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.