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Industry specific-Medical Central Ministry of Consumer Affairs, Food and Public Distribution Drugs and Cosmetics Act, 1940

Implementation of Gastro-resistant and Delayed-release Dosage Forms as "New Drugs"

24-Feb-2025 | File No. ND-13020/2/2024-eoffice

Central Drugs Standard Control Organization has issued a notification regarding the classification of Gastro-resistant Tablets/Capsules and Delayed-release Tablets/Capsules as "New Drugs" under Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019. According to the rule, modified or sustained release forms of any drug, including novel drug delivery systems, are always considered new drugs by the Central Licensing Authority.

By virtue of the notice, it was discussed at the 64th meeting of the Drugs Consultative Committee (DCC) on 19-06-2024 that there was a need for uniform implementation of this rule for Gastro-resistant and Delayed-release Dosage forms (Enteric Coated Tablets/Capsules) across the country. The committee recommended issuing a circular to all States/UTs for consistent enforcement of the rule. Therefore, all State/UT Drugs Controllers are now instructed to ensure that modified or sustained release forms, including Gastro-resistant and Delayed-release Tablets/Capsules, are treated as new drugs as per the provisions of the New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Act, 1940

Please refer the attached documents for more information.

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