The Government of India has approved a proposal to fast-track emergency use authorisation (EUA) for COVID-19 vaccines developed and manufactured in foreign countries, aiming to expand vaccine availability and accelerate the country's vaccination programme.
The decision follows recommendations made during the 23rd meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), held on April 11, 2021, under the chairmanship of Dr V. K. Paul, Member (Health), NITI Aayog.
Under the revised approval process, COVID-19 vaccines authorised for emergency or restricted use by the US Food and Drug Administration (USFDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), or listed under the World Health Organization's Emergency Use Listing (EUL) may be considered for emergency use approval in India.
The revised framework allows these vaccines to receive emergency approval without undergoing a separate local clinical trial, subject to a post-approval parallel bridging clinical trial as prescribed under the Second Schedule of the New Drugs and Clinical Trials Rules, 2019.
Additionally, the first 100 beneficiaries receiving such foreign vaccines will be monitored for seven days to assess safety outcomes before the vaccines are introduced into the wider immunisation programme.
India's COVID-19 Vaccine Development Strategy
India adopted a comprehensive approach to COVID-19 management, with a focus on vaccine research, development and domestic manufacturing.
In May 2020, the government constituted a Task Force under the Principal Scientific Adviser to encourage research and development for vaccine manufacturing. Subsequently, in August 2020, an Expert Group headed by a Member of NITI Aayog was established to support the rollout of the national COVID-19 vaccination programme.
These initiatives contributed to the development and availability of two domestically manufactured COVID-19 vaccines for India's vaccination drive:
Covaxin: Developed by Bharat Biotech International Limited (BBIL).
Covishield: Manufactured by the Serum Institute of India (SII).
Both vaccines received Emergency Use Authorisation from India's national drug regulator, the Drugs Controller General of India (DCGI).
