To effectively check ceiling price violation of coronary stents at the point of care following issuance of NPPA guidelines, the Maharashtra Food and Drug Administration (FDA) Commissioner Dr Pallavi Darade has instructed Joint Commissioners of all seven divisions in the state to keep a vigil on hospitals conducting angioplasty procedures.

On February 14, 2017, drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) had fixed the prices of coronary stents at Rs.7,260 for bare metal ones and Rs.29,600 for drug eluting variety excluding local taxes through a gazette notification. The step was taken to rationalise prices of stent and its MRP to prevent patients from being overcharged. Further to this, NPPA again revised rates for the coronary stents which are effective from February 13, 2018 for one year with trade margin capped at 8 per cent making it more affordable. Under the new price regime, the Drug Eluting Stent (DES) has been priced at Rs.27,890 ex GST and the traditional Bare Metal Stent (BMS) at Rs.7,660 ex GST.

Maharashtra FDA had earlier issued National Pharmaceutical Pricing Authority guidelines to hospitals to prevent overcharging of coronary stents at the point of care. NPPA had directed Maharashtra FDA to clearly spell out the guidelines to ensure better oversight, transparency in compliance and proper billing of the angioplasty procedure at the point of care.

NPPA guidelines stipulate that price of the coronary stent has to be separately specified in the hospital bill among other major things like type of stent, brand name of stent, name of the manufacturer or importer, batch number, expiry date so that patients are not fleeced.

Further, the hospital should display price list of the coronary stent in a conspicuous manner in its premises so that notified price is duly implemented and also the hospital’s website should clearly display the price list so that benefit of low cost stent is passed on to the customer.

Following the notification on February 14, 2017, NPPA however received a number of complaints about stents being sold at higher prices by different hospitals across India. Subsequent to this, Maharashtra FDA detected cases of overcharging in hospitals from Nashik, Pune and Mumbai.

Prior to this, complaints were received against Bharat Heart Institute (Dehradun), Uttarakhand, Oxygen Hospital (Rohtak), Haryana, Max Hospital Saket, New Delhi, Nidaan Multispecialty Hospital (Sonepat), Haryana and Lilavati Hospital, Mumbai. New Delhi’s Max Hospital and Nidaan Multispecialty Hospital from Haryana.

As and when the drug pricing regulator receives complaint, with the help of hospitals’ bills and other documents, it examines the complaint. After preliminary investigations, NPPA sends show-cause notices to concerned hospitals. If the responses are not satisfactory and allegations are confirmed, the government takes a move to recover the amount hospitals have overcharged on stent.