New Delhi: Drug companies conducting clinical trials in India must pay up 60% of the compensation amount within 15 days if a patient dies or suffers a permanent disability in the course of a trial, according to new government rules in the works.

“We want to dispel the impression to the companies conducting clinical trials in India that people can be used as guinea pigs here," a health ministry official said, requesting anonymity.

Additionally, even if it is proved after an investigation that the death did not occur because of the trial, the interim compensation will not be recoverable.

The financial compensation will be over and above expenses incurred on medical management of the subject, according to a second government official with direct knowledge of the matter, who also did not want to be named.

Compensation to victims of clinical trials is given on the basis of a formula that takes into account the age and health risk of the patient.

The Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices and the ministry of health and family welfare are forming the new rules on clinical trials of new drugs.

They have also proposed that in case the patient suffers from any other illnesses during the clinical trial, the sponsor shall provide medical management and ancillary care. These rules will be put up for discussion with stakeholders soon.

In 2013, the government informed the Supreme Court that as many as 2,644 people had died during clinical trials of 475 new drugs between 1 January 2005 and 30 June 2012 and that only 17 of these drugs were approved for marketing in India. Another 11,972 serious adverse events (excluding death) were reported during the same period. Of them, 506 cases were found to be related to clinical trials.

According to the proposed rules, if the injury is related to a clinical trial, in addition to the medical management the participant will also be provided financial compensation by the sponsor as determined by a proposed ethics committee and the financial compensation provided will be over and above any expenses incurred in medical management of the subject.

The ethics committee is a proposed government body that will ensure that medical experiments and research on humans are carried out in an ethical manner and provide feedback on the ethical appropriateness of the trial. It will consist of seven members including experts from medical science, non medical stream, scientific and non-scientific members, a layman and a woman member, according to an official in CDSCO, requesting anonymity.

According to CDSCO, major pharmaceutical companies conducting medical trials in India include global giants such as Novartis, Pfizer, Merck KGaA, AstraZeneca and Indian drug firms such as Torrent Pharmaceuticals Ltd, Sun Pharmaceuticals Industries Ltd and Biocon Ltd.

A Pfizer spokesperson welcomed the move.

“We believe our clinical trials regulations should be at par with international clinical trials regulations and will be completely supportive of the government’s efforts towards this direction. A strong clinical trials regime supported by a sound and predictable Clinical Trials policy will help the pharmaceutical industry in India to achieve its bold ambition and supply innovative medicines to patients in India and globally," the spokesperson added.

The stringent regime on clinical trials, senior officials say, promises greater transparency and better checks for patient safety.

“Keeping in view the need for new drugs which continues to remain unabated, we felt that there was a significant room for improvement in the rules of clinical trials. The new rules will safeguard the interest of the subjects and will bring more clarity to the approach on clinical trails," another health ministry official cited above said.

For speedy recovery of compensation, the proposed rules also make it binding for the ethics committee to complete the investigation within a period of 30 days from the date of death or serious adverse event (SAE) or a permanent disability.

“For removal of doubt it is declared that the amount paid as interim compensation to the trial subject or the legal heir shall not be recoverable irrespective of the case of death," added the second health ministry official cited above.

According to the draft rules, in case injury is not permanent, the quantum of compensation shall be commensurate with the loss of wages of the subject. “The responsibility for medical management or compensation shall be discharged by the sponsor or the person who has obtained permission from the licensing authority," an another official in CDSCO said.

The amount of compensation paid by pharmaceutical companies for clinical trial-related deaths since 2013 till date is approximately Rs8.7 crore; while for clinical trial-related injury other than death, approximately Rs47 lakh has been paid by various firms since 2013, according to the CDSCO.