NEW DELHI: An expert panel of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting emergency use authorisation for 'Covishield', a Covid-19 vaccine developed by Oxford University and Swedish drugmaker AstraZeneca. Now, the Drugs Controller General of India (DCGI) will take the final decision on emergency approval of the vaccine based on the expert.
India has marked the New Year's Day by giving its first-ever approval to a coronavirus vaccine. A government-appointed expert panel on Friday cleared the decks for emergency use of the vaccine developed by AstraZeneca and Oxford University, sources said. The final nod will now come from the Drugs Controller General of India (DCGI).
The recommendation of the Subject Expert Committee (SEC) has come two days after regulators in the United Kingdom approved the use of the Oxford-AstraZeneca vaccine among the British public. The expert body in India was at the time considering an application for clearance for Covishield, which is being tested and manufactured under licence by Serum Institute of India (SII).
The SEC had on Wednesday sought additional information from the Pune-headquartered firm, including a fact sheet of information about the vaccine for the general public.
It had also asked for details of the product that would be included in the package insert, as well as the specific conditions that the UK Medicines and Healthcare products Regulatory Agency (MHRA) had imposed on AstraZeneca while granting emergency authorisation for its candidate, known as AZD1222.
India has now become the third country after the United Kingdom and Argentina to give the go-ahead to the vaccine. The decision would pave the way for the vaccine's rollout in the world's second-most populous country which, after the United States, has the highest number of Covid-19 infections in the world. The recommendation is enormously significant, as it paves the way for India to get its first vaccine against the novel coronavirus that has killed almost 1.5 lakh and sickened more than 1 crore Indians.