An expert panel will tomorrow review the request by three pharmaceutical firms – the Serum Institute of India, Pfizer and Bharat Biotech – to approve emergency use of their coronavirus vaccines in India.
Sources said that on Monday, Hyderabad-based firm Bharat Biotech became the third firm, to put a request for approval of its vaccine – Covaxin, India’s first indigenous candidate for the highly infectious virus.
American firm Pfizer was the first to submit its application last week to the the DCGI (Drugs Controller General of India), followed by Pune-based Serum Institute of India.
After review, the expert panel will share its observations with the drug regulator, as per sources.
An emergency use approval of a drug can be granted after there is sufficient evidence to suggest that the medical product is safe and effective. Final approval is granted only after completion of the trials and analysis of full data.
The Serum Institute of India (SII) on Sunday became the first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for the Oxford COVID-19 vaccine in the country.
Sources said, the approval was sought citing unmet medical needs due to the pandemic and in the interest of the public at large.
A day earlier, the Indian arm of Pfizer, became the first to seek a similar clearance from India’s drug regulator for its own COVID-19 vaccine in the country, after securing such clearance in the UK and Bahrain. The phase-3 clinical trial of the Oxford COVID-19 vaccine, Covishield, is being conducted by the Pune-based SII, co-sponsored by the Indian Council of Medical Research (ICMR), in various parts of the country in addition to clinical studies being carried out by Oxford-AstraZeneca in the UK and Brazil.