New Delhi: 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 RM Lodha and HL 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.