Grant licence to manufacture, stock new drugs, jabs under clinical trial: DTAB tells DCGI

Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India had last year written to Union Health Minister Mansukh Mandaviya for reforms in the drug regulatory systems, the source said.

In his letter, Singh stated that the Health Ministry had issued a gazette notification dated May 18, 2020 to manufacture and stock COVID-19 vaccine which is 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 available COVID-19 vaccine in such a short span of time period to protect millions of lives. It will be a big help for vaccine industry if this rule is implemented for non-COVID-19 vaccines also," Singh had stated.

"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 had mentioned in his letter according to official source.

Various industry experts and subject experts are of opinion that if the government approves recommendation of DTAB and DCGI, it will be a revolutionary change in drug rules in public interest.

This new provision will save substantial time of the manufacturer to produce and launch vaccines in the market and will give a boost to the efforts being put by the government to make India a pharmaceutical hub of the world.