Industry bodies criticise govt for including stents in NLEM

Medical devices sector body AdvaMed and industry chamber CII today hit out at the government's decision to include coronary stents in list of essential medicines saying it will not help improve access to medical devices for patients as it will not impact the overall procedure cost.
The government's step is detrimental to the nascent medical device industry in India and is also contradictory to its recent efforts to press forward with legislation that would create separate and appropriate legislations for medical devices, the two industry bodies said.
"Singular focus on capping prices of stents by way of their inclusion in NLEM (national list of essential medicines) 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," Advanced Medical Technology Association (AdvaMed) said in a statement.

Echoing sentiments, CII said: "Given the clear distinction between medical devices and drug formulations, the methodology for price control of drug formulations cannot be applied to medical devices."
A price control on the nascent Medical Devices sector at this stage does not bode well in creating a conducive environment for FDI, realising Make in India or investment in R&D, both of which are required for growth of this sector, it added.
AdvaMed said stents and medical technology generally do not meet the criteria for inclusion in the NLEM. Quoting World Health Organisation, it said that the methodology used for medicines cannot be replicated with medical devices when it comes to "essentiality".

"Also, according to the recent IMS Health Data on stents, price of stents in India is not the highest contributor to the overall angioplasty cost," it said.

The data showed that significant reduction in stent price over the last four years has not benefited patients so far as the overall procedure cost has largely remained the same, AdvaMed added.
The government's move to include stents in NLEM in order to influence the price of medical devices is detrimental to the nascent medical device industry, it said adding "the quality of products and clinical outcomes do not seem to have been given a priority".

It further said: "More clarity and a comprehensive, consultative multi-stakeholder approach that involves contributions from all stakeholders in the healthcare ecosystem is the need of the hour.