Tighter Control

From December 1, all devices will be treated as drugs and come under the purview of the Central Drugs Standards Control Organisation which will regulate them

According to a draft notification, the health ministry proposes to notify all medical devices under a section of the Drugs and Cosmetics Act, 1940, which would define them as “drugs” starting from December 1. In April, the Drugs Technical Advisory Board (DTAB) had recommended this change.

The draft notification reads: “In pursuance of sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs with effect from the 1st day of December, 2019.”

Under this Act, drugs are defined as those devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the central government.

Therefore, apart from chemicals, plants, medical devices, medical im plants, medical diagnostics, vaccines, blood and medical disposables also qualify as drugs.

Medical devices are essential components of treatment and include thermometers, blood pressure instruments, nebulisers, inhalers, anaesthesia equipment, reagents, pacemakers, knee and hip replacement implants, etc. The increased scrutiny of medical devices came in the aftermath of the recall of Johnson & Johnson’s faulty hip implants which impaired many patients for life.

That created the need for a national registry of medical implants so that in case of a recall, every device can be traced. Also, the MRP of devices was often decided by hospitals and profit margins ranged from 100 percent to 700 percent. Once medical devices are classified as drugs, the Central Drugs Standards Control Organisation (CDSCO), the drug regulator, will regulate them.