In a significant move under the Indian medical device regulation framework, the Ministry of Chemicals and Fertilizers, through its Department of Pharmaceuticals, has revised the ceiling prices of coronary stents. This directive, which impacts all stakeholders involved in medical device import in India and domestic manufacturing, will come into effect from April 1, 2025. The revision aligns with the Wholesale Price Index (WPI) of 1.74028% for the year 2024 over 2023, as mandated by the Drugs (Prices Control) Order (DPCO), 2013.

The price control notification was issued under S.O. 1473(E) dated March 27, 2025, by the National Pharmaceutical Pricing Authority (NPPA), and follows a series of prior regulatory updates. This announcement is especially important for businesses engaged in the registration of medical devices and those seeking medical device approval in India, as it outlines cost compliance expectations going forward.

Revised Ceiling Prices for Coronary Stents (Effective 01.04.2025)

Regulatory Guidelines as per Indian Medical Device Regulation

(a) All existing manufacturers and companies involved in medical device import in India, having MRP lower than the revised ceiling price (plus applicable GST), may revise their pricing based on WPI @1.74028% in accordance with Para 16(2) read with Para 13(2) of the DPCO, 2013.

(b) Importers and manufacturers may add GST to the ceiling price only if it is actually paid or payable to the government, ensuring transparency in medical device pricing.

(c) As mandated under Para 24(4) of DPCO 2013, every retailer and dealer must prominently display updated price lists and supplementary pricing details in an accessible location at their premises. This step is crucial in supporting transparency during the registration of medical devices and subsequent sale.

(d) Non-compliance with these pricing guidelines will result in the recovery of overcharged amounts, along with interest, under the Drugs (Prices Control) Order, 2013, read with the Essential Commodities Act, 1955.

The order, issued by Rajesh Kumar T, Deputy Director, under file number PN/263/131/2025/F/F. No. 8(131)/2025/D.P./NPPA-Div.-II, reinforces the government’s intent to regulate high-cost interventions and maintain affordability under the broader framework of medical device approval in India.

This latest update is an important guide for everyone involved in registering medical devices, setting their prices, or handling rules and approvals under India’s medical device regulations.

Conclusion
The NPPA’s latest revision of coronary stent ceiling prices underscores the government’s ongoing efforts to strike a balance between patient affordability and the sustainability of the medical device industry. For stakeholders involved in the registration of medical devices, medical device import in India, and navigating Indian medical device regulations, this update serves as a critical compliance milestone. It further reinforces the role of transparent pricing and robust regulation in ensuring timely medical device approval in India and wider access to essential healthcare technologies.