High-level government panel suggests single-window system for new drug approvals Read more at: https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/high-level-govt-panel-suggests-single-window-system-for-new-drug-approvals/ar

News date: 21 July 2020Source: https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/high-level-govt-panel-suggests-single-window-system-for-new-drug-approvals/articleshow/77073907.cms

New Delhi: 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 find 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 or import license 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 requireds an import registation certificate. The duration specified for processing this applicaion is 270 days. After getting the RC, it taked at least 30 more dasy to get the import license.

A parallel application system " will reduce the processing duratio by abot 3-6 months", the committee said in its interim report submitted to the Prime Minister's Office.

It has also recommended that market authorization be permitted simltaneously, thereby reducing the rime duration by 2-3 months.