India eyes indemnity for foreign vaccine manufacturers to boost supply

The Indian government has said it is considering a major concession for US pharma giants Pfizer and Moderna by granting them indemnity from liability for their coronavirus vaccines, in order to speed approvals.

Facing an acute shortage of Covid-19 vaccines, India is likely to grant indemnity against legal proceedings to Pfizer and Moderna – a clause no other vaccine maker in India enjoys.

"Pfizer continues to remain engaged with the government of India towards making its Covid-19 vaccine available for use in the immunisation programme... We are unable to share any additional details at this time," said a Pfizer spokesperson.

The pharmaceutical multinational said it will export to India only if the transaction is with the central government and the company will be protected from legal cases.

If the government grants the concession, other vaccine makers, both domestic and foreign, are expected to make the same demand.

Pfizer has indemnity in all the countries it has exported its vaccines.

“India is in need of vaccines now. Considering that it wants to vaccinate its population by December 2021, it can extend indemnity on the lines of what other countries did,” a senior health ministry official told RFI.

Pfizer has said it is ready to provide 50 million doses to India between July and October. Moderna won't be able to supply vaccines to India this year, even if an agreement is reached, as it does not have surplus stock.

"We are engaged with Pfizer and they have indicated the availability of a certain amount of vaccine in the coming months, possibly starting in July," said VK Paul, the head of the National Expert Group on Vaccine Administration.

"They have requested indemnity to all the nations including the country of origin. We are examining this request and will take a decision in the larger interest of people and on merits."

India's Drug Controller General of India (DGCI) also pointed out that vaccines which have been approved by the appropriate agencies in the United States, the United Kingdom, and Japan will not require "bridging trials" in India.

Bridging trials are localised clinical trials that bridge the gap between studies conducted in several regions, generating data in an India-specific context – a key factor since certain pharmaceutical products react differently to Indian genetic makeup than they might in American or European populations.

Since India relaxed its laws governing drugs trials in 2005, foreign drug companies have conducted several trials on populations across the country.

On account of all clinical trials conducted by various pharmaceutical companies, nearly 2,800 patients are said to have died between 2005 and 2012 in India.

A parliamentary panel report then had found all parties involved of gross ethical violations – the health ministry, DGCI, Indian Council of Medical Research and those who conducted the clinical trials.