

Bring pricing of coronary stents under NPPA
The Issue
Stents are small expandable tubes used to treat narrowed or weakened arteries in the body. Usually made of metal mesh, stents are implanted in narrowed coronary arteries during a procedure commonly known as angioplasty. Stenting is minimally invasive because it involves no major incisions. Performed with local anesthesia and having a shorter recovery time than coronary artery bypass surgery, it offers an attractive option in treating heart disease and has gained increasing acceptance in India. It is reported that approximately 2.5 lakh angioplasties were carried out in India in 2014 and 3.1 lakh stents were used in these operations.
There are basically three types of coronary stents used in India, these comprise Drug Eluting Stent (DES), Bare Metal Stent (BMS) and Bio-Absorbable Stent (BVS) Medical devices such as stents are notified as drugs under the Drugs and Cosmetics Act, 1940 but not included under the Drug Price Control Order (DPCO). Hence, their prices are neither monitored nor controlled. Most patients are forced to pay anything between Rs 60,000 and Rs 1 lakh or more for cardiac drug eluting stents (DES) though the same stents cost Rs 28,000-Rs 48,000 even in rich European countries and the UK, where there is price control or a fair pricing mechanism for medical devices
The Food and Drug Administration (FDA) of Maharashtra had done a detailed investigation into the overcharging of various medical devices including stents and had submitted the report to the National Pharmaceutical Pricing Authority (NPPA) over a year back, recommending that medical devices including drug eluting stents be brought under price control. The Maharashtra FDA report cites the example of drug eluting stents manufactured by a Holland-based firm. These stents were imported into India at Rs 40,710 and sold to the distributor at Rs 73,440 against a marked MRP of Rs 1.5 lakh. The distributor then sold it at Rs 1.1 lakh to the hospital, which in turn charged the patient Rs 1.2 lakh, a near three-fold jump over the import price. A recent report regarding the pricing of stents in Ranchi reveals that the MRP of various stents in the market vary from 2.5 times to 8 times the purchase price.
It is obvious from the above that the multinational companies that dominate the market import the devices and mark MRP at whatever level they think the market can bear in the absence of any regulation and the hapless patient gets fleeced.
In a positive development, the National Health Systems Resource Centre (NHSRC), a technical support institution under the ministry of health and family welfare, has submitted its final report to the National Pharmaceutical Pricing Authority (NPPA), which will study it and make final recommendations to the department of pharmaceuticals. In this report NHSRC has backed strong price control measures in relation to stents.
The Honourable Minister is requested to instruct Chairman, NPPA to take urgent action in this matter and bring the prices of stents under price control at the earliest.

Petition Closed
The Issue
Stents are small expandable tubes used to treat narrowed or weakened arteries in the body. Usually made of metal mesh, stents are implanted in narrowed coronary arteries during a procedure commonly known as angioplasty. Stenting is minimally invasive because it involves no major incisions. Performed with local anesthesia and having a shorter recovery time than coronary artery bypass surgery, it offers an attractive option in treating heart disease and has gained increasing acceptance in India. It is reported that approximately 2.5 lakh angioplasties were carried out in India in 2014 and 3.1 lakh stents were used in these operations.
There are basically three types of coronary stents used in India, these comprise Drug Eluting Stent (DES), Bare Metal Stent (BMS) and Bio-Absorbable Stent (BVS) Medical devices such as stents are notified as drugs under the Drugs and Cosmetics Act, 1940 but not included under the Drug Price Control Order (DPCO). Hence, their prices are neither monitored nor controlled. Most patients are forced to pay anything between Rs 60,000 and Rs 1 lakh or more for cardiac drug eluting stents (DES) though the same stents cost Rs 28,000-Rs 48,000 even in rich European countries and the UK, where there is price control or a fair pricing mechanism for medical devices
The Food and Drug Administration (FDA) of Maharashtra had done a detailed investigation into the overcharging of various medical devices including stents and had submitted the report to the National Pharmaceutical Pricing Authority (NPPA) over a year back, recommending that medical devices including drug eluting stents be brought under price control. The Maharashtra FDA report cites the example of drug eluting stents manufactured by a Holland-based firm. These stents were imported into India at Rs 40,710 and sold to the distributor at Rs 73,440 against a marked MRP of Rs 1.5 lakh. The distributor then sold it at Rs 1.1 lakh to the hospital, which in turn charged the patient Rs 1.2 lakh, a near three-fold jump over the import price. A recent report regarding the pricing of stents in Ranchi reveals that the MRP of various stents in the market vary from 2.5 times to 8 times the purchase price.
It is obvious from the above that the multinational companies that dominate the market import the devices and mark MRP at whatever level they think the market can bear in the absence of any regulation and the hapless patient gets fleeced.
In a positive development, the National Health Systems Resource Centre (NHSRC), a technical support institution under the ministry of health and family welfare, has submitted its final report to the National Pharmaceutical Pricing Authority (NPPA), which will study it and make final recommendations to the department of pharmaceuticals. In this report NHSRC has backed strong price control measures in relation to stents.
The Honourable Minister is requested to instruct Chairman, NPPA to take urgent action in this matter and bring the prices of stents under price control at the earliest.

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Petition created on 6 September 2015