Government fast tracks emergency approvals for foreign-produced COVID-19 vaccines
COVID-19 vaccines which have been developed and are being manufactured in foreign countries and are given emergency approval for the restricted use by EMA, USFDA, PMDA Japan, UK MHRA, or that are listed in WHO emergency use listing can be granted emergency approval in India.
The Union Government has fast-tracked the emergency approvals for the foreign-produced Coronavirus vaccines that have been given emergency use authorization in other nations.
According to the Union Health Ministry, the step has been taken to expand the basket of COVID-19 vaccines for domestic use and for fastening the pace and coverage of vaccination in the country.
The matter of increasing the availability of vaccines to fight the pandemic as well as to fasten the coverage of the domestic vaccination program was discussed in the 23rd meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) on April 11, 2021. It was chaired by Dr. VK Paul, Member (Health), Niti Aayog.
Delighted to share GoI's remarkable initiative to augment our basket of #COVID19vaccines#COVIDVaccines 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 given EUA in India. pic.twitter.com/44MW5vX0PF— Dr Harsh Vardhan (@drharshvardhan) April 13, 2021
• After a comprehensive deliberation, NEGVAC recommended that the COVID-19 vaccines which have been developed and are being manufactured in foreign countries and are given the emergency approval for the restricted use by EMA, USFDA, PMDA Japan, UK MHRA, or those that are listed in WHO emergency use listing can be granted emergency approval in India.
|• However, the National Expert Group has mandated the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions under Second Schedule of the New Drugs and Clinical Trials Rules, 2019.|
• The first 100 beneficiaries of the approved vaccines will be assessed for seven days before it is rolled out for further immunization programs within India.
• After due consideration, the Government accepted the recommendation of NEGVAC. The decision will facilitate quicker access to foreign vaccines by India.
• It will also encourage imports including the import of bulk drug material. In turn, it will provide a fillip to India’s vaccine manufacturing capacity and the total vaccine accessibility for the domestic market.
Taskforce for vaccine manufacturing:
The Government of India had constituted a task force headed by the Principal Scientific Advisor in order to encourage Research & Development for vaccine manufacture.
The government also constituted an expert group in August 2020 headed by a member, NITI Aayog for assisting in the rollout of the COVID-19 vaccination program. India became the first country to have two ‘Made in India’ vaccines for the nationwide vaccination drive because of these successful strategies.
COVID-19 vaccines in India:
Currently, two Coronavirus vaccines- COVAXIN by Bharat Biotech and Covishield by the Serum Institute of India have been given emergency use authorization from the Drug Controller General of India.
On April 12, 2021, DGCI also gave the emergency use authorization to Russia’s Sputnik V Coronavirus vaccine which is domestically manufactured by Hyderabad based Dr. Reddy’s laboratories. The vaccine has shown the efficacy of 91.6%.