SC issues notice to Centre on illegal drug trials in India

The Supreme Court today sought the Centre's response on conducting an independent inquiry into alleged illegal clinical trials of untested drugs by pharmaceutical companies in various states.

A bench of justices R M Lodha and H L Gokhale issued a notice to the Centre as also to the Health Ministry and the Medical Council of India seeking their replies on a Public Interest Litigation alleging that the country is being used for illegal clinical trials by the multinational corporation because laws are not implemented strictly.

"India is being used for conducting clinical trials by the multinational corporation owing to the reason that the laws are not implemented strictly, because of legal lacunae and because of poverty and other economic reasons the subjects for these trials are easily available," advocate Sanjay Parekh, appearing for the petitioner, said.

The court passed the order on a PIL filed by Indore-based NGO Swasthya Adhikar Manch which sought appointment of an expert committee to regulate the clinical trials done by many multinational pharmaceutical companies.

The petitioner-NGO pointed out various cases of illegal drug trials are going on in the country and said such trials must be stopped immediately and requested the apex court's intervention in the matter.

The NGO submitted in its petition that the interests of patients are not safeguarded in these trials and their consent is also not taken.

"The report clearly points out how independence of the ethical committees is compromised and the interests of patients are not safeguarded. Not only the most essential principle of informed consent is rampantly violated but the conflict of interest is clearly visible in these clinical trials," the petition said.

"In India, illegal clinical trials are taking place because of lax regulations and their flawed implementation," it said.

"The doctors often receive benefits from the trial sponsors which sometimes become the main source of their income, creating a glaring conflict of interest.

"Doctors conducting trials also receive commissions per patient recruited, creating an incentive to enroll more people in the trials. This leads to a violation of the physician- patient relationship of trust," the petition said.

Whenever a new drug is introduced by a drug company for use by human beings, it is necessary to conduct clinical trials in order to study the effects of the new drug on the human beings.