By
Prabha Raghavan
,
Divya Rajagopal
NEW DELHI | MUMBAI: After coronary stents, the National Pharmaceutical Pricing Authority (NPPA) has wielded its powers of price control on knee implants — devices used to replace parts of the knee joints that are damaged. The difference this time is that the regulator has exercised its own emergency powers to do so, instead of waiting for the government to bring the devices under the National List of Essential Medicines as it did on stents.
The drug pricing watchdog slashed the prices of total knee replacement systems and their individual components by as much as 69%, an NPPA notification issued on Wednesday evening showed.
This decision is expected to lead to a saving of Rs 1,500 crore per year for the people of India, union minister for chemicals and fertilizers Ananth Kumar said. According to him, 1-1.5 lakh orthopaedic knee procedures are done in India annually.
Industry bodies representing manufacturers said they were reviewing the order and would take their suggestions to the regulator for its effective implementation.
The price of total knee implants made of cobalt chromium has now been capped at Rs 54,720, down 65% from its average maximum retail price of Rs 1.58 lakh, data from the Ministry of Chemicals and Fertilizers showed. These are the most widely used complete knee implants, it said.
Total knee implants made of special metals like titanium and oxidized zirconium can be priced at a maximum of Rs 76,600, or 69% lower than the original average MRP. High-flexibility implants have also seen a similar reduction in the maximum price to Rs 56,490. Revision implants, used in repeat procedures when the initial knee implant has failed, is capped 59% lower at Rs 1.14 lakh, down from an average of Rs 2.77 lakh.
Special knee implants for cancer or tumours will follow the prices of revision knee implants, NPPA said.
These prices are exclusive of goods and services tax, but take trade margins for manufacturers or importers, distributors and hospitals into account, NPPA said.
The regulator's latest order specifically highlights the ceiling prices of each component used in a knee replacement procedure, such as femoral, tibial, insert and patellas. In most cases, the ceiling prices of these components have been set according to the materials used, but in the case of certain components, these have been fixed regardless of the materials used.
NPPA's order comes around six months after it slashed the prices of coronary stents by up to 85%.
Unlike stents, the government did not put knee implants on the essential medicines list. Usually, the Department of Pharmaceuticals notifies products for price control and NPPA caps the prices after the health ministry puts it on this list.
Out of 1.5-2 crore patients who require arthroplasty interventions, only around a lakh are in a position to pay for the procedure every year, NPPA stated. Citing a World Health Organization bulletin from 2003, it said osteoarthritis could become the fourth leading cause of disability by 2020. India is likely to be one of the leading countries of such immobilized citizens in terms of numbers.
"As the public is aware, prices remain too high for devices across the board. We would like this to be the start for NPPA to systematically fix prices of all other devices on which data was collected in public interest," said Malini Aisola of patient group All India Drug Action Network (AIDAN). "The price reductions still need study and it will not be successful without a check on the hospital rates," she added.
According to some knee implant manufacturers, the order has left a lot of issues unresolved without which the price cuts might not be possible. One of the companies that ET spoke to said a knee implant device has a number of components, and without fixing the prices of those components, it would be difficult to gauge the price cut.
The Association of Indian Medical Devices Industry (AiMeD) is expected to meet the drug regulator asking for time in implementing these price cuts. The Medical Technology Association of India, another body that represents knee implant makers like Johnson & Johnson, Stryker, Zimmer Biomet and Smith & Nephew, said it is currently reviewing the order and will respond with suggestions to NPPA to ensure practicality of its decision.
"Prices are reasonable and we are with the government. We believe this price cap will help every person of the country who needs implants," stated Rajiv Nath, Forum Coordinator, AiMeD.
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