Even as there has been improvement in the predictability of timelines in Subject Expert Committee (SEC) with increase in number of SEC panels from 12 in the past to 25 currently, experts say that there is also need for a uniform code of operations by laying down of SOPs across the SECs so that they work in an aligned way as per the current regulatory framework for effective functioning of clinical trials (CT) in the country.

This will also bring about uniformity in the constitution, the way of functioning of SECs and also in terms of focus of review because in a global protocol, it has to be determined what is the relevance of that protocol to India and when this is ascertained it forms the respective term of reference and also backbone of the respective SOP. This will help the SECs to work in an aligned way with the global regulatory standards.

There is also a need to define the scope of review and approval of clinical trials besides the functioning of SECs currently. With prominent heads of institutions and academicians being part of the SECs, it becomes imperative that they should be made aware of the regulatory framework which governs the review of clinical trials in the Indian context. Experts have therefore urged that there is an urgent need to streamlining of SEC framework. The subject experts need to understand what their objective evaluation should be focused on.

There is an urgent need to spread public awareness of clinical trials. Concerns raised by NGOs may be genuine, but rejecting or delaying the approval for conducting CTs is not a solution and law should be for the regulation of CTs and not for restricting CTs. A separate setup with suitable guidelines as safety principles is required for monitoring, as there is a huge scope for CROs due to cost competitiveness,which should not be allowed to slip out of India. The Union health ministry’s recent notifications on conditions for paying compensation in case of injury and introducing definitions of new drug and IND are encouraging.