SII asks govt for key drug regulatory reform; seeks nod to stockpile under-trial vaccines

The Serum Institute of India (SII) has written to Union Health Minister Mansukh Mandaviya. In the letter, it suggested bringing reformations in the existing drug regulatory practice. The world's largest vaccine manufacture by volume recommended allowing manufacturing and stockpiling of non-COVID vaccines while undergoing clinical trial.

SII seeks reform in Drug Regulatory Systems in India.

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. He said it allowed manufacturing and stockpiling of COVID-19 vaccine under clinical trial for marketing authorization for sale or distribution. He continued, "Because of this rule, it became possible for us to manufacture and stockpile the COVID-19 vaccine during the clinical trial and we could make the vaccine available in such a short period to protect millions of lives."

He said that the Health Ministry had issued draft rules to allow the remaining quantities of batches of vaccines that have been used in a clinical trial for commercial use after granting of permission in form 46 (now CT-23) and manufacturing licence in Form 28D. Singh added, "However, the gazette notification in this regard has not been issued so far for the implementation of the same." He also sought the implementation of recommendations of a high-powered inter-ministerial committee for reforming the Drug Regulatory Systems in India.

SII to work in line with 'Making in India for the World' project

The letter highlighted few other points also related to regulatory reforms and stated, "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." "Given the genuine difficulties being faced by the vaccine industry, I sincerely request for your kind intervention for the regulatory reforms. This will also be in line with our Prime Minister's vision of ease of doing business in India and will further encourage his dream project 'Making in India for the World'," Singh mentioned in the letter.

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. This was taking place under the chairmanship of then OSD, Rajesh Bhushan who is presently the health secretary. "Recommendations of this inter-ministerial committee should be implemented immediately in line with 'ease of doing business". Singh while communicating in the letter by the ministry said, "It will be a big help for the vaccine industry if this rule is implemented for non-COVID-19 vaccines also." Singh also sought permission to use the remaining batches of Covid and non-Covid vaccines for commercial purposes which have been used in clinical trial. 

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