The Indian government has exempted "well-established" foreign COVID-19 vaccines makers from any bridging clinical trials if it has been certified by the national control lab of the country where it is made.  The decision will pave the way for pharmaceutical companies like Pfizer, Moderna to export vaccines to India, which is slowly recovering from the devastating second wave of COVID-19 pandemic.

The decision has been taken by the DGCI at a time the country is facing an acute shortage of vaccines, which are key to beat the deadly virus, IBNS said.  The exemptions are applied to the vaccines which are already approved for restricted use by US FDA, European Medicines Agency (EMA), UK MHRA, PMDA Japan or the ones listed in the World Health Organisation (WHO) Emergency Use Listing (EUL).

In a major decision to help bridge the vaccine shortage in the country, one of the world's vaccine powerhouses, the mandatory testing of every batch of vaccines at Central Drug Laboratory (CDL) at Kasauli in Himachal Pradesh has also been done away with by the Drug Controller General of India or DGCI.

Raising questions over the government's vaccine strategy, the Supreme Court on Wednesday asked why couldn't the government buy 100 per cent of the anti-COVID-19 vaccines at a discount instead of leaving the states to procure it.

The top court has also said the central government's decision to provide free vaccines to people aged 45 or more, health care workers, and front line workers while leaving all those belonging to the age bracket of 18-44 to pay for the vaccines by the states or private hospitals was "arbitrary" and "irrational".

(SAM)