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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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