After losing a substantial time since the Covid19 pandemic struck India last year, government is slowly doing the necessary to ramp up vaccination in the country.

Central government may grant a major concession demanded by pharmaceutical giants like Pfizer and Moderna. The vaccine manufacturing companies would be provided indemnity from liability. This would be done to speed up the approval of the companies in India, when the nation is staring at an uncertain future of vaccination.

Sources in Health ministry have stated that other countries have done it and that there is no problem in granting indemnity. The companies are looking for indemnity or legal protection from any claims linked to the use of the vaccine manufactured by them.

The sources said, “If these companies have applied for Emergency Use Authorisation in India, then we are ready to give them indemnity.”

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In a parallel development, the drug regulator, Central Drugs Standard Control Organisation (CDSCO) has exempted the companies from India-specific trials for foreign vaccines. The vaccines which have been approved by specific countries and World Health organization have been made free of the requirement of India-specific trials for emergency use. Such trials are known as post-launch bridging trials. This was demanded by companies like Pfizer and Cipla.

Even with this rider given by DCGI, the head of CDSCO, it will take some time for pharma-firms like Pfizer and Moderna to join into Indian vaccination programme. It is because they have paid-orders from other countries to be fulfilled first.

It is worthwhile to note that as part of vaccine diplomacy, India has supplied around 60 million doses of vaccines to around 70 countries, and is now reeling in vaccine deficiency.

Between July and October, Pfizer would be providing 5 crore doses to India and has stressed on the manufacturer indemnity in its talks.

There was requirement that “every batch” of vaccine to be tested by the Central Drugs Laboratory (CDL) in Kasauli, provided “the vaccine batch/lot has been certified and released by the National Control Laboratory of the country of origin”. This condition has now been removed for the companies with WHO-approved vaccines, which are keen to join Indian vaccination drive.

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On June 1, US-drug maker Eli Lilly said that it had received approval for restricted emergency use of its antibody cocktail drugs, bamlanivimab 700mg and etesevimab 1400mg, in India. This combination would be used for the treatment of patients with mild to moderate coronavirus disease (COVID-19). These two are in fact monoclonal antibodies, which mimic the spike protein on the surface (corona) of the Coronavirus. This helps trigger immune response in the body against the Covid19 virions.

Cipla is looking forward to committing over USD 1-billion as advance to the US major-Moderna’s single-dose Covid-19 booster vaccine in India. For this purpose, the company is seeking to fast track approvals for Moderna expeditiously. The Indian firm has requested the government for indemnification and exemptions from price capping, bridging trials and basic customs duty.

While it is close to a major vaccine-deal in India, Moderna has begun the process to win full US regulatory approval for the use of its COVID-19 vaccine in adults in US.