Last Fall, the Indian CDSCO said that high risk Class C and D medical devices could not be sold without an import/manufacturing license after September 30. Risky Class C and D products included – surgical robotic devices, linear accelerators, imaging equipment, etc.... Read More
Recently, India’s Department of Pharmaceuticals (DOP) has set up a new five-person committee to further discuss drug and device prices. While Indian drug price caps have been in place for a while, only a few device price controls (out of 6,200 devices)... Read More
With over 1.4 billion people, India is currently the 3rd largest market in Asia after China and Japan. With geo-political tensions mounting between the US and China, more Western drug companies are thinking about manufacturing and sourcing drugs and drug components from... Read More
In recent months, India has made significant strides in reshaping the regulatory framework of its medical device industry. These initiatives are designed to improve the Indian medical device market and contain healthcare costs. Updates to Medical Device Licensing Requirements The Medical Device... Read More
While Indian drug prices had grown considerably in 2023 (up 12%), in 2022 (up almost 11%) and in 2021 (up almost 11%), drug prices remained flat in 2024 with an increase of only 0.0005%. This tiny price increase is for the National... Read More
On March 12, the Indian Department of Pharmaceuticals issued a new regulation for drug marketing called the – Uniform Code for Pharmaceutical Marketing Practices (UCPMP). Accordingly, all pharmaceutical associations in India are required to set up Ethics committees for Pharmaceutical Marketing Practices. Each... Read More
Earlier this year, the Indian government issued a notification upgrading its drug manufacturing requirements. This notification said that large Indian drug manufacturers had 6 months to upgrade their game, smaller Indian drug makers had 12 months. The notification said Indian drug makers... Read More
India’s National Cancer Grid (NCG) has sparked industry interest with its innovative approach to drug procurement. The pilot project, involving 23 cancer centers within the NCG network, successfully negotiated prices for 40 crucial oncology drugs, leading to significant cost savings of about... Read More
On January 1, India’s Central Drugs Standard Control Organization (CDSCO) put forth a new NSWS program and portal to help monitor and administer healthcare products that it regulates. Drugs, medical devices, and other healthcare products that require product registrations, import/export licenses, control... Read More