Red tape delays stent price fixing

Red tapes and industry lobbying have blocked the price fixing  of coronary stents, though the move was approved by the Union health ministry more than four months ago.

The Department of Pharmaceuticals has been sitting on the health ministry’s recommendations for over 90 days and in the absence of a pharmaceutical department order, the National Pharmaceutical Pricing Authority (NPPA) could not start the price fixation process to include this medical device in the National List of Essential Medicine (NLEM), sources told DH.

Coronary stents are currently sold at hugely inflated price, thus keeping them out of reach for a large number of people requiring angioplasty and compelling many others who received them to spend much more than their paying capacity, an NPPA report stated. The manufacturing and importing companies enjoy large trade margins.

The NPPA had suggested price control on both drug eluting and bare metal stents to aid lakhs of heart patients, whose numbers are on the rise.

On July 19, the health ministry issued an order on the inclusion of coronary stents in the NLEM. However, a subsequent order from the pharmaceutical department to operationalise the health ministry’s decision is yet to come.

Department of Pharmaceuticals Secretary Jai Priya Prakash declined to comment. The department comes under the Ministry of Chemicals and Fertilizers headed by Ananth Kumar. The NPPA fixed a benchmark cost of Rs 19,000 for bare metal stents and Rs 28,000 for drug eluting stents. The benchmark, however, was not acceptable to the industry.

An industry association comprising big stent importers is lobbying with the government to have a differential pricing mechanism, which public health activists claim would defeat the purpose of price control in the first place.

The industry argument is to have a differential pricing system and let the doctors have the final say on which type of stent would work best for a particular patient.

“We believe that all drug eluting stents are not the same because over the years, the complexity of patient conditions with high co-morbidities like diabetes and hypertension has required more evolved solutions. Industry has brought forth innovations in the metallic drug eluting stents to treat this increasing complexity and thus brought benefit to the patients,” said director general of Medical Technology Association of India Pavan Choudary.

But an expert panel, headed by Y K Gupta, head of the department of pharmacology at the All India Institute of Medical Sciences, Delhi, found “no definite superiority among currently available metallic drug eluting stents in terms of their clinical outcome.”