Pfizer and GSK yet to apply for emergency use approval for COVID drugs in India

Pfizer and GSK are yet to apply emergency use approval for Paxlovid and Sotrovimab, respectively, in India. These two COVID drugs have proved to be effective against the omicron variant. It has been approved in Europe, the United States, UK and other countries.

Both drugs worked in laboratory studies against the omicron variant. Paxlovid and Sotrovimab, and Merck’s Molnupiravir are seen to be COVID-specific therapies that work against the omicron and delta variants.

GSK India spokesperson told ET, in regards to Xevudy, that nothing has been confirmed as of yet. The spokesperson said they are discussing options with the global team. Pfizer spokesperson said the company continues to engage with the Government of India to bring the vaccine and anti-viral therapy to the country.

“Globally, Pfizer has entered into advance purchase agreements with multiple countries and is in discussions with several others to bring this COVID-19 anti-viral treatment for use within the required populations,” the spokesperson said.

The pharmaceutical giant announced an agreement with the UN’s Medicines Patent Pool (MPP), in November, for licensing anti-viral intellectual property to MPP with the goal of making the drug available in low and middle-income countries. MPP through the pact can sub-license qualified generic medicine manufacturers worldwide. It can also work with countries where there are no patents.

Moreover, the agreement covers 95 low and middle-income countries, including India. As such, some Indian companies are seeking to apply for manufacturing licences with MPP.

The period of the licensing process is unclear. Companies, as per regulator requirements, have to conduct a bridging trial in India to get approval. The Indian drug regulator can grant a waiver on a case-to-case basis. But this depends on the urgency of the situation.

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On Wednesday, Mankind Pharma and BDR pharmaceuticals launched Merck’s oral COVID-19 anti-viral pill Molnupiravir under the brand name Molulife. This drug was approved by India’s drugs controller general VG Somani for restricted emergency use to treat mild to moderate COVID-19 patients.