3 Review(s)

As of 2025, the Drugs and Cosmetics Act, 1940 remains the primary regulator for pharmaceuticals and cosmetics in India, strengthened by its 1945 Rules. Significant enhancements include the 2025 compounding rules (April 25, 2025) and draft Second Amendment Rules (May 2025), improving procedural ease and quality safeguards. Broader reform is anticipated with the proposed replacement Bill currently under consideration.