Dr KK Aggarwal
Early this week, the National Pharmaceutical Pricing Authority (NPPA) fixed and notified the ceiling prices (inclusive of trade margins) of orthopedic implants used in knee surgeries, both primary knee replacement surgery as well as revision surgery, under para 19 of Drugs (prices control) order (DPCO 2013) with immediate effect.
In 2005, orthopaedic implants were notified as ‘drugs’ by the Ministry of Health and Family Welfare vide its S.O. 1468 dated 6th October 2005. Consequent to this, Drug (Prices Control) Order
(DPCO) 2013 became applicable to these implants, which also came under the purview of the NPPA, which is mandated to monitor the prices of all notified drugs including notified devices.
An estimated 1.5 to 2 crores patients require arthroplasty; however, out of these which only about 1 lakh plus well off patients are in a position to pay for it every year because of the very high cost of orthopedic implants (NPPA Notification, August 16, 2017).
As per WHO estimates, osteoarthritis will be the fourth leading cause of disability by the year 2020.
The ceiling price of different materials and components used in the implant in primary knee replacement system has been fixed between Rs. 4,090/- to Rs 38,740/-. Similarly, the ceiling price of different materials and components used in the implant in revision knee replacement system has been fixed between Rs. 4,090/- to Rs 62,770/-.
As per the notification, “All manufacturers/marketers of knee implants having MRP lower than the ceiling price specified plus goods and services tax as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013”.
The earlier average MRP of cobalt chromium, the most commonly used knee implant has reduced by an average of 65%. The MRP has been capped at Rs. 54,720/- now Wfrom the earlier 1,58,324/-Knee implants made up of special metals like titanium and oxidised Zirconium has been capped at Rs 76,600/- with price reduction by 69%. The price of high flexibility implants have been capped at Rs. 56,490/-, again with a price reduction by 69% (Press Information Bureau, August 16, 2017).
All hospitals/nursing homes/clinics performing orthopedic surgical procedures using knee implants are now required to comply with the ceiling prices notified. The patients cannot be charged any additional charge over and above the ceiling price notified “except applicable goods and services tax, if any, paid or payable”.
The Indian Medical Association (IMA) welcomes this move of the govt. to fix the ceiling price of knee implants as now these implants have become more affordable and within reach of the common people. Many more patients will now be able to undergo the procedure, which earlier they could not because of the very high costs of the implants.
Earlier this year, the Govt. had fixed the ceiling prices of coronary stents, which also came as a relief to the general public.
Disclaimer: The views expressed in this write up are entirely my own.