Key components of Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024

Last Updated on September 16, 2024 by The Health Master

UCMPMD

The Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024 represents a comprehensive framework designed to ensure ethical practices in the marketing of medical devices.

This code addresses various aspects including the promotion of medical devices, claims and comparisons, promotional materials, interactions with healthcare professionals, and the handling of complaints.

This article provides an in-depth summary of the key components of UCMPMD 2024, including its guidelines, procedures, and penalties for non-compliance.

General Points

Promotion and Product Approval

UCMPMD 2024 mandates that no medical device should be promoted prior to receiving the necessary product approval from the Regulatory Authority, as specified by the Medical Device Rules, 2017.

This ensures that any promotional activities are aligned with the official approval and registration of the device.

Promotional activities must be consistent with the documents submitted for obtaining product registration or licenses.

This includes adhering to the Instructions for Use (IFU) or Directions for Use (DFU) of the product.

All product information must be up-to-date, verifiable, and accurately reflect current knowledge or responsible opinion.

Additionally, such information should be accurate, balanced, and substantiated.

Claims and Comparisons

When making claims about the usefulness of a medical device, companies must base these claims on available evidence and the IFU/DFU of the product.

The terms “safe” or “safety” must not be used without proper qualification and should not categorically state that a device has no adverse consequences.

Comparisons of medical devices must be factual, fair, and substantiated by data.

These comparisons should not mislead through distortion or omission, and brand names of other companies should not be used without prior consent.

Disparagement of other companies, their products, or healthcare professionals is prohibited.

Textual and Audio-Visual Promotion

Promotional materials issued by authorized holders must comply with UCMPMD requirements.

They should include:

1. The generic name and/or brand name of the medical device.
2. The name and address of the manufacturer/importer and the entity responsible for marketing.
3. Warnings, precautions, and relevant contraindications.
4. A statement that additional information is available upon request.
5. The date of generation or last update of the information.

Promotional materials must be clearly identifiable as such and should not resemble editorial content.

They should be tastefully presented, without using the names or photographs of healthcare professionals, and must avoid imitating or copying materials from other companies.

Audio-visual materials must be supported by relevant printed materials.

Medical Representatives

Medical representatives, including sales, marketing professionals, and clinical specialists, must maintain high ethical standards and comply with UCMPMD.

They should not use inducements or pay for access to healthcare professionals.

Companies are responsible for ensuring compliance by their employees and representatives, and third parties engaged in marketing activities must also adhere to the Code.

Brand Reminders, Evaluation Samples, and Demonstration Products

Brand reminders (e.g., books, calendars) are permitted if their value does not exceed Rs. 1000 and they do not have independent commercial value.

Evaluation samples, intended for hands-on experience, should only be provided to qualified healthcare professionals and must be accompanied by the latest IFU/DFU.

The quantity and value of samples should be reasonable and tracked for a minimum of five years.

Demonstration products, used for explaining device features, must be identified and returned after use.

Continuing Medical Education

Engagement with healthcare professionals for Continuing Medical Education (CME), Continuing Professional Development (CPD), or similar events must follow transparent procedures.

Foreign training is prohibited except in exceptional cases with prior approval.

CME/CPD events can be conducted by medical colleges, professional associations, or medical device companies in collaboration with these entities.

Companies must disclose event details and expenditures on their websites, and comply with Income Tax regulations.

Support for Research

Research support from medical device companies should be based on approved studies conducted at recognized sites.

Engagements with healthcare professionals for research should involve consultancy agreements with appropriate payments and ensure patient interest and professional integrity are maintained.

Research expenditure by companies is subject to Income Tax provisions.

Relationship with Healthcare Professionals

Gifts, travel facilities, hospitality, and monetary grants are prohibited unless specifically approved for CME/CPD programs.

These provisions aim to prevent undue influence and maintain the integrity of healthcare professionals.

The Indian Medical Council’s regulations will prevail in case of any omissions.

Ethics Committee for Marketing Practices in Medical Devices

Each Indian Medical Device Association must establish an Ethics Committee for Marketing Practices in Medical Devices (ECMPMD) chaired by the Chief Executive Officer.

The Committee handles complaints and transfers them to the relevant association or the Department of Pharmaceuticals if necessary.

Details of complaints and actions taken should be published on the association’s website and UCMP portal.

Lodging of Complaints

Complaints regarding breaches of the Code should be addressed to the ECMPMD.

They must be made in writing, within six months of the alleged breach, with a non-refundable fee of Rs. 1,000.

Complaints should include detailed information about the complainant, the alleged breach, and supporting evidence.

Complaints from medical device companies must be authorized by a senior executive. Media reports may also be treated as complaints.

Handling of Complaints

The ECMPMD is responsible for enquiring into complaints and making decisions by majority.

The committee must request responses from the accused company and may engage professional auditors.

The respondent company must provide comments and evidence within 30 days. The Committee should render a decision within 90 days and notify both parties in writing.

Decisions may include reprimands, corrective statements, or recovery of items, and must be adhered to by the entities involved.

Penalties and References

If a breach of the Code is established, penalties may include suspension or expulsion from the association, reprimands, corrective statements, or recovery of money/items.

Recommendations may be sent to relevant government agencies for further action.

Appeal

Dissatisfied parties can appeal to the Apex Committee for Marketing Practices in Medical Devices (ACMPMD), headed by the Secretary of the Department of Pharmaceuticals.

Appeals must be filed within 15 days, with a possible extension of 15 days.

The ACMPMD will review the case, give both parties an opportunity to be heard, and provide a final decision within six months.

Miscellaneous

The Department of Pharmaceuticals may issue standing orders to support the Code and will notify a panel of auditors.

The Chief Executive Officer of each company is responsible for adherence to the Code and must submit a self-declaration annually.

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