AFPAs India contemplates offering indemnity from future liabilities to foreign manufacturers of Covid-19 vaccines such as Pfizer, government experts seem divided over whether to give the same protection to Indian vaccine manufacturers or not.
“There are two views, and the experts are divided,” one person aware of the matter told ET.
Some experts feel that since the Indian law does not exempt vaccine manufacturers from indemnity it should not be granted to local players, whereas others opine that there should be a parity among both foreign and Indian manufacturers.
The purchase order executed by the government with Indian manufacturers Serum Institute of India and Bharat Biotech stipulated that the companies would have to inform the government authorities immediately in case of reports of any health risks or complications arising from the vaccine.
“Company shall be liable for all adversities as per CDSCO/Drugs and Cosmetics Act/DCGI policy/approval,” it said.
However, the government is expected to offer protection from legal liabilities to Pfizer as the vaccine maker has obtained indemnity in most countries where its vaccine is used, citing the extraordinary situation whereby vaccine development had to be fast-tracked.
Discussions between the government and Pfizer are on for the import of its Covid-19 vaccine.
“In principle, they (foreign manufacturers) expect indemnity to be given. This is what they have said has been the case all over the world. We have also checked with other countries and the World Health Organisation,” NITI Aayog member VK Paul had said last week.
“Yes, indeed they have supplied vaccines only after such indemnities have been given. This appears to be the fact. Particular companies have requested, and we are in negotiation with them. But there is no decision at the moment,” Paul had said at a press conference.
Serum Institute has also sought indemnity from liability for its Covid-19 vaccine, hoping that the rules should be same for all the companies, sources have said.
Source: indiatimes.com