Advisory body recommends dilution of protections

In a well meaning measure, the Union Health Ministry sought to ensure financial compensation for subjects in case of injury or death caused by clinical trials but its apex decision-making body on drugs safety has put a spoke in its wheel.

Till earlier this year, financial compensation was not mandated by law and found mention only as a Good Clinical Practice (GCP) in paragraph 2.4.7 of the Indian Council of Medical Research’s GCP Guidelines for Clinical Trials in India.

However, under fire from medical rights activists and the judiciary, the government amended the Drugs and Cosmetics Act, 1945, to provide compensation. The amended Drugs and Cosmetics Rules (2013) were notified in January with three new rules — 122-DAB, 122-DAC and 122 DD. Sub-rule (5) of rule 122 DAB mandates provision of free medical management in case of injury to a clinical trial subject. If the injury is caused by clinical trial, the subject is entitled to financial compensation. If the trial results in death, financial compensation has to be provided to a nominee of the subject.

However, while the Ministry, in its affidavit in March, apprised the Supreme Court of the government’s new stringent amendments, the Drugs Technical Advisory Board (DTAB) has recommended deletion of the crucial financial compensation aspect of the new amendments. In the minutes of its meeting held in May, the DTAB recommended deletion of “Clause (c) on providing financial compensation in the case of injury or death due to failure of investigational product to provide the intended therapeutic effect.”

The DTAB has also suggested dilution of several other protections provided by the amendments: increasing the time for reporting of Serious Adverse Events by the sponsor and investigator from 10 to 14 days, increasing the time for Ethics Committees to forward reports of Serious Adverse Events and opinion on the quantum of compensation from 21 to 30 days, and doubling to 60 days the time for the Independent Expert Committee to examine cases of death and recommend to the DCG (I) the quantum of compensation. The board further says free “medical management should be provided only in case the injury is due to clinical trial-related activities.”

Between 2005 and 2012, pharma companies paid about Rs. 2.6 crore in compensation for 84 deaths caused by drug trials held in India, says the latest government data. While over 2,644 people died during trials over these years, only 84 fatalities were found to have been directly caused by the trials. The total compensation awarded by 32 firms was Rs. 2,60,30,141, averaging about Rs. 3 lakh per death. Compensation in eight cases, totalling Rs. 34, 38, 318, is still under process.

Among the 32 companies, Bayer Heathcare topped the list, paying compensation in 13 cases, followed by Sanofi India (12), Brsitol Myers Squibb and Sun Pharmaceuticals (six each), Pfizer and Eli Lily (five each), and AstraZeneca, Amgen, Icon and Quintiles (three each). The information was accessed by Sanjai Sharma of the Human Rights Law Network under the Right to Information Act.