DCGI grants regular market approval to Covishield, Covaxin, details here

New Delhi: Drugs Controller General of India (DCGI) on Thursday (January 27) granted conditional market approval for Covid-19 vaccines— Covishield and Covaxin for use in the adult population subject to certain conditions. 

Health Minister Mansukh Mandaviya said, "The regulator has 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." 

Notably, the vaccines will not be available in medical stores. Private hospitals and clinics will be able to purchase these vaccines and administer them. Vaccination data has to be submitted to DCGI every six months and the data will also have to be updated on CoWIN app. 

#COVID19 | The vaccines will not be available in medical stores. The hospitals and clinics can purchase the vaccines. Vaccination data has to be submitted to DCGI every six months. Data to be updated on CoWIN app also. — ANI (@ANI) January 27, 2022

DCGI has granted regular market approval under the New Drugs and Clinical Trials Rules, 2019.

Earlier PTI had cited officials as saying that the price of Covishield and Covaxin is likely to be capped at Rs 275 per dose plus an additional service charge of Rs 150 after getting regular market approval. The National Pharmaceutical Pricing Authority (NPPA) has been tasked with capping the price to make the vaccines affordable.

Currently, Covaxin costs Rs 1,200 per dose while Covishield is priced at Rs 780 in private facilities, including Rs 150 service charge.

This approval has come 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, PTI reported. 

Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3, 2021. 

(With agency inputs)

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