With an aim to expand the basket of Covid-19 vaccines and enhance the pace of inoculation in India, the central government on Tuesday said it has fast-tracked emergency approval for foreign produced jabs that have been granted similar clearances in other countries.
The move is significant as it may make available several vaccines, including those made by Pfizer, Moderna and Johnson & Johnson, in India with certain conditions.
The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country, the Union health ministry said.
The government has decided that Covid-19 vaccines which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by authorities in the US, Europe, the UK, Japan or which are listed in the WHO Emergency Use Listing may be granted emergency use approval in India.
They will be given emergency use approval mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial under the provisions of the New Drugs and Clinical Trials Rules 2019, the ministry said.
“This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity, etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic (use),” the ministry said.
The decision came following the recommendations of the National Expert Group on Vaccine Administration for Covid- 19 (NEGVAC).
Currently, two vaccines- Covaxin by Bharat Biotech and Covishield by Serum Institute of India (SII)-are being used for inoculation in India.
India’s drug regulator has also granted permission for the restricted emergency use of the Russian Covid-19 vaccine Sputnik V with certain conditions on Monday.
The matter of augmenting the basket of vaccines available for fighting the pandemic as well as to accelerate the pace and coverage of domestic vaccination programme were discussed in the 23rd meeting of NEGVAC chaired by Niti Aayog Member (Health) V K Paul on 11 April.
India is following a comprehensive approach to tackle the Covid-19 pandemic in a proactive and pre-emptive manner. In this context, as early as May 2020, India constituted a Task Force headed by the Principal Scientific Advisor to encourage research and development for vaccine manufacture and constituted in August 2020 an Expert Group headed by Member, NITI Aayog to assist in roll-out of the Covid vaccination programme.
It was because of these strategies that India became the first country to have two “Made in India” vaccines for domestic vaccination drive, the ministry said.
India records 1,61,736 infections, 879 deaths
A total of 1,61,736 new Covid cases have been reported in a day pushing India’s tally of cases to 1,36,89,453, while the national recovery rate dropped further to 89.51 per cent, according to data updated by the Union health ministry on Monday.
The death toll increased to 1,71,058 with 879 new fatalities, the data updated at 8 am showed.
Registering a steady increase for the 34th day in a row, the number of active cases rose to 12,64,698.
The number of people who have recuperated from the disease surged to 1,22,53,697, while the case fatality rate has dropped further to 1.25 per cent, the data stated.
The 879 new fatalities include 258 from Maharashtra and 132 from Chhattisgarh. A total of 1,71,058 deaths have been reported in the country so far, including 58,245 from Maharashtra, 12,941 from Karnataka and 12,927 from Tamil Nadu.
Bengal cases: West Bengal logged the highestever daily spike of 4,817 fresh cases and 20 deaths today. The total Covid caseload is 6,24,224 and toll is 10,434 in the state with 29,050 active cases. Kolkata recorded 1,271 cases and 11 deaths.