Times of India
06 June 2011
By Kounteya Sinha
New Delhi, India

Drug Controller Summons 9 Firms, Will Warn Them To Pay Up Or Suspend Experiments
Rs 3 lakh – that’s the price a pharmaceutical company has paid to the family of a person who died in their clinical trial. Others weren’t even this lucky.

According to the Drug Controller General of India’s (DCGI) records, 25 people died in clinical trials carried out by nine pharmaceutical companies in 2010. Families of five of these victims received "compensation for trial related death" – the amount ranging from Rs 1.5 lakh to Rs 3 lakh.

Now, DCGI Dr Surinder Singh has summoned these nine companies on June 6 to question them on the compensation they have decided to pay the victims of their clinical trials. DCGI’s threat is clear – pay up compensation, which is a mandatory part of any clinical trial, or all the other trials of these nine companies going on at present or yet to start, will not be allowed. The nine pharma companies summoned on Monday by the DCGI are Wyeth, Quintiles, Lilly, Amgen, Bayer, Bristol Mayer, Sanofi, PPD and Pfizer.

According to the DCGI’s office, the three companies which have paid up in the five cases are Sanofi, Bristol Mayer and Quintiles. Dr Singh said, "In 2010, according to pharma company records submitted to us, 670 people in total died who were part of clinical trials. However, only 25 of these deaths were drug related. The rest of the deaths were mainly because of the illnesses of the subjects." Dr Singh added that of these 670 cases, treatment expenses were paid by the nine companies only in eight cases. In none of the cases, compensation for trial-related death were provided initially.

"On April 27, I directed the companies to pay up compensation in all death cases. The ethics committees of all these companies were also requested on April 29 to recommend the amount of compensation. So far, only in five of the 25 deaths, financial compensation for deaths have been/are being provided by the companies," Dr Singh added. According to DGCI officials, several pharma companies were trying to avoid paying compensation by saying they couldn’t track the legal heir.

"That’s more of a reason why consent forms should always include the name and contact details of all legal heirs in case a death or injury occur," Dr Singh said.

"From now on, we will monitor more proactively whether compensation is being paid by pharma companies to those who have been injured or have died during clinical trials. Compensation is mandatory according to Good Clinical Practices," he added. The Indian Council of Medical Research had recently framed draft guidelines for compensation to participants for research related injury in India. According to it, mothers, who because of undergoing clinical trials, lose or cause harm to their unborn child may be able to demand compensation from researchers conducting the trial.

The guidelines clearly said compensation has to be paid, irrespective of whether injury was foreseeable/predictable or not and the fact that the participant had freely consented in writing about participating in the research study. Compensation will have to be provided when temporary or permanent injury occurs due to participation. Compensation also has to be paid when the injury was caused by a procedure which was undertaken to manage an adverse reaction occurring during the research.

Defining "compensation," the draft said it could be in the form of payment for immediate medical/surgical management of research related injuries, compensation for research related injuries leading to temporary or permanent disabilities or compensation to legal heir/lawful guardian in case of death.

"The payment will be the responsibility of the investigator/institution," the draft said. The guidelines also said the Informed Consent Document (ICD) would have to clearly state that the participant had the right to claim compensation in case of research related injuries and whom to contact for their rights.