Govt fast tracks emergency approvals for foreign Covid vaccines with EUA
The Union Health Ministry clarified that the first 100 beneficiaries of such foreign vaccines should be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country.
FollowIn a significant move, the Centre has fast-tracked emergency approvals for foreign-produced Covid-19 vaccines that have been granted Emergency Use Authorisation in other countries.Â
The decision comes hours after the Drugs Controller General of India gave Emergency Use Authorisation to Russia's Sputnik V Covid vaccine.
Union Health Ministry, in a statement, said that the National Expert Group on Vaccine Administration for Covid-19 has recommended that "vaccines which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by the US Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency or which are listed in WHO (Emergency Use Listing) may be granted emergency use approval in India.
However, such approvals will require post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019.
The Union Health Ministry clarified that the first 100 beneficiaries of such foreign vaccines should be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country.
The decision will come as a shot in the arm for a nation battling with the second wave of Coronavirus cases.Â
India has reported 161,736 new Covid-19 cases in the last 24 hours, taking the total number of cases to 13,689,453. According to the Union health ministry's data on Tuesday morning, the country also saw 879 fatalities due to the virus.
The latest decision is expected to enable quicker access to foreign vaccines and encourage imports, including import of bulk drug material, optimal utilisation of domestic fill and finish capacity. This will, in turn, provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic use.
