**Summary:**
This circular, issued by the Central Drugs Standard Control Organization (CDSCO), clarifies the interpretation of Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019, concerning gastro-resistant, delayed-release, and enteric-coated tablets/capsules. These dosage forms, as modified or sustained-release versions of existing drugs, are classified as "new drugs" under the aforementioned rule. This directive follows recommendations from the Drugs Consultative Committee (DCC) to ensure uniform implementation of this rule across all States and Union Territories, as per the Drugs and Cosmetics Act, 1940. State/UT Drugs Controllers are instructed to enforce this interpretation.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
New Drugs and Clinical Trials Rules, 2019: A set of rules in India governing the approval and regulation of new drugs and clinical trials.
Rule 2, 1w: A specific rule within the New Drugs and Clinical Trials Rules, 2019 defining 'new drug'.
Drugs Consultative Committee: A committee in India that provides recommendations on drug-related matters.
Gastro Resistant Tablets/Capsules: A type of drug dosage form designed to resist disintegration in the stomach and release the drug in the intestines.
Delayed Release Tablets/Capsules: A type of drug dosage form that releases the drug at a specific time after administration.
Drugs and Cosmetics Act, 1940: An act in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics.
Dr. Rajeev Singh Raghuvanshi: Drugs Controller General of India
File No. ND-13020/2/2024-eoffice
i: Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization (HQ)
(New Drugs Division)
FDA Bhawan, Kotla Road,
New Delhi -110002
io, rate’ 2-4 FEB 2005
All State/UT Drugs Controllers
Subject:- Gastro Resistant Tablets/Capsules, Delayed Release
Tablets/Capsules as “New Drugs” as per Rule 2, (1)(w) of the New Drugs and
Clinical Trials Rules, 2019-Reg.
Sir/Madam,
As per the definition of “New Drug” specified in Rule 2(1)(w) of the New Drugs and
Clinical Trials Rules, 2019, a modified or sustained release form of a drug or novel
drug delivery system of any drug approved by the Central Licensing Authority shall
always be deemed to be a new drug.
The issues relating to uniform implementation of this rule regarding Gastro-resistant
Dosage forms / Delayed-release Dosage forms (Enteric Coated Tablets/Capsules)
across the country was deliberated in 64in meeting of the Drugs Consultative
Committee (DCC) held on 19-06-2024.
After detailed deliberation, the committee recommended to issue a Circular to all the
States/UTs regarding the interpretation of Gastro-resistant Tablets/Capsules
/Delayed release Tablets/Capsules (Enteric Coated tablets/ capsules) as “New Drug”
as per Rule 2 (1) (w) of the New Drugs and Clinical Trials Rules, 2019, for uniform
implementation across the country.
Accordingly, all the State/UT Drugs Controllers are requested 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 /Delayed 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 New Drugs and Clinical Trials Rules, 2019 under the
Drugs and Cosmetics Act, 1940.
Yours faithfully,
(Dr. Raje ingh Raghuvanshi)
Drugs Controller General (India)
Copy to:
1.All Stakeholder through CDSCO website.
2.All Zonal/ Sub-Zonal Offices of CDSCO.
3. CRU Section of CDSCO (HQ)