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Govt mulls faster drug approval process, regulatory system overhaul

The industry, which has been lobbying for faster approvals for quite some time now, says the current pandemic should help expedite the reforms process

The government is now trying to understand how long it will take before the drug’s production can start in India
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Currently, the approval timeline for a new drug application is around six to nine months, even for drugs that have been approved in other regulated countries

Sohini Das Mumbai
The new drug approval process in India is expected to get simpler and faster, with the government initiating discussions on reforming the regulatory system. The Ministry of Health and Family Welfare has called a meeting of the committee constituted for this purpose on Friday, sources familiar with the developments said. This will be the second meeting of the committee.
 
The industry, which has been lobbying for faster approvals for quite some time now, says the Covid-19 pandemic should help expedite the reforms process. India now needs new drugs like Favipiravir (used for influenza in Japan) and Gilead Sciences’ repurposed Ebola