India's drug regulator has granted regular market approval for COVID-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions, Health Minister Mansukh Mandaviya said on Thursday.
However, the two COVID-19 vaccines will be available at shops soon though people would be able to buy them from hospitals and clinics.
"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," Mandaviya said.
Soon after the approval, highly-placed sources said the two vaccines will now be available in private clinics at pre-decided MRP and people can buy those.
The market sale of the two vaccines was approved under the New Drugs and Clinical Trials Rules, 2019.
Gradually, the vaccine will be available in the market at a price lower than at what it was being sold earlier at private hospitals.
(with agency inputs)
Covaxin maker Bharat Biotech and Covishield maker Serum Institute of India, or SII, had given data of ongoing clinical trials to the regulator, which approved the market sale after a subject expert committee on COVID-19 on January 19 recommended approval.
Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, had given an application to the DCGI on October 25 seeking regular market authorisation for Covishield. "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.
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.
In an application sent to the DCGI, V Krishna Mohan, 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, news agency PTI reported.
Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.
