Gastro-Resistant and Delayed-Release Drugs Now Classified as ‘New Drugs’ by CDSCO
The Central Drugs Standard Control Organization (CDSCO) has issued a new directive that classifies 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. This decision was made to ensure uniform regulation and patient safety across India. What Does This Mean? Previously, there was inconsistent […]







