New Delhi: AdvaMed and its members have expressed disappointment on the Department of Pharmaceutical’s (DOP) latest notification for the inclusion of coronary stents in Schedule 1 of DPCO 2013. “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,” said the statement issued by the Association representing multi-national medical technology companies.
AdvaMed further stated that the 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 shortsighted. 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 also pointed out to the fact that it is eager to work with the authorities in India for better ecosystem. “Considering that product quality and dignity of patient care is paramount, 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,” it stated.
AdvaMed and its members have also urged the government to foster an ecosystem that offers predictability, clarity and transparency to India’s nascent medical technology industry where it is rewarded for introducing new and innovative technologies. Its statement mentioned further that the 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 center 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 the statement.