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SII Writes To PMO; Seeks Reforms In Existing Drug Regulatory System For Non-COVID Vaccines

The World's largest vaccine manufacturer by volume, Serum Institute of India, has written to PMO suggesting reforms in the existing drug regulatory system.

Serum Institute

The world's largest vaccine manufacturer by volume, Serum Institute of India (SII), has written to the Prime Minister's Office (PMO) suggesting reforms in the existing drug regulatory system, including allowing manufacturing and stockpiling of the non-COVID-19 vaccine while undergoing clinical trial. 

In the letter, the Director of Government and Regulatory Affairs at Pune-based SII, Prakash Kumar Singh, referred to the Health Ministry's May 18, 2020, gazette notification, saying it allowed manufacturing and stockpiling of Covid vaccine under clinical trial for marketing authorization for sale or distribution. He said, "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 span of time to protect millions of lives."

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Serum Institute of India writes to PMO

Stating that by the end of 2020, SII had already produced 50 million dosages of the Oxford-AstraZeneca COVID-19 vaccine "Covishield", even while it awaited the Drugs Controller General of India's (DGCI) nod for emergency use of its vaccine in the country, Singh said this provision should also be implemented on the non-Covid vaccine.

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In the letter addressed to PMO, SII has also sought permission to use the remaining quantities of batches of COVID-19 and non-Covid vaccine for commercial purpose which have been used in a clinical trial.  The vaccine manufacturer also sought permission for the implementation of recommendations of a high-powered inter-ministerial committee for reforming the Drug Regulatory Systems in India.

The letter further stated that on the directions of Prime Minister Narendra Modi, a high-powered inter-ministerial committee for reforming the Drug Regulatory Systems in India was constituted on May 11 last year under the chairmanship of then officer on special duty Rajesh Bhushan, who is presently the union health secretary.

"A series of meetings of this committee was held starting May 2020. Recommendations of this inter-ministerial committee should be implemented immediately in line with the ease of doing business" he said.

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SII highlighted a few other points related to regulatory reforms and said, "We are putting forward the following points with relation to necessary regulatory reforms in the existing Drug Regulatory system for your kind reference and intervention, which will take the vaccine industry of our country to new heights in the world."

SII also lauded the Prime Minister's vision mentioning, "It is a matter of great pride for all of us that because of our Hon'ble Prime Minister's vision about the regulatory reforms, the vaccine industry of our country is growing very fast and under his global leadership, our country has proved that we are the world leader in vaccine sector."

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(With PTI inputs)

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