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The Drugs Controller General of India (DCGI) has clarified about fixed dose combination (FDC) approval containing a new molecule stating that there is no separate new drug approval required for a drug if first time used in approved FDC.
The clarification comes in the wake of concerns raised that FDCs containing new drugs are approved only after approval of individual new drugs.
Central Drugs Standard Control Organization (CDSCO) receives and processes applications for approval of FDCs in accordance with the provisions of New Drugs and Clinical Trials Rules 2019.
“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,” as per the DCGI notice.
As per the requirements of Paragraph 4 of Second Schedule of the New Drugs and Clinical Trials Rules, 2019, the first group of FDCs includes those in which one or more of the active ingredients are a new drug. For such FDCs to be approved for marketing data to be submitted will be similar to data required for any new drug (including clinical trials).
However, such issues are examined as case-by case basis depending of nature of the products, indication etc in consultation with the Subject Expert Committee (SEC) to ensure safety and efficacy of the FDC.
CDSCO has also clarified that that sub-acute toxicity data for innovator products are neither required nor asked for to conduct BA/BE study in humans for export purpose.
CDSCO receives and process application for permission to conduct BA/BE study in human for export purpose.
Concerns were also raised that sub-acute toxicity study report in at least two species for minimum 14 days is required to be submitted for innovator products.
Concerns have also been raised regarding requirement of stability data on the commercial batches before grant of WHO GMP and Certificate of Pharmaceutical Product (CoPP).
In this regard, CDSCO has clarified that if the stability data is generated during development stage as per the WHO guidelines, no further stability data on the commercial batches are required before grant of WHO GMP and CoPP.
CoPP is issued under the WHO GMP Certification Scheme for the purpose of international commerce i.e. for registration of products in foreign countries.
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