NPPA extends ceiling price regulation on Orthopaedic knee implants

The 20 notes, which followed the price list in the order dated August 16, 2017, also shall remain in force during the period

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NPPA Price of drugs

Last Updated on September 18, 2021 by The Health Master

Download the notification: The National Pharmaceutical Pricing Authority (NPPA) has extended the ceiling price it imposed on orthopaedic knee implants for knee replacement system in August, 2017, to one more year up to September 15, 2022. The ceiling price was applicable till September 15, 2021, according to an earlier notification.

In an order issued vide notification No. S.O. 3670(E) dated 10-09-2021, the drug price regulator has said, “In continuation to the above notifications, the ceiling prices as applicable to the orthopaedic knee implants for knee replacement system up to September 15, 2021 are further extended up to September 15, 2022”.

The 20 notes, which followed the price list in the order dated August 16, 2017, also shall remain in force during the period, it added.

Earlier, the Union ministry of health and family welfare vide its S.O. 1468 dated 6th October 2005, has notified the orthopaedic implants as ‘drugs’, and the DPCO, 2013, is applicable to all notified drugs (including notified devices).

The NPPA is mandated to monitor the prices of these drugs under paragraph 20, so as to ensure availability of such drugs (i.e. notified devices) and also ensure that no unethical profiteering is happening in case of any drugs (i.e. notified devices) at the cost of patients.

In its order in August 16, 2020, NPPA said that it has “noticed that orthopaedic- knee implants are having unjustified, unreasonable and irrational high trade margins leading to their exorbitant prices which affects the out of pocket expenses of patients and lakhs of patients are not able to pay for arthroplasty procedures because of these exorbitant prices and suffering in pain…”.

DPCO NPPA

The estimates of such patients requiring arthroplasty intervention, both diagnosed and undiagnosed, is about Rs. 1.5 to Rs. 2 crore out of which only about Rs. 1 lakh plus well off patients are in a position to pay for it every year.

It has also noted that osteoarthritis is likely to become fourth leading cause of disability by year 2020, as per the WHO Bulletin, 2003, 81,(9) and India is likely to be one of the leading countries of such immobilized citizens in terms of numbers. Preventing such a scenario is essential in individual as well as national interest, it said.

In this context, the NPPA carried out an exhaustive stakeholder’s consultation on the issue of exorbitant cost of orthopaedic knee implants and excessive trade margins and analysis of ‘trade margins’ in the market of knee implants was uploaded in public domain for the sake of transparency and in the spirit of people’s right to information.

Following this, the drug price regulator, in its Authority meeting held on August 10, 2017 which continued on August 14, 2017 after duly examining in detail, has decided that it is necessary to control the excessive trade margins for fixing ceiling price of orthopaedic knee implants which is fair and reasonable based on its intrinsic value of the implants with rational margins to protect public interest.

This was after deliberating and considering all available information/data/viewpoints and all relevant options for price fixation of orthopaedic knee implants, under present extraordinary circumstances of a failed and exploitative market because of information asymmetry between the patient and healthcare delivery system, it opined.

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