Drugs Controller must be told of adverse events within 24 hours

Under sharp criticism for inadequate monitoring of clinical trials in the country, the government is contemplating major changes in the Drugs and Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.

The DGCI will constitute a committee of experts to analyse the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and it shall then recommend the exact quantum of compensation in case of trial-related injury or deaths within three months.

As per the existing procedure, all serious adverse events (SAEs) are reported by the Investigator to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then submits the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that decides on the cause of the injury or death, and announces compensation accordingly.

There is also a proposal which makes it mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required. There will be a specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.

In order to capture the socio-economic background of the persons participating in the trial, it is proposed to modify the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned. Requirements and guidelines for registration of the ethics committee would be prescribed in the Rules.

However, this method has drawn a lot of flak, as there have been complaints related to violation of ethics, and prejudiced reports of the ethics committee. Even the existing manner of securing consent from the subjects has been questioned by rights-based health activists.

As per the available data, the number of serious adverse events in clinical trials reported during 2010, 2011, and up to June 2012, stood at 668, 438 and 211, respectively. However, deaths due to clinical trials were 22 and 16 in 2010 and 2011, respectively.

The Ministry of Health and Family Welfare has already moved amendments to the Rules, wherein 12 New Drug Advisory Committees, consisting of leading experts from the government medical colleges and institutes from all States in the country, have been constituted to advise the DGCI in matters related to approval of clinical trials and new medicines.

Applications of Investigational New Drugs (IND), which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General of the Indian Council of Medical Research.

Deaths may occur during clinical trials due to various reasons, including life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure, and stroke.

They can also be due to the side-effects of the medicines or their administration to critically or terminally ill patients.