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The National Pharmaceutical Pricing Authority (NPPA) has extended the ceiling price fixation for orthopaedic knee implants used in knee replacement systems for at least two more months, till November 2025.
In a notification dated September 15, the drug price regulator said the fixed price ceiling shall remain in force for orthopaedic knee implants for a further period of up to two months, that is, till November 15, 2025, unless amended by a subsequent notification.
According to the notification, the cost of the primary knee replacement system (titanium alloy coated) has been capped at Rs 51,563. The cost of the revision knee replacement system has been capped at Rs 83,547.
The notification comes at a time when manufacturers and industry associations have been submitting representations seeking removal of the ceiling.
Reasons cited by them include fluctuations in foreign exchange, increased manpower and freight costs, a rise in the Wholesale Price Index (WPI), and supply chain problems.
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The regulator added that representations received from manufacturers and industry associations on the subject are being considered by the NPPA.
The NPPA had first notified the ceiling price of orthopaedic knee implants in 2017 by invoking extraordinary powers under Paragraph 19 of the Drugs Prices Control Order (DPCO) 2013, for a period of one year.
The time limit for this price ceiling has been extended every year since then, with the previous extension announced on September 10 last year.
In previous orders, the NPPA had noted unjustified, unreasonable and irrationally high trade margins on orthopaedic knee implants, leading to exorbitant prices that increased out-of-pocket expenses for patients.
India is a major consumer of knee implants, with the country recording more than 250,000 knee replacement surgeries every year.
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