The notice clarifies the regulatory pathway for approval of synthetically manufactured drugs that are similar to previously approved r-DNA derived drugs.
It specifies that applications for such synthetically manufactured drugs should be submitted as a subsequent new drug (synthetic peptide and other than biological product).
Key Changes
For approval of synthetically manufactured drugs that refer to previously approved r-DNA drugs, applicants must submit an application as a subsequent new drug (synthetic peptide and other than biological product).
The application will be processed considering all aspects of safety and efficacy as per the New Drugs and Clinical Trials Rules, 2019.
First time synthetically manufactured peptide will also be treated in a similar manner.
Impact Analysis
Pharmaceutical Manufacturers
Action Items: Review existing pipelines and strategies for drug development to align with the clarified regulatory pathway. Prepare applications for synthetically manufactured drugs as subsequent new drugs, ensuring comprehensive safety and efficacy data.
Regulatory Affairs Professionals
Action Items: Update knowledge on regulatory requirements. Develop standard operating procedures (SOPs) for preparing and submitting applications for synthetically manufactured drugs. Engage with CDSCO for clarifications, if needed.
CDSCO (Central Drugs Standard Control Organization)
Action Items: Ensure internal processes are aligned with the clarified pathway. Provide guidance and support to applicants to facilitate the submission and review of applications. Monitor the impact of this clarification on the development and availability of synthetically manufactured drugs.
Healthcare Providers and Patients
Action Items: Stay informed about new drug approvals and treatment options. Understand the safety and efficacy profiles of synthetically manufactured drugs.
Key Entities Referenced
CDSCO: Central Drugs Standard Control Organization, responsible for granting permission for import/manufacture of new drugs for sale and distribution in India.
New Drugs and Clinical Trials Rules, 2019: The regulatory framework governing the approval of new drugs in India, including requirements for safety, efficacy, and clinical trials.
Drugs Controller General (India): Head of the Central Drugs Standard Control Organization (CDSCO) in India.
r-DNA derived drug: Drug derived from recombinant DNA technology.
Subsequent new drug (synthetic peptide and other than biological product): A new drug application pathway for synthetically manufactured drugs that are similar to previously approved r-DNA derived drugs.
F.No. 12-01/19-DC(PT-195)
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Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
Office of Drugs Controller General (India)
(New Drugs Division)
FDA Bhawan, Kotla Road,
New Delhi-11 0002
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Date: }31'?> I ~ f'
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NOTICE
Subject: Guideline for approval of synthetically manufactured drug which has II
been previously approved as r-DNA derived drug - reg. f
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Under the New Drugs and Clinical Trials Rules, 2019, CDSCO grants
permission for import/manufacture of new drugs for sale and distribution.
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Regulatory pathway regarding approval of synthetically manufactured drug
that refers to a previously approved drug of r-DNA origin has been under discussion
for quite some times now.
In this regard, it is clarified that for approval of such synthetically
manufactured drug which has been previously approved as r-DNA derived drug, the
applicant is required to submit application as a subsequent new drug (synthetic
peptide and other than biological product) and such application will be processed
considering all aspects of safety, efficacy as per the New Drugs and Clinical Trials
Rules, 2019. Further, first time synthetically manufactured peptide will also be
treated in similar manner.
Yours faithfully,
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(Dr. V.G. Somani)
Drugs Controller General (India)
To,
All Stakeholders.