As part of its larger plan to enhance vigilance in hospitals across the state, Maharashtra Food and Drug Administration (FDA) is planning to conduct surprise inspections to check violation of ceiling prices of coronary stents at the point of care.

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 through a gazette notification. The step was taken to rationalise prices of stent and its MRP to prevent patients from being overcharged.

“Maharashtra FDA will do surprise inspections to check the compliance levels at the point of care following issuance of NPPA guidelines on the same,” said Maharashtra FDA Commissioner Dr Pallavi Darade.

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. On February 26, 2017, the official Twitter handle of NPPA tweeted that a complaint was received against Anand Hospital (Meerut), Uttar Pradesh and Mumbai’s KEM Hospital.

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.

NPPA recently issued guidelines to all the state drug controllers and stipulated that hospitals/nursing homes/clinics utilizing coronary stents shall specifically and separately mention the cost of the coronary stent along with its brand name, name of the manufacturer/importer/batch number and other details, if any, in their billing to the patients or their representatives.

It has been observed from the bill copies received along with the complaints received from the complainants/patients that hospitals are not complying with instructions specified in the order.