India’s proposed Drugs Rules, 1945 amendments introducing an acknowledgement-based system for importing drugs for testing and a 12-month residual shelf-life requirement.

Government Proposes Major Reforms to Drugs Rules, 1945: Simpler Import Procedures and Revised Shelf-Life Requirements

The Ministry of Health and Family Welfare has proposed significant amendments to the Drugs Rules, 1945 aimed at simplifying the import of drugs for analytical and non-clinical testing while revising residual shelf-life requirements for imported medicines. The proposed reforms are expected to enhance ease of doing business, reduce compliance burden, promote pharmaceutical R&D, and improve supply chain efficiency without compromising patient safety.
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Medical Devices Rules 2017 Amendment: Government Proposes Faster Manufacturing Licence Approvals

Medical Devices Rules 2017 Amendment: Government Proposes Faster Manufacturing Licence Approvals

The Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules, 2017 to reduce manufacturing licence approval timelines for Class B, Class C, and Class D medical devices. The draft changes aim to improve regulatory efficiency, enhance ease of doing business, and accelerate access to quality medical devices while maintaining stringent safety and performance standards. Learn what these proposed amendments mean for medical device manufacturers and the Indian healthcare industry.
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