On December 4, 2020, Pfizer became the first pharmaceutical firm to approach the Drugs Controller General of India (DCGI) seeking emergency use authorisation for its COVID-19 vaccine. Nearly seven months later, the the company remains in talks with the government, with no clarity as to whether the vaccine will ever come to India. While there have been several reports suggesting that an approval was imminent, others contend that despite changes in policy, India is unlikely to get the Pfizer vaccine through the Covax facility.
Speaking at a recent press conference after India approved the Moderna vaccine, NITI Aayog Member Dr V K Paul said that discussions were ongoing and that the country "will soon close the deal on Pfizer as well". There is however no exact timeline available.
"We have had discussions of multiple sessions with Pfizer, interactions have been held, going through the agreements that are required for such an arrangement to be operationalised and exchange of thoughts inputs are going back and forth that is very much on... we had one intensive meeting last week and we are looking to receiving feedback there and now," Paul said.
Earlier this month, the Drugs Controller General of India had taken several steps that would make it simpler for foreign-made vaccines to come to India. The DCGI decided to waive testing of batches at CDL for foreign-manufactured vaccines that have been approved by international drug regulators. It has also done away with the requirement of local bridging trials for foreign vaccines that have already been approved by certain other health bodies and governments.
Despite this, Pfizer and the Indian administration have been unable to reach an agreement. The main issue now is the indemnity clause that the company insists upon. By definition indemnity means "protection against possible damage or loss, especially a promise of payment, or the money paid if there is such damage or loss". In the case of vaccine makers, an indemnity clause would mean that they would not be held legally responsible in case of unforseen complications that might emerge from vaccination.
And while Pfizer has secured such a guarantee in the US, UK and several other nations, India does not presently provide any such assurance to COVID-19 vaccine makers. Incidentally, other companies including Serum Institute of India have also sought indemnity.
According to reports, this has also become a hurdle for the country to receive free doses via the Covax facility in the US. Those receiving vaccines will have to sign the indemnity clause ahead of roll out.