Fast-track approval for Covid-19 drug, vaccine: DCGI

It said applications from companies will be given “high priority” and that it will assist the companies in speeding up their research

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Mumbai: The Drugs Controller General of India (DCGI) has said that it will fast-track approval of all companies which have a drug or vaccine for Covid-19 treatment, an attempt to speed up research and development (R&D) that could offer treatment or cure for the disease which so far has none across the world.

It said applications from companies will be given “high priority” and that it will assist the companies in speeding up their research. The DCGI has offered seven measures for speeding up the process, from giving fast-track approval for repurposed drug to waiving animal study and offering flexible pathways which earlier would have taken months.

In a note to various drug makers and industry lobbies, the DCGI said that companies or research firms which have protocol for repurposing old drugs will be given priority for review and approval, and that applications for clinical trial permission and applications for importing or manufacturing a drug or vaccine will be expedited.

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If any company has a drug or a vaccine approved for Covid-19 in any other country, then it can approach the DCGI directly and seek a fast-track marketing approval to sell in India. Further, the data requirement for animal toxicity study and clinical study might be waived.

The DCGI also said that applications to import a drug for test and analysis used to check efficacy with original molecules will be processed within seven days.