Understanding the New Price Regulations for Orthopaedic Knee Implants: NPPA

The NPPA's decision is backed by a thorough examination of multiple factors affecting the orthopaedic knee implants market.

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NPPA National Pharmaceutical Pricing Authority
Picture: Pixabay

Last Updated on January 4, 2024 by The Health Master

Knee Implants

In a recent development, the National Pharmaceutical Pricing Authority (NPPA) has provided clarity regarding orthopaedic knee implants, allowing manufacturers and importers to adjust the maximum retail price (MRP) by up to 10 percent from September 16, 2023.

This adjustment will be applicable for the preceding 12 months, extending until September 15, 2024. This decision comes in light of various stakeholders seeking clarification on pricing for these crucial medical devices.

Factors Influencing the Price of orthopaedic knee implants

The NPPA’s decision is backed by a thorough examination of multiple factors affecting the orthopaedic knee implants market.

These factors include fluctuations in foreign exchange rates, increases in manpower and freight costs, and shifts in the Wholesale Price Index (WPI).

It’s worth noting that the WPI showed a varying trend over the last four years, with percentages standing at 1.88468, 0.53638, 10.76607, and 12.1218 from April 1, 2020 to April 1, 2023 respectively.

Regulatory Framework and Scope of Application

The Union Ministry of Health and Family Welfare categorizes orthopaedic implants as ‘drugs’, and thus, they fall under the purview of the Drug Price Control Order (DPCO), 2013.

This implies that the regulations laid down in the DPCO, 2013, apply to all notified drugs, including orthopaedic implants.

Monitoring and Review Mechanism

The ceiling prices for orthopaedic knee implants will be meticulously monitored as per the provisions of paragraph 20(1) of DPCO, 2013.

This ensures that manufacturers adhere to the stipulated pricing guidelines. Furthermore, the NPPA has resolved to conduct a review after a period of one year, ensuring continued fair pricing in the market.

Background and Rationale

The NPPA’s decision stems from concerns over the exorbitant pricing of orthopaedic knee implants, which has led to financial strain for patients in need of arthroplasty procedures.

It has been observed that only a fraction of patients, approximately one lakh, can afford these procedures out of an estimated 1.5 to 2 crore patients requiring intervention.

Additionally, the World Health Organization predicts that osteoarthritis will become the fourth leading cause of disability by 2020.

India, unfortunately, is expected to have a substantial number of citizens affected. Addressing this issue is not only a personal concern but also a national imperative.

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.

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