Last Updated on December 31, 2023 by The Health Master
Orthopaedic Knee Implants
The National Pharmaceutical Pricing Authority (NPPA) has taken a significant step in regulating the prices of orthopaedic knee implants for knee replacement systems.
In the public interest, the NPPA initially fixed the ceiling price on August 16, 2017, a decision that has been extended six times to date.
The recent meeting of the authority on September 6, 2023, resulted in the extension of the ceiling price fixation for an additional year, until September 15, 2024, or until further notice, whichever comes earlier, vide notification No. S.O.-4078(E)-Dt-15-09-2023.
Factors Considered in Decision-making
During the meeting, the NPPA thoroughly discussed various factors affecting the pricing of orthopaedic knee implants.
These included:
- Fluctuations in foreign exchange rates.
- Increase in manpower costs.
- Rise in freight costs.
- Wholesale Price Index (WPI) fluctuations.
- Supply chain challenges.
An important observation was the annual WPI percentages over four years, from April 1, 2020, to April 1, 2023:
- 1.88468%.
- 0.53638%.
- 10.76607%.
- 12.1218%.
Regulatory Framework
The Union Ministry of Health and Family Welfare, through its S.O. 1468 dated October 6, 2005, classified orthopaedic implants as ‘drugs’.
This made them subject to the Drug Price Control Order (DPCO) of 2013, which applies to all notified drugs, including devices.
The NPPA is entrusted with the responsibility of overseeing the prices of these drugs/devices, ensuring their availability, and preventing unethical profiteering that may adversely affect patients.
Non-scheduled medical devices and drugs, including knee implants, are monitored under para 20(1) of the DPCO, 2013.
Monitoring Maximum Retail Prices
According to Para 20(1) of the DPCO, 2013, the government is mandated to monitor the Maximum Retail Prices (MRP) of all drugs, including non-scheduled formulations.
Manufacturers are prohibited from increasing the MRP by more than ten percent in the preceding twelve months.
Any increase beyond this threshold must be reduced to ten percent of the MRP for the following twelve months.
Addressing Patient Concerns
The NPPA’s decision to regulate the prices of orthopaedic knee implants stems from a crucial concern for patients.
In its order on August 16, 2020, the NPPA pointed out the unjustifiably high trade margins associated with these implants.
This resulted in exorbitant prices, making it financially burdensome for a significant number of patients.
This has led to a situation where only a fraction of well-off patients can afford arthroplasty procedures.
Future Considerations
The NPPA has committed to reviewing the ceiling price of orthopaedic knee implants after a period of one year.
This decision reflects a proactive stance toward ensuring that patients have access to essential medical interventions without incurring excessive financial strain.
Conclusion
The NPPA’s continued efforts to regulate the prices of orthopaedic knee implants are a significant stride towards ensuring accessibility and affordability in healthcare.
By extending the ceiling price fixation, the authority demonstrates its dedication to safeguarding the interests of patients and preventing unjustified profiteering in the healthcare sector.
This decision will undoubtedly have a positive impact on the accessibility of arthroplasty procedures, ultimately benefiting a wider demographic of patients in need.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
NPPA extends ceiling Price Fixation for Orthopaedic Knee Implants
NPPA extends ceiling price fixation on orthopaedic Knee Implants
NPPA extends ceiling price regulation on Orthopaedic knee implants
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