class="MsoNormal">The Central Drugs Standard Control Organization (CDSCO) on February 24, 2025, notified regarding the 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.
It recommended issuing a circular to all States/UTs clarifying that formulations such as Gastro-resistant/Delayed-release dosage forms (Enteric Coated Tablets/Capsules) shall be classified as "New Drugs." Accordingly, State/UT Drugs Controllers are directed to ensure consistent enforcement of this rule under the Drugs and Cosmetics Act, 1940.
[Notification No. ND-13020/2/2024]
