High-Level Panel Suggests Single-Window System For New Drug Approvals

New Delhi, 21 July 2020:

A high-level committee has proposed a single-window approval system to speed up availability of new drugs in the country, even as the world is in a rush to nd vaccine and cure for the Covid-19 pandemic.

The committee, set up by the cabinet secretary after Prime Minister Narendra Modi sought overhauling of the country’s drug regulatory system, has suggested restructuring the process of permission for new drugs by allowing parallel submission of applications for new drug approval and for grant of importlicence and manufacturing license.

Under the present system of sequential processing, getting import licence for a new drug can take about a year. It takes 90 days to get permission to import and market a new drug. Once it is obtained, then the company requires an import registration certicate. The duration specied for processing this application is 270 days. After getting the RC, it takes at least 30 more days to get the import license.

A parallel application system “will reduce the processing duration by about 3-6 months”, the committee said in its interim report submitted to the Prime Minister’s Oice.

It has also recommended that market authorisation be permitted simultaneously, thereby reducing the time duration by 2-3 months.

The committee was formed after Modi raised concerns over the ability of the regulatory framework to keep pace with industry and scientists.

It includes representatives from the Department of Biotechnology (DBT), Indian Council of Medical Research (ICMR), Indian Council for Agricultural Research, Council for Scientic and Industrial Research, and other experts. Economic Times