MEDICAL STENT

A stent is a small mesh tube that's used to treat narrow or weak arteries. Arteries are blood
vessels that carry blood away from your heart to other parts of your body.
A stent is placed in an artery as part of a procedure called percutaneous coronary intervention
(PCI), also known as coronary angioplasty. PCI restores blood flow through narrow or
blocked arteries. A stent helps support the inner wall of the artery in the months or years after
PCI. Doctors also may place stents in weak arteries to improve blood flow and help prevent
the arteries from bursting. Stents usually are made of metal mesh, but sometimes they're
made of fabric. Fabric stents, also called stent grafts, are used in larger arteries. Some stents
are coated with medicine that is slowly and continuously released into the artery. These stents
are called drug-eluting stents. The medicine helps prevent the artery from becoming blocked
again.1
India has moved a step closer to capping prices of cardiac stents with the National Health
Systems Resource Centre backing high price control measures in a report to national drug
price watchdog. 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. The last parameters to fix prices of
stents will be based on the findings of the NHSRC report and the price lists submitted by
manufacturers. Going to the report, prices of bare metal stents could be capped at Rs 19,000
and the maximum price for drug-eluting stents may be fixed at Rs 28,000. At present, bare
metal stents cost between Rs 12,000 and Rs 20,000 in the domestic market while drug-eluting
stents cost anywhere between Rs 23,000 and Rs 1,20,000, depending on the product
specifications.2
As compared to the US market, that range is seen as equal to or slightly higher, given that the
US has an insurance and reimbursement-based healthcare system and patients do not pay the
1 What Is a Stent? - NHLBI, NIH - U.S. National Heart, Lung ..,
http://www.nhlbi.nih.gov/health/health-topics/topics/stents/ (accessed February
10, 2016).
2 Capping cardiac stent prices gets NHSRC backing ..,
http://articles.economictimes.indiatimes.com/2015-0812/news/65490470_1_bare-met (accessed February 10, 2016).
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entire expense. Industry estimates suggest stent prices in China, Singapore and Malaysia are
roughly one and half times higher as compared to India
The National health system Resource Centre (NHSRC) study, however, said the absence of
stent price regulation in the country has led to a gross exploitation of consumers due to
extreme overpricing of stents, mainly imported brands. Over the last two years, several social
organizations and political parties have raised the issue, alleging that there is an enormous
gap between the imported price of stents and the price charged to patients. They have argued
that market prices of these life-saving devices in the country are as much as ten times their
factory costs. The NHSRC report has assessed the clinical effectiveness of drug-eluting stents
and bare-metal stents across three broad outcomes mortality, revascularization, and major
adverse cardiac events which will be used to determine a reasonable, or affordable, price
for stents.
The expert group's findings to understand the cost-effectiveness of the two types of stents
were further analyzed using the Quality Adjusted Life years (QALYs) and DisabilityAdjusted Life Years (DALYs) approaches and another formula used by the World Health
Organization (WHO) for delivery of cost-effective medical products. The report by NHSRC
has faced multiple criticisms. The sector, much like the pharmaceutical industry, is deeply
split between domestic and multinational companies. Global stent makers argue that the
regulators should give due weight to the quality aspects of imported brands and the overall
hospitalization costs before imposing any price control.3
The drug pricing authority, however, seems to share the domestic industry's view as it in one
reference blamed "steep information asymmetry and aggressive promotional expenses of big
companies" for imports accounting for almost three-fourths of stents used in the country.
According to preliminary indications, although the government intends to take the
discussions forward with industry players, it may still lean its outlook for stents made by
domestic producers. 4
3 Capping cardiac stent prices gets NHSRC backing ..,
http://articles.economictimes.indiatimes.com/2015-0812/news/65490470_1_bare-met (accessed February 10, 2016)
4 http://articles.economictimes.indiatimes.com/2015-0812/news/65490470_1_bare-metal-stents-drug-eluting-stents-drug-eluting-stents
( last accesed on 10th February,2016,4:10 p.m.)
2

In the last five years, the coronary stent market in India has been growing at an impressive
rate due to rise in coronary angioplasties which have resulted from a surge in cardiovascular
diseases (CVDs). According to the National Interventional Council (NIC), coronary
interventions in India have increased from 117420 since the year 2010 to 248152 in the year
2014.
However, in the last few months, the success of the stent market in India has been constantly
under the scanner by various government agencies and the media. The industry is presently
battling against two broad accusations- over pricing and use. Express Healthcare chose to dig
deep and examine this situation.5
U.S STENT MARKET VS INDIA
If we take a look at the global scenario, the increasing numbers of PCIs has been questioned
worldwide by several research agencies. There are a constant misuse and overuse of stents. In
the year 2010, a stent scandal broke out after the arrest of Dr. Mark Midei, a star cardiologist
at St Joseph Medical Center in Townson, Maryland. The New York Times published a headturning tale about this well-acclaimed cardiac surgeon who was found to be taking illegal
kickbacks from a leading multinational stent making company that operates in India as well.
After this incident, leading cardiologists in the US confessed that some doctors were
overusing heart stents to make up for lost revenue due to health revenue cutbacks and also
because of kickbacks received from multinational stent makers.
The multinational stent maker who was involved in the scandal is still freely doing and
growing its business worldwide and enjoys a huge market share in Indias thriving stent
market.
The recently published NIC registry data suggested that only 0.02 percent of the coronary
artery disease (CAD) patients in India go through angioplasty whereas, in the US, 3.24 per
cent of the population undergoes angioplasty every year. Interestingly, NIC registry data also
reflected a trend contrary to the claims of overuse, with the rate of growth of angioplasties
going down from 22 percent in 2013 to 14 percent in 2014. The reduction of growth rate in

5 The Stent Saga The Financial Express,

http://www.financialexpress.com/article/healthcare/cardiac-care-special/the-sten
(accessed February 10, 2016).
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procedure points towards reducing treatment adoption of angioplasty. These data points may
not suggest an overuse.
OVERUSE OF STENTS IN INDIA: DECODING THE ISSUE
A well-read daily recently published a study by interventional cardiologists in the country
which revealed that 50 percent of patients who have been advised stents to remove heart
blockages do not require it! The study further states that every heart block does not need a
stent and can be managed with medical treatment. And again, every block does not require a
drug eluting stent or the latest technology of absorbable stents (costing between Rs 1.5 to Rs
2 lakhs).6
It has been observed that 40% patients are advised by their doctor for stent implants or bypass
procedure that does not require these surgeries. They can be cured only with proper
medication.
THE COST ISSUE
The other and the most talked about the issue in the use of stents in India is the problem of
high costs associated with these procedures. If we compare the Indian value with the rest of
the world, we are far more affordable. Our healthcare costs are lower compared to that of our
neighboring countries, Europe, and the US. Dr. Chandra informs that nearly 30- 35 percent of
patients from the US, Europe, Africa and some Asian neighbors seek cardiac treatment in
India. Dr. Panda also reveals that Indias healthcare costs are cheaper than those of even
Pakistan and Bangladesh. However, coming back to the expenses of stents in the US, in 2010
the price of a stent was less than $1000, but the cost of the procedure for implant would range
anywhere from $30,000 to more than $100,000. Today, the cost would vary only by a small
margin. However, in India, there is an assumption that the cost of stent implants is high due to
the high cost of the device and also because cardiologists still choose imported stents over
local ones.7
6 The Stent Saga The Financial Express,
http://www.financialexpress.com/article/healthcare/cardiac-care-special/the-sten
(accessed February 10, 2016).
7 The Stent Saga The Financial Express,
http://www.financialexpress.com/article/healthcare/cardiac-care-special/the-sten
(accessed February 10, 2016).
4

To understand the real cost difference between imported stents and local ones. We further
spoke to some cardiologists and some distributors of stent both domestic and imported stents
after which we derived from the average prices of stents sold in India.
But before this, it is important to note that, the Union health ministry has fixed Rs 23,625 as
the price of a DES under various government schemes. One of the principal reasons why
Indian stents are not preferred is that Indian stents are not clinically proven to the extent that
it can recommend it to patients. Imported stents become an obvious choice because these
FDA-approved stents have gone through several clinical trials. For any stent to get an FDA
approval, manufacturers will not only have to conduct many clinical trials, but they also will
have to conduct two to three compound studies on the device before undergoing certification.
8

So, since these stents have gone through so many trials and are acclaimed world over, these

stents are preferred. 9

In India regulations regarding medical device is by essential drugs standard control
organization. Under these guidelines for import registration and manufacture of medical
devices are briefly described which apparently deals about stents.10
In the US, the Food and Drug Administration (FDA) administers everything concerning the
regulatory process. In Europe, the position is somewhat different. There are two levels. First,
there is a competent authority, established by each member country. This is responsible for
implementing, monitoring and enforcing the law. Second, there are notified bodies nominated
by the competent authority, which are responsible for verifying conformance to the law.
Compliance is described as gaining CE compliance.
In China, China Food and Drug Administration (CFDA) looks after the regulation of cardiac
stents which looks after the price, quality, etc. related to the medical device. CFDA is the
authority which looks after both foreign and domestic product registration. Earlier it uses to
8 The Stent Saga The Financial Express,
http://www.financialexpress.com/article/healthcare/cardiac-care-special/the-sten
(accessed February 10, 2016).
9 http://www.financialexpress.com/article/healthcare/cardiac-care-special/thestent-saga/133121 ( last accesed on 10th February,2016,3:50 p.m.)
10 http://www.cdsco.nic.in/forms/list.aspx?lid=1696&Id=1 ( last accesed on 10th
February,2016,4:05 p.m.)
5

share its responsibility with Administration of Quality Supervision, Inspection, and quartine
(AQSIQ) but now CFDA is the sole regulatory body.
CE compliance is at this moment limited to the European countries, but it will soon be
extended to those countries that have been granted accession. These are the Czech Republic,
Cyprus, Estonia, Hungary, Poland, and Slovenia. CE compliance is not recognized in
countries outside this geographical area, although it is regarded as a de facto standard in most
countries bordering it.11
The Indian Council for Medical Research (ICMR) has a set of guidelines for the
investigational use of medical devices. Devices manufactured abroad that are not approved in
the country of manufacture may not be used in India. Further, clinical trials of remote devices
may not be conducted in India alone; in particular circumstances, they may be a part of a
multi-Centre clinical trial.
All the research ethics principles relevant to drug tests apply for trials of medical devices.
Clinical trials being conducted for approval of a new drug or device must follow all the
applicable regulations: they must obtain regulatory clearance, the trial protocol must undergo
ethics review, patients' consent should be taken, they must be informed of the experimental
nature of the device, the drug or device should be offered free of cost, and so on. Safety
procedures to introduce a medical device in the patient should also be followed as the
procedure itself may cause harm to the patient. As for drugs, safety evaluation and pre-market
efficacy of methods with data on adverse reactions should be obtained before certification.12
The current status of such regulation in India cannot give much confidence to patients. This
should be changing. The chief executive of the Society of Biomedical Technology, set up
under the Defense Research Development Organization, has drafted a proposal for setting up
a regulatory authority, tentatively named the Indian Medical Devices Regulator Authority.
This regulator must be given teeth to be effective. Penalties for violators should be
documented and ensured. This would be a deterrent to unscrupulous elements amongst the
11 http://www.cxvascular.com/cn-archives/other-stories-cn4/will-regulatory-andreimbursement-issues-slow-down-the-adoption-of-drug-elutingstents#sthash.DwvTvICA.dpuf ( last accesed on 10th February,2016,4:20 p.m.)
12 The controversy of drug-eluting cardiac stents | Magotra ..,
http://www.issuesinmedicalethics.org/index.php/ijme/article/view/639/1597
(accessed February 10, 2016).
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industry and the profession and do away the need for setting up various inquiry committees
every time such a case comes up.13
Cardiac care is controlled globally by a group of multinationals. The pressure of capitalintensive market forces can threaten clinical decisions and the correct delivery of health care.
The nexus between the industry and doctors always existed; it has only become more intense.
Doctors need to reclaim their earlier role of being initiators of good practice, changing from
their current status as clinical validators of industry handouts. The latest or the most
expensive is not always the best.14

13 http://www.issuesinmedicalethics.org/index.php/ijme/article/view/639/1597 ( last
accesed on 10th February,2016,4:10 p.m.)

14 Ghosh Probal, Magotra Ratna: Adequate cardiac care? Conundrum for nonaffluent countries. The Cardiothoracic Surgery Network [cited 2005 Dec 20].
Available from: http://www.ctsnet.org/doc/9227 ( last accesed on 10 th
February,2016,3:50 p.m.)
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