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) has 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.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.globallegalinsights.com/practice-areas/pricing-and-reimbursement-laws-and-regulations/india