Seeking fast-track approvals to bring Moderna’s single-dose Covid-19 booster vaccine in India expeditiously, 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, sources said on Monday, reports Hindustan Times.
Commending the government for its efforts to increase the vaccine availability in the country for achieving effective protection against Covid-19, the Indian pharma giant has said its discussions with Moderna on the Covid-19 booster vaccine are nearing finalisation and for that, they are seeking the “partnership and support of the government to make this programme successful”.
Requesting the government to provide confirmation on four critical points --- exemption from price restriction, indemnification, bridging trial waiver and basic customs duty exemption, Cipla has said such an assurance will help make this significant financial commitment of more than USD 1 billion (over ₹7,250 crore) advance to Moderna for its booster vaccine in India, sources privy to the development said.
Cipla’s latest communication to the government, dated May 29, follows a high-level meeting held recently during which it was discussed that Moderna has proposed to launch a single-dose vaccine for the Indian market, for which, they were in discussion with Cipla and other Indian companies.
It was also discussed in that meeting that orders for supply of the vaccine in 2022 may be placed with Moderna expeditiously and that Cipla has evinced interest to procure 50 million doses from Moderna for 2022. It was also suggested that Cipla may be asked to submit their specific requests to the government on their request for a “confirmation from the Government of India in respect of stability in regulatory requirements/policy regime” and a decision on that can be taken thereafter expeditiously.
Taking the matter forward, Cipla has now written to the government, “It is imperative Cipla brings Moderna booster vaccines to India urgently, having immediately made available the largest portfolio of Covid-19 drugs amongst Indian pharmaceutical companies, including the state-of-the-art antibody cocktail of Casirivimab and Imdevimab.”
Stating that Moderna’s vaccine has been rated at the highest efficacy with least side effects, Cipla has told the government that it needs assurance to include Moderna booster vaccine under the Liberalised Pricing and Accelerated National Covid-19 Vaccination Strategy, announced in April and made effective from May 1.