Stung by the recent criticism by the Supreme Court on the regulation of clinical trials in the country, the Union Health Ministry has notified the rules and procedures for fixing  compensation to the victims of trials, thus giving legal backing to the existing guidelines.

The rules notified by the Government recently under Drugs & Cosmetics (D&C) Rules also put the Drug Controller General of India (DCGI) as the final authority in the matters relating to the compensation in the cases of serious adverse events like deaths and injuries during the trials.

The pharma firms sponsoring the clinical trial will no longer have the power to recommend its own compensation amount in case of drug trial-related death or injury. As per the practice now, the ethics committees set up by the companies have the responsibility to fix the quantum of compensation.

According to the new notification the sponsor of the trial, its investigator and the ethics committee of the medical institute conducting the trial will report any injury or death of a subject within 24 hours to the DCGI. They will also submit independent reports to the DCGI on the causes of death and their own assessment. The DCGI will then set up an independent inquiry committee to review the case and recommend compensation.

The DCGI, based on the report, will take the final decision about the compensation. The new notification will apply to all such cases of clinical trial including bio-availability and bio-equivalence studies-related injuries or death occurring during clinical trial of drugs, including biological and medical devices covered under the D&C Act.

The categories of injuries have been laid down from minor harms (bruises or infected wounds) to major injuries (organ damage or temporary disability) to catastrophic injuries (permanent disability or death).

Some time back, the CDSCO had issued guidelines in this regard. The guidance document described the methods to be followed by the Ethics Committees for calculating the quantum of financial compensation to be paid in case of clinical trial  related injury or death. The guidelines also has made specific methods to calculate the quantum of financial compensation, based on parameters like the age and income of the deceased, seriousness of the injury, and the percentage of the permanent disability.