The Drug Controller General of India (DCGI) has issued guidance for getting marketing approval of fixed dose combination (FDC) drugs in India. The draft has classified the FDCs into different categories and have stated various requirements for each in a detailed manner. These guidelines apply to manufacture, import and marketing approval of FDCs as a finished pharmaceutical product considered as new drug as per Rule 122(E) of Drugs and Cosmetics Act & Rules.
Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945) specifies the requirements for approval for marketing of various types of FDCs. The same is further elaborated in the draft to provide a detailed guidance for industry.The aim behind elaborating the requirements for approval for marketing as mentioned in the draft was because, "FDCs should always be based on convincing therapeutic justification. Each fixed dose combination should be carefully justified and clinically relevant." The draft guidance prepared by the government clearly put lots of focus on the importance on filing Form-44.
Another notable point highlighted in the draft is on the FDC's that are not marketed in India but the active ingredients are approved or marketed individually and it is likely to have significant pharmacokinetic or pharmacodynamic (PK/PD interactions. This group of FDCs includes those in which active ingredients already approved, marketed individually are combined for the first time for marketing in India, for a particular claim and where the ingredients are likely to have significant interaction of a PK/PD nature.
Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945) specifies the requirements for approval for marketing of various types of FDCs. The same is further elaborated in the draft to provide a detailed guidance for industry.The aim behind elaborating the requirements for approval for marketing as mentioned in the draft was because, "FDCs should always be based on convincing therapeutic justification. Each fixed dose combination should be carefully justified and clinically relevant." The draft guidance prepared by the government clearly put lots of focus on the importance on filing Form-44.
Another notable point highlighted in the draft is on the FDC's that are not marketed in India but the active ingredients are approved or marketed individually and it is likely to have significant pharmacokinetic or pharmacodynamic (PK/PD interactions. This group of FDCs includes those in which active ingredients already approved, marketed individually are combined for the first time for marketing in India, for a particular claim and where the ingredients are likely to have significant interaction of a PK/PD nature.
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