New Delhi: The Modi government is not inclined to give indemnity to foreign drug manufacturers against liabilities in case recipients of their Covid vaccines develop severe adverse reactions.
This despite the fact that domestic manufacturing has not picked up as much as the government had hoped and the year-end target of vaccinating all eligible people with at least one dose looks difficult at current estimates of production and supplies.
Officials say this will be India’s position on indemnity unless it looks like the country’s vaccination goals are impossible to meet without foreign vaccines.
Among the drug companies that have been keen to enter the Indian market are American giants Pfizer and Moderna with their mRNA vaccines and Johnson & Johnson with its viral vector vaccine.
Earlier this year, when Pfizer had made a demand for indemnity, the Modi government had not relented, forcing the company to withdraw its application with the regulatory authority. Reacting to Pfizer’s demand, the Serum Institute of India — which manufactures the Covishield vaccine — had in June said that all companies should be treated equally.
Indemnity is the legal bond that protects a company from being sued in case its vaccine ends up causing any side-effects.
At present, Moderna is the only foreign company still in talks with the Modi government over supplying vaccines.
“Even in the case of Covaxin and Covishield, the manufacturers are adhering to Indian rules and regulations, which are very robust. Manufacturers coming to India will have to respect the local rules. We will not discriminate against anybody. If at some point we decide to give indemnity, it will be given to all, not just Moderna or any other manufacturer,” the source said.
‘Talks on with Moderna’
The Modi government is hopeful that vaccines manufactured within the country will be sufficient to meet its year-end target of vaccinating all eligible Indians — about 90 crore — with at least one dose.
The health ministry, while replying to a question in the Lok Sabha during the ongoing Monsoon Session, said that 135 crore doses of vaccines are expected to be available between August and December 2021.
A highly placed source in the government said that though talks are still on with Moderna, the government is of the view that “indemnity in its present form is not feasible”.
ThePrint reached Moderna over email for a comment, but there was no response until the time of publishing his report.
According to other sources in the government, there is a general consensus in the government that once a decision is taken to extend indemnity to one company, all vaccine manufacturers will have to be accorded the same privilege.
“We are discussing many things with Moderna right now — the contract, conditionalities and also their demand for indemnity. We have had several exchanges with them,” said another official.
Sources said the government is very clear that the “interest of Indian people and their health is paramount”.
“We will always ensure that the interest of our people is protected,” said the first source quoted above, adding that the government has conveyed these views to Moderna.
Replying to a question on the status of talks with Moderna, Niti Aayog member (health) Dr V.K. Paul Tuesday said, “We are still in consultation with them. As we have explained to you previously, it takes coming together on the ground on the conditions of the contract, on other issues. We have made progress, we hope to make more progress.”
Also read: Pfizer wants it, so do Serum Institute & Moderna — but what exactly is indemnity?
‘Vaccine availability will increasingly go up’
While there may be a consensus, the first source quoted said that no final decision on granting indemnity has been taken yet.
“Discussions are still continuing on various issues,” the source said, adding that India is treading cautiously on the indemnity issue.
With many more indigenous vaccines in the manufacturing process, government officials say the government is not hastening the decision on the indemnity issue. The first source said by September, India will be getting 1 crore vaccines daily.
“The vaccine availability will increasingly go up. Enough number of vaccines are getting manufactured now in India,” the source said.
Additionally, officials said, India’s current vaccinations are happening with vaccines that are priced very low by international standards — Rs 215 for Covishield and Rs 225 for a single dose of Covaxin.
Moderna, as and when it does come to India, may not be amenable to these prices, making its procurement for the national vaccination programme difficult. It is currently priced more than $25 in the international market — about more than Rs 1,800 per dose.
Moderna’s vaccine needs to be stored at -50°C and -15°C though unopened vials may be stored between 2-8°C for upto a month. Work is also ongoing at the Pune-based Gennova Pharmaceuticals to develop a mRNA vaccine in India. They have started phase 1 and 2 trials at KEM Hospital in Pune, Dr D.Y. Patil Medical College, Hospital & Research Centre in Pimpri-Chinchwad and at Rajarshi Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital in Kolhapur.
(Edited by Manasa Mohan)
Also read: Second mRNA vaccine shot safe for people who had allergic reactions to first shot: US study