The Indian government is in the process of notifying rules for compensation for those affected by serious adverse events (SAE) during a pharmaceutical drug trial, which is the first law of its kind in the country.
The law will ensure adequate compensation is awarded in the case of injury or death caused by participation in a pharmaceutical drug trial. Previously there was no clear compensation rules in the Drugs and Cosmetics Rules, which govern clinical drug trials in the country.
Under the new law, compensation will have to be given to the claimant within three months of the reporting of injury or death. The Drug Controller General of India (DCGI), the apex drug regulator, will have the final decision of causes of injuries or death in clinical trials and will also approve the final compensation amount for each case.
Under the current law, ethics committees set up by the sponsors of clinical trials take on this role, and compensation they award is generally seen as very low.
Average compensation handed out to the 2,242 people who have died during drug trials in India over the past five years is Rs 2.2 lakh, according to health ministry data.
Under the new law, the ethics committee of the medical institute conducting the trial, the sponsor of trial and its principal investigator will be required to report injury or death within 24 hours and file a report with the independent expert committee set up by the DCGI who will then review the case.
"With the notification of procedures of compensation, the Government has ensured the safety and rights of subjects participating in clinical trials. Henceforth all trials will be monitored at all the stages," a senior Ministry officer told Zeenews.com, an India-based news website.
Last year the BBC news programme Newsnight revealed that poor people in India may have been used as guinea pigs in drug trials without their consent, and suffered injury and death as a result. Also, as recently as last month, GlaxoSmithKline and MSD Pharmaceuticals were accused of conducting illegal tests of their HPV vaccines on tribal girls in Andhra Pradesh and Gujarat.
