Centre fast tracks emergency approvals for foreign-produced COVID-19 vaccines

To expand India’s basket of vaccines and accelerate the pace of domestic vaccination programme, the Centre on 13 April recommended that foreign-made COVID-19 vaccines that have been granted emergency approval

By Newsmeter Network  Published on  13 April 2021 10:00 AM GMT
Centre fast tracks emergency approvals for foreign-produced COVID-19 vaccines

New Delhi: To expand India's basket of vaccines and accelerate the pace of domestic vaccination programme, the Centre on 13 April recommended that foreign-made COVID-19 vaccines that have been granted emergency approval for restricted use by global regulators be granted emergency use approval in India.

This decision will facilitate quicker access to foreign vaccines and would encourage imports, including import of bulk drug material and optimal utilization of domestic fill and finish capacity, which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic.

At present, two vaccines - Covaxin by Bharat Biotech International Limited (BBIL) and Covishield by Serum Institute of India (SII) - have received emergency use authorization from the national regulator Drugs Controller General of India (DCGI).

During the 23rd meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) held on 11 April, it was recommended that "vaccines for COVID-19, which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO (emergency use listing) may be granted emergency use approval in India, mandating the requirement of 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 and Clinical Trials Rules 2019".

Further, it was decided that the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country.

The Union Government, after due consideration, accepted the recommendation of NEGVAC.

On Monday, the Subject Expert Committee of the DCGI had recommended Sputnik V, the vaccine developed by Russia's Gamaleya Institute and manufactured by Hyderabad-based Dr. Reddy's, for emergency use.

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