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Monday, 26 March 2012

Illegal Clinical Trials and Death Continue even as the Supreme Court Hears the Case




SWASTHYA ADHIKAR MANCH
6, BIJASAN ROAD, OPPOSITE MAHAVIR BAGH, INDORE, MADHYA PRADESH-452005.
Press Note
New Delhi, 26th March 2012 : The Writ Petition filed by Swasthya Adhikar Manch came up for hearing today before a bench consisting of Justice R.M. Lodha and Justice H. L. Gokhale. The Senior Counsel appearing for the Union of India sought time to file counter affidavit. The Medical Council of India as well as State of Madhya Pradesh also asked for time and were granted six weeks. Thereafter, petitioner Swasthya Adhikar Manch has been granted time to file Rejoinder Affidavit. The counsel for Swasthya Adhikar Manch, Mr Sanjay Parikh, pointed out that it has been acknowledged by Minister of Health and Family Affairs, that illegal trials have been conducted and some of them are even without approval of the DCGI. He also mentioned that no Placebo Trials should be conducted in the country. The Hon'ble Judges remarked that the situation is serious and deaths are taking place. On the application for impleadment filed on behalf of Contract Research Organizations, the Supreme Court sought information about their legal status for operating in the Country. The Counsel for the petitioner pointed out that these Contract Research Organizations outsource and offshore the clinical trials on behalf of the multinational drug companies and ensure one window solutions for getting approval of the DCGI.
Meanwhile, the issue, being of national importance has been raised in MP Vidhan Sabha and the Rajya Sabha. In response to a question in the Madhya Pradesh Vidhan Sabha, it was stated that out of 81 patients who had suffered serious adverse effects, 33 persons have died. A list of names and addresses was provided which indicate death of 33 persons including children. No action has been taken by State of Madhya Pradesh inspite of such shocking state of affairs.
The Union Minister of Health and Family Welfare in a recent answer on March 13th to a question in Rajya Sabha pointed out that during the last 3 years 2009, 2010 and 2011 a total of 1229 trials were conducted in which 1743 deaths occurred in last 3 years and 2163 deaths in last 5 years as per data collected from Rajya Sabha and RTI documents. It was also mentioned that only in 22 cases of death in 2010 that the compensation has been paid by sponsors / clinical research organizations. The Petitioners - Swasthya Adhikar Manch are extremely concerned at this situation and further increasing number of deaths. We urge that even during pendency of the Writ Petition, the Union Ministry of Health and Family Welfare should take steps to stop the illegal clinical trials.
Amulya Nidhi, Chinmay Mishra
(9425311547), (9893278855)


National Alliance of People's Movements
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