New Delhi: The Supreme Court on Monday expressed concern over alleged illegal clinical trial of drugs in the country, saying its "unfortunate" that  humans were being treated as "guinea pigs".

A bench headed by Justice R M Lodha pulled up the Centre and the Madhya Pradesh government for not filing their response on PILs alleging large-scale illegal drug trials in the state and other parts of the country.

The bench said, "There has to be some sense of responsibilty (on the part of the government). "Human beings are being treated as guinea pigs. This is unfortunate," the bench said granting the government and Medical Council of India eight weeks more time to file their replies.

The bench was hearing two PILs filed by a group of doctors and an NGO alleging that illegal and unethical clinical trials were being done on poor persons including juveniles, tribals and dalits who were used as guinea pigs for testing of drugs and vaccines produced by multinational corporations.

The petitioners had also urged the court to order formation a Committee of Experts, consisting of members of civil society especially, the All India Drug Action Network, to examine the present legal provisions concerning clinical trials both in India and abroad and to make recommendations for framing guidelines on the issue.

Prior to introduction of a new drug for use by humans, a company is required to conduct clinical trials to study its effects on people. The PILs have alleged the country is being used for illegal clinical trials by multinational pharmaceutical firms because of laxities in implementation of the laws.

Pointing out various cases of illegal drug trials in Indore, the petitioners have said many people have lost their lives during the trials.

"Over 3,300 patients were used for the tests. Approximately 15 government doctors were involved. About 40 private doctors in 10 private hospitals were involved.

"Clinical trials were conducted on 233 mentally-ill patients, 1,833 children in the age group of one day to 15 years....Approximately Rs. 5.5 crore were paid to the government doctors alone. In 2008, there were 288 deaths, in 2009, there were 637 deaths, and in 2010, there were 597 deaths," the PILs have alleged.

They claimed that there was lack of transparency in the clinical trials as the subjects were not aware of their rights. Majority of the people on whom the tests were performed were poor and illiterate individuals who came from marginalised communities and suffered serious adverse effects, they have said while pointing to various such incidents in Indore.


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