Health ministry regulates eight more medical devices as drugs

NEW DELHI: In order to ensure quality of medical devices imported into the country, the Union ministry of health and family welfare has added eight more devices to the list of drugs under the Drugs and Cosmetics Act, 1940, and will now require strict regulatory compliance.

The ministry, t hrough a Gazette notification issued on Fr i d a y , s p e c i f i e d t ha t a l l implantable medical devices such as cardiac tents, orthopaedic and ocular implants etc, CT scan equipment, MRI equipment, defibrillators, dialysis machines, PT equipment, X-ray machines and bone marrow cell separator as drugs.

“There are implantable devices that are placed inside the human body and other equipment that come in direct contact with patients that need to be of good quality. Most of these devices are imported and those not r egulated di dn’t r equire a l i cense. After having been included in the list these devices will have to follow all norms that are followed by the drug manufacturers and importers,” said a senior health ministry official, requesting anonymity as the person is not authorised to speak to the media.

The health ministry had earlier regulated as many as 23 devices and with the addition of eight more such devices the total number of devices to be specified as drugs has increased to 31 that would require same checks as drugs.

“”Right now if it’s not part of the list then anyone can import and sell anything in our country, without much accountability in case the device malfunctions. This new regulation will change that scenario,” said the official.

There are at least 5000 different types of medical devices in market and almost all of these are imported in India.

“The i dea i s t o gradually bring in more and more medical devices under our regulatory ambit. Quality assurance is our top priority, and there will be no comprise as far as patient safety is concerned,” said Arun Singhal, additional secretary, health ministry.

The notification will come into effect from April 1, 2020.

The experts have been demanding these devices to be regulated since long.

“It’s a good thing to check the quaity of these devices in market but it would be ideal if they can have an idependent medical devices regulator in place,” said Dr KK Talwar, former member, MCI board of governors.