With the final notification of revised Schedule Y round the corner, the drug regulatory authorities have started worrying about the challenges and constraints before them. As the resources are limited at their disposal, the authorities are wondering how to ensure sufficient trained / competent staff needed to handle any possible spurt of clinical trials activities in the country.

Commenting the issue of regulating clinical trials, Ashwini Kumar, Drugs Controller General of India (DCGI) said that the new rules would allow outsourcing of trained evaluators, but they are at dark to find out ways and means to remunerate them. The rules call for setting up of ethical committees, but the regulatory system to monitor the committees is yet to emerge clearly.

There are also concerns over the regulation of trials on medical devices / diagnostics, novel drug delivery systems, pharmacogenetics, as in all these cases, regulatory protocols are yet to be evolved completely.

The pharmaceutical companies who are willing to conduct their clinical research activites in the country are very particular about the cost, speed and quality of trials that are to take place. While the cost factor is independent of the functioning of the regulatory system, speed and quality of research, which can have indirect impact on the cost factor, are directly linked to the performance of the regulatory authorities.

The drugs control authorities also feel the need for more discussions on issues like data exclusivity, transparency, ADR monitoring, rDNA based drugs / biogenerics etc. Above all, comes the urgent need to deal with the public perception triggered by the media reports, they say.

The DCGI said that only a balanced regulatory agency, one that is progressive and well informed, could withstand the onslaught of the negative campaigns that are likely to arise in the eventuality of increased clinical research in the country. According to DCGI, drug regulatory system in India is a dynamic one and is positively influenced by country specific priorities / situation, advances in science and technology, international harmonization of standards and the pro-active industry.