UncategorizedUCMPMD 2024 AND ITS ROLE IN REGULATING MEDICAL DEVICE’S MARKETING

INTRODUCTION

The Ministry of Chemicals and Fertilizers Department of Pharmaceuticals  has issued an official notification regarding the Uniform code for Marketing Practices in Medical Devices, 2024 issued under F.No.31026/23/2022-Policy on 06.09.2024 (hereinafter referred to as “UCMPMD”) which is  aimed at ensuring the ethical standards in the marketing and distribution of medical devices. This UCMPMD outlines the regulatory measures, which states the formation of Ethics Committees for Marketing Practices (hereinafter referred to as “ECMPMD”) within associations, along with the establishment of procedures for lodging complaints, which will be linked to the Department of Pharmaceuticals’ UCPMP portal.

In addition to the compliance requirements, the UCMPMD focuses on the need for transparent disclosure by medical device companies. These disclosures, particularly regarding the distribution of evaluation samples and expenses related to educational and professional events such as Continuing Medical Education (hereinafter referred to “CME”), Continuing Professional Development (hereinafter referred to as “CPD”), workshops, and seminars, must be submitted regularly. This analysis will explore the implications of this UCMPMD on medical device companies, the role of associations in upholding ethical marketing practices, and the broader impact of the UCMPMD on regulatory compliance and transparency within the industry.

ANALYSIS OF THE UCMPMD

The Government of India has introduced new uniform marketing UCMPMD for the medical devices Industry to promote ethical marketing practices and to enhance transparency and accountability.

The UCMPMD states that the companies cannot promote the medical device until the receipt of the product approval is not receive by them from the Regulatory Authority for its sale. It is mandatory for the companies to be consistent with the documents which has been submitted by them for the promotion of devices for product registration and licenses to manufacture, import, distribute of sale in India and more specifically instruction and direction given for use. It is given in the UCMPMD that the product information should be accurate, balanced and not be misleading and it is made necessary that the information shall be provided with the time frame if it is requested by HCPs also it is mentioned the devices should “be up to date, verifiable and accurately reflect current knowledge.” In this UCMPMD the Department have mentioned that the claims for usefulness of any medical device cannot be made if it not based on “evaluation available and publish evidence and Instruction for Use (hereinafter referred to as “IFU”) and Direction for Use (hereinafter referred to as  “DFU”) of that product.”. the companies cannot mention that the devices have no particular consequences and unwanted affect also, the UCMPMD has prohibited the companies to use the word “safe and safety” without any qualification and understanding.

All the claims reveled about the device should be in accordance with the terms mentioned in the document summitted to the department. If the comparison is made so it should be “factual, fair capable of substantiation” also it should not be a mislead by distortion, undue emphasis, omission or any other way”. Without the prior permission of the companies the others brand name shall not be used for comparisons also opinions of healthcare professionals should not be disregarded and shown worthless in any circumstances.

According to the UCMPMD some prior information like brand name, name and address of the manufacturer, warnings, any additional information If requested  has to be provided by the persons who are qualified to prescribe the device for the use also anything use for promotion shall be in accordance with the UCMPMD. Any promotion like advertisement shall not misguide the actual motive of the device also if the company publishes something about the device it should co relate with the editorial matter.

If any publication/Journal  has published any promotional material of the companies or has any relation to their promotional matters then they have to comply with this UCMPMD. Some few points need to be remembered is that healthcare professionals pictures cannot be used for promotions, this promotions cannot copy the same phrases, or slogans, or some general layout which they think might be misleading, things like “ postcards, envelope, wrappers, etc.” shall not have similar terms or phrases or anything which is not acceptable for public in general, Audiovisual content must be accompanied by pertinent written or printed materials.

MEDICAL REPRESENTATIVES UNDER UCMPMD

This UCMPMD outlines who qualifies as medical representatives, as detailed below:

• Sales representatives,
• Medical affairs or marketing professionals,
• Clinical specialists including personnel retained by way of contract with third partied or any other company representative who call on HCPs,
• Pharmacies,
• Pathology labs,
• Research labs, hospitals,
• Other health care facilities having connection with the promotion

Further, UCMPMD requires that these representatives adhere to all relevant provisions and conduct themselves in a bona fide manner. Payments should not be made to healthcare professionals for any approach or connections. Companies must sign a contract with their employees and medical representatives, stipulating that the company will be responsible for any non-compliance with the UCMPMD by these individuals. Additionally, all third parties working for the companies must possess extensive expertise and comply with this UCMPMD.

Regarding evaluation samples, they should be provided to offer prior knowledge and experience with the devices. Evaluation samples must be given only to qualified individuals who have the authority to prescribe them or are authorized to receive them. These samples should be the latest models and come with the relevant Instructions for Use (IFU) or user manual. If provided for evaluation, they should be free of charge, provided their value does not exceed the amount required for use.

When providing evaluation samples, the following details must be included: product name, healthcare professional’s name and contact information, date of supply, etc. This information should be maintained for a minimum of five years. Additionally, the total monetary value of such samples should not exceed 2% of the company’s annual domestic sales. Samples should be clearly marked as “NOT FOR SALE” and used solely for demonstrating and educating healthcare professionals.

Samples intended for educational or mock-up purposes differ from evaluation samples. The same documentation requirements apply to these educational samples, including maintaining records for at least five years. All devices provided are subject to income tax provisions, which must be managed by both the giver and continuing medical education.

According to the UCMPMD there should be proper procedure first and then the engagement of medical device companies with health care professionals for CME, CPD, various training, conferences, workshops.

Primarily, holding  events in foreign countries is generally not allowed, except under there are some special circumstances which would be advanced clinical training, such as when qualified trainers, equipment, or necessary products are unavailable domestically.

If training must take place abroad, comprehensive documentation is required. This includes a detailed justification, a list of participating healthcare professionals (hereinafter referred to as “HCPs”), the duration and location of the training, information on trainers, equipment, and facilities, as well as an outline of the costs for travel and accommodation. These details must be submitted to the department at least three months prior to the planned date, and approval from the department is mandatory for any foreign training sessions to proceed also the  institutions like medical colleges, universities, hospitals, doctors, specialist, laboratories, research institutions and etc. can conduct and hold such events and after holding such events they should reveal every small detailed on their website also it is necessary for the organizing team has to show the on which criteria they have selected participants and speakers and reveal funding source. A

SUPPORT FOR RESEARCH

It is necessary for every industry to have good research to keep the development and inventions on going hence likewise it to have a good support for research there should be a proper interaction between medical devices companies and health care professionals. Therefore, in order to conduct any research an approval is needed from the competent authorities like ICMR, Ethics committee.

Moreover,  to properly support this research it is important to have pure and Bona-fide intention of the both the sides in consultancy- advisory capacity such engagements should take care that the probity shall be maintained of health care professionals.

RELATIONSHIPS WITH HEALTHCARE PROFESSIONALS

It is strictly prohibited to offer any kinds of pecuniary benefits and gifts in personal capacity to any healthcare professional or to their family member by any company or any person incapacity or employee, agent, distributors, whole seller, etc. These companies and their representatives acting on their behalf are also prohibited to provide the health care professionals with travel arrangements wwhether domestic or international such as rail, air, cruise tickets, or paid vacations. Similarly, offering hospitality in the form of hotel accommodations, luxurious meals, or resort stays to healthcare professionals or their family members is also forbidden.

Exceptions are made only if the healthcare professional is a speaker at a CME or CPD program, or they are participant in a training program that has received prior approval from the relevant department.

ETHICS COMMITTEE FOR MARKETING PRACTICES IN MEDICAL DEVICES

This UCMPMD mandates that every Indian Medical Device Association post the UCMPMD and the comprehensive complaint filing process on their websites. These postings must be linked to the UCPMP portal. Additionally, ECMPMD will be established, consisting of 3 to 5 members, to oversee company management.

If a complaint is received that does not involve any members of the association, the association must forward the complaint to the Department of Pharmaceuticals. Once resolved, associations are required to publicly disclose details of the complaints, the involved companies, and the actions taken. This information must be maintained on their websites for five years and also uploaded to the UCPMP portal of the Department of Pharmaceuticals.

COMPLAINTS 

The ECMPMD deals with the complaints. Anyone can file the complain at one time and must be made in six months of any violation. To file the complaint one should provide the details of the offence made, give the details about the company against who the complaint is made, provide the basic information about themselves and submit a Rs. 1000 which is a refundable amount.

Once complaints are filed, they must be managed effectively to avoid any bias. According to the UCMPMD, the ECMPMD is required to initiate and complete the investigation process promptly after a complaint is received. The committee will make a decision based on a majority vote, and members with a conflict of interest must recuse themselves. The CEO of the company under investigation must provide a detailed explanation to the committee, and it is the respondent’s responsibility to ensure a comprehensive response is submitted within the designated timeframe. The committee may request relevant supporting evidence from the respondent company.

Associations may choose to employ qualified auditors to conduct a thorough and impartial investigation to aid in making an informed decision. The responding company must submit its response and supporting documentation to the committee within 30 days of receiving the UCMPMD.

The committee has 90 days to respond to all complaints. If the committee finds no violation or determines the complaint is outside the UCMPMD scope, the complainant will be informed in writing, with guidance on where to direct further inquiries. If  violation of the UCMPMD is found, written notices will be sent to both parties involved. If a party fails to appeal, the ECMPMD’s decision will be final and binding.

For the breach conducted the committee has the authority to suspend the company, “ Reprimand the entity” and update the full information about the same, they can ask to issue a statement in the media, can ask to pay compensation, the committee can also send the recommendation to the department where there any authority lies.

AMLEGAL REMARKS

The medical device industries plays a significant role in healthcare sector, therefore unethical market practices like fake and unfair slogans, misleading advertisement can adversely impact on patients health hence this UCMPMD.

 The UCMPMD is necessary to ensure that all companies engage in ethical marketing and avoid making false claims about their products. The UCMPMD ensures that companies are transparent in their marketing practices and accountable for the information they provide. It creates a standard framework for promoting medical devices in a responsible manner, ensuring that healthcare professionals and consumers receive accurate and unbiased information. This UCMPMD also maintains the fair competition between the companies by restricting them using unethical methods to promote the devices and have edge on other competitors.

Self-declaration depends on what voluntary information the companies provide which sometimes may be not reliable if the companies have something to gain by withholding the information hence the practices like regulatory checks strengthen the UCMPMD.

Compliance to this UCMPMD is very essential to ensure the ethical and transparent practices in the industry. As reflected in UCMPMD companies are required to fill the particulars related to their compliance with these guidelines within two months of the financial year-end this self-declaration helps the authority in enforcing the UCMPMD. This UCMPMD also emphasizes the importance of corporate social responsibility.

Team AMLEGALS

For any query or feedback, please feel free to get in touch with rohit.lalwani@amlegals.com