Serum Institute writes to Union Health Minister proposing reforms in drug regulatory system

Prakash Kumar Singh, Director, Government and Regulatory Affairs at Pune-based SII, in a letter, referred to a gazette notification by the Union Health Ministry on May 18, 2020

World’s largest vaccine manufacturer by volume, Serum Institute of India (SII) has written to Union Health Minister Mansukh Mandaviya suggesting reforms in the existing drug regulatory system, including allowing manufacturing and stockpiling of non-Covid vaccines while undergoing clinical trial. According to official sources, Prakash Kumar Singh, Director, Government and Regulatory Affairs at Pune-based SII, in a letter, referred to a gazette notification by the Union Health Ministry on May 18, 2020. He said it allowed manufacturing and stockpiling of COVID-19 vaccine under clinical trial for marketing authorization for sale or distribution.