NEW DELHI: COVID-19 vaccines Covishield and Covaxin on Thursday have finally received the nod for market sale from India's drug regulator.
The two vaccines are for use in the adult population subject to certain conditions.
"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.
"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," he went on to add.
The approval was granted under the New Drugs and Clinical Trials Rules, 2019.
The two vaccines had been granted Emergency Use Authorisation on January 3 last year.
The Serum Institute of India (SII) and Bharat Biotech had submitted applications to the Drugs Controller General of India (DCGI), which approves licenses of specified categories of drugs in India, seeking regular market authorization for their respective vaccines.
DCGI approval came after the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation on January 19 recommended granting regular market approval to the two vaccines.
Pune-based Serum Institute’s director Prakash Kumar Singh had applied for approval last October for Covishield, but the government authority had sought more details from the company. After the company supplied the relevant data and documents, the expert committee went through them and granted the approval.
Covaxin-maker Bharat Biotech, the indigenous vaccine supplier, made a similar request. The company attached data to substantiate its claim for regular market sale approval.
The price of the two vaccines are likely to be capped at Rs 275 per dose, reports said. An additional service charge of Rs 150 will be added.
Currently, Covaxin is priced at Rs 1,200 per dose while Covishield costs Rs 780 in private facilities, which includes Rs 150 service charge.