Much more severe than the sting of a scorpion or a wasp, they sting the heart of every economically less fortunate patient who needs a coronary angioplasty in India. They are cardiac stents laden with malpractices in medical devices industry. Dominated by multinational firms with over 80 percent market share, they come tagged with exorbitant prices.
An ongoing scam of huge proportion recently popped up and which propelled Delhi High Court to order the Department of Pharmaceuticals (DoP) and associated parties to fix and label the maximum retail price (MRP) of every cardiac stent used for angioplasty is a pointer to the cold-hearted crime done by the business world on warm hearts of human beings. Now that December 22, the date for fixing prices given by the two-judge Bench of Justices Sangeeta Dhingra and G. Rohini, has elapsed, we ought to take a close look at this heartless stent industry in India.
In an ever evolving healthcare landscape across the world, India with no exception, the use of cardiac stents in angioplasty is commonplace. A stent is a metal mesh device inserted into arteries to strengthen weak blood vessels blocking the blood-flow. The length of a stent could be from 8 mm to 38 mm. There are three types of stents namely bare metal stents, drug eluting stents and bio-engineered stents, all varying in quality and cost. However, the drug eluting stents are the most commonly used ones in India as they are coated with medication that is released (eluted) to help prevent the growth of scar tissues in the artery lining.
The insertion of a stent in the weak artery is usually one of the procedures done in a PCI or percutaneous coronary intervention known as angioplasty. An angioplasty is a process used to widen narrow or blocked cardiac arteries done when an artery collapses leading to the reduction in the amount of blood being pumped by the heart to the rest of the body. The procedure is done through a catheter inserted in the artery through which a stent is placed to balloon the collapsed artery.
The cost of angioplasty is around Rs.200,000-250,000 on average in a private hospital, depending on the complexity of the case, number of stents and types used. A bare metal stent on average costs about Rs.10,000- Rs.20,000, while a drug eluting stent (DES) ranges between Rs.55,000 and Rs.80,000. In India patients reportedly spend per annum about Rs 2,500 crore on cardiac stents alone the bulk of it being paid from their own pockets. This is exclusive of the cost of blood tests, angiography procedures, charges for hospital stay and doctors’ fees. An estimated four lakh stents were implanted in India in 2014. Of this, over 85% were drug eluting stents (DES). Annually, the stent market is estimated to grow by 15 percent with the growing incidence of cardiovascular diseases.
Despite the rampant malpractices within the cardiac stent industry in India there has been no system in place to regularize the prices of medical procedures of stents. There exists strong lobby of doctors who are against price regulation in stent industry that thwarts reforms in the field.
Consumer activists across India allege that doctors and hospitals make a killing through indiscriminate use of stents for which they gain a cut either through a big mark-up in the price or as bribe. As per the Cardiology Society of India in 2015 as many as 4,20,000 angioplasties were performed. India’s stent industry reels in a relay of scam where the cost of importing stents falls between Rs. 10,000 and 15,000 per stent. The importer sells it to the distributor at a profit of 100-200 per cent. The distributor provides them to hospitals where they are sold at a further profit of 120 per cent. Hospitals buy each stent at Rs. 20,000-25,000.
Distributors approach hospitals on behalf of companies and importers. Doctors who perform angioplasties in general earn a cut for every stent deployed. Bribes both in cash and kind too fall in line. These stents then are supplied to patients at prices ranging from Rs 50,000 to 2 lakh with a mark-up of 300-700 per cent.
Worst still is the practice of some surgeons scaring patients into an expensive procedure. At least 15 per cent of stents implanted reportedly are not needed. With more than one lakh stents used in 2014-15, according to the data released by the Cardiology Society of India, experts say it is necessary to decide if a patient requires a stent or by-pass surgery. As per a senior cardiologist in Gandhi Hospital, “Twenty per cent of our patients have been advised stent implants or bypass procedures though they require only medication.”
( May 4, 2016, http://www.deccanchronicle.com)
Cardiac stents manufactured mostly by multinational companies are supplied directly to hospitals often sans an MRP that makes it easy for hospitals and doctors to make a huge profit. In the absence of standardized regulations, misuse or overuse of stents goes un-noticed by the patients. With 80 per cent of the market for stents is shared by multinational companies such as Abbott, Medtronics, Meril Lifesciences and Boston Scientific, India’s coronary stents market was reportedly valued at $481 million in 2015, and was expected to reach $531 million by 2016-end.
Dealers for several multinational companies are known to offer hefty amounts as incentives to doctors and hospitals for every stent used. The margin between the import price and the final price paid by patients is huge enough to accommodate the cost of these large 'incentives'.
The Union Health Ministry on July 19 had included stents in the National List of Essential Medicines (NLEM) after the Delhi High Court demanded action on a public interest petition filed by advocate Birender Sangwan, a consumer activist who sought price control on stents. The petitioner alleged that the government and the National Pharmaceutical Pricing Authority (NPPA) are being “insensitive and irresponsible” towards the people by not taking any step to fix the price of the medical device which is allegedly being sold at high price in the country.
According to Mr Sangwan, ‘w ithout an MRP, patients are charged anywhere between 300-700 percent of the price at which the hospital would have bought it. It had also claimed that people in all age groups in the country suffer from heart ailments, requiring use of stents and not all of them can afford this treatment. However, the government based its decision on a sub-committee report that recommended putting all types of stents including the latest biodegradable stents onto the list. This was found wanting by Confederation of Indian Industry (CII) Medical Technology Division.
On December 22, the Delhi High Court asked the Centre to fix the maximum retail and ceiling price of coronary stents by March 1, 2017. The order, passed by a division bench of Chief Justice G Rohini and Justice Sangita Dhingra Sehgal, came a day after coronary stent was notified by the department of pharmaceuticals (DoP) as a Schedule-I drug under the Drug Price Control Order (DPCO) 2013, making it eligible for price control. This means that the National Pharmaceutical Pricing Authority (NPPA) can now start the process of fixing ceiling prices for a variety of stents. (http://www.hindustantimes.com, December 23, 2016).
Since stents used in India are mostly sold by multinational corporations at a huge price, the order of the court is expected to bring relief to poor patients burdened by the soaring cost of stents. India urgently needs an effective legislation for medical devices in place a la other countries like Sri Lanka. In the largest democracy of the world there should be a national body similar to the National Institute for Health and Care Excellence (NIHCE) of Britain to evolve and issue guidelines on optimal use of high-tech devices in diagnosis and treatment. Ultimately governments and courts apart, it’s the small inner voice of individual conscience that should stem the rot. Ethics and morality should guide every action of a medical care giver. For that to happen, ethical practice should be made compulsory all through the training period of a medical student. Medical professors should be role models whose research and teaching should be based on ethical parameters.(Published on 02nd January 2017, Volume XXIX, Issue 1)#