Serum writes to Health Minister to propose 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 Serum Institute of India writes to Health Minister PTI Updated Jul 22, 2021, 7:52 AM IST 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.