Sputnik V vaccine against Covid-19 developed by Russia's Gamaleya National Center will be available in Indian markets from early next week said NITI Aayog member V.K. Paul at a press conference.
“We are also proactively engaging with foreign vaccine manufacturers like Moderna, Pfizer, Johnson and Johnson asking them to apply for Emergency Use Authorization in India so that these vaccines can be easily imported and made available in India. Simultaneously, we along with other like-minded countries are stressing on IPR waiver for the Covid-19 vaccines. These two interventions, taken in conjunction, will ensure easy availability of Covid -19 vaccines not only in India but globally too,” added Dr. Paul. Stating that overall 216 crore doses of vaccines could be available in India between August-December Dr. Paul said that there is no doubt that vaccines will be available for all as we move forward. “The current mismatch in demand and supply is just an initial dynamic situation which is being faced across the world,” he said.
Speaking about Sputnik-V Dr. Paul said that local production is expected to begin in July with Hyderabad-based Dr. Reddy's Laboratories manufacturing the vaccine in India. Sputnik V was given emergency use authorization (EUA) by the Drugs Controller General of India (DCGI) in April and was first approved in Russia last year.
With an efficacy of 91.6%, as published in the Lancet Medical Journal, the Russian Direct Investment Fund (RDIF) has signed a deal to produce 750 million doses of Sputnik V in India.
Meanwhile, the Ministry in a statement issued on Thursday added that allegations about the delay in licensing for Covaxin and delayed approval for technology transfer for manufacturing Covaxin vaccine in the country are completely baseless and factually incorrect.
“Central Government in its new liberalized strategy has made specific provisions that vaccines for COVID-19, which have been developed and are being manufactured in foreign countries and which have been granted emergency use authorization by National Regulators of United States, European Medicine Agency (EU), United Kingdom, Japan or which are listed in WHO (Emergency Use Listing), will be granted emergency use approval in India,” it noted.
The Ministry added that it also provides for post-approval parallel bridging clinical trial in place of conduct of prior local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019.
“This is a radical departure from past allowing rapid and simplified authorization of foreign vaccines by Drugs Controller General of India (DCGI),” it said, adding that the move will ease and facilitate the import of Covid-19 vaccines and ensure increased availability of Covid-19 vaccines in India.
Speaking at the conference Dr. Paul explained that the new “Liberalized Pricing and Accelerated National Covid-19 Vaccination Strategy” aims at liberalized vaccine pricing and scaling up of vaccine coverage to incentivize vaccine manufacturers to rapidly augment their production and to attract new vaccine manufacturers.
“It would make pricing, procurement, and administration of vaccines more flexible and ensure increased vaccine production as well as wider availability of vaccines in the country,” he said.
The Health Ministry said that as part of its policy to augment the domestic production of the Covid-19 vaccine, it has proactively encouraged Public Sector Undertakings (PSUs) as well as private companies to enter into technology transfer agreements with Indian vaccine manufacturers.
“Two Central Government PSUs -- Indian Immunologicals Ltd (IIL) and BIBCOL have entered into a technology transfer agreement with Bharat Biotech. In addition, one State Government Undertaking -- Haffkine Institute, has also entered into a technology transfer agreement with Bharat Biotech. All these technology transfer agreements have been actively promoted and assisted by the Government of India,” said the Ministry.
The Central Government said that it has also extended substantial financial assistance to all the three undertakings and as a result, Indian Immunologicals Limited will be in a position to start production of Covaxin from September 2021, while Haffkine Institute and BIBCOL will start production of Covaxin from November 2021.
“Government is also engaged in dialogue with Bharat Biotech and some other PSUs, as well as private companies to execute technology transfer agreements. This would further enhance and augment the production of Covaxin in the country. Under the new policy, 100 percent doses of imported and ready to use foreign vaccine will be available for other than Government of India channel comprising State Governments, private hospitals, and hospitals of industrial establishments,” said the Ministry.
It added that the new Liberalized Pricing and Accelerated National Covid-19 Vaccination Strategy also incentivizes in terms of prices to attract private manufacturers including offshore vaccine manufacturers to enter the country.