Talks with foreign vaccine makers stuck on indemnity clause

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Indemnity issues are further delaying the availability of foreign Covid-19 vaccines in India even though some of them have received the approval of the drug regulator in the country. Foreign vaccine makers are demanding indemnity against legal liability in case of adverse reactions post-vaccination.

Pfizer and Moderna are the two vaccine makers who have sought indemnity protection. The discussions are going on with foreign vaccine makers, according to a report in Business Standard. The consensus is that if indemnity is to be given at all, it will be for all vaccine makers. But a final decision is still awaited. The report further said that India has proposed some changes in the clauses and indemnity in the “current form” is most unlikely.

Serum Institute of India, which makes the Covishield vaccine, had earlier said that all drug makers should be treated equally. Its comments came after Pfizer sought indemnity protection. Pfizer later withdrew its request for approval after the government did not relent on indemnity protection.

Moderna continues to be in discussions with the government on the indemnity issue. “We hope to make more progress (in talks with Moderna),” Niti Aayog member (health) Dr V.K. Paul said.

India is not worried now as supplies of domestically produced vaccines are likely to go up in the next couple of months. Foreign vaccines are not expected to play a big role in India’s massive vaccination programme.

US pharma major Johnson & Johnson’s (J&J) viral vector single dose vaccine was the latest vaccine to get approval from the Drugs Controller General of India (DCGI). Johnson & Johnson is however silent on the availability of the vaccine in India. The company has entered into a manufacturing contract with local vaccine maker Biological E.

The talks are on between the Indian government and J&J on indemnity issues and supplies will begin once these issues are resolved, as per a report in the Business Standard.

So far talks between the Indian government and Pfizer and Moderna are on to come to mutually acceptable contract terms.

The government is of the view that manufacturers coming to India will have to respect the local rules, according to the media report. Covaxin and Covishield manufacturers are already adhering to Indian rules and regulations.