Serum seeks reforms in drug regulatory system

New Delhi, July 21: The world's largest vaccine manufacturer by volume, Serum Institute of India (SII), has written to Union health minister Mansukh Mandaviya suggesting reforms in the drug regulatory system, including allowing manufacturing and stockpiling of nonCovid 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 authorisation for sale or distribution.

"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 a short span of time to protect millions of lives.

"It will be a big help for the vaccine industry if this rule is implemented for non-Covid-19 vaccines also," a source quoted

Singh as having communicated in the letter.

Singh also sought permission to use the remaining batches of Covid and non-Covid vaccines, which have been used in clinical trials, for commercial purposes.

He also sought the implementation of recommendations of a highpowered inter-ministerial committee for reforming the Drug Regulatory Systems in India.

The letter stated that on the directions of the prime minister, a highpowered inter-ministerial committee for reforming the drug regulatory systems was formed under the chairmanship of then OSD, Rajesh Bhushan who is currently the health secretary.

"Recommendations of this inter-ministerial committee should be implemented immediately in line with 'ease of doing business".