The National Pharmaceutical Pricing Authority (NPPA) has extended the ceiling price on orthopaedic knee implants for knee replacement systems by two months, pushing the deadline to 15 November 2025. The ceiling price, originally imposed in August 2017 in public interest, had been extended periodically, most recently up to 15 September 2025.

The drug price regulator noted that representations from manufacturers and industry associations regarding price revisions are still under review. In the meantime, the existing notification issued on 10 September 2024—capping prices of various knee replacement systems—will remain in force until mid-November, unless modified by a fresh order.

Under the September 2024 notification, ceiling prices were set from ?5,443.79 per unit for a primary knee replacement system with patella, to ?83,546.87 per unit for a revision knee replacement system with femoral component. Manufacturers and associations have argued that rising manpower costs, freight charges, fluctuations in foreign exchange, supply chain issues and increases in the Wholesale Price Index (WPI) should be factored into revisions.

Knee implants were classified as “drugs” by the Union Health Ministry in 2005, making them subject to the Drugs (Prices Control) Order (DPCO), 2013. While knee implants are non-scheduled devices under the order, NPPA monitors their maximum retail prices (MRPs) under Paragraph 20 to prevent unethical profiteering and ensure affordability for patients.

The regulator first intervened in August 2017 after identifying “unjustified and irrational” trade margins that led to exorbitant prices, forcing many patients to forgo arthroplasty procedures due to unaffordable costs. At the time, it estimated that 1.5–2 crore patients in India required knee replacement, though only about one lakh well-off individuals could afford it annually. With osteoarthritis projected by WHO to be the fourth leading cause of disability, NPPA argued that preventing widespread immobility was both a health and national priority.

Following consultations with stakeholders and an analysis of trade margins in the knee implant market, the Authority decided that fixing ceiling prices was necessary to protect patients from exploitative pricing. Since then, the cap has been extended year after year to maintain affordability and transparency in the orthopaedic implant sector.