The Supreme Court of India had directed Secretary, Ministry of Health and Family Welfare to organise a meeting of all chief Secretaries / Secretary 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.
This direction was given in the writ petition filed by Swasthya Adhikar Manch before the bench of the Supreme Court consisting of Justice R.M Lodha and Justice Mr 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.
Mr. Sanjay Parikh Senior Counsel for Swasthya Adhikar Manch argued and highlighted the 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 2,644 persons died out of which only 80 deaths were attributed to clinical trials. Similarly, out of 11,972 SAEs, 506 alone were attributed to clinical trials. He mentioned that total 259 applications regarding NCEs / NMEs have been recommended for approval between 3rd July 2013 to 31st August 2013 out of them 162 have been approved for clinical trials by Drug controller General of India.
The Petitioners pointed that in their affidavit Ministry of Health and Family Welfare had mentioned that due to Clinical trials of New Chemical Entities/ New Molecular Entities (NCEs/NMEs) 164 deaths had occurred in the year 2010, out of which 125 alone had died on account of clinical trial of Rivoroxaben by Bayer. However, as per the Ministry of Health and Family Welfare office memorandum dated 26.04.2011 to the Lok Sabha Secretariat a total 671 cases of death occurred in the Year 2010 out of which 89 deaths were related to clinical trial.
The above data is contradictory to Ministry of health and family welfare in which they are claiming that only 80 deaths due to clinical trials occured from year 2005 to 2012. 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.
Counsel for Swasthya Adhikar Manch- Mr. Sanjay 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. It was also urged by the Counsel that the clinical trial of NCEs/ NMEs is not at all beneficial to the Country and therefore, should not be allowed.
As per the letter dated 26.04.2011 written by the Ministry to Lok Sabha Secretariat, from the year, 2005 to 2010 alone 1243 global clinical trials has been permitted.
In the other letter dated 06.06.2011 by DCGI it has been mentioned that out of 645 cases of death response has been received only in 300 cases and out of 300 in only 2 cases compensation and treatment expenses have been paid.
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.
Mr. Sanjay 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.
The Supreme Court also issued notice on an intervening application filed by Swasthya Adhikar Manch based on the 72nd Parliamentary standing Committee on Health and Family welfare report dated 30th August 2013 where in it has been recommended that action should be taken against PATH, State Government of Andhra Pradesh, Gujarat, ICMR, and other Government officials including Drug controller General of India. In the said case HPV vaccine was given to 14,091 girls in Khammam district of Andhra Pradesh and 10,686 girls in Vadodra, Gujarat. These girls were between age group of 10-14, of which 7 girls died due to these illegal vaccine trials.
The Court appreciated Mr. Sanjay Parikh, Senior Counsel and Swasthya Adhikar Manch for bringing to notice the fact that Indian citizens are being exploited by multinational drug companies and without proper regulatory framework clinical trials are happening in the country. The next hearing is scheduled after two weeks.