DTAB Agrees To Amend Rules For Manufacturing Of Unapproved New Drugs Still Under Development

New Delhi : The Centre is expected to amend the New Drugs and Clinical Trial (ND&CT) Rules, 2019 to enable manufacturing of unapproved new drugs while it is still under development, subject to conditions. An amendment in this regard was discussed and recommended at the last Drug Technical Advisory Board (DTAB) meeting held in 2021, in view of the drugs being developed for emergencies like Covid-19 and similar such conditions of public health importance.

Currently as per the Rule 83 of ND&CT Rules, 2019, a person shall make an application for grant of license to manufacture for sale or distribution to State Licensing Authority (SLA) only after obtaining permission in Form CT-23 granted by Central Licensing Authority (CLA) as per Rule 81 of ND&CT Rules, 2019.

A committee constituted by the ministry of health and family welfare (MoHFW) had one of its recommendations related to making provisions for grant of license to manufacture and stock of new drug for sale and distribution which is under clinical trial.

It was proposed to amend the ND&CT Rules, 2019 providing that in case a person intends to manufacture and stock a new drug which is under clinical trial, subject to condition that the licensee shall sell or distribute the drug only after obtaining permission for such drug (new drug) in Form CT-23 from the Central Licensing Authority under the ND&CT, 2019, the requirement of obtaining the permission in Form CT-23 under Rule 81 shall be deferred for grant of license to manufacture for sale or for distribution under Drug Rules, 1945.

Such person shall obtain the said permission after successful completion of the clinical trial and submission of application along with fees, data and particulars in accordance with the provisions of the ND&CT, 2019, it added.

A draft amendment in this regard, on the rules was placed before the DTAB and the Board in its meeting held on November 8, 2021, has recommended “that the proposed provisions for (grant of license 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 trials results, it added.

Besides, there was also a recommendation by the Committee that there should be provisions of deemed approval of proposals in various permissions, license approvals for various stages of drug development such as manufacturing of trial batches, conduct of phase I, II, III and IV clinical trial etc. except in cases of grant of permission or license for import or manufacture of drugs including new drugs and vaccines, biologicals etc., for sale and distribution for domestic purpose. It has agreed for the necessary amendment in the Rules of 2019 according to a draft amendment in the rules placed before the DTAB.

Another recommendation from the Ministry-appointed committee related to making provisions for setting up of provisions for regulation of clinical research organisations was also agreed by the Board meeting.


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