Local trials for Covid shots scrapped to fast-track imports
The local clinical trial requirement for well-established vaccines manufactured abroad has been altogether waived to facilitate their easy entry into India, Niti Aayog member (health) VK Paul said on Thursday and added the Centre is working with Pfizer for the earliest possible import of its Covid-19 vaccine.
He underlined vaccines are in limited supply globally, and companies have their own priorities, game plans and compulsions in allocating stocks. “They also give preference to countries of their origin just as our own vaccine makers have done unhesitatingly for us.”
Paul said the Centre proactively eased the entry of vaccines approved by the US Food and Drug Administration, European Medicines Agency, UK’s Medicines and Healthcare products Regulatory Agency, Japan’s Pharmaceuticals and Medical Devices Agency, 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,” he said.
Bridging trials refer to supplementary trials performed in a new region or country to get more clinical data on efficacy, safety and dose regimen.
States like Delhi have asked the Centre to procure vaccines and distribute them across the country as many of them have failed to get global vaccine makers to supply shots to them directly amid a shortage of jabs after a widened inoculation drive.
The government in April said it will allow certain foreign-made vaccines to be rolled out and conduct parallel bridging clinical trials after they get the authorisation instead of requiring them to conduct bridging trials prior to seeking approval. It had said coronavirus vaccines cleared for use in the US, the UK, the European Union, and Japan will get fast-track approval in India to boost the pandemic response when India was recording the world’s biggest surge in infections.
Paul said as soon as Pfizer indicated vaccine availability, the Central government and the company began working together. “Multiple rounds of discussions have happened with Pfizer, J&J & Moderna,” he said. “The government offered all assistance to have them supply and/or manufacture their vaccines in India,” said Paul in response to questions about India’s Covid-19 vaccine strategy.
Paul said that no application of any foreign manufacturer for approval was currently pending with the drugs controller. “However, it is not that their vaccines are available in free supply. We need to understand that buying vaccines internationally is not similar to buying off the shelf items.”
Paul said the Centre has remained engaged with all the major international vaccine manufacturers from mid-2020 and as a result of its efforts, Russian made Sputnik V vaccine trials got accelerated. He added with timely approval, Russia has 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.”
He referred to allegations that the Centre did not approve vaccines available globally, Paul said regulatory modifications were specially made to facilitate entry of foreign Covid-19 vaccine manufacturers. He added that included the condition of submitting local bridging studies while applying for emergency use authorisation in India.
Pfizer is believed to have offered 50 million doses to India between July and October this year and sought indemnification among other regulatory waivers to export vaccines. In a statement to HT, the company said it remains committed to continuing its engagement with India towards making the Pfizer BioNTech Covid-19 vaccine available for use in the country. “Since the ongoing discussions are confidential, we cannot provide any further comments.”
Paul denied allegations that the Centre was not doing enough to ramp up domestic Covid-19 vaccine production. “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 [intellectual property]. The government...has ensured that 3 other companies/plants will start production of Covaxin apart from enhancing Bharat Biotech’s own plants, which have increased from 1 to 4.”
Bharat Biotech’s Covaxin production is also being ramped from about 10 million doses per month to nearly 100 million doses by October.
Covishield and Covaxin were the first two shots to be approved in the country.