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System of preliminary scrutiny by CDSCO at the time of receipt of application for approval of Fixed Dose Combinations

Fixed Dose Combinations (FDCs) refer to products containing two or more active ingredients used for a particular indication(s). As per Rule 122-E of Drugs & Cosmetics Rule, A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration are considered new drugs.

Further, a new drug shall continue to be considered as new drug for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia, whichever is earlier. The development of FDCs is becoming increasingly high either to improve compliance or to benefit from the added effects of the two or more active drugs given together. They are being used in the treatment of a wide range of conditions and are particularly useful in the management of chronic conditions.

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