Covishield, Covaxin get regular market approval for use in adult population

Highlights

The new approval doesn't mean that Covishield & Covaxin will be available at regular medical shops
However, people can buy the two vaccines from hospitals and clinics, subject to certain conditions
Covishield and Covaxin were granted Emergency Use Authorisation in January 2021

Covishield and Covaxin, the two Covid-19 vaccines widely used for the inoculation drive in the country, have been granted regular market approval by the drug regulator, according to news agency PTI. The regular market approval is restricted for use in the adult population subject to certain conditions, official sources told the agency.

The Drugs Controller General of India's (DCGI) approval came after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on January 19 recommended granting regular market approval to the Serum Institute of India's (SII's) Covishield and Bharat Biotech's Covaxin for use in adult population subject to certain conditions.

The regular market approval has been granted under the New Drugs and Clinical Trials Rules, 2019, PTI reported.

The regular market approval doesn't mean that the two vaccines would be available at chemist shops for the general population to purchase. More details related to the regular market approval are awaited.

However, hospitals and clinics can purchase the vaccines, news agency ANI reported. Hospitals and clinics will have to submit the vaccination data to DCGI every six months and related data will be updated on CoWIN app.

Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting. Adverse event following immunisation will continue to be monitored, a PTI report said.

Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, had submitted an application to the DCGI on October 25 seeking regular market authorisation for Covishield.

The 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. "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, V Krishna Mohan, whole-time director at the Hyderabad-based 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.

With PTI Inputs