The Indian government issued the National Medical Device Policy 2023 to help develop more locally-made medical devices in India. Currently, India imports about 82% of their medical devices and the Government is looking to change this. While this 2023 Policy was a progressive policy, it also discussed device pricing. Recently a special group under the Union Health Ministry (including outside experts, the Department of Pharmaceuticals, and the Health Authority) have begun working, for the first time, on a National List of Essential Medical Devices.
This list will outline price ceilings for certain medical devices in India. Right now, under the Indian National List of Essential Medicines, only 4 medical devices are considered drugs (IUDs, condoms, stents, and drug-eluting stents) and thus have price controls. Some devices in India like disposable surgical products, syringes, etc. are only allowed to increase their price annually by 10%. Normally, new devices are permitted to be priced at the manufacturer’s discretion, but this will likely change in the future. Also, in 2022, a group from the Health and Family Welfare Organization released a report entitled – Medical Devices: Regulations and Control. Obviously, new price controls in India are a major concern for Western device manufacturers exporting and selling to India.