After wasting almost a year in terms of vaccine procurement, central government is now gradually easing the norms for procurement of vaccines from pharmaceutical giants abroad. This comforting news comes as the Covid19 threat has amplified in the second wave and with the arrival of new mutants.
Also See: New mutants of Coronavirus
Steps are being taken for clearing the deck for the foreign-made vaccines for use in India and building an in-principle consensus on an indemnity waiver. As a result, the government officials expect that Pfizer’s vaccine supply can be made available by July. Price negotiation on Pfizer’s vaccine is underway between the firm and GOI.
The agreement between the government and the US-based drug maker is still to get its final shape, though both have arrived at an in-principle consensus.
GOI may give a complete waiver to foreign-made vaccines that have been approved for restricted use by the US FDA, EMA of EU, Medicines and Healthcare Products Regulatory Agency, UK, Pharmaceuticals and Medical Devices Agency, Japan. Additionally, the waiver is expected for those vaccines which are mentioned in the WHO Emergency Use Listing.
Also Read: Indemnity from liability to be granted to vaccine manufacturers like Pfizer and Moderna
Pfizer, which promises to make 5 crore doses of vaccines available between July and October, is planning out a mechanism whereby a price can be fixed with the states and UTs. The centre is chalking out a price mechanism where the states can directly purchase the jabs from the firm at the fixed rate.
Final signing of the agreement may take a few days. For any company which intends to import the vaccines, a formal application has to be made, with documents of approval secured abroad. It also needs emergency use authorization from the drug regulator of the country where the vaccine would be imported.
Also Read: An uncertain wait for vaccines by India despite a liberalized regulatory framework
India firm Cipla with another US-based drug company, Moderna is looking forward to committing over USD 1 billion as advance for procurement of Moderna’s single dose Covid19 booster vaccine in India. The American drug maker has begun the process to win full US regulatory approval for the use of its COVID-19 vaccine in adults in US.