**Summary:**
This notice, issued by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India, on December 12th, clarifies the approval process for Fixed Dose Combinations (FDCs) containing new drugs. The CDSCO processes applications for FDC approvals in accordance with the New Drugs and Clinical Trials Rules, 2019. This notice addresses concerns that FDCs containing new drugs are approved only after the individual new drugs have already been approved. The CDSCO clarifies that the approval processes for new drugs and FDCs containing those new drugs are *not* sequential. It is *not* required that a new drug must first be approved before an FDC containing that new drug can be approved. The approval of FDCs is governed by the requirements outlined in Paragraph 4 of the Second Schedule of the New Drugs and Clinical Trials Rules, 2019.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the approval of drugs, including FDCs.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO) in India.
New Drugs Division: A division within the Central Drugs Standard Control Organization (CDSCO) responsible for handling new drug applications.
New Delhi, Delhi: The location of the Central Drugs Standard Control Organization (CDSCO) headquarters.
FDCs: Fixed Dose Combinations, referring to drugs containing two or more active pharmaceutical ingredients in a single dosage form.
New Drugs and Clinical Trials Rules 2019: The regulatory framework governing the approval process for new drugs and clinical trials in India.
Paragraph 4 of Second Schedule of the New Drugs and Clinical Trials Rules, 2019: Specific section within the New Drugs and Clinical Trials Rules, 2019, relevant to the approval of Fixed Dose Combinations (FDCs).
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Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
ce of Drugs Controller General (India)
(New Drugs Division)
FDA Bhawan, Kotla Road,
New Delhi-110002
Date: >1)2!>°
NOTICE
Subject: Approval of FDCs containing new drugs — reg.
CDSCO receives and process application for approval of FDCs in accordance
with the provisions of New Drugs and Clinical Trials Rules 2019.
Concerns have been raised that FDCs containing new drugs are approved
only after approval of individual new drugs.
In this regard, it is clarified that there is no such requirement that approval
process of new drug and FDC containing that particular new drug are sequential and
first approval of new drug needs to be obtained followed by approval of FDC
containing that particular new drug.
¥e As per the requirements of Paragraph 4 of Second Schedule of the New
D ie Rules, 2019, the first group of Fixed Dose Combinations