State/UT Drugs Controllers are requested to ensure uniform implementation of definition of New Drug as defined under Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019 that modified or sustained release form of a drug including Gastro-resistant Tablets/Capsules /DeIayed release Tablets/Capsules (Enteric Coated Tablets/Capsules) or novel drug delivery system shall always be deemed to be new drug as per the provisions of Act & Rules made there under.
As defined under Rule 2(1)(w) of New Drugs and Clinical Trials Rules, 2019, a modified or sustained release form of a drug or novel drug delivery system shall always be deemed to be a new drug. Howver, there is no uniform implemetation of the said rule across the country in regard to Gastro-resistant Dosage forms / Delayed-release Dosage forms (Enteric Coated Tablets/Capsules).
The issue was deliberated in 64th meeting of the Drugs Consultative Committee (DCC) held on 19-06-2024 and after detailed deliberation, the committee recommended to issue a Circular to all the States/UTs regarding the interpretation of Gastro-resistant Tablets/Capsules/DeIayed release Tablets/Capsules (Enteric Coated tablets/ capsules) as New Drug under the above saide Rules for uniform implementation across the country.
Accordingly, the DCGI vide letter No. ND-13020/2/2024-eoffice dated 24-Feb-2025, has requested to all the State/UT Drugs Controllers to ensure uniform implementation of the Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019 that modified or sustained release form of a drug including Gastro-resistant Tablets/Capsules /DeIayed release Tablets/Capsules (Enteric Coated Tablets/Capsules) or novel drug delivery system shall always be deemed to be new drug under the provisions of New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Act, 1940.