India’s medical device industry protests NPPA stent price caps

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Indian medical device manufacturers and associations are voicing their opposition to price caps on stents and other devices imposed by India’s National Pharmaceutical Pricing Authority, according to a report from the Economic Times India.

The price cap has reportedly left little to no room for innovation in the country, with industry groups now demanding an expansion of the National List of Essential Medicine board, which evaluates the price caps, to include different stakeholders within the industry.

“Continuing in the spirit of inclusiveness, we request the ministry of Health & Family Welfare to reconstitute the NLEM committee to enable inclusion of representatives from other relevant sections of the healthcare ecosystem. The broader constitution will give a real chance to the committee to review its previous decision on price capping. The committee, in its current form, is invested in the decision it took last year and the review would be fair if it is done by a broader panel,” Medical Technology Association of India director general Pavan Choudary said, according to the Economic Times India.

The industry groups have floated solutions to the caps, including labeling of higher priced, more “innovative” stents under a different sub-category, but so far the efforts have been rejected by the NPPA citing a lack of evidence.

Advocates for removal of the price cap, including industry groups such as AdvaMed, have argued that medical devices, unlike pharmaceuticals, cannot be adjudged on clinical superiority evidence, according to the report. They also argue that the lifecycle of medical devices are often cut short due to continuous improvements, making it difficult to make appropriate efficacy comparisons.

Industry groups are reportedly supportive of an idea floated by the government’s Committee on High Trade Margins in the Sale of Drugs which recommended capping of margins instead of flat price caps.

“Singular focus on controlling the price of devices without attempting to address the larger picture will not improve patient access. We need to consider alternatives to price control such as trade margin rationalization and more scientific approaches that facilitate differential pricing for innovative medical technologies,” AdvaMed VP Dr. Abby Prat said, according to Economic Times India.

Last November, the NPPA was reportedly looking to revisit its decision to impose price caps on coronary stents in February of 2018 and it is looking for input from manufacturers, the agency said in a statement last week.

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