The Health Ministry notification to include coronary stents in the National List of Essential Medicines (2015) is likely to weaken the industry sentiment further, according to FICCI. The government took the decision after the sub-committee looking into issues involving stents recommended their inclusion in the NLEM (2015).
“As the Indian medical device industry braces up for new opportunities, it remains tied up in the restrictive business environment. With the recent announcement on inclusion of coronary stent of all categories in National List of Essential Medicine the industry sentiment has further weakened,” said FICCI in a press statement.
Pharmaceutical formulations and medical devices are two inherently different sectors and cannot be dealt with by the same formula. “Unilateral and unsuitable price controls on stents and medical devices will adversely affect the usage of innovative and high quality products in India and thus reduce the levels of patient outcomes. This will have an unfavourable impact on the Make in Indiaintentions and FDI inflow in the sector,” said Probir Das, chairman, FICCI Medical Device Forum.
Industry feels that with the recent notification the access to latest technologies to patients in India is likely to be prohibited and will hugely impact both medical tourism which thrives on availability of latest medical technology, and clinical outcome for Indian patients. Attracting global investments for realising Make in India would need a mature handling of policy decisions for this sector, to keep investor sentiment high and a positive outlook on investing in India for this sector.
Das informed, “Innovation and incremental improvement is the foundation of the medical devices sector that has to regularly invest in research and development for upgrading medical technology for the benefit of the patients. Price controls create disincentive for manufacturers to bring new technology to market.”
Stents are wire-like mesh that are inserted into blood vessels to remove blockages in patients having heart problem. There are various types of stents available in India such as old generation bare metal stents, drug-eluting stents (DES) and new-generation absorbable stents. Some consumer groups claim that doctors, hospitals and retailers charge high commission for stents increasing the cost of stents to ultimate user (ie patients). It is alleged that a stent with ex-factory cost of Rs 30,000 is sold at Rs 40,000-45,000 by distributor to a hospital, while the patient has to pay Rs 1,00,000 for the product. This prompted government to look at ways to bring price regulation of stents under the National Pharmaceutical Pricing Authority, which monitors the prices of medicines.
However, the industry experts believe that the price control will not improve access. “In no market around the world has access to high quality medical treatment improved without a combination of strong reimbursement mechanism and high quality medical technology adoption. It is time for the government, insurers, manufacturers, and providers to embrace common objectives and to acknowledge and fully support the crucial role of medical technology assessment in the enhancement of the quality of health care,” FICCI added.