Covid-19: Centre fast tracks emergency approvals for foreign produced vaccines

Russian-made Covid vaccine Sputnik V cleared for emergency use by the DCGI on a day that India’s reported over 1,61,736 new cases

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On April 9 Union Minister Ravi Shankar Prasad had in a lengthy Twitter thread taunted, Congress leader Rahul Gandhi accusing him of “lobbying for pharma companies by asking for arbitrary approvals for foreign vaccines.” 

However just days after this deluge of taunts, the Government of India has announced that it will soon allow all foreign-made vaccines in India. The Russian-made Covid vaccine Sputnik V has already been cleared for emergency use by the Drugs Controller General of India (DCGI). The announcement of more international vaccines came on a day that India’s reported over 1,61,736 new cases. Apart from Maharashtra which has reported the highest daily new cases at 51,751, it is Uttar Pradesh which had an alarming 13,604 new cases, followed by Chhattisgarh reported 13,576 new cases.

Basket of vaccines for domestic use 

The Centre has announced that it has “fast-tracked emergency approval for foreign produced Covid-19 vaccines that have been in use in other nations” and these will be added to “the basket of vaccines for domestic use and increase the pace and coverage of vaccination”. At the moment citizens over 45 have access to two vaccines i.e. Covaxin by Bharat Biotech International Limited (BBIL) and Covishield by Serum Institute of India (SII). The choices will expand once the international vaccines that received Emergency Use Authorization (EUA) from the National Regulator (Drugs Controller General of India) are made available.

The government has stated that this EUA has been given to “accelerate the pace & coverage of domestic vaccination programme” and the issue was  discussed in a meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) held on April 11, it was  chaired by Dr. V K Paul, Member (Health), Niti Aayog.

According to the official statement the NEGVAC, has recommended that Covid-19 vaccines “which have been developed & 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 & Clinical Trials Rules 2019.” The first 100 to get these foreign vaccines will be “assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country.” Five more vaccines are expected to get approval this year. The list includes Johnson and Johnson (Bio E), Zydus Cadila, Serum’s Novavax and a nasal vaccine from Bharat Biotech.

Will Sputnik V be available for all?

According to the Union Health Ministry, the Russian-made Covid vaccine Sputnik V has already been cleared for emergency use by the Drugs Controller General of India. Limited doses of the vaccine may be available by the end of this month.  

M/s Dr. Reddy’s Laboratories Ltd. (M/s DRL) had applied for the grant of permission to import and market Gam-COVID-Vac combined vector vaccine, that is better known as Sputnik-V, developed by M/s Gamaleya Institute, Russia for Emergency Use Authorization. The vaccine is approved in 30 countries across the world. Now the govt has shared that Dr. Reddy’s Laboratories Ltd. has collaborated with National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation to get approval for import for marketing in India. 

The government says that this vaccine is “indicated for active immunisation to prevent COVID-19 disease in individuals of ≥ 18 years of age” and should be administered intramuscularly in two doses of 0.5 ml each with an interval of 21 days. However there is no word yet from the Government on if the vaccination drive will soon be inclusive of all adults seeking protection from Covid-19 contamination. Even as states continue to flag shortages and citizens get messages informing them that their appointments have been canceled or postponed the government has said that cumulatively, 10,85,33,085 vaccine doses have been administered through 16,08,448 sessions, till April 13.


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