India Proposes Medicine Safety Act After Maharashtra FDA Revelation
核心洞察
Maharashtra FDA inspections found a large gap between medical device procurement costs and the prices charged to patients, prompting the commissioner to seek central price controls.
FDA Commissioner Tukaram Mundhe wrote to the Department of Pharmaceuticals (搜索) and the NPPA demanding price control on medicines and medical devices.
The Pune Patient Rights Council wants a Medicine Safety Act modeled on the Food Safety Act, with direct imprisonment for offenders.
Inspections by Maharashtra's Food and Drug Administration found a wide discrepancy between the procurement cost of medical devices and their selling price. FDA Commissioner Tukaram Mundhe wrote to the Central Government's Department of Pharmaceuticals (搜索) and the National Pharmaceutical Pricing Authority (搜索) demanding price control, and urged a comprehensive review of medical equipment prices with guidelines to cap profit margins on devices, improve coordination across systems and give patients more transparency in billing. His report notes similar complaints from Punjab, Rajasthan and Tamil Nadu alongside Maharashtra.
Umesh Chavan, president of the Patient Rights Council in Pune, is now calling for a separate Medicine Safety Act, modeled on the Food Safety Act, to impose direct government control over medicine prices and to provide for direct imprisonment for those found guilty. He cited an IV set with an original procurement cost of Rs 11 that is sold to patients for Rs 350 to Rs 400, and IVIG injections, used for serious conditions such as GBS or pneumonia (搜索), purchased for Rs 4,000 to Rs 4,500 but printed with an MRP of Rs 20,000, a net profit of Rs 15,000 to Rs 16,000 per injection. Chavan said the council has corresponded with central and state governments on the issue for 10 to 12 years.
Ashok Shinde described a relative's treatment in which the hospital ran what he called a battery of unnecessary tests, from blood sugar and X-rays to MRIs, and charged a bill of Rs 10 lakh that scrutiny suggested should have been around Rs 2 to Rs 3 lakh. He alleged the hospital included charges for medical equipment patients had never heard of. The pricing structure of medical devices remains under review.