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  • DCGI regular market...

DCGI regular market nod to Covaxin, Covishield for adults

Ruchika SharmaWritten by Ruchika Sharma Published On 2022-01-28T12:06:27+05:30  |  Updated On 20 Feb 2024 11:48 AM IST
DCGI regular market nod to Covaxin, Covishield for adults
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New Delhi: 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 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 DCGI's 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.
Read also: Covishield, Covaxin get regular market approval
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.
Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.
Read also: Covid-19: Covaxin, Covishield prices likely to be capped at Rs 275 per dose
covaxincovishieldbharat biotechbharat biotech newsserum institute of indiaserum institute of india newscoronavirus vaccinecovid19coronavirusdcgidrugs controller general of india
Source : PTI
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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