India’s drug regulator Drugs Controller General of India’s (DCGI) on Thursday granted regular market approval for Covid-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions, official sources said. The vaccines is likely to be capped at Rs 275 per dose plus an additional service charge of Rs 150, according to reports.
The approval was granted under the New Drugs and Clinical Trials Rules, 2019. 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. 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.
Union Health Minister Dr Mansukh Mandaviya said, “the Central Drugs Standard Control Organisation (CDSCO) 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 added.
Price of Vaccine in India
The vaccines will not be available in medical stores, reported ANI. Hospitals and clinics can purchase the vaccines. Vaccination data will be required to be submitted to DCGI every six months and it can be updated on the CoWIN app.
The National Pharmaceutical Pricing Authority (NPPA) has been directed to start working towards capping the price to make the vaccines affordable, sources said on Wednesday.
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. Both the vaccines are only authorized for emergency use in the country.
Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.
(With inputs from PTI)
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