Pfizer wants significant regulatory relaxations, including indemnification, say sources
India’s Ministry of External Affairs, on Thursday, said the government was in touch with major vaccine manufacturers such as Pfizer, J&J and Moderna for sourcing and local manufacturing of their vaccines in India.
“We have also helped expedite the introduction of Sputnik-V vaccines,” the external affairs ministry spokesperson Arindam Bagchi told ANI.
Meanwhile, foreign secretary Harsh V Shringla said India will participate in “creating global scale capacities needed to deal with pandemic scale challenges. Global conversations are underway the G7, G20, QUAD, BRICS, UN & WHO itself,” said Shringla while speaking at WHO’s South-East Asia Regional Health Partners’ Forum on COVID.
India is trying to procure vaccines from Pfizer and Moderna to ramp up its vaccine supply and meet an ambitious target of inoculating its entire adult population by the end of December this year.
The Indian government will reportedly grant foreign vaccine makers indemnity or legal protection against any claims in case their vaccines cause any adverse side effects.
On Thursday, sources told ANI that after Pfizer and Moderna, Serum Institute of India (SII), which is currently manufacturing the Covishield vaccine and will soon produce more vaccines, has also sought an indemnity bond.
The Drug Controller General of India has also waived the requirement of post-launch bridging trials for vaccines cleared by the drug regulators of the US, UK, EU, Japan or listed for emergency use authorisation by WHO.
Pfizer could reportedly provide 50 million doses of its Covid vaccine to India between July and October. Indian pharma giant Cipla is also close to committing Rs 7295 crores as advance to Moderna for sourcing its booster vaccine.
Amid the second wave of the Covid-19 pandemic, the Indian government is facing mounting criticism over its Covid-19 vaccination drive. This week, the Supreme Court came down heavily on the Centre’s paid Covid vaccination policy for the 18-44 age group, calling it “arbitrary and irrational”.
The Supreme Court has sought a response from the central government asking it to clarify how Rs 35,000 crore earmarked for Covid-19 vaccine procurement in the Union Budget was being spent. The court asked why the same could not be utilised for vaccinating persons in 18-44 age group.
The court has also questioned the Centre’s logic that manufacturers are selling it vaccines at a hefty discount because it places bulk orders.
“The Central government justifying its lower prices on account of its ability to place large purchase orders for vaccines raises the issue as to why this rationale is not being employed for acquiring 100% of the monthly CDL [Central Drugs Laboratory] doses,” a Bench led by Justice DY Chandrachud noted in a 32-page order.
The Centre can buy vaccines for Rs 150, while the States have to shell out between Rs 300 and Rs 600.