The Ministry of Health and Family Welfare (MoHFW) on February 10, 2022 has issued a notification regarding the manufacture and stock of new drugs which are related to Covid-19 outbreak.
The following points have been issued by the MoHFW under Drug rules 1945 and clinical trials rules 2019:
(a) In case a person intends to manufacture and stock a new drug for COVID-19, which is under clinical trial for marketing authorisation for sale or distribution, then, such person shall have to obtain permission in Form CT-06 to conduct clinical trial of such drug and on successful completion of the clinical trial and after obtaining permission in Form CT-23 from the Central Licensing Authority under the New Drugs and Clinical Trials Rules, 2019, he shall make an application under rule 69 or rule 70A or rule 75 or rule 75A of the Drugs Rules, 1945, as the case may be, to the concerned Licensing Authority appointed by the State Government along with the permission obtained for conducting clinical trial in Form CT-06 under the New Drugs and Clinical Trials Rules, 2019, for grant of license to manufacture and stock the drug for sale or distribution under the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) (hereinafter referred to as the said Act) and the rules made thereunder:
Provided that the requirement of prior permission from the Central Licensing Authority under rule 81 of the New Drugs and Clinical Trials Rules, 2019 to manufacture the new drug as required under rule 83 of the said rules shall be deferred in public interest to meet the emergent situation arisen out of COVID-19 and 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 New Drugs and Clinical Trials Rules, 2019.
The Central License Approving Authority or the State Licensing Authority, as the case may be, if satisfied that requirements under the provisions of the said Act and the Drugs Rules, 1945 and the New Drugs and Clinical Trials Rules, 2019 have been complied with, grant License in accordance with the provisions of the Drugs Rules, 1945 to manufacture and stock the new drug subject to the condition that the licensee shall sell or distribute the new drug only after obtaining permission for such new drug in Form CT-23 from the Central Licensing Authority under the New Drugs and Clinical Trials Rules, 2019.
[Notification No. S.O. 553(E)]
