The Drug Technical Advisory Board (DTAB) recently recommended to the Drugs Controller General of India (DCGI) amendment in provisions of the New Drugs and Clinical Trials Rules, 2019. These mamendments were mentioned for granting licence to manufacture and stock new drugs and vaccines, under clinical trial, for sale or distribution, according to a news report by PTI.

DTAB though said that such drugs should be marketed, sold and distributed only after clearance of clinical trial results.

DCGI has now sent a draft proposal to the union health ministry for approval based on the recommendation.

According to PTI report, the DCGI mentioned in the draft proposal, “DTAB has recommended that the proposed provisions for grant of licence to manufacture and stock of new drug which is under clinical trial is considered appropriate for drugs/vaccines being developed for emergency/life-saving/COVID-19 and similar such conditions of public health importance. However, such drugs should be marketed, sold and distributed only after clearance of clinical trial results.” Accordingly, a draft notification has been prepared and forwarded to the ministry, the official source said.

Prakash Kumar Singh, Director, Government and Regulatory Affairs, 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 18th May, 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 the 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 the public interest.