The government is expected to amend the New Drugs and Clinical Trial (ND & CT) Rules, 2019 to enable the manufacturing of unapproved new drugs while they are 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 C-19 and similar conditions of public health importance.
Currently, as per Rule 83 of the ND & CT Rules, 2019, a person shall make an application for a grant of a license to manufacture for sale or distribution to the State Licensing Authority (SLA) only after obtaining permission on Form CT-23 granted by the Central Licensing Authority (CLA) as per Rule 81 of the 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 to provide that in the event a person intends to manufacture and stock a new drug which is under clinical trial, subject to the condition that the licensee shall sell or distribute the drug only after obtaining permission for such drug (new drug) on Form CT-23 from the Central Licensing Authority under the ND & CT, 2019, the requirement of obtaining the permission on Form CT-23 under Rule 81 shall be deferred for grant of license to manufacture for sale or for distribution under the Drug Rules, 1945.
Such person shall obtain the said permission after successful completion of the clinical trial and submission of the 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 to the rules was placed before the DTAB and the Board, in its meeting held on November 8, 2021, recommended “that the proposed provisions for (grant of license to manufacture and stock of new drugs which is under clinical trial) be considered appropriate for drugs/vaccines being developed for emergency /life-saving / C-19 and similar conditions of public health importance”.
However, such drugs should be marketed, sold and distributed only after clearance of clinical trials results, it added.
Furthermore, there was also a recommendation by the Committee that there should be provisions for deemed approval of proposals in various permissions and license approvals for various stages of drug development, such as manufacturing of trial batches, conduct of phase I, II, III, and IV clinical trials, etc. except in cases of grant of permission or license for the import or manufacture of drugs, including new drugs and vaccines, biologicals, etc., for sale and distribution for domestic purposes.
It has agreed to 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 the setting up of provisions for the regulation of clinical research organizations was also agreed upon by the Board meeting.
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