SII writes to PMO on reforms in drug regulatory system

The  world’s largest  vaccine production company Serum Institute  of India (SII) has written letter to the PMO on reforms in existing drug regulatory system, including allowing companies manufacturing and stockpiling of  non-COVID vaccine while undergoing clinical rials.In the letter Prakash Kumar Singh who is the Director of Government and Regulatory Affairs at the Pune – based  Serum Institute of India (SII) referred to the Central  Union Health Ministry’s May 18,2020, gazette notification , saying it allowed manufacturing and stockpilling of COVID-19 vaccine under clinical trial for marketing authorisation sale or distribution.

In the letter Prakash kumar has written, “Because of this rule , it became possible for us to manufacture and stockpile the COVID-19 vaccine during clinical trial and we could make the vaccine available in such span of time to protect millions of lives.”

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