in other countries but have to be marketed in India.
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