The Department of Pharmaceuticals
(DoP) issued a notification yesterday putting bare metal stents
(BMS) and drug eluting stents
(DES), which include metallic DES & biodegradable stents, in schedule-I of the Drugs Prices COntrol Order, 2013 (DPCO). As a result of this notification, the National Pharmaceutical Pricing Authority (NPPA) will soon start the process of fixing ceiling prices for these stents.
Expressing disappointment over the decision, Advanced Medical Technology
Association (AdvaMed), the medical device trade association based in Washington (USA), said, “Putting all drug eluting stents
(DES) into one category undermines the progress made in innovative device development over the years and could lead to equating less tested devices or devices not approved for use in complex patient cases or coexisting conditions, at par with innovative devices with large clinical evidence and due approvals for complex cases and coexisting conditions.”
According to AdvaMed, the DoP move hinders the fundamental right of a patient to have access to advanced, clinically proven, patient condition-specific and high quality devices. “To overlook this clinical and patient-centric need through preoccupation to ‘price capping’ is short-sighted. It is also not reflective of the discussions held during the Department’s consultative meetings with the physicians and the industry to embrace common objectives that support the role of medical technology
in the enhancement of the quality of health care,” the association said in a press release.
stated that the medical device industry is eager to work with the government to find an effective solution based on differentiation and categorisation for achieving its objective of improved patient access to quality healthcare and cutting-edge technologies in India. The need of the hour is a multi-stakeholder approach where the industry and other stakeholders in the healthcare delivery system (hospitals, distributors, etc) work together to come up with a framework that takes the value of a product into consideration.
Stating that the government should reward the industry for the introduction of new and innovative technologies, AdvaMed
urged the government to foster an ecosystem that offers predictability, clarity and transparency to India's nascent medical technology
industry. Medical Devices
are more complex than drugs and therefore, adopting, an appropriate pricing mechanism is key ensuring the continued availability of new and efficacious medical technologies for Indian patients.
“The government should place patients’ health at the centre of such policy decisions. Policy measures need to achieve a balance between the patient need for affordability and availability of physician choice to broad treatment options to address complex disease conditions,” said AdvaMed.