In a move to further regulate the medical devices industry, the Centre has notified eight new devices as “drugs”. According to a notification issued on February 8 by the Union ministry of health and family welfare, eight devices have been notified as drugs—all implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine, and bone marrow cell separator.
With this notification, their import, manufacture and distribution is now regulated under the Drugs and Cosmetics Act, 1940. Until last year, 27 categories of devices were notified as drugs, including blood pressure monitoring devices, digital thermometers and glucometers that were notified in December 2018.
“The eight new categories of devices in the latest notification are used to make a diagnosis. The main issue is of quality, and the safety of the patient. If the diagnosis is incorrect, then the patient could be exposed to unneccesary treatment,” a senior official from the union health ministry told THE WEEK. "When it comes to smaller private establishments the issue of quality becomes even more important. We know that in a large number of establishments, the imported diagnostic equipment is second hand, machines that have been cast away after being replaced with the latest versions in other countries,” he said. The official also added that the move had support of the medical device industry. “Though these devices are classified as drugs, and will be regulated under the Drugs and Cosmetics Act, the parameters of regulation will be defined by the Medical Device Rules under the Act,” he said.
The latest decision to notify these drugs comes after a proposal to regulate high-end medical devices such as implantable medical devices, CT scan equipment and X-ray machines was cleared by the Drugs Technical Advisory Board in May 2018.
With this notification, these devices will also fall under the ambit of price control by the National Pharmaceutical Pricing Authority—albeit only by next year when the notification comes into effect.
“The majority of medical devices are completed unregulated in India. With this move, all implantable devices and some diagnostic equipment will be brought into the regulatory framework. This is important from a patient safety perspective and we welcome this step,” said Malini Aisola, co-convenor, All India Drug Action Network. “However, we are disappointed about the delay with which the notification takes effect. It also sends mixed messages because the government is deliberating a roadmap for bringing new and separate regulatory framework for devices,” said Aisola.
Mahesh Zagade, former FDA commissioner, Mumbai, said that though the step was necessary, merely having a law was not enough. Zagade, who had filed an FIR in the against Johnson and Johnson in hip implant row and has voiced his support for patient rights, said that it was the implementation of the law that was at stake. “In the J&J case, for instance, the drug controller could not stop the import the faulty implant [hip implants were already classified as drugs] and failed to take action against the company. Besides, people also need to be made aware of the fact that a robust law [Drugs and Cosmetics Act] exists in the country,” said Zagade.