The National Pharmaceutical Pricing Authority (NPPA), the Central government agency that regulates prices of drugs and other essential medical products, including devices used for implants in the body, has recently fixed prices of orthopaedic knee implants, slashing them by almost 70 per cent from the current market price. This is the second such market intervention in the medical devices space by the government this year, after a similar move on cardiac stents in February.
Predictably, the move was welcomed by local manufacturers and opposed by overseas device makers, who have been selling products imported from parent facilities in the domestic market. Medical devices, especially implant material, have historically been imported, in the absence of technology and manufacturing capability within the country.
Local products, including heart stents and knee caps have been available in the country of late, but these products are not time-tested yet for ultimate quality and safety assurance, as these companies are comparatively new in the market. Moreover, quality assurance systems for medical devices in the country are still not as competent as quality regulators in the developed markets.
While the government’s intention to make essential medical devices affordable and prevent profiteering by manufacturers or importers is laudable, the sudden move to slash the prices may affect the availability of quality products in the market. It is important to analyse the cost structure of products developed through genuine research, under strict quality compliance and those developed without an authentic technology base and loose regulation.
A price cut would have made more sense had it come after a thorough examination of the technical and economic aspects of the industry and on the basis of the opinion of the industry and users (experienced surgeons) on the actual cost and the quality respectively. But, any decision without complying with these standard practices may limit the intention to a mere populist measure.
It is critical to understand the ground-level situation in India. The implant surgeries are not always costly because of the price of the device, but because of the still unregulated procedural costs charged by hospitals. So, it is not necessary that patients benefit from the price ceiling, as hospitals and doctors can still charge exorbitantly high fees and other charges.
So, the question that comes to mind is why the government hesitates to regulate the unscrupulous fee structure in hospitals, which could make healthcare more affordable for all?