In the last hearing the Hon’ble court had directed the Director General, Health Services or the Secretary, Ministry of Health to file an affidavit on different aspects concerning the Clinical trials of new Chemical Entities. The Court had also issued notices to all States and UTs for filing status report on the ongoing clinical trials. The affidavit was filed by the Dy. Drug Controller, CDSCO and not by the Secretary, Ministry of Health and Family Welfare or by Director General of Health Services. At the outset, the Hon'ble Court refused to take the said affidavit on record as it was not in compliance with the order dated 8th October 2012. The Court directed that a proper affidavit should be filed within four weeks.

Advocate Shri Sanjay Parikh appearing for the petitioner Swasthya Adhikar Manch drew attention of the court regarding the data which was provided in the affidavit of the Dy. Drug Controller regarding ongoing clinical trials of New Chemical Entities which are not approved as drugs for human use anywhere in the world. He pointed out that as per the affidavit from January 2005 to 30th June 2012, 475 New Chemical Entities were tested in the clinical trials out of which only 17 were approved for marketing. In these clinical trials, a total number of 57,303 subjects were enrolled, and out of which a total no of 39,022 subjects have completed the clinical trials.

In the affidavit it was mentioned that “around” 11,972 subjects suffered Serious Adverse Effects (SAE) and 2,644 deaths occurred. Parikh pointed out, these figures of total 14,616 SAEs and deaths out of 57,303 (25%) enrolled subjects is a very alarming. Out of these 506 SAEs and 80 deaths alone are stated to be related to clinical trials.

Further, the details of Clinical Trials which caused deaths and SAEs has not been given. It is not clear as to on what basis it has been decided that death or serious injury has been caused as a result of clinical trial while excluding other cases. The data which has been submitted by DCGI is not on basis of their own record but provided by sponsors i.e. companies.

In the affidavit it was further pointed out that, 40 out of 80 cases of death, from 2008-2011, due to clinical trials have been compensated, out of which in 2 cases interim compensation has been paid and in 3 cases legal heirs could not be traced. It is not clear as to how much amount has been paid and when. The Hon'ble Court's attention was also drawn to the report of Parliamentary Standing Committee which recorded that foreign drug companies are using the vulnerable sections of our Country as guinea pigs for clinical trials.

After hearing the Addl. Solicitor General Mr. Luthra, the Hon'ble court directed that until further orders, all clinical trials should be conducted under the supervision of Secretary, Ministry of health and family welfare.

During the hearing, the Hon'ble Court showed its displeasure with the GOI for not taking adequate action and merely putting up certain draft laws despite repeated opportunities being given. The Court remarked that even after 7 months of parliamentary committee report, no concrete steps have been taken by the Government. The Hon'ble Justices observed that life of each individual is important for them and for the country.

The court also issued notice to Indian Council of Medical Research and Govt of Madhya Pradesh, on the application of Bhopal Gas Peedith Mahila Udyog Sangathan (BGPMUS) and Bhopal Gas Peedith Sangarsh Sahayog Samiti, who joined the petition as interveners. They petitioned that 250 survivors of the Bhopal Gas Tragedy were subjected to clinical trial of new chemical entity from 2004 to 2008, and that it was withdrawn only in 2008 on directions given by the Director of Bhopal Memorial Hospital and Research Centre (BMHRC). The Hospital BMHRC reportedly earned Rs. 100 lakhs for conducting such clinical trials. Mr. Sanjay Parikh represented Bhopal Gas Peedith Mahila Udyog Sangathan (BGPMUS) and Bhopal Gas Peedith Sangarsh Sahayog Samiti.

Swasthya Adhikar Manch has regularly brought to notice the fact that Indian citizens are being exploited by Multinational drug companies using the loopholes and lacunae in law and regulatory framework.