India’s drug regulator Drug Controller General of India (DCGI) on Thursday approved the regular market of Covid-19 vaccines Covishield and Covaxin for use in the adult population, subject to certain conditions, official sources said. As per reports, the vaccines are likely to cost Rs 275 per dose and an additional service charge of Rs 150.
The approval was given under the New Drugs and Clinical Trials Rules, 2019. Under the terms, firms will submit data on vaccines to be supplied for ongoing clinical trials and programmatic settings. Adverse event monitoring will be done after vaccination. Following the approval of the Drug Controller General of India (DCGI) by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on COVID-19 on 19 January, 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.
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. Singh had recently submitted a response with more data and information, after DCGI sought more data and documents from the Pune-based company. He had said, ‘Vaccination and prevention of Kovid-19 infection on such a large scale from Kovidshield is in itself a proof of the safety and effectiveness of the vaccine.
In an application sent to DCGI, Hyderabad-based Bharat Biotech’s whole-time director V Krishna Mohan, seeking pre-clinical and clinical data, chemistry as well as regular market authorization for Covaxin, furnished complete details about manufacturing and control . Mohan had said in the application that Bharat Biotech International Limited (BBIL) is 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 evaluation.
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ANI reported that the vaccines will not be available at medical stores. Hospitals and clinics can buy vaccines. Vaccination data needs to be submitted to DCGI every six months and can be updated on the CoWIN app.
Sources said on Wednesday that the National Pharmaceutical Pricing Authority (NPPA) has been directed to start work towards reducing the prices to make the vaccines affordable.
As of now, Covaxin costs Rs 1,200 per dose, while CoviSheeld costs Rs 780 in private facilities. Prices include a service charge of Rs 150. Both vaccines are authorized for emergency use in the country only.
Covaxin and Covishield were granted Emergency Use Authorization (EUA) on 3 January.
(with inputs from PTI)