Pfizer on Wednesday said it continues to remain engaged with the Indian government towards making its coronavirus vaccine available for use in the government immunisation programme.
The company's statement came after Drugs Controller General of India (DCGI) exempted specific trials of COVID-19 vaccines that have been approved by some other international regulatory bodies.
"Pfizer continues to remain engaged with the Government of India towards making its COVID-19 vaccine available for use in the Government immunisation programme in the country. As these discussions are ongoing, we are unable to share any additional details at this time," a Pfizer spokesperson said.
DCGI has done away with specific trials of COVID-19 vaccines that have been approved by other international regulatory bodies - a move likely to clear the way for foreign vaccines like Pfizer and Moderna for the country's urgent requirement.
In a letter, DCGI Chief VG Somani said that this will be applicable for vaccines that have already been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed for Emergency Use by the World Health Organisation.
Mr Somani added that for the vaccines that are well established from the standpoint that millions have already been vaccinated with the said vaccines, the requirement for conduction post-approval bridging clinical trials and the requirement of testing of every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli can be exempted, if the vaccine batch/lot has been certified and released by the National Control Laboratory of the Country of Origin.
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