The Drug Controller General of India is all set to bring in a significant amendment to Schedule Y of the Drugs and Cosmetics Act allowing simultaneous trials of new drugs in India. At present, trials of new molecules are one step behind the trials conducted at the country of original discovery is allowed in India.

The proposed amendment is in a bid to promote the country as an ideal clinical research base and also to encourage contract research organizations (CROs). However, according to Ashwini Kumar, Drug Controller General of India, the actual regulatory framework for permitting parallel trials is yet to be formulated and the drug control department is currently in that process.

Considering the additional risk of allowing the clinical investigation of entirely new molecule parallel to the research going on in the country of origin, the clearance and monitoring would need to be more systematic and stringent. The evaluation of application, verification of documents and analysis of the claims should be in a manner that suits the internationally accepted procedures. And also the verifying and clearing agency should be competent enough to analyze the documents and samples that perhaps the first time is being experimented upon.

The DCGI said that if the drug is to be manufactured in a pilot plant for experimentation purpose, the licensing has to be done with due care and enough scrutiny. This may need a more sophisticated procedural mechanism along with competent testing laboratories for analysis and validation to ensure bioequivalance and the related parameters.

However, as there are different schools of thought about the competent agency that can deal with the more systematic and vigilant regulatory procedures in the country. It is learnt that the Indian Council for Medical Research (ICMR) may act as the clearing agency in case of parallel trials. Whereas, CDSCO sources said that since the central Drug Control Department has the expertise in licensing and inspection in view of the regulations and administration, it can coordinate with the scientific experts and institutions to handle the approval procedures for the parallel trials.

The DCGI said that though there is risk involved in allowing human trials in the country simultaneous with other countries, the approval process here will be comparatively simpler if the country of origin has a strong regulatory system devised to clear the same there. At the same time, if the original country does not have systematic regulatory regime it may be difficult for us to accept the same here.