Last Updated on January 6, 2024 by The Health Master
The Central government has relaxed the norms related to the manufacturing and stocking, sale or distribution of new drugs under phase III clinical trials, for the treatment of C-19 and related disease in public interest vide notification No. S.O. 553(E) dt 09-02-2022.
The provision is made to stock the drugs subject to condition that it shall sell the new drug only after obtaining permission as per the regulations.
According to a notification issued by the ministry of health and family welfare, the outbreak of C-19 pandemic throughout India and the resulting dangerous and opportunistic infections like mucormycosis, there is an emergency to make new drugs for treatment or management of the viral infection and related disease.
Making suitable new drugs available is essential to meet the requirements of emergency arising due to the pandemic, and in public interest, the government has decided that it is necessary and expedient to regulate the manufacture and stock for sale or distribution of such new drugs for prevention and treatment of these infections.
While the regulations in the Drugs Rules, 1945 and New Drugs and Clinical Trials (ND&CT) Rules, 2019, are there for the purposes of making available suitable drugs to meet the requirements of emergency arising due to C-19, the Central government is now using its powers to regulate or restrict manufacture of these drugs in public interest, to address the situation, it said.
In case a person intends to manufacture and stock a new drug for C-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 ND&CT Rules, he shall make an application under Rule 69 or Rule 70A or Rule 75 or Rule 75A of the Drugs Rules, 1945 to the concerned Licensing Authority with the State government.
Along with this, the permission should be obtained for conducting clinical trials in Form CT-06 under the ND&CT Rules for grant of license to manufacture and stock the drug for sale or distribution under the provisions of the Drugs and Cosmetics Act, 1940.
“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 C-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,” said the notification.
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 Drugs Rules, 1945, and the ND&CT Rules, 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 ND&CT Rules, 2019.
“In case of any inconsistency between the notification and any rule made under the said Act, the provisions of this notification shall prevail over such rule in public interest so as to meet the emergency which has arisen due to C-19 pandemic,” said the notification, which come into force from the date of its publication on official Gazette.
It may be noted that in the last meeting of the Drug Technical Advisory Board (DTAB), the experts have decided to amend the rules to enable manufacturing of unapproved new drug while it is still under development subject to conditions, in view of the drugs being developed for emergencies like C-19 and similar conditions of public health importance.
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 (CLA) 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.
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