The Drugs Controller General of India’s (DCGI) subject expert committee (SEC) has recommended the regular market approval to Serum Institute of India and Bharat Biotech for their COVID-19 vaccines Covaxin and Covishield with conditions for the adult population.
According to the Central Drugs Standard Control Organisation (CDSCO), “SEC of CDSCO has recommended for the upgrade of Covishield and Covaxin status from restricted use in emergency situations to grant of new drug permission with conditions in the adult population, DCGI will evaluate the recommendations and give its decision.”
The subject expert committee during the meeting that was held last week asked both the companies to submit more data before granting market approval. Serum Institute of India had applied for market approval for Covishield in December 2021 and Bharat Biotech has also applied for the same.
The market authorisation for vaccines means that they can be authorized for use without reservation and conditions.
Further, Bharat Biotech has informed that Covaxin is now a universal vaccine for adults and children. However, both Covaxin and Covishield are currently authorised for emergency use only. The subject expert committee of the CDSCO sat on January 1-2 and made recommendations in respect of the proposal for restricted emergency approval of COVID-19 vaccines of Serum Institute of India and Bharat Biotech.
The subject expert committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics and internal medicine.
It had reviewed the data on the safety and immunogenicity of the vaccines and recommended for grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution in clinical trial mode to have more options for vaccination especially in case of infection by mutant strains.
The clinical trial ongoing within the country by the firm will continue. The Serum Institute of India and Bharat Biotech vaccines have to be administered in two doses. These vaccines have to be stored at 2-8 degrees celsius.