Unable to send vaccines to India due to legal hurdles: US

Vaccine shots have reached several developing Asian countries like Pakistan, Nepal, Bhutan and Bangladesh. However, reaching India is taking time as there are some legal hurdles for emergency import.

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The US is waiting for the Indian government's green signal for dispatching the doses of the Covid-19 vaccine. The country has already donated anti-Covid vaccines to several nations across the world. "We are ready to ship those vaccines expeditiously when we have a green light from the Government of India,” State Department spokesperson Ned Price said, 

Vaccine shots have reached several developing Asian countries like Pakistan, Nepal, Bhutan and Bangladesh. However, reaching India is taking time as there are some legal hurdles for emergency import, said Ned Price. 

Earlier, the US had announced that it will share 80 million doses from its domestic stock with the world and India was supposed to get 3-4 million doses of Moderna and Pfizer vaccines. 

The Drug Controller General of India has approved the Moderna vaccine, but Pfizer has not yet applied for an emergency authorization in India.

What are the legal barriers coming in the way?

Price said that before the US can ship those doses, however, "each country must complete its own domestic set of operational, regulatory, and legal processes that are specific to each country. Now, India has determined that it needs further time to review legal provisions related to accepting vaccine donations."

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Once India has worked through its legal processes, the vaccine donations to India will be done without delay, Price said. Further adding that "We would need to refer you to the Government of India on the status of its discussions with COVAX, which, in this case, is helping to facilitate that delivery."

The US is donating millions of vaccines throughout South Asian nations like  Afghanistan, Bangladesh, Bhutan, Nepal, the Maldives, Pakistan, and Sri Lanka. So far around 40 million Coronavirus vaccine doses have been delivered worldwide, he added. 

"We are partnering to strengthen the global response to COVID-19 on issues ranging from addressing infectious disease outbreaks to strengthening health systems to securing global supply chains,” he said.

"We recently welcomed an initiative to collaborate through the International Center of Excellence in Research focused on infectious diseases, and in this case that includes COVID-19 and other emerging threats. We look forward to an overarching MOU, a memorandum of understanding, to enhance health cooperation beyond that,” he added.

Legal reimbursement

The vaccine shots that will be made available to India is now an aspect of US donations, while no deal on commercial supplies of these vaccines in India has been prepared yet.  

As DCGI approved Moderna, Cipla will import the vaccines from the US. However, no legal decision on reimbursement has been made yet. 

Meanwhile, Moderna and Pfizer have sought legal protection in India which will protect them from any legal cases in the country.

India and the US are working further on diagnostics, therapeutics, vaccines to fight the infection, along with acknowledging the importance of manufacturing crucial drugs during this time and getting them accessible globally.

Price stated: "We can do that because India's pharmaceutical sector is strong, it's well-established, it has played a central role in manufacturing vaccines for global use over some time.”

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It is a pleasure that the US pharmaceutical firms have been coordinating with their Indian counterparts since the beginning of the pandemic, added Price. 




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