The Health Ministry will soon formally notify the procedures and amount of compensation to be paid by the pharmaceuticals companies, if a volunteer dies or gets injured during a clinical trial.

“The Government has already published the draft rules for the new schedule Y1 under the Drugs and Cosmetic Rules, 1945 and it is under the stipulated process of examination before the final notification. However, with a view to tighten the norms on clinical trials, several sections of the amendment have already been implemented,” Drug Controller General of India (DCGI) Dr G N Singh said.

“We are in the process of finalising the detailed procedures and amount of compensation and on making the companies liable for causes of damages during the trials. This will be notified within a couple of months,” he said.

The Drug Technical Advisory Board (DTAB) had already given approval to the Central Drugs Standard Control Organization (CDSCO) to prepare a “compensation chart” or extensive guidelines that will specify the amount to be paid. Ethical committees of the company will have to decide the quantum of compensation on the basis of these guidelines.

The Indian Council of Medical Research (ICMR) recently framed draft guidelines for compensation to participants for research-related injury. With the notification, these guidelines will be made effective as rules.

Twelve New Drug Advisory Committees (NDACs) and Six Medical Device Advisory Committees (MDACs) have been constituted to evaluate clinical trials proposals. These committees consist of leading experts from Central and State Government medical institutions. The draft notification provides for medical treatment financial compensation to the trial subjects in case of trial related injury or death and procedure for payment of financial compensation, the DCGI said.

The amendment also lays down provisions for enhancement of responsibilities of Ethics Committee (EC), Sponsor & Investigator to ensure that financial compensation as well as medical care is provided to the trial subjects who suffer trial related injury or deaths and such information is provided to DCG(I), Dr Singh said.

All clinical trials, the permission for which have been granted by the office of DCG(I) on or after 15th June 2009, have to be mandatorily registered on the clinical trial registry at www.ctri.in of Indian Council of Medical Research (ICMR). CDSCO has issued guidelines for conducting inspection of clinical trial sites and Sponsor/Clinical Research Organisations (CROs).