Health Policy

CII calls for separate regulation of medical devices

The Government has recently introduced the Drugs and Cosmetics (Amendment) Bill, 2007 in order to facilitate setting up of a Central Drugs Authority and introduce centralized licensing for manufacture of drugs. The inclusion of medical devices as a part of the overall description of drugs has drawn serious concerns from the medical devices industry. It is suggested that medical equipments / medical devices be added as a independent definition and be defined as per the Global Harmonization Task Force to include any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used alone or in combination, for human beings for one or more of the specified purposes. There is also a need for separate provisions for the regulation of medical devices since they cannot be clubbed with provisions relating to drugs and cosmetics in view of the completely different characteristic of devices and equipments as compared to drugs and cosmetics. The proposed constitution of the Central Drugs Authority of India and Drugs Consultative Committee needs to be reconsidered to increase the maximum number of members to include representatives from all fields including manufacturers of drugs, cosmetics and medical devices who can understand and analyze the points from the industry specific perspective. It is also learnt that the Government of India is proposing to set-up the Medical Devices Regulatory Authority of India (MDRA). The MDRA would be expected to formulate appropriate guidelines to be a national certifying and regulatory agency in India for medical equipment and devices. In this connection, it is very important to ensure that there is not regulatory overlap for the medical devices industry. The Draft Medical Device Regulation Bill 2006, and the proposed MDRA is based on tenets of European Medical Device Directive, which is largely accepted even by the Global Harmonization Task Force (GHTF) recommendations. Such an independent act or such a separate comprehensive regulation for medical devices is essential for appropriately and comprehensively regulating medical devices.

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