Health regulatory agencies likely to come under DCGI ambit

Single-window system to take care of regulatory need for drugs, vaccines

The Union government is working to bring scattered agencies that look after various aspects of a drug or vaccine approval process under one roof. The initiative is in the works and necessary amendments in rules and acts would be done, said a senior government executive.

Speaking at the Global Innovation Summit 2021, Union Health Secretary Rajesh Bhushan said a major issue that acts as a critical challenge to innovation as far as regulatory processes are concerned is regulatory processes being multi-pronged and scattered. For example, an innovator or a private sector entity has to traverse a multitude of entities before requisite approvals are given.

“We have the Central Drugs Standards Control Organisation (CDSCO), which is the nodal body for giving such approvals. We also have the Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology, then we have the Genetic Engineering Approval Committee (GEAC), which is in the domain of MoEF, and we also have the Indian Council of Medical Research (ICMR) for certain kind of products,” Bhushan said.

He said a major initiative was in the works to ensure that all these processes are brought in one place and requisite amendments are done to the Rules and Acts so that everything happens in the national regulator’s office. The Drugs Controller General of India (DCGI) heads the CDSCO and is the national regulator.

Bhushan said a similar approach would be taken when it comes to control and supervision of experiments on animals. “Timelines for disposal of applications by the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) would be brought in. The CPCSEA is under the ministry of animal husbandry,” he said.

The idea is to bring the scattered agencies which look at various aspects of regulatory approvals at one place.

This apart, Bhushan highlighted that the Centre was working to ensure parallel submission of applications for marketing authorisation, import registration and import license. “Presently, it is sequential. If this is made parallel, it saves time. We also incentivise people who are ideating, innovating, and who are eventually manufacturing,” the health secretary said.

The Cabinet secretariat will implement the process moving towards a single window approach to take care of regulatory requirements for drugs and vaccines etc, as several departments and ministries are involved.

DCGI VG Somani, who was also present at the summit, said during the pandemic there was pressure to develop diagnostics, therapeutics, immunobiologicals, devices, which can solve the problems of Covid-19. “We had to devise methodologies where the regulator becomes the facilitator. The old process of leisurely looking at the data multiple times, looking at the complete data set before we move on to the next step sequentially was changed,” Somani said. He said an approach to had an adaptive clinical trial design was taken.

There have been 180 Subject Expert Committee (SEC) meetings that have happened in the past two years or so. “We started hand-holding the local FDAs, the innovator, the researcher and had regular meetings in between the SEC meetings to expedite the processes,” Somani said.

Last March, there was not a single Covid-19 diagnostic kit in the country, Somani said. “Now we have 400 kits, of which 50 per cent are made locally,” he said.