NHRC sends notice about trial-related deaths: Health ministry plans to finalize Schedule Y1

INDIA: Since the topic  concerning mortalities related to clinical trials in India is being addressed by the National Human Rights Commission (NHRC), the drug control authorities want to make an official announcement regarding the proposed Schedule Y1 for efficient and timely streamlining of the sector.

The draft notification was issued in January 2011. In view of the recent controversies regarding the number of clinical trial-related deaths, the Health Ministry now wants to finalize the Schedule Y1 document by incorporating suitable recommendations from stakeholders.

In the interim, sources confirm that the NHRC has served notices to the Drugs Controller General of India (DCGI) office and the Indian Council of Medical Research (ICMR), and are in the process of filing detailed reports to the human rights body.

Official versions of the incidents declare that, “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.”

The year 2010 witnessed as many as 22 cases of trial-related deaths. In April, the DCGI sent a directive to sponsors/clinical research organizations (CROs) involved in the clinical trials of 2010 to compensate the families and dependents of the deceased. Sources confirmed that the Ethics Committees were also asked to look into the above death cases and suggest compensatory payment.

Sources reveal, “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.”

The list generated by the authorities feature 161 clinical trial related deaths between January and June this year. The death figures for 2010 and 2009 are 668 and 637, respectively.

The 161 trial related deaths were reported by 35 sponsors/CROs including 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. As per the official list with health ministry, 44 companies reported 668 cases in 2010, while 50 companies were involved in such cases during 2009.

The compensation provided for 22-trial related deaths is a follows:

Sr. No Sponsor/CRO’s Investigational Product (IP) Compensation
1 Merck Safinamide Rs. 1,50,000/-
2 Wyeth Temsirolimus Rs. 1,50,000/-
3 Quintiles MLN0002/Placebo Rs. 3,00,000/-
4 Quintiles BI 1744/Trial Procedure Rs. 3,00,000/-
5 Lilly H3E-MC-JMHR Rs. 1,08,000/-
6 Lilly H3E-EW-S124 Rs. 2,00,000/-
7 Lilly Pemetrexed Rs. 2,00,000/-
8 Bayer Rivaroxaban/ Placebo/Warfarin Rs. 2,50,000/-
9 Bayer Rivaroxaban Rs. 2,50,000/-
10 Bayer Clexane/Placebo Rs. 2,50,000/-
11 Bayer Rivaroxaban Rs. 2,50,000/-
12 Bayer Rivaroxaban Rs. 2,50,000/-
13 Amgen AMG-706 Rs. 1,50,000/-
14 Amgen AMG-479/AMG102 Rs. 1,50,000/-
15 Bristol Myers Brivanibalaninate/ Sorafenib Rs. 2,50,000/-
16 Sanofi Aventis Blind Rs. 1,50,000/-
17 Sanofi Blind Rs. 1,50,000/-
18 Sanofi Blind Rs. 2,00,000/-
19 PPD XL-184/Placebo Rs. 10,00,000/-
20 Pfizer Sitaxsentan/Placebo Rs. 1,50,000/-
21 Pfizer Sitaxentan/Placebo/Sildenafil Rs. 2,25,000/-
22 Pfizer Axitinib Rs. 1,50,000/-

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