GoI has invoked emergency for manufacture of Coronary Stents

  • Moving to ensure there is no shortage of stents due to price control, the government has invoked an emergency provision making it mandatory for manufacturers to maintain production and supply of coronary stents at previous levels for at least six months.
  • Stent makers and importers have also been directed to submit a weekly report on stents production and distribution to the National Pharmaceutical Pricing Authority (NPPA), which regulates prices of drugs and medical devices.
  • Following reports of artificial shortage of stents after it imposed price caps, the NPPA had written to department of pharmaceuticals asking it to invoke the provisions.
  • After due deliberations on the current situation and alternatives available with the government to resume normal supply of the coronary stents, it has been decided to invoke the powers of Section 3 (i) of DPCO, 2013.
  • Withdrawal of any brand having got a license earlier without NOC (No objection Certificate) from NPPA shall be dealt firmly.
  • Last week, NPPA had fixed prices of bare metal stents at Rs 7,260, whereas both drug eluting stents (DES) and biodegradable stents were capped at Rs 29,600.

    Section 3 of DPCO

  • Under Section 3 (i) of DPCO, 2013, the government can regulate distribution.
  • It can also direct any manufacturer to increase production and sell products to institutions, hospitals or any agency as the case may be in case of emergency.
  • This is also in circumstances of urgency or in case of non-commercial use in public interest.

Coronary stent:

  • A coronary stent is a tube-shaped device placed in the coronary arteries that supply blood to the heart, to keep the arteries open in the treatment of coronary heart disease.
  • It is used in a procedure called percutaneous coronary intervention (PCI).
  • Stents reduce chest pain and have been shown to improve survivability in the event of an acute myocardial infarction.
  • Similar stents and procedures are used in non-coronary vessels e.g. in the legs in peripheral artery disease.

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