Manufacturers face risk of whistle-blower suits and government enforcement actions when emergency use authorizations expire and pandemic recedes, attorneys say, but interaction with FDA and documentation may mitigate risk.

No one wants to take away from India’s flair and prowess in the vaccines segment, but there should be no place for doubt when it comes to rigor in scientific and regulatory processes. Experts have raised questions around the restricted emergency use clearance of two COVID-19 vaccines in India.

Indian regulator is likely to ask Pfizer/BioNTech to conduct clinical trials before granting an accelerated approval, but recruitment could prove challenging for the COVID-19 vaccine as anaphylactic reactions in the US and UK sparks worry.