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Medical Devices Regulation Bill Proposes Penalty Provisions Against Defaulters

The draft Medical Devices Regulation Bill, 2006, aimed at regulating the medical devices market, has proposed for classification of devices in relation to the risks and penalties for non-compliance with safety, registration and other regulatory norms.

The devices would be classified as Class A (devices involving lowest risk levels), Class B (low to moderate risks), Class C (moderate to high risks) and Class D (highest risks) for efficient monitoring and regulation.

With ample powers on the enforcement side, the proposed Medical Devices Regulatory Authority can slap huge fines on the defaulters. The penalty for non-compliance of the provisions could attract fine up to Rs 5 lakh or one-year rigorous imprisonment. The misbranding would lead to Rs 3 lakh fine or six months imprisonment while tampering with devices; package or labeling could be penalized with Rs 2 lakh or six months imprisonment.

"Whoever bound under the Act to register his product with the MDRA, manufactures, imports, sells, stores or distributes any medical device without such registration shall be punishable with rigorous imprisonment for a term which may extend to six months or with fine which may extend to Rs l lakh," it says on registration.

According to the Bill, the scope of definition of the expression of drugs to cover the devices in the existing Drugs and Cosmetic Act did not adequately cover all the products which are covered by the current internationally accepted definition of 'medical devices'.

“With a diverse range and multitude of medical devices are in use, which are manufactured using a wide variety of technologies with the result that for ensuring the safety of the public in the use of medical devices, an entirely different system and method of regulation from the current national and international practices that are being applied for the regulation of drugs and cosmetics is required," it says on the need for such an act.

(Ref: The Chronicle Pharmabiz dated 21, February 2008)


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