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The medical device industry has sought clarity from the Centre on misbranded and adulterated medical devices with reference to Draft New Drugs, Medical Devices and Cosmetics Bill, 2022.
According to industry experts, the draft bill stipulates that medical devices shall be deemed to be misbranded if it “containing colours not expressly permitted in the license or permission issued under this Chapter” with reference to Section 127 (d) misbranded medical devices.
Speaking on the sidelines of the recently concluded IPC at Nagpur, Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) said, “In this regard, we would like to clarify that in medical devices colours are used not only for brand and logo but also for the identification of size/gauge of medical devices. The colour are as per the relevant standard (e.g. IS/ISO 6009 for colour coding of devices).
As per the draft bill, a medical device shall be deemed to be adulterated, “if it consists in whole or in part, of rusted or corroded or filthy or putrid or decomposed substance” with reference to Section 128 (a) adulterated medical device.
“In this regard, we would like to submit that the above definition of adulterated medical device does not fit well with the construction and nature of most of the medical devices. These devices are engineered products made under a tolerance where the storage, usage conditions and usage skills need to be considered before putting a criminal insinuation on a manufacturer,” an industry official clarified.
For example, a medical device made of standard stainless steel (e.g. SUS 304 grade) can get rusted/corroded in case it is exposed to acidic or corrosive fumes (during transportation or storage) or with anesthesia fluids during usage/surgery which may not be in control of the manufacturer. By application of above definition, the device manufacturer can be held responsible and be punished up to 7 years imprisonment for a defect which is beyond his control and not done willfully.
“The Law needs to be fair and not punish innocent law-abiding licensed manufacturers. The definition needs to be deleted and expunged as impractical for engineering goods,” the industry official emphasized.
With reference to Section 130 (4) Prohibition of import or manufacture and sale of medical devices no person shall himself or by any other person on his behalf sale, distribute or offer for sale the medical devices by online method, as may be prescribed, for which a license or permission is required to be obtained from the licensing authority, except under and in accordance with such license or permission subject to such exemptions and conditions and in such form and manner as may be prescribed.
It has been suggested by the industry to define what is online and offline mode for greater clarity and understanding of all stakeholders from a policy maker/regulatory perspective. Both methods of sale are totally different and the community's health and well-being is compromised with sale/delivery formats which have no clarity.
With reference to Section 134 (1), the provisions of a Medical Device Officer (MDO) is required to be linked to his competency and should not be a mirror copy of a ‘Drug’ Inspector under a different name.
With reference to Section 134 (1) a, the word ‘Inspection’ needs to be expunged from the regulation and replaced with the word ‘Audit’ for seeking compliance and improvements and the word ‘Search’ needs to be replaced with ‘Surprise Audit’.
“The word search and seizure or use of police support should be restricted to non-licensed illegal manufacturing facilities. If a manufacturer got a license that is indicative that he was by and large compliant and for lapses done subsequently, he is ready to seek improvement in demonstrating conformity assessment,” Rajiv Nath concludes.
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