Mumbai: The Subject Expert Committee (SEC) on Saturday recommended India Biotech’s Coronavirus vaccine (Covaxin) to be allowed “restricted emergency use”. The development came after a government-appointed panel, in the first day, considered the second time India Biotech’s emergency use request.
The panel has submitted its findings to the national regulator- Drugs Controller General of India, which will take a final decision on the case. If all goes well and the vaccine gets final approval, Bharat Biotech’s coronavirus virus can be launched soon for vaccination in the country.
The Government of India stated, “The Subject Expert Committee (CDSCO) of the Central Drugs Standard Control Organization (CDSCO) recommends DCGI to allow for limited emergency use of the vaccine for the Serum Institute of India, Pune.” in a statement.
“CDSCO recommends allowing for restricted use in emergencies in the public interest, particularly in clinical trial mode, especially in the context of mutant strain infection, to Bharat Biotech&for conduct of PhaseIII Clinical Trial Protocol to Cadila.”
CDSCO recommends for granting permission for restricted use in emergency situation in public interest as abundant precaution,in clinical trial mode,specially in context of mutant strain infection,to Bharat Biotech&for conduct of PhaseIII Clinical Trial Protocol to Cadila:GoI(2/2) https://t.co/kt7nUwWbSb
— ANI (@ANI) January 2, 2021
The Drugs Controller General of India (DCGI) will now take a final decision on the emergency approval of vaccines based on the recommendations of the expert panel.
According to the Union Ministry of Health and Family Welfare, the meeting of the Subject Expert Committee (SEC) of the National Drug Regulator will make appropriate recommendations to DCGI before taking a final decision.