Bharat Biotech’s COVAXIN will now be available in the regular market as the Drug Controller General of India today gave conditional market approval to the indigenous made Covid vaccine on Thursday.
The subject expert committee of the Central Drug Standard Control Organisation has earlier recommended granting regular market approval to the two Covid-19 vaccines for the adult population, subject to certain conditions.
Market approval was also given to the Serum Institute Vaccine, the regulator however stated that the approval does not mean that the vaccines will be available in medical shops. People will have to buy Covishield and Covaxin from hospitals and clinics.
COVAXIN will now be available in Clinics and Hospitals says DCGI
Vaccination data has to be submitted to DCGI every six months. Data will have t to be updated on CoWIN app also.
Earlier, it was reported that the Centre was planning to cap the price of the vaccines at ₹275 per dose.
What are the conditions along with market approval
The approval has been granted under the New Drugs and Clinical Trials Rules, 2019.
The firms, in this case, Bharat Biotech (Covaxin) and Serum Institute of India (Covishield), shall submit data of ongoing clinical trials. All vaccination data will be recorded on the CoWIN platform. The approval is only for the adult population.
Adverse events following immunisation will continue to be monitored as part of the conditions.
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.