India may get Pfizer’s vaccine in July

India may get Pfizer’s vaccine in July

Final Deal Still Pending Between Govt & American Drug-Maker

Sushmi.Dey@timesgroup.com

New Delhi:03.06.2021

The government’s decisions to ease regulatory norms for clearing foreign-made vaccines for use in India and an in-principle consensus on an indemnity waiver are intended to facilitate supply of Pfizer’s vaccine against Covid-19, which officials hope can be made by July.

The final agreement between the government and the American drug-maker on indemnity and procurement norms are still pending, though the two parties have arrived at an in-principle consensus, sources said.

According to a source, the government may give a complete waiver to foreign-made vaccines that have been approved for restricted use by the US Food and Drug Administration, European Medicines Agency, Medicines and Healthcare Products Regulatory Agency, UK., Pharmaceuticals and Medical Devices Agency, Japan, or which are mentioned in WHO Emergency Use Listing.

While Pfizer has been insisting on supplying the vaccines through the Centre, the government is working out a mechanism whereby the Centre can negotiate a price with the company and states and UTs can procure the jabs directly from the company at the pre-fixed price, the source said.

However, final signing of the agreement may still take a few days. Besides, despite the waivers and agreements, any company importing the vaccines will have to make a formal application, with documents of approval secured abroad, seeking emergency use authorisation from the drug regulator.

“Once all the documents are submitted and a formal application is made, the approval can come in around 10 days but supplies will take time to arrive and depend on the existing bookings and available stockpile with the company,” a senior regulatory official said.

Pfizer too said it is in talks with the government to make its Covid-19 vaccine available in India.

Apart from Pfizer, Cipla too has been negotiating with the government seeking fasttrack approvals to bring Moderna’s single-dose Covid-19 booster vaccine to the country.

Full report on www.toi.in

DOSE OF IMMUNITY: Students and employees who are travelling to foreign countries for education and employment line up to get vaccinated at a special camp in Bengaluru on Wednesday