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Supreme Court seeks reply from health ministry on strengthening of regulatory framework of clinical trials
The Court has given 10 weeks time to the MOHFW to come out with the actual implementation of the suggestions given by State Government, NHRC, Petitioner and NGOs to strengthen the regulatory framework of clinical trials in the country.

A writ petition filed by Swasthya Adhikar Manch came up for hearing today before the bench of the Supreme Court consisting of Justice R.M Lodha and Justice Singh. This case was filed in February, 2012 and this is the seventh hearing of the case, last hearing was held on 26th July, 2013.

In the last hearing, the Honorable Supreme Court had directed Secretary, Ministry of Health and family Welfare to organize a meeting of all chief Secretaries from all states to discuss all the facets and aspects concerning legal framework for strengthening the regulation of clinical trials and other incidental matters. They had also asked the Government to take opinion of Petitioners, National Human Rights Commission and NGOs.

Today Sanjay Parikh Senior Counsel of Swasthya Adhikar Manch argued highlighted facts contained in the two affidavit filed by the Ministry of health and family welfare. In the additional affidavit filed by the Ministry of Health and Family Affairs it was stated that out of 475 New Chemical Entities only 17 were approved for marketing which comes to less than 4%. But in these clinical trials 2644.

The Petitioners in their earlier affidavit had already pointed out that due to Clinical trials of New Chemical Entities/ New Molecular Entities (NCEs/NMEs) though the Ministry of Health and Family Welfare had mentioned 164 deaths in the year 2010, out of which 125 alone had died on account of clinical trial of Rivoroxaben by Bayer but in the letter which was written by Ministry of Health and Family Welfare dated 26.04.2011 to the Lok Sabha Secretariat.

The list of drug companies that conducted the trials included several pharmaceutical companies such Bayer, Eli Lilly, Pfizer, Sanofi Intas, Merck, Boahringer, Astrazeneca, Novartis, etc.

Parikh mentioned that the reason for so many deaths is because NCEs/ NMEs are being tested on Indian citizens without following the regulations and taking necessary precautions taking advantage of poverty and tardy implementation including corruption.

Parikh also represented the Bhopal Gas Peedith Mahila Udyog Sangathan (BGPMUS) and the Bhopal Gas Peedith Sangarsh Sahayog Samiti (BGPSSS) who are interveners in this case.

Direction has also been issued in the application filed by Swasthya Adhikar Manch where investigation has been sought on the basis of 72nd Parliamentary standing Committee report on health and family welfare dated 30th August 2013 where in, it has been recommended that action should be taken against PATH, State Government of Andhra Pradesh and Gujarat, ICMR, and other Government officials including Drug controller General of India.

In the said case HPV vaccine was given to 14091 girls in Khammam district of Andhra Pradesh and 10686 girls in Vadodra Gujarat. These girls were between age group of 10-14 and 7 girls were died due to vaccine.

Indian citizens are being exploited by multinational drug companies and without proper regularatory framework clinical trials happening in the country. The next hearing in the case is scheduled after two weeks. 

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