Amid discussions over possible legal protection to Pfizer and Moderna over the use of their COVID-19 vaccines in India, a former senior ICMR official has said that no company in India's vaccination history has ever paid indemnity and the government, which is the biggest user of vaccines, has also not done it.

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"No Indian company has ever paid indemnity in India's vaccination history, and neither the government, the biggest vaccine user, has done that. Even deaths after COVID-19 vaccination have not come under this umbrella", former Indian Council of Medical Research (ICMR) chief Dr Nirmal K Ganguly told ANI on 2 June. He said there is a risk-benefit ratio in vaccination and benefits far more outweigh any risks. "In vaccination, the risk-benefit ratio works. Even if there is one serious adverse effect in a million, the benefit to the community at large is more than if you don't vaccinate them", he said.

A decision by the government to grant legal protection to foreign companies could spur similar demand from Indian companies manufacturing COVID-19 vaccines. Pfizer, the US pharma company, is seeking an indemnity bond that will exempt it from any legal claims in case there are any adverse effects from the vaccine. In a step that will clear the way of foreign COVID-19 vaccines such as Pfizer and Moderna, the Drugs Controller General of India (DCGI) has exempted specific trials of COVID-19 vaccines that have been approved by some other international regulatory bodies.

DCGI Chief VG Somani said in a letter that the decision will be applicable for vaccines that have already been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed for Emergency Use by the World Health Organisation. Pfizer said in a statement that it continues to remain engaged with the Indian government towards making its coronavirus vaccine available for use in the government immunisation programme.

"Pfizer continues to remain engaged with the Government of India towards making its COVID-19 vaccine available for use in the Government immunisation programme in the country. As these discussions are ongoing, we are unable to share any additional details at this time," a Pfizer spokesperson said. NITI Aayog Member (Health) Dr VK Paul had said earlier that the government is still examining the American pharma company's request for indemnity.

"We are examining this request and will take a decision in the larger interest of people and on merit. This is under discussion and there is no decision as of now", he had said.