According to the Drug Controller General of India’s (DCIG), twenty-five people died in clinical trials carried out by nine pharmaceutical companies in 2010 out of which families of five received compensation amount ranging from Rs. 1.5 lakh to 3 lakh. Dr. Surinder Singh, DCIG, has summoned these nine pharmaceutical companies namely, Weyth, Quintiles, Lilly, Amgen, Bayer, Bristol Mayer, Sanofi, PPD and Pfizer on June 6, 2011 to question them on the amount of compensation they have decided to pay to the victims and also threatened that if they failed to pay the compensation, all the trials and present and the ones yet to start will not be allowed.
Dr. Singh added that according to company records submitted 670 people died out of which 25 were drug related. On 27th of April, 2011 the companies were directed to pay compensation for all death cases but only five companies have paid the compensation.
According to DCIG officials, pharma companies avoid payment due to difficulties in tracking down legal heirs. Dr.Singh opined that consent forms should always include the name and contact details of all legal heirs in case a death or injury occurs.
The Indian Council of Medical Research had recently framed draft guidelines for compensation which clearly states that the irrespective of whether the injury was foreseeable or not, compensation must be provided to research participants when the injury is of a permanent or temporary nature or if it was a procedure undertaken to manage an adverse reaction. The guidelines also state that the Informed Consent Document (ICD) must state the right to claim compensation and the person to be contacted. At present, as per schedule Y of the Drugs and Cosmetics Act (amended in 2005), the Institutional Ethics Commmittee (IEC) is responsible for the well being of all the trial subjects.
Report by Sumit