A DAY after the National Pharmaceutical Pricing Authority (NPPA) introduced a price cap on knee implants, bringing down the rates of some products by as much as 65 per cent, doctors are concerned that international pharma companies may withdraw from Indian markets specialised products that involve expensive research and development.
The NPPA and the Maharashtra Food and Drug Administration (FDA) have started their respective helplines for patients to register complaints of over-priced knee implants billed on or after Thursday.
“We will monitor each complaint against hospitals and manufacturers,” an FDA official said. The NPPA has already requested hospitals to refund the extra amount charged on knee implants from Thursday.
In India, Zimmer, Johnson and Johnson (J&J), Biomet, Smith and Nephew, and Stryker are among the international companies that supply implants to private hospitals.
“The price regulation framework must consider different categories of implants. Like in any device, there are different technologies and qualities and we need to ensure patient choice. This has been a successful approach in other countries that India can adopt,” a spokesperson from J&J said, adding that implant cost accounts for 25-30 per cent of total procedure cost.
Pharma giants have claimed that the categorisation for price caps is very broad, making it difficult for companies as high-end products see a ceiling as regular ones.
According to Dr Pradeep Bhosale, the head of joint replacement in Nanavati Hospital, Persona implant (Zimmer) and Atune (J&J) are specialised implants used for premium surgeries.
“These surgeries constitute 10 per cent of total knee implants. But these patients may suffer if the company decides to withdraw its premium product,” Bhosale said, adding that for general knee implants, the price cap will encourage more surgeries.
“There is room for reduction in prices of implants and it is a good move. But there are different types of material used for implants, and research and quality differs in the products used for complex revision surgeries. It is unclear how prices will be for them,” said Dr Kaushal Malhan, orthopaedic surgeon at Fortis Hospital, Mulund.
A report by the NPPA, released earlier this month, found the ‘joint component of knee system’ was being sold to patients at a profit of 369 per cent. The landing cost stood at Rs 1.98 lakh per unit, while the maximum retail price was marked at Rs 9 lakh.
With the price cap, a general knee implant will cost a patient 65 per cent less — from Rs 1.58 lakh to Rs 54,720, while revision implants’ prices have been slashed by 58 to 81 per cent.
Doctors fear that knee implants may face a situation similar to stents after the price control was implemented, where manufacturers could no longer provide certain brands due to lower profits.
“There are different categories in femoral or tibial implants. But irrespective of specification, the prices are uniform,” a doctor from Hiranandani Hospital said.
The Medical Technology Association of India (MTaI), an umbrella association of all pharma medical device companies in the country, is reviewing the order and will soon submit its recommendations to the NPPA.
According to officials, MTaI has been in touch with the NPPA over the price cap issue. The association includes Stryker, Zimmer, Smith and Nephew and all other manufacturers for medical devices.