Industry opposes move to control stent prices

Says move runs contrary to govt's recent efforts to come out with separate legislation for medical devices

The Indian medical devices industry has opposed the Centre’s decision to bring coronary stents under the price control regime.

Medical device makers and their associations have said there could be confusion about the Centre’s policy that this decision will likely give rise to. This is because, on June 22, the government withdrew the Drugs and Cosmetics Bill from the Parliament, as it felt there was a need for a separate law and guidelines to regulate the sector.

Himanshu Baid, chairman, CII Medical Technology Division, said the move to include stents in the National List of Essential Medicines (NLEM) runs contradictory to these recent efforts to create a separate legislation for medical devices.

As stents have been brought under NLEM, they would soon be made part of the Drug Pricing Control Order, 2016 (DPCO, 2016), which means their price can be controlled by the government’s National Pharmaceutical Pricing Authority (NPPA).  Even though coronary stents are a medical device, the government has classified them as a drug to make them a part of NLEM. “Given the clear distinction between medical devices and drug formulations, the methodology for price control of drug formulations cannot be applied to medical devices,” Baid added.  ADVAMED, the industry organisation of global device makers, echoed Baid’s view. “Stents and medical technology generally do not meet the criteria for inclusion in NLEM. According to the World Health Organization, the methodology used for medicines cannot be replicated with medical devices. Moreover, coronary stents are a category and not products, just like antibiotics/ vaccines are also a categories of medicines,” it said.

However, Rajiv Nath, forum coordinator of AIMED, industry body for domestic device manufacturers, said this was a “good move, given the circumstances and we support it  even though we believe that there needs to be a different price control mechanism for medical devices as a long-term measure.”  Nath said domestic and foreign manufacturers were not the villains in this context as hospitals dictate and drive the printed maximum retail price of medical devices in their quest to cover costs. “Bringing stents under NLEM will stop this artificial inflation by hospitals,” he said.  

HEART OF THE MATTER

• On June 22, the government had withdrawn the Drugs and Cosmetics Bill from Parliament
• One of the reasons the government gave was there was a need for a separate law and guidelines to regulate the medical devices sector
• Industry organisations were asking why was it necessary to bring stents under price control when the sector was getting a new law
• National List of Essential Medicines is for drugs only. The government had classified stents as ‘drugs’, even though it is a medical device

The Federation of Indian Chambers of Commerce & Industry too called for a differentiation between drugs and devices. “Pharmaceutical formulations and medical devices are two inherently different sectors and cannot be dealt with by the same formula,” it said. “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 added.

“'Price control does not improve access.”