The Indian Ministry of Health and Family Welfare has declared that starting from April 1, 2020, medical equipment will be classified as ‘drugs’ under Section 3 of the Drugs and Cosmetics Act (D & CA), 1940. This determination is backed by the release of the Medical Devices Amendment Rules, 2020. The rules will also be implemented from the same date.
Medical Device Registration
According to the newly released set of rules, medical devices need to be registered with the Central Licensing Authority using a specific online portal managed by the Central Drugs Standard Control Organisation (CDSCO). However, this registration will remain voluntary for an initial period of 18 months, after which it will become compulsory.
Section 3 of the Drugs and Cosmetics Act, 1940
In line with Section 3 of the Drugs and Cosmetics Act, 1940, the Central Government and the Drugs Technical Advisory Board (DTAB) are to designate the devices intended for utilization in humans or animals as drugs.
Role of Drugs Technical Advisory Board
DTAB is a legal body formed under the Drugs and Cosmetics Act, 1940. Its primary function is to provide advice to both central and state governments on technical aspects related to drugs and cosmetics.
Key Points of the Notification
At present, only 23 medical devices are classified as drugs. The recent notification expands the definition of medical devices. All devices used for diagnosis, monitoring, treatment, assistance, investigation, replacement, modification, or support of human anatomy or physiological processes will now fall under the category of ‘Drugs’.
This expanded definition will include implantable medical devices like knee implants, CT scan machines, MRI equipment, defibrillators, dialysis machines, PET devices, X-ray machines, and more. The primary intended action of these devices on humans or animals should not be pharmacological, immunological, or metabolic in nature.
Quality Control and Safety
The objective of this change is to regulate all medical devices, ensuring they meet certain quality standards. Medical device companies will also now be held accountable for the quality and safety of their products. Any manufacturing, importing, and selling of all medical devices must be approved by the Central Drugs Standard Control Organisation.
Potential Impact
This decision can significantly impact small players in the low-value high-volume segment of the medical devices industry. The high-tech diagnostic imaging sector, dominated by large companies, will possibly be least affected. There are concerns that the new rules, being very rigid, could result in any non-compliance being treated as a criminal offense by any drug inspector under the Act at their discretion.
Way Forward
Expanding the scope of regulation to all devices is not considered sufficient given the increasing number of safety disasters involving devices. Hence, there is an important need for the creation of a new medical devices act.