Last Updated on January 6, 2024 by The Health Master
The Drugs Technical Advisory Board (DTAB) has given its nod for the necessary amendment in the Drugs Rules for parallel submission of applications for import registration, marketing authorization, and import license for new drugs.
A similar amendment has been recommended related to marketing authorization and the grant of a manufacturing license of new drugs under Form 28-D of the regulation, with the Central Drugs Standard Control Organization (CDSCO).
The decision was taken based on a draft of the rules, following a recommendation from a committee constituted by the ministry of health and family welfare (MoHFW), regarding making provisions for the parallel submission of applications for import registration, marketing authorization and import license.
In the case of the import of new drugs, the applicant initially files an application for the grant of permission for the import and marketing of new drugs with the CDSCO. As per the current practice, 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 one to three years depending upon the phase of the clinical trial and the amount of data required.
After obtaining the permission to import and market the new drug, the applicant is required to obtain an import registration certificate (RC). The duration specified for processing such an application is 270 days.
After obtaining the RC, the applicant shall submit an application for the grant of an import license, which will require 30 days for processing. Thus, the entire process of obtaining new drug permission, importing registration, and importing license is sequential, which leads to delays in placing the product on the market.
In this regard, the committee has recommended making provisions for the parallel submission of applications in such a way that the applications for the grant of RC 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.
Accordingly, a draft of the amendment to the rules was placed before the DTAB. The Board, in a meeting in November, 2021, after detailed deliberation, agreed to the necessary amendment in the Rules in this regard.
A similar decision was taken with regards to the submission of applications for marketing authorisation and grant of manufacturing licence in Form 28-D.
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 Authorization [MA]) of new drugs with CDSCO. As per the current practices, the application is disposed of within a period of 90 days.
Drugs Technical Advisory Board (DTAB): Minutes of meetings
However, if clinical data is required to be submitted along with the application, the applicant will conduct a clinical trial, which may take anywhere from 1-3 years depending upon the phase of the clinical trial and the 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 on Form 28-D to the DCGI for approval. The application is processed at CDSCO within 30 days.
The committee constituted by the MoHFW has recommended that provisions may be made such that the applications may be submitted simultaneously so that they are processed simultaneously instead of the present practice of sequential processing. This may reduce the processing duration by about 2-3 months.
Accordingly, a draft of the amendment to the rules was placed before the DTAB. The Board, after detailed deliberation, agreed to the necessary amendment in the rules to reflect the decision.
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