Health ministry to add Schedule Y1 to D&C Rules to streamline clinical trials sector

New Delhi -The Health Ministry is planning to incorporate a new schedule 'Y1' to the Drugs and Cosmetic Rules 1945, to specify all rules regarding clinical trials including guidelines for registration of trials, penalty provisions for defaults, registration of ethics committees and on-site audits of trials.

The draft guidelines on trials and requirements for registration of clinical research organisations, prepared by an expert panel, and proposed amendment in rules have already been approved by the Drug Technical Advisory Board (DTAB) and the DCC, and are waiting to be notified. After the approval of the minutes of the last DTAB meeting, the guidelines are likely to be announced, sources said. It is also proposed to incorporate Rule 122DAB for the proposed new Schedule Y1, it is learnt.

Compulsory Registration of CROs is expected to begin by the middle June. While granting permission for conducting trials, the DCGI office will also advice the applicants to register them in the web-based Clinical Trials Registry maintained by the ICMR. This will be made mandatory later. Besides, the DCGI office have also prepared guidelines for registration of ethics committees so that some uniform pattern can be worked out and they can be made more effective.

Another proposal is to ask the trial companies to get the finger-prints of all volunteers in phase-III trials and share the data between the CROs. This will ensure that the same man is not going for another trial by another company, after being a subject in one trial. The number of trials that a principal investigator also will be limited for more effective end results, sources said.

The DCGI office, in collaboration with agencies like US FDA, WHO, Health Canada and Brazil, is in the process of giving training to its staff to conduct on-site inspections of trials. These audits will make sure that the trials are conducted as per the norms and the CROs are registered. Special teams comprising drug inspector, pharmacologist and clinical trials expert will carry out the audits.

India ranks as the second most preferred destination for trials in the world and the industry is expected to touch 1.52 billion dollar mark by 2010, according to reports. The country has a good infrastructure to attract the global business. It has 290 medical colleges, 15630 hospitals and every year it is producing 24000 graduates in medicine. It also enjoys edge in IT and IT-enabled services.