Govt. rolls out Draft Uniform Code for Medical Devices Marketing Practices ( a voluntary code for Indian Medical Device Industry); invites public comments within 15.04.2022

The Department of Pharmaceuticals (“Department”) has rolled out a Draft Uniform Code for Medical Devices Marketing Practices (“Draft Code”) seeking comments and suggestions from the public / medical device industry. Comments and suggestions may be sent to ucmdmp-22@gov.in by 15th April, 2022.

Background:

The marketing practices of the Medical Device Sector are currently being voluntarily regulated by the Uniform Code of Pharmaceuticals Marketing Practices. Based on the requests of the Medtech industry to have a separate uniform code, the Department has prepared the Draft Code in consultation with the industry.

This is a voluntary code of Marketing Practices for Indian Medical Device Industry presently and its implementation will be reviewed after a period of six months from the date of its issue. If it is found that it has not been implemented effectively by the Medical Device Associations/Companies, the Government may consider making it a statutory code.

Key Takeaways:

1. A Medical Device must not be promoted prior to receipt of the product registration (wherever applicable) by the Regulatory Authority, authorizing its sale or supply as per the Medical Device Rules.

2. 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 and sell these Medical Devices in India; and specifically the Instructions for Use (IFU)/Directions for Use (DFU) of the relevant product.

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

4. Product Information about Medical Devices must be accurate, balanced, fair, objective, and must not mislead either directly or by implication.

5. Claims & Comparisons:

• Claims for the usefulness of a Medical Device must be based on evaluation of the available and published evidence and/or 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 in accordance with the terms of documents submitted by the Companies for obtaining product registration or licenses to manufacture, import and sell the Medical Devices in India; and specifically the IFU/DFU/eIFU/ User manual of the relevant product
• 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, by undue emphasis, omission or in any other way.
• For comparative advertisements:

1. 1. It should be factual, accurate and capable of substantiation
   2. Should not present a good or service as an imitation or replica of a good or service with a protected trademark or trade name

• Advertisements/ Promotional Material containing comparisons with other manufacturers, suppliers, producers or with other products, including where a competitor is named, shall be permitted in the interest of promoting competition, where—

1. 1. the features of the competitor’s product being compared to the features of the advertiser’s products are specified clearly within the advertisement;
   2. the subject matter of the comparison is not of such nature so as to confer an artificial or unjustifiable advantage upon the advertiser; and

• the nature of comparisons is such that they are factual, accurate and capable of being substantiated.

• Other Companies, their products, services or promotions must not be disparaged either directly or by implication. Any discussions and substantiation in this regard shall be based on available and published evidence
• The clinical and/or scientific opinions of members of HCPs, which are based on available clinical evidence must not be disparaged either directly or by implication.

6. Textual and Audio-Visual Promotional Material:

• All Promotional Material issued by Company, must be consistent with the requirements of this Code and the applicable laws.
• Promotional material must not be designed to disguise their real nature. Where a Company pays for or otherwise secures or arranges the publication of Promotional Material in journals, such Promotional Material must not resemble editorial matter.
• All Promotional Materials, the publication of which is paid for or secured or arranged by a Company and referring by brand name to any product of that Company, must comply with Clause 3.3 of this Code as appropriate, irrespective of the editorial control of the material published
• Promotional material must conform, both in text and illustration, to canons of good taste and must be expressed so as to recognize the professional standing of the recipients and not be likely to cause offence
• The names or photographs of HCPs must not be used in Promotional Material.

7. Medical Device Representatives and other third parties:

• The term “medical device representatives” means sales representatives, clinical specialists including personnel retained by way of contract with third parties and any other Company representatives who call on HCPs, pharmacies, pathology lab/ research lab, hospitals & health authorities, or other healthcare facilities in connection with the promotion of Medical Devices.
• Medical representatives must at all times maintain a high standard of ethical conduct in the discharge of their duties. They must comply with all relevant requirements of the Code.
• Medical representatives must not employ any inducement or subterfuge to gain an interview. They must not pay, under any guise, for access to a HCP.
• Companies are responsible for the activities of all their employees including Medical Representatives for ensuring compliance of the Code
• Other third parties working for or on behalf of Companies, and those that do not act on behalf of Companies (such as joint ventures and licensees) commissioned to engage in activities covered by the Code should also have a good working knowledge of the Code and should abide by applicable laws

8. Evaluation Samples:

• Free evaluation samples of Medical Devices shall not be supplied to any person other than HCPs or as per hospital protocol to reach the HCPs
• Where evaluation samples of products are distributed by a medical representative, the sample must be handed directly to a person qualified to use &prescribe such product or to a person authorized to receive the sample on their behalf
• The following conditions shall be observed in the provision of evaluation samples to a person qualified to prescribe such product:

1. 1. Such samples are provided for the purpose of acquiring experience in using such a product, hands on experience and evaluation
   2. An adequate system of control and accountability must be maintained in respect of the supply of such samples by all Companies including maintaining proper documentation and rationale
   3. Each sample shall be accompanied by a copy of the most up-to-date version of the Product IFU/DFU/ e-IFU (link to the website/digital IFU), wherever applicable, relating to that product
   4. The number of evaluation samples (single use products) provided at no charge should not exceed the quantity reasonably necessary for the adequate evaluation of the products.
   5. Demonstration products: Company demonstration products are different from Evaluation Samples. Demonstration products can be either single use products, mockups, temporary software or equipment that are used for HCP and Patient awareness & education. Demonstration products are typically identified as not intended for patient use and demonstration equipment are taken back by Company after the demonstration period is over. However, consumables used in live procedural demonstration usually cannot be taken back. Clause 5 of this code does not apply to demonstration products and is limited to Evaluation Samples only. Demonstration products shall be specifically identified and tracked by the Company

Please note, the companies have to maintain details, such as product name, HCP’s name& contact information, Quantity of evaluation samples given, Date of supply of evaluation samples distributed to HCPs, relevant product traceability information

9. Gifts:

• No gifts, pecuniary advantages or benefits in kind shall be supplied, offered or promised to persons qualified to use, prescribe or supply Medical Devices, by a Medical Device Company or any of its agents i.e., distributors, wholesalers, retailers etc.
• 2 Gifts for the personal benefit of HCPs and family members (both immediate and extended) (such as tickets to entertainment events) shall not be offered or provided
• Companies may occasionally provide modest, appropriate educational items to HCPs that benefit patients or serve a genuine educational function for HCPs. Educational items can include but are not limited to product manuals and anatomical models. Hence, Companies can supply Medical education materials like books including e-books, and subscription to online portals etc.

10. The Draft Code also provides for the relationship of the companies with health care providers.

11. Mode of Operation:

• All the Medical Device Manufacturer associations in India (“Association”) will have UCMDMP uploaded on their website.
• Once a complaint is lodged and Association receives information from which it appears that a Company may have contravened the Code, the managing director or chief executive or equivalent of the Company or authorized person(s) of the Company concerned will be requested to investigate, take corrective actions and provide a response to the matters of complaint to the Association.
• All the associations will also have a provision on their website for uploading the details of complaints received i.e.,the number of complaints received, the current status, time taken to close, the nature of complaint and the action taken in brief. The name of the Company shall be kept confidential only revealing the details of the matter. Further, this information must be updated frequently to reflect the latest status

12. The Draft Code also provides for a procedure of lodging a complaint. All complaints about any one activity of breach of code should to the extent practicable be made at one time. The complaint must be made within three months of breach of code.

Please refer to the hyperlink below for a detailed read of the document.

Source: Department of Pharmaceuticals