Covishield and Covaxin get DCGI's conditional approval for sale in regular market
New Delhi/IBNS: Covishield and Covaxin have been granted approval by drugs regulator Drugs Control Regulator General of India (DCGI) for sale in the regular market.
The approval has been given for use in the adult population and comes with certain conditions, the regulator has said.
It is worth noting that the vaccines cannot be purchased by the general public and only hospitals and clinics can buy them for inoculation.
They have to furnish data related to vaccination every six months to the DCGI and update data on the CoWIN app.
The approval for the sale of the two Covid-19 vaccines manufactured in India was given under the New Drugs and Clinical Trials Rules, 2019.
It follows the recommendation of the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) on January 19 to allow Serum Institute of India and Bharat Biotech to sell their respective vaccines in the regular market.
The @CDSCO_INDIA_INF has now 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, Union health minister Dr Mansukh Mandaviya tweeted on Thursday.
The conditions include supply for programmatic settings including registration on the CoWin platform and to continue to submit safety data on a six-monthly basis.— Dr Mansukh Mandaviya (@mansukhmandviya) January 27, 2022
On October 25, Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, had given an application to the DCGI seeking regular market authorisation for Covishield.
DCGI, however, sought more data and documents from SII, following which Singh responded with more data and information, reported media.
"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, 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.