New Delhi: The Drugs Controller General of India (DCGI), India’s drug regulator, granted regular market approval for the COVID-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions, on Thursday, official sources informed news agency PTI. The regular market approval was granted under the New Drugs and Clinical Trials Rules, 2019.
The Serum Institute of India (SII), which manufactures Covishield, and Bharat Biotech, which developed Covaxin, shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting, under certain conditions. According to the report, adverse events following immunisation will continue to be monitored.
The vaccines will not be available in medical stores, and hospitals and clinics can purchase the vaccines, news agency ANI reported. Vaccination data has to be submitted to DCGI every six months, and will be updated on the CoWIN app also.
On January 19, a Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) recommended granting regular market approval to Covishield and Covaxin for use in adults, subject to certain conditions.
The price of Covishield and Covaxin is likely to be capped at Rs 275 per dose along with an additional service charge of Rs 150, official sources said on Wednesday, PTI reported.
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The National Pharmaceutical Pricing Authority (NPPA) has been directed to start working towards capping the price to make the vaccines affordable, according to the sources.
Covaxin and Covishield are priced at Rs 1,200 per dose and Rs 780 per dose respectively, in private facilities, as of now. A service charge of Rs 150 is included in the prices.
Quoting an official source, a PTI report said that the NPPA has been asked to work towards capping the price of the vaccines, and that the price is likely to be capped at Rs 275 per dose along with an additional service charge of Rs 150.
On October 25, Prakash Kumar Singh, the Director of Government and Regulatory Affairs at the Pune-based Serum Institute of India, had submitted an application to the DCGI seeking regular market approval for the Covishield vaccine, according to media reports.
Singh had recently submitted a response to the DCGI along with more data and information after India’s drug regulator sought more data and documents from the SII.
Quoting Singh, a PTI report said that 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, the whole-time director at Bharat Biotech, had submitted complete information on the chemistry, manufacturing and controls of Covaxin, along with the pre-clinical and clinical data, a few weeks ago, while seeking regular market authorisation for the vaccine.
Mohan had said in the application that 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 a PTI report.
On January 3 last year, Covaxin and Covishield were granted EUA.