India’s drug pricing regulator has decided to allow knee implant companies to increase the maximum retail prices (MRP) of their products by not more than 10 per cent this year, the central government stated in a release on Tuesday.
The development comes around two years after the regulator first slashed MRPs of knee implants by up to 69 per cent, using extraordinary powers granted under the country’s drug pricing regulations.
Since then, the government claims that there has been “increased access” due to these medical devices becoming more affordable to patients.
Knee implants are devices used to replace parts of damaged knee joints in patients.
In a release on Tuesday, the Ministry of Chemicals and Fertilisers stated, “As per the data submitted by manufacturers and importers, an increase of 30 per cent in the sales of knee implants has been reported during the period of July 2018 to June 2019.”
Following a review of the move in August 2018, the National Pharmaceutical Pricing Authority (NPPA) — India’s drug pricing regulator — had decided to extend the capped ceiling price for another year.
The extension was granted despite knee implants being classified as a non-scheduled medical device, for which the Drugs (Prices Control) Order, 2013, permits an annual price increase of up to 10 per cent.
NPPA’s allowed price increase is less than what the industry had requested it during its latest review of knee implant prices this year.
“Though the industry has requested for a 20 per cent (10 per cent for the year 2018 and 10 per cent for the year 2019) increase in the price of knee implants, it was decided to further monitor the price increase of knee implants as per para 20 of the DPCO (Drug Price Control Order), 2013 that restricts price increase beyond 10 per cent in a given year,” stated the Ministry release.
It further said that the decision shall be subject to a review after one year.
In 2017, NPPA capped prices of widely used cobalt chromium total knee implants at Rs 54,720, bringing its average MRP down 65 per cent from Rs 1.58 lakh, according to previous data available with the Ministry.
Prices of total knee implants made from special metals, such as titanium and oxidized zirconium, were slashed 69 per cent to Rs 76,600.
Prices of revision implants, which are used in repeat implant procedures when the first implant has failed, were slashed 59 per cent to Rs 1.14 lakh.
NPPA did so even though the Health Ministry did not notify these products in the country’s National List of Essential Medicines (NLEM), even while the Department of Pharmaceuticals (DoP) did not notify them for price control.
According to the regulator, only one lakh out of 1.5-2 crore patients requiring arthroplasty interventions are in a position to pay for the procedure every year.
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