The Central Drugs Standard Control Organization (CDSCO) has issued a directive clarifying that gastro-resistant and delayed-release dosage forms of drugs are to be considered “New Drugs” under the New Drugs and Clinical Trials Rules, 2019. This includes enteric-coated tablets and capsules. This directive, dated February 24, 2025, has been issued to to all State and Union Territory (UT) Drugs Controllers.
This clarification aims to ensure uniform implementation of the regulations across the country.
“New Drug” Definition
As per Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019, a “New Drug” includes any modified or sustained-release form of a drug or a novel drug delivery system of any drug approved by the Central Licensing Authority.
The issue of the uniform implementation of this rule, particularly concerning gastro-resistant and delayed-release dosage forms, was deliberated in the 64th meeting of the Drugs Consultative Committee (DCC) held on June 19, 2024.
Following detailed discussions, the DCC recommended issuing a circular to all States and UTs to ensure consistent interpretation and application of Rule 2(1)(w).
Uniform Implementation Mandated
The CDSCO has instructed all State and UT Drugs Controllers to:
- Ensure the uniform implementation of Rule 2(1)(w) of the New Drugs and Clinical Trials Rules, 2019.
- Treat modified or sustained-release forms of drugs, including gastro-resistant tablets/capsules, delayed-release tablets/capsules (enteric-coated tablets/capsules), and novel drug delivery systems, as “New Drugs” under the Drugs and Cosmetics Act, 1940.
