Making adequate compensation to the victims of clinical trials has been a critical matter the pharma companies and clinical research organizations have been ignoring ever since clinical trials started in India. A probe by the Union Health Ministry in 2010 into the ways in which pharmaceutical giants and CROs were conducting clinical trials in the country had revealed that most of them have not been paying compensation to majority of the volunteers who died during the course of trials. Of the 671 deaths recorded during trials in 2010, the ministry had evidence of just three cases of offering compensation. The ministry then sought clarifications from 44 pharmaceutical companies on the compensation given by them for trial deaths. Top multinationals such as Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson, Sanofi Aventis and others who had been conducting clinical trials for years had given the standard explanation that deaths were due to progression of underlying diseases of the trial subjects. Therefore, they were not bound to pay any compensation. MNCs and CROs knew very well that the rules pertaining to compensation to trial victims are quite lax in the country. Health activists and patient groups have been, therefore, representing to the health ministry that the pharmaceutical companies and their agents should not get away with this kind of gross unethical practices in the name clinical trials.
The Supreme Court has taken note of this state of affairs and had made some scathing remarks on the health ministry’s neglect in this matter recently. The health ministry subsequently notified the rules and procedures for fixing compensation to the victims of trials giving legal backing to the existing guidelines. The rules thus notified by the government under Drugs & Cosmetics Rules had put the DCGI as the final authority in the matters relating to the compensation in the cases of serious adverse events like deaths and injuries during trials. A significant clause in the rules is that the pharma companies sponsoring clinical trials will no longer have the power to recommend compensation amount in case of trial-related death or injury. The responsibility to fix the quantum of compensation will be entrusted with the ethics committees. The CDSCO had issued guidelines with regard to compensation some time back. These guidelines outlined methods to be followed by the ethics committees for calculating the quantum of compensation to be paid in case of trial related injuries or deaths. The guidelines also specified methods to calculate the quantum of financial compensation, based on parameters like age and income of the deceased, seriousness of the injury, and the percentage of the permanent disability. Now as per the rules, 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 also have to 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, recommend compensation and the DCGI based on the report will take a final decision on the matter. The procedure laid down for making compensation to the trial victims sound quite reasonable and transparent. What is to be seen is how effectively the ethics committees will enforce these rules and help the victims.