Govt Plans Regulations For Critical Medical Devices Like Pacemaker, X-Ray Machines

New Delhi, 24 May 2018: Critical medical devices such as pacemakers, CT scanners and X-ray machines will soon have an assurance of quality, with the government set to regulate their manufacture, import and sale in the country.

The Drugs Technical Advisory Board approved a proposal on May 16 to include implantable medical devices and high-end medical equipment under the purview of the Drugs and Cosmetics Act, 1940, according to the minutes of its latest meeting. This will allow the country’s apex drug regulatory body to set quality standards for implantable medical devices and equipment, including defibrillators, dialysis and X-ray machines as well as PET, CT scan and MRI equipment.

None of these devices is under regulation currently, a senior government official aware of the development said on condition of anonymity. “Once brought under the new regulation, the government can regulate the licences to manufacture, sell and import (these products),” said the official.

This will help improve the quality of the products and could encourage the domestic industry because the benchmarks will be defined, the official said, adding that this could promote exports.

The government wanted to regulate implantable medical devices because they are high-risk and inserted into the human body using surgical means, remaining there for over 30 days, according to another person aware of the development. It wanted to set standards for high-end equipment like CT scanners, MRI machines and defibrillators because of their potentially life-saving roles, according to the person.

“This implies that the medical device rules will apply (to these devices) for approval and quality. It is positive that these will be regulated now,” said Malini Aisola of the All India Drug Action Network, a patient activist group.

The Central Drugs Standard Control Organisation, India’s drug regulatory body, will be able to audit these devices on its own or with the help of expert and third-party certification bodies, said Rajiv Nath, forum coordinator of the Association of Indian Medical Devices Industry, a lobby group.

“The advantage is that now the concerns regarding patient safety will be addressed because there will be a regulator to look at these issues for addressing all of the risks associated with (the devices),” Nath told ET. He said it was not clear whether implants used in the body for less than 30 days would be regulated.

“It’s a win-win situation for all. It will lead to a clear distinction between the compliant and noncompliant players,” said Nalinikanth Gollagunta, South Asia CEO of GE Healthcare, which makes ultrasound machines, MRI machines and CT scanners. Efforts must also be taken to ensure that the introduction of new products does not take a long time, he added.

In 2017, the company captured around a third of India’s diagnostic medical devices market, estimated at about .`6,800 crore, an industry expert said, requesting anonymity.

Both Nath and Gollagunta said a separate act was required for medical devices. As of now, these devices will be defined as “drugs” under the Drugs and Cosmetics Act and regulated using the Medical Devices Rules, 2017. ET Healthworld