Department of Pharmaceuticals

Applications Invited for Medical Device Clinical Studies and Import Reduction Schemes under SMDI

Posted by: Prabhas Chakraborty July 27, 2026

Department of Pharmaceuticals Invites Applications for Medical Device Cluster Support under SMDI

Posted by: Prabhas Chakraborty July 27, 2026

Corrigendum/Addendum Dated 4.5.2026 in the Guidelines under PLI Scheme for Bulk Drugs

Posted by: Prabhas Chakraborty May 11, 2026

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11th May, 2026

Amendment to the Uniform Code for Marketing Practices in Medical Devices 2024 -regarding

Posted by: Prabhas Chakraborty May 7, 2026

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Regulation/Guidelines

The Future of Biological Regulation in India: Biosimilars, CAR-T, AI & Advanced Therapies

India's Biological Regulatory landscape is at an inflection point. The country that pioneered affordable Biosimilar access, built one of the world's largest vaccine manufacturing ecosystems, and established the framework for...

14th August, 2026

Regulation/Guidelines

Recall Management for Medical Devices in India

A Recall is one of the few regulatory events where speed of response directly influences both patient safety outcomes and a company’s regulatory standing. Yet many manufacturers only consider their...

13th August, 2026

Regulation/Guidelines

How to Build an Indian Regulatory Strategy for Advanced Biologicals Before Entering the Market

The decision to enter the Indian market with an advanced Biological product should be made with a comprehensive regulatory strategy in place. India's multi-authority regulatory environment, distinct clinical data requirements,...

7th August, 2026

Regulation/Guidelines

AI in Regulatory Affairs and Clinical Development: What Pharmaceutical Companies Need to Know in 2026

Artificial intelligence is reshaping Pharmaceutical research and development, regulatory affairs, and clinical operations at a pace that few industries have previously experienced. From AI-accelerated drug discovery and predictive Clinical Trial...