The
Supreme Court of India today admitted a
Public Interest Litigation (PIL) regarding the alleged illegal clinical trials
that were conducted on adults, children and mentally ill patients across the
country. The PIL was triggered by the recent news reports that found illegal
and unethical drug trials were conducted on mentally challenged patients at the
M G M Medical College in MP.
The PIL filed by NGO Swasthya Adhikar Manch has quoted the report by Economic Offence Wing that found gross irregularities in clinical trials at Madhya Pradesh, where the principal investigator who was also part of the ethics committee violated the guidelines prescribed by the Indian Council for Medical Research. It also pointed out on the inadequate compensation paid to the patients who were affected by drug trials. They petitioners have asked for a strict regulatory framework for Contract Research manufacturing companies or CRO's who are responsible for drug trials.
According to a statement made by Union Minister for Health, Gulam Nabi Azad, in the last three years alone 1727 patients died while participating in a drug trial. The PIL has demanded for a through investigation of the 4000 odd drug trials carried out in the last 5 years. It further demands to examine the present legal set up and guidelines concerning the clinical trials, direct the Govt. of Madhya Pradesh to act on report of EOW, grant of compensation and other reliefs including medical treatment to trial patients adversely affected.
The apex court has send notices to the Ministry of Health, the Government of India, ICMR, Drug Controller of India and the State of Madhya Pradesh, asking them to respond to this PIL.
The PIL filed by NGO Swasthya Adhikar Manch has quoted the report by Economic Offence Wing that found gross irregularities in clinical trials at Madhya Pradesh, where the principal investigator who was also part of the ethics committee violated the guidelines prescribed by the Indian Council for Medical Research. It also pointed out on the inadequate compensation paid to the patients who were affected by drug trials. They petitioners have asked for a strict regulatory framework for Contract Research manufacturing companies or CRO's who are responsible for drug trials.
According to a statement made by Union Minister for Health, Gulam Nabi Azad, in the last three years alone 1727 patients died while participating in a drug trial. The PIL has demanded for a through investigation of the 4000 odd drug trials carried out in the last 5 years. It further demands to examine the present legal set up and guidelines concerning the clinical trials, direct the Govt. of Madhya Pradesh to act on report of EOW, grant of compensation and other reliefs including medical treatment to trial patients adversely affected.
The apex court has send notices to the Ministry of Health, the Government of India, ICMR, Drug Controller of India and the State of Madhya Pradesh, asking them to respond to this PIL.
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