Health ministry plans to notify Schedule Y1 after NHRC sends notice about trial-related deaths

With the National Human Rights Commission (NHRC) suo motu taking up the issue of deaths happening during the course of clinical trials in the country, the drug control authorities want to officially notify the proposed Schedule Y1 to streamline the sector at the earliest.

After the draft notification was issued in January 11, the Health Ministry now wants to finalise it by accommodating relevant suggestions from the stakeholders in the wake of recent controversy about the number of deaths happened during the clinical trials.

Meanwhile, sources said the Drugs Controller General of India (DCGI) office and the Indian Council of Medical Research (ICMR) who were served with notices by the NHRC were seized of the matter and are in the process of filing the detailed reports to the human rights body.

According to official version about the incidents, “The death of a subject enrolled in the clinical trials may occur during the trial due to various reasons. These could be disease related deaths like cancer or other serious diseases, administration to critical, and terminally ill patients, side-effects or other unrelated causes. Such deaths are investigated for causal relationship to the study trial.”

As many as 22 cases of trial-related deaths were reported in the year 2010. The sponsors/clinical research organisations (CROs) involved in the clinical trials in 2010 were directed by the DCGI in April to provide compensation to the dependents of the deceased. The concerned Ethics Committees were also requested to review the above death cases and recommend payment of compensation, sources said.

“It is proposed to further strengthen the regulations relating to clinical trials by making specific provisions under the Drugs and Cosmetics Rules for providing financial compensation to trial subjects in case of trial related injury or death. The responsibilities of Ethics Committee, Sponsor & Investigator are also proposed to be enhanced to ensure that financial compensation as well as medical care are provided to trial subjects who suffer trial related injuries or deaths. The format for obtaining informed consent of trial subjects is also proposed to be amended to include the details of address, occupation, annual income of the subject so as to have information regarding socio-economic status of trial subjects,” sources said.

According to the list prepared by the authorities, a total 161 cases of deaths were already reported during the course of trials during January and June this year itself. As many as 668 deaths happened during 2010 and 637 during 2009.

Amgen, Bayer, Bharat Serums, Boehringer Ingelheim, Catayst, CD Pharma, Dr Reddy’s, Excel Life Science, Frensenius Kabi, GSK, Icon, Inc GVK Bio, Invida, J & J, Jubilant Clinsys, Lambda Therapeutic, LG Life Sciences, Manipal Acunova, Max Neeman, Merck Specialties, MSD, NIMR of New Delhi, Novartis, Parexel, Pfier, Piramal Life Sciences, PPD, Quintiles, Sanofi Aventis, SIRO Clinpharma Pvt Ltd, Spectrum, Sristek of Hyderabad, St. John National Academy of Health Sciences, Sun Pharma and the George Institute are the 35 sponsors/CROs that reported 161 deaths during trials this year so far. During 2010, 668 cases were reported by 44 companies while 50 companies were involved in such cases during 2009, as per the official list with health ministry.

The compensation paid so far on account of trial related deaths in 22 cases.