India Sets Price Limits for Coronary Stents (other devices to follow)

India’s National Pharmaceutical Pricing Authority (NPPA) moved swiftly and sharply to set the Maximum Retail Price (MRP) for coronary stents at INR7,260 (US$105) for bare metal stents and INR29,600 (US$440) for drug eluting stents and bioresorbable vascular scaffolds. These are ceiling prices (exclusive of local taxes and VAT but no other charges) at which all hospitals can charge patients. The announcement was published on February 13, 2017, with immediate effect.

The market is expected to go through significant rationalization in reaction to the deeper than expected cuts with some high-cost providers reducing their participation in the market. Low cost suppliers and those with high sales channel efficiency will be greatly advantaged in this new market environment.

Effected are 11 domestic companies with manufacturing licenses listing coronary stents. Additionally, there are 22 foreign manufacturers (12 EU, 3 US, 3 Chinese, 2 Middle Eastern, 1 Singaporean and 1 Japanese) with 35 Product Registration Certificates that include coronary stent Device Master Files.

The NPPA will monitor the situation closely and may make adjustments to assure supply. Reversals of price controls are not uncommon. Since the release of the National List of Essential Medicines in 2015, 70 medicines have been removed from the ambit of price control.

While coronary stents are the first high-risk medical devices to be regulated by the NPPA, others will follow with next likely candidates being orthopedic implants, cardiac pacemakers, and intraocular lenses. The process involves the Ministry of Health and Family Welfare adding a device to the National List of Essential Medicines (NLEM). Next, the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals incorporates it onto the Drug Prices Control Order. Finally, a meeting is convened by the NPPA at which point the exact pricing structure is established. This process took less than 7 months for coronary stents.

Asia Actual is available to help companies understand and stay compliant with the NPPA’s statutory reporting requirements.