New Delhi : 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 from September 16, 2022. The ceiling price was applicable till September 15, 2022, according to an earlier notification.

The price regulation was imposed by the NPPA through a notification in August 16, 2017, which was extended through notifications in the subsequent years and the last order was issued on September 10, 2021.

The drug price regulator in its latest order said, “This order shall be applicable for the period of one year from September 16, 2022 unless revised by another notification. The ceiling prices for orthopaedic knee implants will be reviewed after a period of one year”.

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.”

The estimates of such patients requiring arthroplasty intervention, both diagnosed and undiagnosed, is about Rs. 1.5 to 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 the fourth leading cause of disability by year 2020, as per the W.H.O 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.