The alleged illegal clinical trials of untested drugs by pharmaceutical firms in the country, has come under the judicial scrutiny with the Supreme Court seeking the Centre's stand on a plea for an independent probe into it.
A bench of justices R.M. Lodha and H.L. Gokhale issued notices to the Centre, the Union 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 multinational pharmaceutical firms because laxities in implementing laws here.
The court passed the order on the PIL filed by a group of doctors alleging that illegal and unethical clinical trials are being done on poor persons including juveniles, adivasis, and dalits who were used as guinea pigs for testing of the drugs and vaccines produced by multinational corporations.
The petitioners, also urged the court for forming a Committee of Experts, consisting of members of civil society especially, the All-India Drug Action Network, be appointed 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 introducing a new drug for use by human being, a company is requiered to conduct clinical trials to study its effects on people.
Pointing out various cases of illegal drug trials in Indore, the petitioner said many people have lost their lives during the trial.
"Over 3,300 patients were tested. 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 one day to 15 years, where 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 petition said.
"Given the lack of transparency surrounding the clinical trials, subjects' lack of awareness about their rights where many hail from poor illiterate individuals from marginalised communities, many persons who have been victimised, suffered serious adverse effects, or the death of a family member through the process of the clinical trials have not come forth," the petitioner said while pointing to various such incidents in Indore.
Earlier, in a similar petition filed by an NGO, the Supreme Court had issued notice to Centre and the MCI.