Clinical research has been projected as the next big business opportunity for the pharmaceutical entrepreneurs in India by industry chambers and consultancy organizations. It is proving to be so when one takes the unhindered growth of clinical trial activity in India during the last five years. More than 100 CROs and pharmaceutical companies have already sprung up in this space today. As per the latest estimates, 700 trials are currently going on in the country for several chemical and biotech compounds of different international companies. By its very nature human trials are highly risky as it involves deaths or serious injuries to the subjects undergoing trials. Information about deaths and injuries of the subjects during the trials are usually suppressed by CROs and pharma companies. Deaths of some patients during the trial of a Wyeth drug in Bangalore and of some children at AIIMS last year are some recent cases which have come out in the public. Even India's health ministry comes to know about these deaths and injuries much later. CROs and pharma companies involved in such cases often escape without paying proper compensation to the subjects or penalty for neglect. This is because the laws governing the clinical research in the country are vague on the issue of giving proper compensation to the trial participants. The ICMR's Ethical Guidelines for Biomedical Research on Human participants, 2006 have specified the need for a provision for compensation to participants for research related injuries.
In October 2008, ICMR had invited comments from the experts on the draft guidelines as the next step before notifying them as rules. The draft guidelines apply to all clinical research, whether sponsored by the pharmaceutical or medical devices industry, government or academia or individual investigators. As per the guidelines, compensation should be provided to the research participants when temporary or permanent injury occurs in the clinical research and also when injury is caused by a procedure which has been undertaken to manage an adverse reaction occurring during the research. The guideline proposes compensation to the participants irrespective of whether injury was foreseeable, predictable or not, the fact that the research participant had freely consented in writing to participate in the research and irrespective of the fact that the injury was caused through a departure from the agreed protocol, scientific misconduct or negligence by the investigator. The guidelines as drafted by the ICMR reads quite comprehensive and claim to protect the trial participants. Now the question is how the same will be enforced once it is notified. Ethics committees in trial sites are supposed to be independent monitoring bodies of trials. But, a majority of these ECs are ineffective in the country today. They need to be activated first and should be made to report overall progress of the trials and status of the subjects on a regular basis to a designated authority in the DCGI's office. They should also be made accountable to report any default in payment of compensation to the subjects by the sponsors if the new initiative has be meaningful.