The Indian government is waging a two-pronged attack on pricey implants, with the National Pharmaceutical Pricing Authority investigating reports of excessively high prices on orthopedic implants while a regional regulator office asks NPPA to look at cardiac stent pricing.

Indian law limits price increases on most medical products to no more than 10 percent of the suggested retail price in any given year. To determine if orthopedics makers violated the policy, NPPA requested detailed information on each product made, imported or marketed—including production and distribution costs, the maximum retail price and the percentage by which the maximum retail price has increased each year since 2013.

Companies charging excessive prices will be required to reimburse the government for the overcharged amount, plus interest, going back to the date of the price increase.

Meanwhile, the Maharashtra FDA is asking NPPA to cap prices on cardiac stents after a probe found markups as high as 700 times the actual cost of the implant.

According to Commissioner Harshadeep Kamble, stent prices are inflated when they are imported into the country and local distributors then sell them to hospitals at a profit margin of up to 125 percent.

Kamble’s charges were based on an investigation of six distributors and seven hospitals in and around Mumbai, Pune and Nasik.

View the notice on pricing of orthopedic implants at www.fdanews.com/05-25-15-pricing.pdf. — Elizabeth Orr