The Central Drugs Standard Control Organisation (CDSCO) has 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, Health Minister Mansukh Mandaviya said on January 27.
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, the health minister added.
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.— Dr Mansukh Mandaviya (@mansukhmandviya) January 27, 2022
The approval was granted under the New Drugs and Clinical Trials Rules, 2019, news agency PTI has reported citing official sources. Adverse event following immunisation will continue to be monitored.
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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.
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.
As per the official sources, the price of Covishield and Covaxin is likely to be capped at Rs 275 per dose plus an additional service charge of Rs 150.
According to them, the National Pharmaceutical Pricing Authority (NPPA) has been directed to start working towards capping the price to make the vaccines affordable. As of now, Covaxin is priced at Rs 1,200 per dose while Covishield costs Rs 780 in private facilities. The prices include Rs 150 service charge.
Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.
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(With inputs from PTI)
