The Serum Institute of India (SII) has urged the Government for reforms in the existing regulatory system. It has written to Union Health Minister Mansukh Mandaviya suggesting manufacturing and stockpiling of non-COVID vaccines while undergoing clinical trial.
Prakash Kumar Singh, Director, Government and Regulatory Affairs at Pune-based SII, in the letter referred to a gazette notification by the Union Health Ministry dated May 18, 2020, which allowed manufacturing and stockpiling of COVID-19 vaccine under clinical trial for marketing authorization 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,” Singh said. “It will be a big help for the vaccine industry if this rule is implemented for non-COVID vaccines also.” Singh also sought permission to use the remaining quantities of batches of COVID and non-COVID vaccines for commercial purposes which have been used in clinical trial.
He said the Health Ministry has issued draft rules dated April 12, 2018 to allow remaining quantities of batches of vaccines which have been used in clinical trial for commercial use after granting of permission in form 46 (now it is form CT-23) and manufacturing licence in Form 28D. “However, the gazette notification in this regard has not been issued so far for the implementation of the same.”
Serum Institute has also sought the implementation of recommendations of a high-powered inter-ministerial committee for reforming the Drug Regulatory Systems in India. The letter stated that on the directions of the Prime Minister, a high-powered Inter-Ministerial Committee for reforming the drug regulatory systems in India was formed under the chairmanship of then OSD, Rajesh Bhushan, who is presently the health secretary. It said recommendations of this inter-ministerial committee should be implemented immediately in line with ease of doing business.
Moreover, the letter highlighted few other points related to regulatory reforms – “If few rules, regulatory provisions are amended, it will be a great help and encouragement for the vaccine industry to grow faster. We are putting forward the following points w.r.t. Reforms in the Drug Regulatory System for your kind consideration which will take the vaccine industry of our country to further new heights.”