The requirement for local clinical trials for well-established overseas-made vaccines has been completely removed to facilitate their easy entry into India, Niti Aayog (health) member VK Paul said on Thursday, adding that the Center was working with Pfizer for the fastest possible import of its Covid19 vaccine.
He pointed out that vaccines are in limited supply around the world and that companies have their own priorities, game plans and constraints in allocating inventory. “They also give preference to the countries of origin, just as our own vaccine manufacturers have done without hesitation for us.”
Paul said the Center has proactively facilitated the entry of vaccines approved by the United States Food and Drug Administration, European Medicines Agency, UK Medicines and Health Products Regulatory Agency, l Japan Pharmaceuticals and Medical Devices Agency and the World Health Organization Emergency Use List in India in April. “These vaccines will not need to undergo any pre-transition testing. The provision has now been further amended to completely waive the testing requirement for well-established vaccines manufactured in other countries, ”he said.
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Transition trials refer to additional trials performed in a new region or country to obtain more clinical data on efficacy, safety and dosing regimen.
States like Delhi have asked the Center to procure vaccines and distribute them nationwide, as many of them have failed to convince global vaccine manufacturers to provide them with vaccines directly in the midst of a shortage of vaccines after an expanded vaccination campaign.
In April, the government said it would allow the deployment of some overseas-made vaccines and the conduct of parallel bridging clinical trials after getting approval instead of requiring them to conduct bridging trials before they are released. ask for approval. He had said coronavirus vaccines cleared for use in the US, UK, EU and Japan would get fast-track approval in India to boost pandemic response as India records the largest increase in infections in the world.
Paul said that as soon as Pfizer announced the availability of the vaccines, the central government and the company started working together. “Several rounds of discussions have taken place with Pfizer, J&J and Moderna,” he said. “The government has offered all the help needed to enable them to supply and / or manufacture their vaccines in India,” Paul said in response to questions about India’s Covid-19 vaccination strategy.
Paul said that there are currently no requests for approval from a foreign manufacturer pending with the Drugs Supervisor. “However, it’s not that their vaccines are available for free. We need to understand that buying vaccines internationally is not the same as buying off-the-shelf items. “
Paul said the Center has remained engaged with all major international vaccine manufacturers from mid-2020, and as a result of their efforts, Sputnik V vaccine trials in Russia have gained momentum. He added that with timely approval, Russia sent two slices of the vaccine and carried out a technology transfer to Indian companies that would start manufacturing very soon. “We reiterate our call for all international vaccine manufacturers to come and manufacture in India – for India and for the world.”
Referring to claims that the Center has not approved vaccines available globally, Paul said regulatory changes were made specifically to facilitate entry for foreign manufacturers of Covid-19 vaccines. He added that this included the condition of submitting local transition studies when applying for emergency use authorization in India.
Pfizer reportedly offered 50 million doses to India between July and October of this year and sought compensation among other regulatory waivers to export vaccines. In a statement to HT, the company said it remains committed to continuing its engagement with India to make the Pfizer BioNTech Covid-19 vaccine available for use in the country. “As the current discussions are confidential, we cannot provide any further comments.”
Paul has denied claims that the Center was not doing enough to increase national production of the Covid-19 vaccine. “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] who has the IP [intellectual property]. The government … ensured that 3 more companies / factories started production of Covaxin in addition to upgrading Bharat Biotech’s own factories, which went from 1 to 4. ”
Bharat Biotech’s production of Covaxin also increased from around 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.