According to PTI, the Drugs Controller General of India (DCGI) awarded normal market authorization for innovative coronavirus vaccines Covaxin by Bharat Biotech and Covishield by Serum Institute of India for use in the adult population to specified conditions on Thursday. The New Drugs and Clinical Trials Rules of 2019 were used to grant the approval.
The New Drugs and Clinical Trials Rules of 2019 were used to grant the approval.
Union Health Minister Mansukh Mandaviya said, "The @CDSCO_INDIA_INF has now upgraded the permission for COVAXIN and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions."
"The conditions include supply for programmatic settings including registration on the CoWIN platform and to continue to submit safety data on a six-monthly basis." he further said.
The vaccines will not be sold in medical stores, according to the Union Ministry of Health. Vaccines can now be bought by hospitals and clinics. Vaccination data has to be given to DCGI every six months. The info has to be updated on CoWIN app also.
Have a look, at what the Union Health Minister has to say about this.
The DCGI's decision comes after the CDSCO's COVID Subject Expert Committee (SEC) recommended conditional regular market authorization for Covaxin and Covishield on January 19. Both Bharat Biotech and SII must submit data from ongoing clinical trials as well as COVID vaccines to be supplied for the programmatic setting under the terms of the agreement. The DCGI stated that adverse effects following immunization will be closely monitored.
On October 25, SII submitted a request to the FDA for normal market approval of its vaccine. DCGI requested more information from SII, which was provided by Prakash Kumar Singh, Director, Government, and Regulatory Affairs at SII. The DCGI had requested further data and papers from the Pune-based firm, and Singh had just responded with additional data and information.
He further said, "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."
V Krishna Mohan, a full-time director at Bharat Biotech, had submitted complete data on chemistry, production, and controls, as well as pre-clinical and data when seeking regular marked approval for Covaxin.
In an application, Mohan said, "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."
According to Mohan's application, Bharat Biotech International Limited (BBIL) accepted the challenge to develop, produce, and clinically evaluate a vaccine (Covaxin) based on SARS-CoV-2 strains obtained from COVID-19 patients in India.
On January 3, Covaxin and Covishield received Emergency Use Authorization (EUA).
Also read: Government gives approval to covaxin and covishield for market use
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