Sale of High-end Medical Devices to be Regulated

In a move aimed at curtailing arbitrary pricing by private hospitals and diagnostic facilities, the regulatory authorities are set to bring high-end vital diagnostic equipment under the definition of drugs, which then can be brought under a regulatory body. Following a series of complaints and feedback from patients and even senior doctors, the regulatory authorities of Central Drugs Standards Drug Control Organization (CDSCO) have chosen CT scan, MRI equipment, dialysis machines, PET equipment, X-ray machine, bone marrow cell separators, defibrillators and all implantable medical devices to be defined as drugs so that they can be included in the essential drugs list and regulated. Among the many implications, once this decision comes into effect, manufacturers of medical devices will now have to take permission from national drug regulatory authorities to sell these products in the country.

Tough norms

The new regulations of CDSCO will ensure high quality products to be used in healthcare of patients and will discourage production and usage of sub-standard products, health authorities believe. According to members of Medical Technology Association of India (MTAL), a body representing medical-technology companies, such new regulations will also erase red tape and help in ease of doing business in the country. “We welcome the plans to regulate manufacture, import and sale of critical medical devices in India. Apart from helping patients, the new regulations will make it easy for manufacturers also,” MTAL said. Persons familiar with the issue said that due to lack of regulations, at present many government departments impinge in medical electronic device sector, creating jurisdictional challenges and delays.

Compliance mandatory

For instance, X-Ray manufactures need to comply with regulations of the Ministry of Health and Family Welfare (MOHFW) and even Atomic Regulatory Board (AERB). At several steps, including importing the product and usage of equipment, the X-ray manufacturers will have to comply with two independent regulatory authorities. According to CDSCO, the identified devices will be defined as drugs under the Drugs and Cosmetics Act for the price and quality control and regulated using Medical Device Rules of 2017. Senior doctors here said that the regulatory authorities should hold widespread consultations and quickly notify it in the official gazette so that the decision comes into effect as early as possible. – Telangana Today