Facing accusations of delay in placing orders for vaccines, the government on Thursday defended its vaccine procurement policy saying it has been pursuing Pfizer, J&J and Moderna since mid-2020 for the earliest possible imports, and has even waived local trials for well-established foreign vaccine makers.
'Buying vaccines internationally is not similar to buying 'off-the-shelf' items,' the government said in a statement titled 'Myths & Facts on India's Vaccination Process'.
The statement said the central government has proactively eased entry of vaccines approved by United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and World Health Organisation's Emergency Use Listing into India in April.
'These vaccines will not need to undergo prior bridging trials. The provision has now been further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries,' it said.
The statement said no application of any foreign manufacturer for approval is pending with the drugs controller.
The Modi government has often been criticised by opposition parties particularly the Congress for placing orders for vaccines as late as January this year and delaying approvals for foreign manufacturers to sell shots in the country.
The statement, however, did not give out details of when and how many vaccines were ordered.
The statement further pointed out that vaccines are in limited supply globally, and companies have their own priorities, game-plans and compulsions in allocating finite stocks.
'They also give preference to countries of their origin just as our own vaccine makers have done unhesitatingly for us. As soon as Pfizer indicated vaccine availability, the Central government and the company are working together for the earliest possible import of the vaccine,' it said.
According to the statement, the Centre has engaged continuously with all the major international vaccine manufacturers right from mid-2020.
'Multiple rounds of discussions have happened with Pfizer, J&J & Moderna. The government offered all assistance to have them supply and/or manufacture their vaccines in India,' it said.
The statement said as result of the government's efforts, Sputnik vaccine trials got accelerated and with timely approval, Russia has already sent two tranches of vaccines and accomplished tech-transfer to Indian companies that would start manufacturing very soon.
'We reiterate our request to all international vaccine makers to come and make in India -- for India and for the world,' it said.
The government has faced criticism from several quarters over the shortage of vaccines and inability of the immunization programme to pick up pace at a time when the country is facing a tidal wave of infections and a rising death toll.
The statement also refuted the claim by some opposition leaders that the Centre is not doing enough to ramp-up domestic production of vaccines.
'The central government is playing the role of an effective facilitator to enable more companies to produce vaccines from early 2020.
'There is only one Indian company (Bharat Biotech) which has the IP. The government of India has ensured that three other companies/ plants will start production of Covaxin apart from enhancing Bharat Biotech's own plants, which have increased from 1 to 4,' it said.
The statement further said that Covaxin production by Bharat Biotech is being increased from under 1 crore per month to 10 crore per month by October.
Additionally, it said the three PSUs will together aim to produce up to 4 crore doses by December.
'With constant encouragement of the government, Serum Institute is ramping up Covishield production from 6.5 crore doses per month to 11.0 crore doses per month.
'The government of India is also ensuring in partnership with Russia that Sputnik will be manufactured by six companies coordinated by Dr Reddy's,' the statement noted.
The statement also rejected the allegation that the Centre has abdicated its responsibility to the states saying it is doing all the heavy-lifting, from funding vaccine manufacturers to giving them quick approvals to ramping up production to bringing foreign vaccines to India.
According to the statement, in fact, the government of India ran the entire vaccine program from January to April and it was quite well-administrated compared to the situation in May.
'But states, who had not even achieved good coverage of healthcare workers and frontline workers in 3 months wanted to open up the process of vaccination and wanted more decentralisation.
'Health is a state subject & the liberalised vaccine policy was a result of the incessant requests being made by the states to give states more power,' it said.
On allegations by some states that the Centre is not giving enough vaccines to the states, it pointed out that the Centre is allotting enough vaccines to the states in a transparent manner as per agreed guidelines.
'The behaviour of some of our leaders, who in spite of full knowledge of the facts on vaccine supply, appear on TV daily and create panic among the people is very unfortunate.
'This is not the time to play politics. We need everyone to unite in this fight,' the statement said.
India is currently using mainly two 'made-in India' jabs -- Covishield manufactured by the Serum Institute and Covaxin of Bharat Biotech -- and Russian-made Sputnik V at a smaller scale to inoculate its population, all of which are approved only for those aged 18 years and above.
