India has amended its Medical Devices Rules 2017 to ease regulatory requirements for their medical device sector. Rule 63 now recognizes European Union approvals as sufficient grounds to waive clinical... Read More
India’s health ministry has put together a proposal to overhaul the country’s pharmaceutical rulebook, much of which has been in place since 1940. The draft Drugs, Medical Devices and Cosmetics... Read More
India’s Central Drugs Standard Control Organization (CDSCO) released its finalized Guidance Document on Medical Device Software (The Guidance Document) on July 21, 2026. The Guidance Document provides comprehensive guidance dedicated... Read More
India is taking efforts to strengthen the safety oversight of healthcare products. One key initiative is the establishment of a national registry for implantable medical devices, such as cardiac stents... Read More
India’s Department of Biotechnology (DBT) is developing plans to introduce “regulatory sandboxes” for the pharmaceutical sector to fast-track approvals and shorten drug development timelines. A sandbox would allow innovators to... Read More
India’s Central Drugs Standard Control Organization (CDSCO) has released the final list of risk classifications for oncology-related medical devices. The classification system, published on January 2, 2026, improves transparency concerning... Read More
In January 2026, India’s Ministry of Health and Family Welfare made major amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019. This has shortened the timeline for clinical... Read More
For the first time, India’s Central Drugs Standard Control Organization (“CDSCO”) has issued a Draft Guidance on Medical Device Software to regulate software-based medical devices, including AI-based devices. This guidance... Read More
The Government of India has issued the Legal Metrology (Packaged Commodities – “LMPC”) Amendment Rules, 2025, a pivotal reform that exempts medical devices from the purview of the LMPC Rules,... Read More
India is moving toward an extensive revision of its legal drug-quality measures, which will be aligned with the various drug standards of the US, EU, and Japan. The Indian Pharmacopoeia... Read More