The Drugs Technical Advisory Board (DTAB) has announced that blood pressure monitors, nebulisers, digital thermometers and glucometers will now be included under the new additions to the Drugs and Cosmetics Act, 1940. A total of 27 devices, including these, will be incorporated into the Act. The updated Act will come into effect from January 1, 2020, ensuring that these basic medical devices are available to people at a reduced rate.
A notice issued by the Ministry of Health and Family Welfare states: “The Ministry of Health has, through a notification dated December 3, specified devices intended for use in humans for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, to be included in the definition of drug under the Drugs and Cosmetics Act, 1940; effective from January 1, 2020.”
This would mean that the price of devices that fall under the Act will be regulated, making the devices more affordable. If the proposal is cleared, all the companies involved in manufacturing these devices will have to approach the Drug Controller General of India to obtain the appropriate permissions or licenses to import the equipment.
Furthermore, it would ensure that all such devices being sold are subject to the proper quality checks and assurances.
“A majority of people in our country go to government hospitals for check-ups and treatment. By introducing such a measure and bringing down the price of several commonly used medical equipment, they will certainly benefit significantly,” stated Dr Keerthi, a general physician from Chennai who works at a public health centre. “There are so many patients from low income households who cannot afford to pay for simple tests itself. Bringing the prices down will be extremely helpful to them,” she added.
Drugs and Cosmetics Act, 1940
The Act was passed to ensure that drugs, devices and several other commercially utilised medical products are subject to proper quality checks. The different sections of the Act deal with different aspects of quality checks. From misbranding products, to subpar quality products to even fake or contaminated drugs, the Drugs and Cosmetics Act of 1940 addresses several issues concerned with the production of medicines and medical equipment.
Under the new additions to the Act, eight different categories of medical devices have been listed for consideration. These include implant devices, MRI, CT and PET scan equipment, X-ray machines and dialysis machines.