The government’s Subject Expert Committee (SEC) on Wednesday recommended granting regular market approval to Covishield and Covaxin coronavirus vaccines, but with certain conditions. The Serum Institute of India (SII) and Bharat Biotech had submitted their respective applications to the country’s drug regulator, the Drugs Controller General of India (DCGI), seeking full market authorisation for their vaccines. The vaccines are currently only authorised for emergency use in the country.
A market authorisation label for a vaccine means it can be authorised for use without reservations or conditions. For full market authorisation, the regulator would need to evaluate more data about the vaccines collected over a longer period of time.
Taking to Twitter, the Central Drugs Standard Control Organisation (CDSCO) said that the recommendation has been sent to DCGI.
SEC of CDSCO has recommended for upgrade of covishield and covaxin status from restricted use in emergency situations to grant of new drug permission with conditions In adult population ,DCGI will evaluate the recommendations and give its decision.— CDSCO_INDIA_INFO (@CDSCO_INDIA_INF) January 19, 2022
Prakash Kumar Singh, director (government and regulatory affairs) at SII, had submitted an application to the DCGI on October 25 on this matter. The DCGI had sought more data and documents from the Pune-based company following which Singh had submitted a response along with more data and information recently.
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 Bharat Biotech, 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 on Covid-19 of the Central Drugs Standard Control Organisation, 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,” PTI quoted an official source as saying.
During last week’s meeting, the SEC had sought more data and information from the two companies. At the time, the SEC had asked both the companies to come back with specific conditions backed with data for the full market approval. The SEC was of the view that it cannot allow SII and Bharat Biotech to sell Covaxin and Covishield in the open market till the government was mapping vaccination through specific nationwide drives via the Cowin app.
(With PTI inputs)
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