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  • Covishield, Covaxin...

Covishield, Covaxin get regular market approval

MD BureauWritten by MD Bureau Published On 2022-01-20T16:39:44+05:30  |  Updated On 20 Jan 2022 4:39 PM IST
Covishield, Covaxin get regular market approval
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New Delhi: India's two main vaccines, Bharat Biotech's Covaxin and Serum Institute of India's Covishield, on Wednesday got the nod for regular market authorisation.

An expert panel of Central Drugs Standard Control Organisation (CDSCO) -- India's regulatory body for pharmaceuticals, medical devices and cosmetics -- on Wednesday recommended granting regular market approval to Covishield and Covaxin, which are currently only authorised for emergency use in the country, subject to certain conditions.

Also Read:More than 50 lakh healthcare, frontline workers, 60 years plus-given Precaution Dose: Health Minister

"CDSCO has recommended for upgrade of Covishield and Covaxin's status from restricted use in emergency situations to grant of new drug permission with conditions in adult population. The DCGI (Drugs Controller General of India) will evaluate the recommendations and give its decision," CDSCO said in a tweet.

Indian vaccines manufacturer Serum Institute of India and Bharat Biotech had submitted applications to the DCGI seeking regular market authorisation for their respective Covid vaccines.

Prakash Kumar Singh, director of government and regulatory affairs at Serum Institute, had submitted an application to the DCGI on October 25 last year on this matter.

The DCGI had sought more data and documents from the Pune-based company following which Singh recently submitted a response along with more data and information.

Hyderabad-based Bharat Biotech had submitted complete information on chemistry, manufacturing, and controls, along with the pre-clinical and clinical data while seeking regular market authorisation for Covaxin.

Also Read:Bharat Biotech receiving reports on wrong COVID vaccine administration in 15-18 years old

covidCovishieldCovaxinregular market approvalCentral Drugs Standard Control OrganisationCDSCOBharat BiotechSerum Institute of Indiacovid vaccine
Source : IANS
MD Bureau
MD Bureau

    Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in.

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