THD NewsDesk, New Delhi: Serum Institute of India (SII); the world’s largest vaccine manufacturer has written to the Prime Minister’s Office recommending reforms in the existing drug regulatory system, proposing allowance for manufacturing and stockpiling of non-COVID vaccines while undergoing clinical trial.
In the letter, referring to the Health Ministry’s May 18, 2020, gazette notification, Prakash Kumar Singh, the Director of Government and Regulatory Affairs at the Pune-based Serum Institute of India (SII) said that it allowed manufacturing and stockpiling of COVID-19 vaccine under clinical trial for marketing authorization for sale or distribution.
He further wrote “Because of this rule, we could make the vaccine available in such a short span of time to protect millions of lives and it became possible for us to manufacture and stockpile the COVID-19 vaccine during the clinical trial and.”
Meanwhile, waiting the Drugs Controller General of India’s (DCGI) nod for emergency use of its vaccine in the country, SII has already produced around 50 million dosages of the Oxford-AstraZeneca COVID-19 vaccine ‘Covishield’ by the end of 2020. It got the nod in early January this year.
Singh said, “In view of the successful result of this provision for COVID-19 vaccine, This provision should also be implemented for non-COVID-19 vaccines.”
In the letter, he also sought permission to the PMO to use the remaining quantities of batches of COVID and non-COVID vaccines for commercial purpose which have been used in a clinical trial. In this context, he further said “To allow the remaining quantities of batches of vaccines the Health Ministry had issued draft rules dated April 12, 2018. These remaining vaccines, after the grant of permission in Form 46 (now it is Form CT-23) and manufacturing licence in Form 28D, have been used in a clinical trial for commercial.”
“To avoid wastage of life-saving vaccines, this draft rule has not been implemented till now. However, this draft rule should be implemented shortly” Singh pointed out. Also, Singh sought 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 Prime Minister Narendra Modi and under the chairmanship of then officer on special duty Rajesh Bhushan, who is presently the union health secretary, a high-powered inter-ministerial committee for reforming the Drug Regulatory Systems in India was constituted on May 11 last year.
Recommendations of this inter-ministerial committee should be implemented immediately in line with the ease of doing business. Therefore, he said “A series of meetings of this committee was held starting May 2020”.
Singh’s letter highlighted a few other points also 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.”
Singh also lauded the prime minister’s vision, mentioning, ” Because of Hon’ble Prime Minister’s vision about the regulatory reforms, it is a matter of great pride for all of us that our 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.”
