In a move to curtail the pricing freedom of stent makers, India has decided to cap the maximum retail price (MRP) of coronary stents sold in the country.A health ministry notification on July 19 stated that the government has accepted the recommendation of an expert committee and decided to include coronary stents in the National List of Essential Medicines (NLEM), 2015 with immediate effect.
Medicines whose MRP get capped are picked up from the NLEM list. While the price cap may not be unrealistically lower than the average MRP of a coronary stent that is already in the market, it will take away the pricing freedom enjoyed by companies in new product introductions.
US-based Advanced Medical Technolgy Association (Advamed) termed the move as "detrimental" to the growth of a nascent medical device industry in India. "The quality of products and clinical outcomes do not seem to have been given a priority. Singular focus on capping prices of stents by way of their inclusion in NLEM will not help improve access to medical devices for patients, as it will not impact the overall procedure cost and limit the introduction of innovative products," an Advamed statement said.
The lobby group, consisting of global medical technology majors as its members, also pointed out that the prices of stents is not the highest contributors to the overall angioplasty cost as a significant reduction in stent price over the last four years has not benefited patients as the overall procedure cost has largely remained the same.
Quoting World Health Organisation (WHO), Advamed said that "the methodology used for medicines cannot be replicated with medical devices when it comes to essentiality"
"Stents and medical technology generally - do not meet the criteria for inclusion in the NLEM. Moreover, coronary stents is a category and not products, just like antibiotics/ vaccines are also a category of medicines, which have different drug molecules within them, which can be essential," the statement said.
"Stents and medical technology generally - do not meet the criteria for inclusion in the NLEM. Moreover, coronary stents is a category and not products, just like antibiotics/ vaccines are also a category of medicines, which have different drug molecules within them, which can be essential," the statement said.
The health ministry has clarified that the decision was taken to comply with a Delhi High Court order that came last year.