Drugs Controller General of India early this month decided to do away with the restrictions on the number of clinical trials an investigator can undertake at a time in the country. Currently, no investigator is allowed to conduct more than three trials at any given period of time. However, the health ministry empowered the ethics committee to take a final call on the number of clinical trials an investigator can do at a time after examining the risk and complexity of the trials. The decision to relax the rules on clinical trials comes in the wake of widespread resentment against restrictions on clinical trials during the last few years. The experts were of the view that restricting the number of studies for an investigator is not justified in the interest of clinical research in the country. The health ministry thus convened several meetings in the past with the industry associations and other stakeholders on the issue. Two such important meetings were held in months of August and October last year under the chairmanship of the secretary, Ministry of health and other experts. Clinical trial approvals had almost come to a halt since 2012 with very few applications being cleared by the DCGI. The situation was a result of growing criticism on the way trials were being conducted in India by certain pharmaceutical companies and contract research organizations (CROs). Between July and August 2013, the DCGI had received as many as 1122 applications for clinical trials and of which the New Drug Committee approved only 285 applications but the DCGI office cleared only 162 out of that. And the Supreme Court issued an order in October, 2013 staying all the 162 approvals granted by DCGI.
The health activists, however, are not happy with the relaxation of the rules as they think that it will only seek to promote the interests of pharma companies and CROs rather than uphold the public interest. They feel that changed rules do not ensure quality checks like criteria to select the researcher or investigator conducting the trial and adequate punitive provisions are missing against those conducting unethical trials. It is a fact that several hundreds of deaths had taken place in the past during clinical trials mainly on account of unethical practices indulged in by pharmaceutical companies and CROs. The Supreme Court’s order in October, 2013 staying all 162 approvals granted by DCGI was in the wake of these developments. Now, after the intervention of the apex court the new drug research did come to almost a standstill during the last three years. This is certainly an alarming situation for the Indian pharmaceutical industry as its growth is under threat with very few new drugs being approved for marketing. But, after the Supreme Court’s stand, the health ministry laid down some stringent safeguards and provisions to ensure that rights and safety of subjects in clinical trials are not compromised. These measures with proper legal backing and effective monitoring by DCGI should ensure fair conduct of clinical trials in the country.