Govt proposes to bring medical devices under Drugs and Cosmetics Act

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The Central Drug Standard Control Organisation (CDSCO), two days before, had issued a notification wherein it proposed to include all implantable medical devices and other high-end equipment under the purview of the Drugs and Cosmetics Act, 1940. The list includes all implantable devices, CT scan equipment, MRI equipment, defibrillators, PET equipment, dialysis machine, X-ray machine, bone marrow cell separator. Hitherto, these equipments and medical devices have been in the control of private players with no regulation and the government hopes that once these equipments are brought under the new act, it will be able to regulate the licences to manufacture, sell and import them.

When asked whether this will mean the end of rampant profiteering in the healthcare sector and reduction in prices of these testing and imaging devices for patients, Dr Roy Patankar, gastroenterologist and director, Zen multispeciality hospital, Mumbai, said that it will also improve the quality of products as "these are medical devices that are inserted into the human body and remain there for many days." Another official from the Food and Drugs Administration, who did not want to be named, said that although he welcomed the central government's move, he wondered, "why it is done now? why wasn't this action taken before?", adding that he hopes the NPPA fixes the prices of these devices as soon as possible. Some experts also suggested that the move will help in keeping a check on instances of sex determination done using the ultrasound equipments and will help in easier implementation of the Post Natal Diagnostics Technique Act, 1994.

According to Rajiv Nath, forum coordinator of Association of Indian Medical Device Industry (AIMED), the government's move will address the questions of safety of patients and quality of devices and will keep second hand equipments entering the market via the route of imports, at bay.

The CDSCO is awaiting suggestions and comments from all stakeholders before 21 days of the issue of the notification.