Covishield, Covaxin receive routine market approval for use in adult populations
According to news agency PTI, two Kovid-19 vaccines, Covishield and Covaxin, which are widely used for the vaccination campaign in the country, have been given regular market approval by the drug regulator. Official sources told the agency that regular market approval for use in the adult population is restricted, subject to certain conditions.
Following the approval of Drug Controller General of India (DCGI) by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on COVID-19 on January 19, Serum Institute of India (SII) recommended regular market approval. was done. Covishield and Bharat Biotech’s Covaxin for use in the adult population subject to certain conditions.
Regular market approval has been given under the New Drugs and Clinical Trials Rules, 2019, PTI reported.
Regular market approval does not mean that the two vaccines will be available to the general public for purchase at chemist shops. More details regarding regular market approval are awaited.
However, hospitals and clinics can buy the vaccines, news agency ANI reported. Hospitals and clinics will have to submit vaccination data to DCGI every six months and the relevant data will be updated on the CoWIN app.
Under the conditions, firms will submit data on vaccines to be supplied for ongoing clinical trials and programmatic settings. A PTI report said that post-vaccination adverse events would be monitored.
Prakash Kumar Singh, director of government and regulatory affairs at SII, had submitted an application to DCGI on October 25 seeking regular market authorization for Covishield.
After DCGI had sought more data and documents from the Pune-based company, Singh had recently submitted a response with more data and information. “Vaccination and prevention of COVID-19 infection on such a large scale with Kovidshield is in itself a proof of the safety and efficacy of the vaccine,” he had said.
In an application sent to DCGI, V Krishna Mohan, whole-time director at Hyderabad-based Bharat Biotech, sought regular market authorization for Covaxin, along with pre-clinical and clinical data, chemistry, Presented complete information about manufacture and control. ,
Mohan had said in the application that Bharat Biotech International Limited (BBIL) has been involved in the development, production and diagnostics of a vaccine (Covaxin) from SARS-CoV-2 strains isolated from COVID-19 patients in India. Took the challenge of evaluating.
With PTI inputs
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