According to the guidelines, "No gift should be offered or provided for the personal benefit of any healthcare professional or their family members (both immediate and extended) by any Medical Device Company or its agents, including distributors, wholesalers, retailers, etc."
Published Sep 09, 2024 | 3:24 PM ⚊ Updated Sep 09, 2024 | 3:24 PM
New guidelines set to regulate medical device industry marketing practices. Representational Image.
The Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilisers, has introduced the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024. These guidelines aim to regulate marketing practices within India’s medical device industry, emphasizing ethical interactions between medical device companies and healthcare professionals.
The UCMPMD specifically prohibits practices such as offering gifts, travel facilities, or free samples to healthcare professionals. According to the guidelines, “No gift should be offered or provided for the personal benefit of any healthcare professional or their family members (both immediate and extended) by any Medical Device Company or its agents, including distributors, wholesalers, retailers, etc.”
Similarly, no monetary advantage or benefit in kind may be offered, supplied, or promised to any individual qualified to prescribe or use medical devices by any company or its agents.
The guidelines also stipulate that companies, their representatives, or anyone acting on their behalf should not provide travel facilities — whether domestic or international — including rail, air, ship, or cruise tickets, or paid vacations to healthcare professionals or their family members. Exceptions are only made if the healthcare professional is a speaker at a Continuing Medical Education (CME) or Continuing Professional Development (CPD) program, or a participant in a training session that has received prior approval from the Department.
Additionally, companies are restricted from offering hospitality, such as hotel stays, lavish meals, or resort accommodations, to healthcare professionals or their family members. The guidelines further clarify that “Companies or their representatives should not provide cash or monetary grants to healthcare professionals or their family members under any pretext.”
Moreover, the UCMPMD mandates that medical devices must not be promoted prior to receiving regulatory approval under the Medical Device Rules, 2017, which authorises their sale or distribution.
The new regulation also introduces guidelines for claims and comparisons in medical device marketing. It mandates that any claims about the usefulness of a medical device must be based on evaluated and published evidence.
The guidelines emphasise that terms like “safe” or “safety” must not be used without proper context. “It must not be stated categorically that a medical device has no adverse consequences.
All product claims should align with the documents submitted by companies for product registration or licenses to manufacture, import, distribute, or sell the device in India,” the regulation states.
Additionally, comparisons between medical devices must be factual, fair, and substantiated by available data. Care must be taken to ensure that comparisons do not mislead through distortion, undue emphasis, omission, or any other misleading tactic.
The regulation also restricts the use of other companies’ brand names in comparisons unless prior consent has been obtained. Furthermore, companies must not disparage competitors’ products, services, or promotions, either directly or indirectly. Similarly, the clinical or scientific opinions of healthcare professionals should not be disparaged in any manner, either directly or by implication.
The guidelines stipulate that items such as calendars or diaries offered for professional use must not exceed a value of ₹1,000 and should not possess independent commercial value.
Free samples must be provided only to qualified healthcare professionals (HCPs), with details recorded and tracked. The total value of such samples should not exceed 2 percent of the company’s annual domestic sales. These samples, used to demonstrate device features, should be returned after use and tracked separately. They must be clearly identified and are not intended for patient use.
For Continuing Medical Education (CME) activities, the procedures must be transparent and documented on the company’s website. Foreign CME events are generally prohibited unless exceptional circumstances are justified.
CME events can be conducted by medical colleges, professional associations, and recognized research institutions.
Regarding support for research, studies must have the necessary approvals and be conducted at recognized sites. Healthcare professionals involved in research should receive fair compensation, and the research must comply with tax regulations.
The Ethics Committee for Marketing Practices in Medical Devices (ECMPMD) has established clear guidelines for lodging and handling complaints related to breaches of the Code.
Complaints should be addressed to the Chief Executive Officer of the relevant association and submitted within six months of the alleged breach, with a possible extension of six months for justified delays.
The process requires that complaints be written and include the complainant’s full contact details, the company alleged to have breached the Code, and specific details of the breach, including relevant Code clauses and supporting evidence.
A non-refundable fee of ₹1,000 is required with the complaint, with payment instructions available on the association’s website. Complaints from Medical Device Companies must be authorised by the company’s Managing Director, CEO, or equivalent.
Media reports suggesting a breach may also be considered complaints, with additional information requested from the publication. Complaints received by the Department of Pharmaceuticals may be forwarded to the relevant association or handled directly, possibly involving a special audit.
Upon receiving a complaint, the ECMPMD will conduct an inquiry and reach a decision by majority vote, with members having conflicts of interest recusing themselves. The respondent company will be asked to provide a complete response and necessary supporting materials within the given timeframe.
The Committee may use professional auditors to assist in the examination and must render a decision within 90 days, notifying all parties in writing.
If a breach is confirmed, the Committee may impose penalties including suspension or expulsion from the Association, reprimand and publication of details, the requirement for a corrective statement, recovery of money or items given in violation of the Code, or referral to a government agency for further action.
The Committee’s decision is final if no appeal is filed, with adherence required for continued membership. All decisions will be published on the association’s website and the UCPMP portal of the Department of Pharmaceuticals.
Meanwhile, the Association of Indian Medical Devices Industry (AiMeD) has welcomed the guidelines as a long-awaited and highly anticipated development.
The guidelines, which have been tailored specifically for medical devices, are seen as a significant improvement over the previous code that applied to the pharmaceutical industry.
Rajiv Nath, Forum Coordinator of AiMeD, told South First, “This will help ethical manufacturers and marketing companies succeed based on the value of product performance and assist in cleaning up the marketplace from malpractices involving undue influences based on tertiary inducements.”
In contrast, Vishwaprasad Alva, Managing Director of Skanray Technologies, criticised the merging of pharmaceutical and medtech regulations, stating, “It is a mistake to group pharmaceuticals and medtech together — they are fundamentally different. Focusing on minor issues while neglecting the major ones is counterproductive. MedTech covers a broad range of advanced healthcare technologies, including electromechanical medical devices such as CT scanners, MRI machines, diagnostic imaging systems, ventilators, anaesthesia machines, and heart-lung machines. This field encompasses electrical, mechanical, software, hardware, embedded systems, image processing, material science, and more.”
“Many associations, including AiMeD, focus on low-tech items like syringes, which involve large-volume production and are technologically distinct from MedTech devices. Some associations are part of the problem, flattering government officials and seeking personal favours rather than addressing critical issues. While some associations praise these policies as revolutionary and enlightening, this is far from the truth,” Alva noted.
(Edited by Muhammed Fazil)
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