India may look at providing indemnity, under certain conditions, to foreign Coronavirus disease (Covid-19) vaccine makers, even though no final decision has been taken on this, people familiar with the matter said on condition of anonymity.
Pfizer and Moderna have both reportedly sought protection from lawsuits related to unforeseen complications from their vaccines, much like the indemnity they have been provided in the US and the UK, and it is believed that this issue is holding up their entry into India, which is short of vaccines to protect its huge population.
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India has not provided indemnity to any vaccine makers so far, including Indian vaccine makers Serum Institute of India, which makes a version of the AstraZeneca/Oxford shot locally, and Bharat Biotech , which makes Covaxin.
During the Carnegie India’s Global Tech Summit 2020 in December, SII CEO, Adar Poonawalla, also talked about the need for the government to provide indemnity to vaccine manufacturers against frivolous complaints.
“No formal decision has been taken on the matter yet but the request is being seriously considered by experts, especially the conditions under which it should be allowed — probably only during a pandemic. It is a big decision, and needs to be thought through. They might agree eventually with certain riders but at this stage nothing can be said for sure,” said one of the people cited in the first instance.
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Dr VK Paul, member (health), Niti Aayog, who heads the empowered group responsible for procurement, manufacturing, import, logistics, daily supply, and utilization of vaccines id not respond to queries.
In a media briefing last wee Paul said Pfizer’s request for an indemnity is being examined.
India has already waived for vaccines approved by regulators of some countries (such as the US and UK) or WHO, local bridging trials and the need for testing every vaccine batch at the central drugs laboratory. The national drugs regulator, VG Somani, formally issued an order in this regard on Tuesday.
According to media reports, Pfizer indicated the availability of 50 million doses of its Pfizer-BioNtech vaccine between July and October. A Pfizer spokesperson said in a statement on May 25 that the company was in talks with the Indian government .
“Pfizer remains committed to continuing our engagement with the Government of 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.”
In another statement on May 25, it said, “…during this pandemic phase, across the world, Pfizer is supplying its Covid-19 vaccine only to central Governments and supra-national organizations for deployment in national immunization programs. Neither Pfizer Inc nor any of its affiliates globally, including in India, have authorized anyone to import/market/distribute the Pfizer-BioNTech Covid 19 vaccine. We continue to have ongoing discussions with the Government of India towards making our vaccine available for use nationally.”
Indian generics giant Cipla Ltd, is also working on importing the Moderna vaccine to India. HT learns that Cipla is seeking fast-track approvals to bring Moderna’s single-dose Covid-19 booster vaccine into India expeditiously.
The company has refused to disclose any details of the ongoing discussion except for the fact that it is seeking seeking clarity and guidance from the government.
“Cipla has been at the forefront of Covid care. We are in the process of seeking clarity & guidance from the Government of India for exploring the possible roadmap for vaccine importation to India. At this stage, no definitive terms have been finalized and hence, the Company cannot comment further,” the company said in an email on Tuesday.