NEW DELHI: The Centre on Tuesday issued a notification declaring all medical devices used on humans or animals as drugs — paving the way to ensure that they meet certain standards of quality and efficacy.
It will also bring the devices under the purview of price control later. The notification said that all devices used in diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder will now be specified as drugs.
The other devices included in the category also include those used in the investigation, replacement or modification or support of the anatomy or of a physiological process, those supporting or sustaining life, disinfection of medical devices and contraceptives.
The move comes following the recommendation by the drugs technical advisory board of the Central Drugs Standards Control Organisation (CDSCO) last year. Some of the devices, however, will be treated in the new category only in the next 2.5-3.5 years.
Senior officials in the health ministry said that many medical devices were available in the market without any certification or regulatory control.
“Our concern is patient safety as medical devices can have serious adverse events. The latest move will ensure that we can bring in adequate regulatory interventions as far as medical device regulatory system is concerned,” an official said.
Reacting to the move, All India Drugs Action Network said that while this is positive, consumer groups are sceptical about how the CDSCO’s current ability to regulate devices. “We are particularly wary of the CDSCO’s competence, expertise and most importantly its commitment towards patient safety given its dismal track record,” said a statement by AIDAN.
“We urgently need comprehensive reforms to strengthen the regulatory mechanism in relation to patients’ safety.” It also said that these may include guidelines for the approval of devices.
Future ramifications
Once the notification is issued, the CDSCO will be the nodal authority to probe complaints related to quality and safety of medical devices and can suspend the registration or cancel licences of firms.
Manufacturers and importers will have to upload information on the devices for registration on the “Online System for Medical Devices” established by CDSCO.
Upload names of manufacturers
According to the notification, the manufacturer or the importer will have to upload name and address of
the company or firm or any other entity manufacturing the medical device along with name and address of manufacturing site of medical device, details of medical device like generic name, model no, intended use, shelf life and certificate of compliance
Syringes are now drugs
Devices used in diagnosis, monitoring or treatment included in the category
All types of
Syringes
Catheters
Nebulizers
Glucometer
Condoms
Digital thermometer
Machines such as MRI machine, CT scanner Blood pressure monitors
Blood sugar kits
Contraceptive devices
Defibrillators
How will it help patients?
Government can now ensure quality standards for all devices including imported ones
Can control price by putting them on the essential drugs list later
Officials said the decision was taken up after studying the Singapore model after systems in the US, Canada, Australia and Japan were examined
23 devices were classified as drugs in the country at present
37 more categories of devices will now be regulated after the new rule