Implementing the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024: A Summary Guide

As of March 12, 2024, the Department of Pharmaceuticals at Shastri Bhawan, New Delhi, issued a Uniform Code on Pharmaceutical Marketing Practices to all Pharmaceutical Associations. Here are the summary points for your record. ?

Chief Executive Officer of the company responsible for adherence to this Code, and a self-declaration in the format given in the annexure shall be submitted by the executive head of the company within two months of the end of every financial year to the Association for uploading on their website, or directly on the UCPMP portal of the Department of Pharmaceuticals in case not a member of such a body, or a member of more than one such bodies.

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Headings of code summarized:

• Ensuring ethical and responsible drug promotion practices
• Claims & Comparisons
• Textual and Audio-Visual Promotion
• Implementing the specified content
• Definition of Medical Representative (Company’s Responsibility-HR role)
• Brand Reminders and Free samples
• Conditions for Providing Samples
• Record-Keeping and Limits (monetary value of samples)
• Continuing Medical Education (CME) and Continuing Professional Development (CPD) (guidelines and framework)
• Support for Research
• Relationship with Healthcare Professionals (Gifts/Travel/Hospitality/Monetary Grants)
• Authorization Requirement (Chief Executive Officer)

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?Summary points for implementing the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) 2024:

General Points:

1.1. "Promotion" includes all activities inducing prescription, supply, purchase, and use of drugs.

1.2. Drug promotion must align with marketing approval terms and not precede approval receipt.

1.3. Drug information must be balanced, verifiable, up-to-date, and capable of substantiation.

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Claims & Comparisons:

2.1. Claims about drug usefulness must rely on current evidence.

2.2. Avoid categorically stating a drug is "safe" or has no side effects, toxicity, or addiction risk.

2.3. Avoid using "new" for drugs available or promoted in India for over a year.

2.4. Fair and factual comparisons of drugs are permitted.

2.5. Obtain consent before using brand names of other companies in comparisons.

2.6. Do not disparage other companies, products, services, or promotions.

2.7. Avoid disparaging healthcare professionals' clinical or scientific opinions.

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Textual and Audio-Visual Promotion:

3.1. Promotional material must comply with UCPMP requirements.

3.2. Minimum information required for prescription decision-making must be provided clearly in promotional material.

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Relevant Drug Information:

a. Include the name and address of the authorization holder or responsible business entity.

b. Provide the drug name and a list of active ingredients, prominently displaying the generic name alongside the brand name.

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Dosage and Administration:

a. Clearly state the recommended dosage, method of use, and administration instructions.

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Safety Information:

a. Disclose adverse reactions, warnings, precautions, and contraindications for product use.

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Additional Information:

a. Mention that additional information is available upon request.

b. Include the date when the provided particulars were generated or last updated.

c. Ensuring that promotional materials contain this essential information will facilitate informed decision-making by healthcare professionals and ensure compliance with regulatory standards.

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Specified content:

Authentic Presentation:

1. Promotional materials, including mailings and journal advertisements, should not be designed to camouflage their true nature.
2. Any promotional material published in journals, whether paid for or arranged by a pharmaceutical company, must clearly distinguish itself from editorial content.

Distinctive Promotion:

1. Promotional material funded or arranged by a company, particularly if it refers to the company's product by brand name, must adhere to the guidelines outlined in the Code.
2. Compliance with these guidelines is mandatory regardless of the level of editorial oversight over the published material.

Professional Presentation:

1. Promotional material should adhere to standards of good taste in both text and visuals.
2. It should acknowledge the professional status of recipients and avoid content that may cause offense.

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Respectful Representation:

1. Names or photographs of healthcare professionals should not be used in promotional material.

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Originality and Clarity:

1. Promotional material should not imitate the design or layout of other companies' materials in a way that could mislead or confuse.

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Transparency and Accuracy:

1. The date of printing or last review of promotional material should be included where appropriate.
2. Audio-visual material should be accompanied by relevant printed material to ensure all requirements are met.

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Public Presentation:

1. Postcards, mailings, and envelopes should not contain content that could be viewed as advertising to the general public or deemed unsuitable for public viewing.

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Definition of Medical Representative:

1. A medical representative refers to sales representatives and other company representatives involved in promoting drugs to healthcare professionals, pharmacies, hospitals, or healthcare facilities.

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Ethical Standards:

1. Medical representatives must uphold high ethical standards in their duties and adhere to all relevant requirements of the Code.

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Prohibited Practices:

1. Medical representatives must not use inducement or subterfuge (dishonest) to secure interviews with healthcare professionals, nor should they pay for access to them.

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Company Responsibility:

1. Companies are responsible for the actions of their employees, including medical representatives, and must ensure compliance with the Code through appropriate clauses in employment contracts.

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Third-Party Compliance:

Third parties working for or on behalf of pharmaceutical companies must also have a thorough understanding of the Code if they engage in activities covered by it, including joint ventures and licensees.

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Brand Reminders and Free samples:

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Permissible Categories:

a. Brand reminders are allowed in two categories: informational and education items, and free samples provided by companies to medical professionals.

b. Informational and educational items include books, calendars, diaries, journals, dummy device models, and clinical treatment guidelines, with a value not exceeding Rs. 1000 per item. These items should not have independent commercial value for healthcare professionals.

c. Free samples of drugs can only be supplied to qualified prescribers, and samples must be handed directly to them or to an authorized person on their behalf. Details of the recipient must be recorded for records.

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Conditions for Providing Samples:

a. Samples are provided for creating awareness about treatment options and acquiring experience with the product.

b. Sample packs should be limited to prescribed dosages for up to three patients for the required course of treatment.

c. Each sample should be marked as "free medical sample not for sale" or with a similar legend.

d. Each sample pack should not exceed the smallest pack available in the market.

e. An adequate system of accountability and control must be maintained for sample distribution.

f. Certain drugs, such as hypnotics, sedatives, or tranquillizers, cannot be provided as samples.

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Record-Keeping and Limits:

a. Companies should maintain details of samples distributed, including product name, doctor name, quantity, date of supply, etc.

b. The monetary value of samples distributed should not exceed two percent of the company's domestic sales per year.

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Endorsement Clarification:

a. Receipt of brand reminders by healthcare practitioners does not constitute endorsement activity unless it involves recommending or issuing a statement about the brand.

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Tax Compliance:

a. Both the giver and recipient of brand reminders must comply with relevant provisions of the Income Tax Act, 1961, regarding deductions and reporting of income.

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Continuing Medical Education (CME) and Continuing Professional Development (CPD):

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Guidelines for Engagement:

Pharmaceutical industry engagement with healthcare professionals for CME, CPD, conferences, seminars, workshops, etc., should adhere to well-defined, transparent, and verifiable guidelines.

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Operational Framework:

a. Conducting events in foreign locations is prohibited.

b. Authorized entities to conduct CME/CPD meetings include medical colleges, teaching institutions, universities, hospitals, professional associations of doctors/specialists, research institutions, and pharmaceutical companies in collaboration with professional bodies and academic institutions.

c. Pharmaceutical companies should share event details and expenditures on their website and may be subject to independent audits.

d. Organizers must disclose participant and speaker selection procedures, funding sources, and expenditures on their website and may undergo special audits.

e. All entities involved must comply with relevant provisions of the Income Tax Act 1961.

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Support for Research:

These points outline the guidelines for industry-academia linkage and interaction between pharmaceutical companies and healthcare professionals to support research and innovation, ensuring compliance with regulatory requirements and ethical standards.

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Approval and Conduct:

Research or studies must have approval from competent authorities such as ICMR, DCGI, Ethics Committee, Institutional Authority, etc., and should be conducted at recognized sites or locations as applicable. Compliance with instructions from relevant bodies like NMC is required.

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Engagement of Healthcare Professionals:

Healthcare professionals may be engaged in consultant-advisory capacity for bona fide research services under a consultancy agreement, involving consultancy fees or honorarium-based payments. These engagements must adhere to relevant provisions of the Income-Tax Act, 1961, ensuring patient interests are not compromised and healthcare professional integrity is maintained according to NMC regulations.

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Expenditure on Research:

Expenditure on research by pharmaceutical companies is considered allowable expenditure, subject to provisions of the Income Tax Act, 1961, as amended from time to time.

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Relationship with Healthcare Professionals:??

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Gifts:

Pharmaceutical companies or their agents, including distributors, wholesalers, and retailers, should not offer or provide gifts for the personal benefit of any healthcare professional or their family members (extended also). Similarly, no pecuniary advantage or benefit in kind should be offered or promised to any person qualified to prescribe or supply drugs.

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Travel:

Companies or their representatives should not provide travel facilities, including rail, air, ship, or cruise tickets, paid vacations, etc., to healthcare professionals or their family members for attending conferences, seminars, workshops, etc., unless the person is a speaker for a CME or CPD Program.

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Hospitality:

Companies or their representatives should not offer hospitality such as hotel stays, expensive cuisine, resort accommodations, etc., to healthcare professionals or their family members unless the person is a speaker for a CME or CPD program.

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Monetary Grants:

Companies or their representatives should not provide cash or monetary grants to any healthcare professional or their family members under any pretext.

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Complaints:

Transfer of Complaints:

1. If a complaint received by a particular association is not related to its members, the association will record the details of the complaint and transfer it to another association where the respondent company is a member.

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Handling by Non-Members or Multiple Members:

1. Complaints concerning companies that are not members of any association or are members of multiple associations should be addressed by the Pharmaceutical Industry Association to which the complainant has directed the complaint. Guidance may be sought from the Department of Pharmaceuticals as needed.

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Procedure for Handling Complaints:

Authorization Requirement:

1. Complaints from pharmaceutical companies must be signed or authorized in writing by the company's managing director, chief executive officer, or an individual at an equivalent level.

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Media Reports as Complaints:

1. If it is evident from media reports (excluding letters to the editor) that a company may have violated the Code, the matter can be considered as a complaint. The committee may request additional information from the relevant publication, and the source or correspondent of the report may be treated as the complainant.

The Committee should take decision within 90 days of the receipt of complaint, promptly notify the parties of its decision, the reasons thereof in writing and send it by recorded mail.

In conclusion, adherence to the UCPMP 2024 is essential for maintaining ethical standards in pharmaceutical marketing practices. Compliance ensures transparency, accuracy, and professionalism in drug promotion activities, ultimately benefiting both healthcare professionals and patients.