COVID-19 Vaccine
'Well established' foreign COVID-19 vaccines makers need no bridging clinical trials in India
New Delhi/IBNS: 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, media reports said.
The 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.
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).
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.
Earlier, the Punjab and Delhi governments had approached US pharmaceutical giants Pfizer and Moderna for exportation of their vaccines but the manufacturers had cleared they would only deal with the Centre in India.
Following which, Delhi Chief Minister Arvind Kejriwal had requested the Narendra Modi government to import vaccines from other countries and distribute them among the states and union territories.
So far, India has two three vaccines in hand, namely, Serum Institute of India (SII)'s Covishield, Covaxin developed by Bharat Biotech and Russia's Sputnik V.
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