What does indemnity to foreign vaccines mean for India?

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India is currently facing an acute shortage of COVID-19 vaccines with the Centre receiving brickbats for its vaccination policy, which fell short when the country was hit by a severe second wave of COVID-19 in March-April. The central government had halted the exports of COVID-19 vaccine shots earlier, given under the 'Vaccine Maitri' programme and scrambled to procure more jabs to address the shortage. The government is now likely to grant indemnity to Pfizer and Moderna to expedite the vaccination process in the country. The Pune based Serum Institute of India has become the latest pharma company to ask for indemnity from liability, stating that all vaccine manufacturers, whether Indian or foreign, should be protected against legal suits for any severe side effects.

What is indemnity?

Indemnity means protection against a loss or any other financial stress. In the case of India, if the government gives an indemnity to foreign vaccine makers to roll out their vaccine in the country, the government, and not the vaccine maker, would be liable to compensate any citizen who claims to have side effects after taking the vaccine jab. The central government has thus far not provided indemnity to any COVID vaccine maker.

Who has demanded indemnity?

The indemnity clause is a key issue between the Centre and the foreign pharma majors, such as Pfizer and Moderna, who have said that they will export their COVID-19 vaccines to India only if the company is guarded against legal cases. The Serum Institute of India has also joined the list, becoming the latest pharma company to ask the Centre to ensure protection against liability.

Performance of the foreign vaccines

Pfizer and Moderna vaccines are among the best COVID-19 vaccine shots in the international market, which have been rated over 90 per cent effective and approved by over 40 countries, comprising the UK and the US.

Centre's take on the indemnity clause

The central government is reportedly likely to grant indemnity to foreign drugmakers like Pfizer and Moderna to expedite approvals of the coronavirus vaccines in India. This is along the lines of the approach adopted by the US and other countries that have rolled out their COVID-19 vaccines.

Removing Roadblocks

Besides clearance on indemnity clause, foreign vaccine makers including Pfizer and Moderna had sought relaxation on the requirement for a post-approval bridging trial for its vaccine. Acting on the same, the Drugs Controller General of India (DCGI) on June 1 exempted foreign COVID-19 vaccines approved by specific nations or health bodies from post-approval bridging trials in the country. DCGI chief VG Somani said the decision to waive trials will only apply to the vaccines that have been approved for restricted use by the US FDA and other countries or which are listed on the WHO Emergency Use Listing (EUL).

'Bridging trials' are localised clinical trials which generate data related to the impact of foreign medicines/vaccines on the indigenous population before they are rolled out for the public. These trials are important in ascertaining the efficacy and potential side-effects related to the medicine/vaccine.

When will Pfizer, Moderna vaccines be available in India?

Several sources in the government have indicated that Pfizer has already signalled that it would be able to export some vaccine doses to India by July 2021. In response to India Today's query on its ongoing discussions with the Centre, Pfizer said that it's an ongoing discussion with the government. It added that the organisation will supply COVID-19 vaccines only to the central governments and supranational organisations for deployment in national immunisation programs. The allocation of doses and implementation plan within a country is a decision for local governments based on relevant health authority guidance.