NEW DELHI : The Indian Health Ministry’s recent notification of eight more medical devices categories, including the entire range of implantable devices, as 'drugs' has raised concern in the healthcare community.
Stakeholders have claimed that the notification comes at a time when the medical industry in the country was hoping for a separate regulatory framework for devices.
Set to come into effect from April 2020, the decision has left the healthcare experts questioning the approach behind the move.
Dr B B Chanana, Head of the Department of Interventional Cardiology, Maharaja Agrasen Super Specialty Hospital, said, “We need a scientific approach to regulatory issues, particularly for devices, which are engineering-driven products and not chemical entities like drugs.”
He said, “You cannot ensure patient safety by putting drugs and devices under the same regulations." He further asked, "The notice lacks clarity. Is an implantable device the same as a medicine?”
Dr. Tejinder Kataria, Chairperson, Radiation Oncology, Cancer Institute-Medanta - The Medicity, said, “Medical devices and pharmaceuticals vary in their development, evolution, manufacturing, method of delivery, and impact on patients. Each one of these devices has a unique functionality.”
She said, “An implantable device cannot be treated the same as a drug. The patient cannot have both under the same banner. The notification will not help patients but risk their lives.”
The healthcare experts argue the move will do little to improve the condition of the already “unregulated” medical device sector in India.
The country has long ignored the need to recognize medical equipment as a separate vertical. With the new notification of the government, the question is where are we headed with the regulation of some of the most significant devices in the medical industry?