Medical devices industry asks govt to define and bring clarity on online sale of devices in New Drugs Bill, 2022
The medical devices industry in the country has sought the Centre to define online and offline mode of sale, provide more clarity on the regulations that are binding the online sales and suggested inclusion of online medical devices players under the Uniform Code for Medical Devices Marketing Practices (UCMDMP).
The Association of Indian Medical Device Industry (AiMeD), in its feedback to the government on the draft New Drugs, Medical Devices and Cosmetics (NDMDC) Bill, 2022, has said that there needs more clarity to some of the sections which points on regulations related to online sales of medical devices.
For instance, in the Section 130 (4) of the draft, where it discusses prohibition of import or manufacture and sale of medical devices, the government intends to make regulations that 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.
“We would suggest defining what is Online and Offline Mode for greater clarity and understanding of all stakeholders from a policy maker/regulatory perspective,” said the Association.
“Both Methods of Sale are totally different and communities’ health and well being is compromised with sale/delivery formats which have no clarity,” it added.
Under the Section 158 (z) of the draft, where it discusses the powers of the Central Government to make rules for the Chapter VI related to medical devices after consultation with or on recommendation of the Medical Devices Technical Advisory Board and subject to previous publication, the government has powers to prescribe the manner of regulating online sale or distribution or offer for sale of the medical device.
“We would like that better clarity is provided on the following: Whether online players in medical devices are also covered under Consumer Protection (Ecommerce Rules), 2020 under Consumer Protection Act 2019? Whether they are also subject to Medical Device Regulation?,” said the Association.
The online players are also covered under IT Act and this means the online businesses will be subject to multiple regulations and all acts have to be cross referenced for better clarity to protect consumer safety.
Communities, consumers are often under the impression that online businesses are strictly regulated and all regulatory, licensing aspects are already addressed. Food Safety Standards and Regulations Authority can be referred to as FSSAI has brought all Online FBOs under strict regulatory mechanism with well defined Regulatory specification, it added.
Besides, the Association also suggested that the online players should also be brought under the marketing code of conduct.
“Marketing Code of Conduct (UCMDMP) should include the Marketing Code of Conduct for Online players based on the Consumers Protection (ecommerce rules) 2020, released by the ministry of consumer affairs under the Consumer Protection Act 2019. Basic Marketing Code of Conduct is defined for online players under the said rules,” it added.
As reported earlier, the Association also sought the Centre to include software or an accessory to the definition of In-vitro diagnostics device which is referred to in the Section 3 (zd)(b) of the draft Bill.
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