Download notification No. GSR 654(E) dt-24-08-2022: The Union ministry of health and family welfare (MoHFW) has issued the final notification amending the Drugs Rules 1945 vide notification No. GSR 654(E) dt-24-08-2022.
Download notification No. GSR 654(E) dt-24-08-2022
This is notified to allow parallel submission of applications for grant of renewal of manufacturing and sales license for large volume parenteral, vaccines and recombinant DNA (rDNA) derived drugs, applications for grant of manufacturing permission for new drugs under the New Drugs and Clinical Trials Rules, 2019 and application for approval to manufacture new drug under Rule 122B of the Drugs Rules.
The final notification, issued on August 24, adds a Sub-Rule under Rule 75 (3), which stipulates the submission of an application with the licensing authority on Form 27D for the grant or renewal of a license to manufacture for sale or for distribution in large volume parenteral, sera, vaccine, and rDNA-derived drugs.
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The new Sub-Rule, (3A), will add that the application referred to in Sub-Rule (3) or for grant of permission to manufacture a new drug for sale or distribution under Rule 80 of the New Drugs and Clinical Trials Rules, 2019, or the application for manufacturing a new drug under Rule 122 B of the Drugs Rules, 1945, may be made simultaneously.
The Sub-Rule (6) of Rule 75-mandates that an application under this rule is for the manufacturing of drug formulations falling under the purview of new drugs as defined in Rule 122-E.
Such an application shall also be accompanied by approval, in writing, in favor of the applicant, from the licensing authority as defined in clause (b) of Rule 21 - will also be substituted with a new sub-rule, as per the draft amendment.
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The substituted Sub-Rule now mandates that if the application is made under Rule 80 of the NDCTR 2019 or Rule 122B of the Drugs Rules, 1945, the license to the manufacturer for sale or distribution of the drug shall be granted after approval of the drug as a new drug.
The move comes as part of simplifying the process of application of new drugs and reducing the timeline for approval of these applications.
The Ministry said that it has received objections and suggestions from the public, which were considered by the Central government before issuing the final notification.
It may be noted that the provisions for parallel submission of applications have been under the consideration of the drug regulatory and policy-making bodies in the past too.
In the last meeting of the Drug Technical Advisory Board (DTAB), in November 2021, it has given a nod for necessary amendments in the Drugs Rules for parallel submission of applications for import registration, marketing authorization, and import license for new drugs.
A similar amendment was recommended related to marketing authorization and grant of manufacturing license of new drugs under Form 28-D of the regulation, with the Central Drugs Standard Control Organisation (CDSCO), in the same meeting.
The entire process of obtaining new drug permission, importing registration, and importing license are sequential, and filing one after the other leads to a serious delay in placing the product on the market.
In this regard, the committee has recommended making provisions for parallel submission of applications in such a way that the applications for the grant of the registration certificate and import license shall be processed simultaneously instead of the present practice of sequential processing, with the application for the grant of permission of a new drug. This will reduce the processing duration by about 3-6 months.
In the case of the manufacture of new drugs, the applicant initially files an application for the grant of permission for the manufacture and marketing (Marketing Authorisation ) of new drugs with CDSCO.
As per the current practices the application is disposed of within a period of 90 days.
However, if clinical data is required to be submitted along with the application, the applicant will conduct a clinical trial which may take from 1-3 years depending upon the phase of the clinical trial and data required.
After obtaining the MA for the new drug, the applicant shall make an application to the state authority for a grant of a manufacturing license on Form 28-D.
The application is processed by the State Licensing Authority in about 60 days without inspection.
If an inspection needs to be carried out the application is processed in 90 days. The state authority will forward the manufacturing license in Form 28-D to the DCG(I) for approval. The application is processed at CDSCO within 30 days.
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