Not MRP, We Need Fair Pricing For Med Devices, Pg15

Key Highlights:

• Maharashtra FDA Commissioner Tukaram Mundhe highlighted exploitative margins in medical devices, advocating for a distinct regulatory framework.
• India's medical device sector currently operates under the Drugs (Prices Control) Order (DPCO), leading to inflated Maximum Retail Prices (MRPs).
• Medical devices like pacemakers and syringes are sold at 10-30 times their real cost, eroding patient trust.
• Previous price caps by the National Pharmaceutical Pricing Authority (NPPA) on stents and knee implants significantly reduced costs and improved access.
• The Association of Indian Medical Device Industry (AiMeD) proposes a trade margin-based capping mechanism at the GST trigger point.

Detailed Insights:

• The Medical Devices Rules, 2017, addressed quality and safety but pricing remains under drug-centric mechanisms.
• This disconnect is problematic as the device market involves diverse technologies, costs, and supply chains.
• Hospitals often prioritize profit margins when selecting devices, rather than patient welfare.
• A pacemaker imported at ₹25,000 can be billed at over ₹2 lakh, and heart valves imported at ₹4 lakh marked up to ₹26 lakh.
• The proposed AiMeD model suggests capping trade margins by price band, such as 50% for devices above ₹1 lakh.
• This system aims to ensure affordability for patients, viability for distributors, and parity between domestic and overseas manufacturers.
• Monitoring and enforcement would be facilitated by GST data at the first point of sale.
• AiMeD recommends a 12-18 month pilot for six categories, including pacemakers and cardiac catheters, to ensure supply continuity.

Key Concepts Involved:

• Drugs (Prices Control) Order (DPCO): A government order that enables the National Pharmaceutical Pricing Authority (NPPA) to fix and revise prices of essential drugs.
• Maximum Retail Price (MRP): The highest price that can be charged for a product sold in India, inclusive of all taxes.
• National Pharmaceutical Pricing Authority (NPPA): A government regulatory body that controls the prices of pharmaceutical drugs in India.
• Goods and Services Tax (GST): An indirect tax used in India on the supply of goods and services.