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Maha FDA finds no ceiling price violation of stents in city hospitals based on verification reports
Shardul Nautiyal, Mumbai | Friday, March 24, 2017, 08:00 Hrs  [IST]

Maharashtra Food and Drug Administration (FDA) in its verification reports have ascertained that no hospital in Mumbai, Pune and Nashik were found violating the ceiling prices for cardiac stents as stipulated by the drug pricing regulator National Pharmaceutical Pricing Authority (NPPA).

The state regulator had stepped up its vigilance as a part of its larger plan to detect overpricing of stents in government and private hospitals subsequent to NPPA receiving complaints about stents being sold at higher prices at KEM Hospital, Lilavati Hospital and a few hospitals in Pune and Nashik.

One such hospital from Nashik which was detected recently for overcharging patients on coronory stents at the point of care was also given a clean chit by the state FDA as the stent was deployed in the patient on 11 February, 2017 and billed on 12 February, 2017.

“The price capping exercise by NPPA became effective from 14 February 2017,” says an FDA official associated with the development.

On February 14, NPPA announced cut in prices of coronary stents by up to 85% by capping them at Rs.7,260 for bare metal ones and Rs.29,600 for drug eluting variety. The step was taken to fix a standardised specification of stent and its MRP to stop fleecing and cheating of patients. NPPA had written to all its chief secretaries and state drug controllers to ensure compliance of stents price capping, its availability and uninterrupted cardiac care services.

Two complaints of overcharging had been received against the KEM hospital. The first complaint was received on February 26, followed by another complaint on March 1, 2017. The other hospitals include Lilavati Hospital, Bandra, the complaint of which was received on February 23, 2017 and Bhaktivedanta Hospital, Mira Road, Thane, the complaint of which was received on March 4, 2017.

Two other hospitals in Maharashtra include Pune Hospital and Research Centre, Pune, the complaint of which was received on March 4, 2017 and Six Sigma Medicare and Research Ltd, Nashik, the complaint of which was received on February 25, 2017.

The number of cardiac interventions in the country has grown more than five-fold during the past 10 years and affects around 32 million people with a mortality of around 1.6 million per annum. A cardiac stent is specifically used for the treatment of coronary artery closure. Nearly 2% of CAD patients are treated with angioplasty.

As and when the 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, then the government will take a move to recover the amount hospitals have overcharged on stent, said officials.

NPPA has directed 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.

Non-compliance of these instructions shall be treated as deliberated distortion of evidence along with charges of overpricing. Such cases may also be taken up for prosecution under Essential Commodities (EC) Act.

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