The revised Schedule Y of the Drugs and Cosmetics Rules, to be notified within two weeks, will allow export of biological samples on the basis of the protocols that are duly approved. The change is expected to facilitate the growth of domestic clinical research sector in a big way. The export permission of biological samples will enable international CROs engaged in global trials to see India as one of their potential hubs.
The revised Schedule Y is known to cover all aspects of new drug research including GCP, CLP and stability testing. Aimed at speeding up the regulatory approval procedures for clinical trials, the revised Schedule Y would have various templates for clinical trial documents in readymade format.
The new Schedule Y is to allow concurrent clinical trials from phase II level. The only area where the phase lag would continue is phase I. Here, the government is to ask for details of the phase I conducted in the country of origin before the drug innovator can seek permission for repeat phase I trial for study of genetic variations. This is to be followed by approval for concurrent phase II trials.
On the enforcement side, the Central Drugs Standard Control Organisation (CDSCO) is in the process of identifying doctors from medical colleges to provide special training to play the role of clinical trial inspectors. These medical experts will have the powers to inspect the clinical trial sites and also go through the proceedings.
Meanwhile, the CDSCO is gearing up to the challenges of the post revised-Schedule Y era. The central agency has already cut down the delays in clearing new drug investigation applications. "The IND committee has cleared 13 IND molecules for phase I and few phase II applications during the current year. The average time taken by the committee to clear an IND application has come down to two months now," officials claim.