Regulatory issues cause delay in COVID-19 supplies to India from US

India is yet to receive coronavirus vaccines from the US under its global donation programme as certain regulatory issues are holding up the supplies, people familiar with the development said.

Last month, the US pledged to ship 80 million doses of American made COVID-19 vaccines to countries around the world to help them fight the pandemic. A large number of countries, including India’s neighbourhood, have already received the vaccines from the US.

It was estimated then that India could get one to two million doses of the vaccines.

The people cited above said the issue of indemnity is linked to the supply of US vaccines to India and a reason for the delay. Grant of indemnity would provide vaccine suppliers protection from legal liability in the event of adverse reaction among the vaccine recipients.

When asked what was holding back the supplies of the vaccines to India, a US embassy spokesperson said the delay is not from the US side.

“As President Joe Biden announced earlier this year, the United States will share 80 million doses from our own vaccine supply with countries around the world,” the spokesperson said.

“As part of that, before we can ship doses, each country must complete its own domestic set of operational, regulatory, and legal processes that are specific to each country,” the spokesperson added.

Several countries in the region have already received the vaccine doses from the US as part of the donation.

“In the case of India: the delay is not from the US side. India has determined that it needs further time to review legal provisions related to accepting vaccine donations. Once India works through its legal process, our donation of vaccines to India will proceed expeditiously,” the spokesperson said.

External Affairs Minister S Jaishankar visited the US in May during which he had met senior executives of the leading US pharma companies. The supply of raw material by the US to India to boost its domestic production was a major focus of Jaishankar’s five-day visit to the US.

In early June, the US announced allocating the first 25 million coronavirus vaccines to various countries.

It said at least 75 per cent of the total doses or nearly 19 million would be shared through COVAX, including approximately six million doses for Latin America and the Caribbean, and approximately seven million for South and Southeast Asia.

It said approximately five million would be sent to Africa and the remaining six million would be shared directly with countries experiencing surges and other partners and neighbours, including Canada, Mexico, India, and the Republic of Korea.

On June 23, the US came out with an allocation plan of 55 million doses.

It announced that approximately 41 million would be shared through COVAX.

Out of 41 million doses, the US said around 14 million would be for Latin America and the Caribbean countries while approximately 16 million doses would go to India, Nepal, Bangladesh, Pakistan, Sri Lanka, Afghanistan, Maldives, Bhutan, Philippines, Vietnam, Indonesia, Thailand, Malaysia, Laos, Papua New Guinea, Taiwan, China, Cambodia, and the Pacific Islands.

It said approximately 10 million doses would be shared with Africa.

The remaining 14 million – or 25 per cent of the 55 million vaccines was to be shared under regional priorities and other recipients such as Colombia, Argentina, Haiti, Dominican Republic, Costa Rica, Panama, Afghanistan, Bangladesh, Pakistan, Philippines, Vietnam, Indonesia, South Africa, Nigeria, Kenya, Ghana, Cabo Verde and Egypt, among others.