Covishield, Covaxin cleared for market approval by expert panel

An expert panel of India's central drug authority on Wednesday recommended granting regular market approval to Covid vaccines Covishield and Covaxin, which are currently only authorised for emergency use in the country, subject to certain conditions, official sources said.

Pharma companies Serum Institute of India (SII) and Bharat Biotech had submitted applications to the Drugs Controller General of India (DCGI) seeking regular market authorisation for their respective COVID-19 vaccines Covishield and Covaxin.

Prakash Kumar Singh, director (government and regulatory affairs) at SII, had submitted an application to the DCGI on October 25 on this matter.

On that DCGI had sought more data and documents from the Pune-based company following which Singh recently had submitted a response along with more data and information.

In addition to the successful completion of phase 2/3 clinical study in India, till now, more than 100 crore doses of Covishield vaccine have been administered to the people in this country and worldwide, Singh is learnt to have stated in the response. ''Such a large-scale vaccination with Covishield and containment of COVID-19 infection is in itself a testimony of the safety and efficacy of the vaccine,'' he had said.

In an application sent to the DCGI a couple of weeks ago, V Krishna Mohan, whole-time director at the Hyderabad-based company, submitted complete information regarding chemistry, manufacturing and controls, along with the pre-clinical and clinical data while seeking regular market authorisation for Covaxin. Bharat Biotech International Limited (BBIL) took up the challenge to develop, produce and clinically evaluate a vaccine (Covaxin), from the SARS-CoV-2 strains isolated from COVID-19 patients in India, Mohan had said in the application.

Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.

''The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) which reviewed SII and Bharat Biotech's application for the second time on Wednesday has recommended granting regular market approval to Covishield and Covaxin subject to certain conditions,'' an official source said.

The recommendations will be sent to DCGI for final approval. During last week's meeting the SEC had sought more data and information from the two companies.