Context: Recently, the National Pharmaceutical Pricing Authority slashed prices of stents by up to 85 per cent. Introduction:

  • The National Pharmaceutical Pricing Authority is controlling stent device prices.
  • The Indian Government recently announced a significant price capping on the cardiac stents available in the market.
  • Even before the price control move was initiated, only 40 per cent of the stents used in the country were indigenously manufactured; the rest were imported. With prices of imported stents and Indian stents now being the same, doctors and patients could prefer the imported devices.
  • India imports the stents manufactured by top MNCs, which raises the price because of high import duties.

What is a 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.
  • 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.
  • These metal tubes have revolutionized modern cardiology.

Uses of Stents:

  • Stents are small, expandable tubes that treat narrowed arteries in patient body.
  • In people with coronary heart disease caused by the buildup of plaque, they can:
  1. Open narrowed arteries
  2. Reduce symptoms like chest pain
  3. Help treat a heart attack. These types are called heart stents,
  4. but they’re also referred to as cardiac stents or coronary stents.

  • These are usually made of metal mesh; they’re put into arteries in a procedure called a percutaneous coronary intervention or, its more common name,
  • angioplasty.

  • Doctors also may place stents in weak arteries to improve blood flow and help prevent the arteries from bursting.
  • 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.

Advantages of stent:

  • The devices save thousands of live every year.
  • Emergency angioplasty is the treatment of choice during an acute heart attack, wherein the clot is crushed with a balloon and a stent is placed.
  • It improves the chance of the patient surviving by almost 30 per cent when compared to clot dissolving medication (thrombolysis).

Issue of pricing:

  1. Positive implications of price capping:
  • The thousands of patients who couldn’t afford stents can now afford the devices at a fraction of the cost.
  • Bringing the devices under price control will enable more patients to make use of this life-saving procedure.
  • This comes as huge relief for many patients who have to undergo coronary angioplasty.
  1. Negative implications of price capping:

Capping the prices of stents has had unexpected outcomes:

  • Preference for stenting even in cases when it is not the best treatment.
  • Disturbing increase in multi-vessel stenting.
  • With cheaper stents and a fall in procedure costs, many more patients are opting for angioplasty.
  • Several studies across the globe have shown that in patients with multiple blocks in all three vessels, open heart surgery is a better procedure than the use of multiple stents.
  • The lower stent prices, ill-informed patients often choose multi-vessel angioplasty as it is cheaper than open heart surgery.
  • With the increasing use of the tiny metal tubes, the chances of a stent blocking with consequent damage to the heart muscle will increase.
  • In India, emergency angioplasty was carried out in less than 10 per cent of patients mainly because of the cost involved in the procedure and the lack of access to stents.
  • There is a growing concern among those in the hospital authority that technologically advanced devices may stop coming in because of the price cap as manufacturers may not prefer a slash on the price premium for advanced products.
  • Some health care providers feel that the stent price capping may even result in reserve medical tourism due to concerns over the quality of stent available in the Indian market.
  • This move will have a more crucial and negative effect on distributors and manufacturers that operate through local distributors.
  • Reducing stent prices will have adverse effects on the development of improved stents.
  • International companies may be able to offset their losses with profits in other markets, and from profits from other products.

Present situation:

  • In April, major international stent companies had filed for withdrawing their latest products from the Indian market.
  • Discussions are still going on between major manufacturers and the government about the withdrawal of already available stents.
  • If this logjam continues, innovative stent technology will never be introduced in India.
  • Research on indigenous stents has become a victim of the government’s ambitious plan.

Regulatory Hurdles:

  • In India, before innovating, manufacturing and marketing a stent, a company has to go through several regulatory hurdles.
  • The process involves testing on animals, trials on humans and controlled studies.
  • The procedural delay can sometimes take as long as five years and financial institutions, including banks, do not have any provision that allows them to accord special status to funding such research.

Challenges

  • Lack of government funding for clinical research in India.
  • Lack of indigenous research and development will make the country dependent on imported stents.
  • Medical tourism will be hit as it will become apparent that Indian hospitals do not have the latest generation stents.
  • With time, paradoxically,
  • patients who were the intended benefactors of this price control measure may actually turn out to be losers.

  • The procedural costs and its ceiling have not been addressed by the government.

Conclusion: India needs to have more stent manufacturers and medical device research so that we do not need to depend on imported stents. All aspects involving medical device development like clinical research, animal testing, human trials etc must be fast-tracked and should be as transparent as possible. The current step of price capping taken by the Indian government is only a small step towards making health care accessible for all. Moving ahead,

  • there may be several policy refinements or newer strategy implementations in the cards,

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