New Delhi: 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 the 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, the 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 shots are likely to arrive by July-August. We are trying to expedite the processes so that the vaccines which have shown promise globally are also available for citizens of our country. Discussions are going on as certain issues need clarity. We will hopefully arrive at a final agreement very soon. The decision will be taken keeping in view a larger public interest,” a senior official told TOI.
Pfizer too said it is in talks with the government to make its Covid-19 vaccine available in India.
“Pfizer continues to remain engaged with the Government of India towards making its Covid-19 vaccine available for use in the government immunisation programme in the country. As these discussions are ongoing, we are unable to share any additional details at this time,” a Pfizer spokesperson said.
The Drugs Controller General of India (DCGI) on Tuesday waived the requirement of conducting bridging clinical trials and testing of every batch of vaccine by the Central Drugs Laboratory (CDL), Kasauli, for foreign-made vaccines, if the batch/lot has been certified and released by the National Control Laboratory of the country of origin.
Apart from Pfizer, Cipla too has been negotiating with the government seeking fast-track approvals to bring Moderna‘s single-dose Covid-19 booster vaccine to the country. Cipla has requested the government for indemnification and exemptions from price-capping, bridging trials and basic customs duty, while stating that it is close to committing over $1-billion as advance to the US major.
The availability of imported vaccines is also crucial to ramp up the coverage of vaccination drive against Covid-19 in the country. The government has estimated around 20 crore of domestic production of anti-Covid jabs in July, whereas it is targeting to inoculate an average of 1 crore people every day from mid-July or August onwards. To meet this target, it would need close to 10 crore more doses.