The Supreme Court on Monday issued notice to the Centre on a writ petition alleging that illegal clinical trials of untested drugs were being conducted by pharmaceutical companies on adults, children and even mentally ill persons in various States.
The Indore-based Swasthya Adhikar Manch was the petitioner.
NGO's counsel Sanjay Parikh told the Bench of Justices R.M. Lodha and H.L. Gokhale that in a large number of cases, multinational corporations were using contract research organisations for carrying out clinical trials of unapproved drugs. As a consequence of these trials, 1,727 patients had died from 2007 to 2010.
The Bench sought a response from the government in six weeks.
The petitioner said these trials “are conducted in India either because they are not allowed elsewhere or because they are cost prohibitive in the country of origin. Further, the poor, illiterate and vulnerable sections become subjects of these trials. In conducting them, the doctors, with the sole aim of making money, grossly compromise with ethical medical practices.
The trials are conducted without regard to the consent of the subjects, despite apparent conflicts of interest.”
The NGO said: “The manner in which these trials are conducted is grossly illegal and violative of Article 21 of the Constitution. The inaction of the government in not banning/restricting these trials is violative of Article 14. The issue has been raised in the Rajya Sabha, the Vidhan Sabha of Madhya Pradesh, by the Economic Offences Wing (EOW) Madhya Pradesh and in several study reports/magazines/journals/newspapers etc. The government has still not taken any action concerning this extremely important and sensitive issue.
There has been a rampant compromise with human life and the entire episode demonstrates a sordid nexus, which is nothing but a scam.”
The petitioner said that as per the guidelines the subject should know the nature, duration and purpose of the experiment; the method and means by which it was to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which might possibly come from his participation in the experiment. But it said there was no transparency in these tests and patients were not informed. Hence, it sought a ban on them.
