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Q. Need of credible medical regulatory body: In the backdrop of controversy on stents pricing, comment on need of strong regulatory body.
Feb 28, 2017 Related to : GS Paper-2

Ans :

Introduction-

A stent is a small mesh tube that's used to treat narrow or weak arteries. Recently the National Pharmaceutical Pricing Authority has fixed the cap price for drug eluting stents (DES) and bio-resorbable stents. This ceiling has brought a huge relief to lakhs of patients who have to undergo coronary angioplasty to insert stents to open up clogged arteries, but many pharmaceutical companies have shown their displeasure on this move. This aspect has erupted controversy among various stake holders.  

Issues-

  • According to many experts, the ongoing controversy over ceiling limit of pharmaceutical products is direct result of absence of a credible standards-setting and certifying authority for stents and other medical devices. Absence of credible body prevents the much needed competition in stents and other medical devices.
  • Similarly there are many Indian companies who manufactures stents, and exports to European countries, but unable to sell in India. A vital reason is the absence of a body whose stamp of validation is sufficient to elicit public faith in the adequacy of a critical medical device like the coronary stent.

What can be done-?

  • Government authorities, instead of focusing on price cap policy, it should use various available market based alternatives to regulate. There is a necessary to maintain that, neither it choke off research and development nor prices may go up unnecessarily high. 
  • To maintain balance between promotion of research and development and a competitive price, there is a need to establish a strong and credible regulatory authority. 

Conclusion-

In a recent past India has witnessed various controversies in the pharmaceutical sector and issues related to price ceiling of stents is recent one. Any country should ensure the right balance between research and development cost and selling cost of product, so that no stake holder gets adversely affected. It is possible through establishment of credible standards through strong and credible regulatory body.


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