Centre notifies Uniform Code for Marketing Practices in Medical Devices

Centre has notified the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024.

In a communiqué, Ravindra Pratap Singh, Joint Secretary, MedTech Policy, Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, has urged all medical devices associations to circulate and implement the code among their members.

“All associations should constitute an Ethics Committee for Marketing Practices in Medical Devices (ECMPMD), upload the UCMPMD on their website along with the detailed procedure for lodging of complaints, which will be linked to the UCPMP Portal of the Department of Pharmaceuticals,” he said.

Additionally, in the exercise of the powers conferred by Para 14.1 of the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024, the DoP requires disclosure from medical devices companies of particulars related to the distribution of evaluation samples and expenses incurred on Continuing Medical Education/ Continuing Professional Development/ Conferences/ Workshops/Training/ Seminars, etc. I have also included the format for such disclosure.

“The particulars are to be filled on an ongoing basis and mandatorily within two months of the end of every financial year on the UCPMP portal of the Department within the time limit fixed for submitting self-declaration under Para 14.3 of the Cod,” said Singh

Key highlights:
General points:
A medical device must not be promoted before receipt of the product approval (wherever applicable) by the Regulatory Authority, authorizing its sale or distribution as per the provisions of the Medical Device Rules, 2017.

The promotion of a medical device must be consistent with the terms of documents submitted by the Companies for obtaining product registration or licenses to manufacture, import, distribute, or sell these devices in India; and more specifically, with the Instructions for Use (IFU)/Directions for Use (DFU) of the relevant product.

Product Information about medical devices must be up-to-date, verifiable, and accurately reflect current knowledge or responsible opinion.

Product Information about medical devices must be accurate, balanced, not misleading directly or by implication, and capable of substantiation.

Substantiation that is requested under para 1.4 above must be provided within a reasonable time frame, by the authorized sources of the Company at the request of Health Care Professionals (HCPs).

Claims & comparisons:
Claims for the usefulness of a medical device must be based on the evaluation of available and published evidence and IFU/ DFU of the relevant product.

The word “safe” or “safety” must not be used without qualification and it must not be stated categorically that a medical device has no adverse consequences.

All product claims should be by the terms of documents submitted by the Companies for obtaining product registration or licenses to manufacture, import, distribute, or sell the Device in India and the IFU/DFU/User Manual for the same.

Comparisons of medical devices must be factual, fair, and capable of substantiation by way of available data. In presenting a comparison, care must be taken to ensure that it does not mislead by distortion, undue emphasis, omission, or any other way.

Brand names of products of other companies must not be used in comparison unless the prior consent of the companies concerned has been obtained.

Other companies, their products, services, or promotions must not be disparaged either directly or by implication.

The clinical or scientific opinions of healthcare professionals must not be disparaged either directly or by implication.

Textual and audio-visual promotion:
Any promotional material issued by an authorized holder must be consistent with the requirements of this Code. Where the purpose of promotional material is to provide persons qualified to prescribe or use with sufficient information upon which to reach a decision for prescribing or for use, the following minimum information must be given clearly and legibly and must be an integral part of the promotional material:

1. Generic name and/or brand name of the medical device;
2. The name and address of the manufacturer/importer of the medical device and the business name and address of the entity responsible for marketing the Device; c. Warnings and precautions for use and relevant contraindications of the product; d. A statement that additional information is available on request; and
3. The date on which the above particulars were generated or last updated. 3.2 Promotional material such as mailings and journal advertisements must not be designed to disguise their real nature. Where a company pays for, or otherwise secures, or arranges the publication of some promotional material in journals, such promotional material must not resemble the editorial matter.

Relationship with healthcare professionals:
Gifts: No gift should be offered or provided for the personal benefit of any healthcare professional or family member (both immediate and extended) by any medical device company or its agent viz. distributors, wholesalers, retailers, etc. Similarly, no pecuniary advantage or benefit in kind may be offered, supplied, or promised to any person qualified to prescribe or use medical device, by any medical device company or its agent viz. distributors, wholesalers, retailers, etc.

Travel: Companies or their representatives, or any person acting on their behalf, should not extend travel facilities inside or outside the country, including rail, air, ship, cruise tickets, paid vacations, etc., to healthcare professionals or their family members (both immediate and extended) for attending conferences, seminars, workshops, etc., unless the person is a speaker for a CME or a CPD Program or a participant in a training program for which specific approval has been obtained from the Department as per clause 6.2 above.

Hospitality: Companies or their representatives, or any person acting on their behalf, should not extend hospitality like hotel stay, expensive cuisine, resort accommodation, etc., to healthcare professionals or their family members (both immediate and extended) unless the person is a speaker for a CME or a CPD program or a participant in a training program for which specific approval has been obtained from the department as per clause 6.2 above.

Monetary grants: Companies or their representatives should not pay cash or monetary grants to any healthcare professional or their family members (both immediate and extended) under any pretext.

Where any item is missing, the Code as per the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002, as amended from time to time, will prevail.

Ethics Committee for Marketing Practices in Medical Devices:
All the Indian Medical Device Associations will upload the UCMPMD on their website along with the detailed procedure for lodging complaints, which will be linked to the UCPMP portal of the Department of Pharmaceuticals.

There will be a committee for handling complaints named as “Ethics Committee for Marketing Practices in Medical Device (ECMPMD)” in each Association, chaired by its Chief Executive Officer. The Committee will have three to five members, and its composition will be approved by the Board of the Association and prominently placed on its website.

If a complaint received in a particular association is not concerned with its members, the receiving association will record the abstract of the complaint and will transfer the complaint to another association where the respondent company is a member, or to the Department of Pharmaceuticals in case the company is not a member of any association.

In the case of companies that are members of more than one Association, the complaint should ordinarily be handled by the Medical Device Association to whom the complaint is addressed, and where necessary, it may seek guidance from the Department of Pharmaceuticals.

After disposal all Medical Device Associations should share on their website the details of complaints received, the company against whom the complaint was received, the action taken on the complaint, and such details should remain uploaded for five years. Such details should also be uploaded on the UCPMP portal of the Department of Pharmaceuticals.
MB Bureau