Uniform Code for Pharmaceuticals Marketing Practices, 2024

On December 12, 2014, the central government, under the oversight of CDSCO, released the Uniform Code of Pharmaceutical Marketing Practices, intended to be voluntarily complied with by pharma industries with respect to marketing practices in India. It was mentioned in the code that if the code is not implemented by the companies, the Government may consider converting it to a statutory code. The Indian Government’s Department of Pharmaceuticals has released the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) on 12th March 2024 (F.No.3 1026/23/2022-Policy) and has directed all Associations to constitute an Ethics Committee specifically for Pharmaceutical Marketing Practices (ECPMP), create a UCPMP-dedicated portal on their websites, and undertake necessary measures to ensure the implementation of this Code, reflecting a comprehensive regulatory framework.

In a nutshell

Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) 2024

1. General Points

As per the ‘Ethical Criteria for Medicinal Drug Promotion’ endorsed by the World Health Assembly in 1988, “Promotion” refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medical drugs.
Drug promotions cannot occur before marketing approval is granted
Drug information must be accurate, current, and cannot mislead. Ensuring up-to-date information often requires adherence to MD-14 documentation practices.

2. Claims & Comparisons

Claims regarding a drug’s efficacy must be up to date and available on request .
The term “safe” should always come with qualifications; assertions that a drug is without side effects, toxicity and risk addiction must be substantiated through regulatory approvals.
The label “new” cannot be used for drugs available or promoted in India for over a year unless registered as such under new CDSCO guidelines.
Drug comparisons should be factual, equitable, and verifiable, avoiding misleading through distortion, emphasis, omission, or other means.
Brand names from other companies can only be used in comparisons with prior approval from those companies.
It’s prohibited to disparage other companies, their products, services, or promotions, whether directly or indirectly.
The clinical or scientific opinions of healthcare professionals must not be disparaged either directly or by implication.

3. Textual and Audio-Visual Promotion

Promotional materials from or approved by the authorization holder must align with this Code’s standards
To inform prescribers, promotional content must clearly provide essential information, including:
- The drug’s details, the authorization holder’s name and address, or the marketing entity’s details.
- The drug’s name and a list of active ingredients, with generic names prominently near the drug’s name, aligned with the latest MD-14 requirements.
- Recommended usage, dosage, and, if not clear, the administration method.
- Information on adverse reactions, warnings, usage precautions, and significant contraindications.
- A note that more information is available upon request and the date of the information’s creation or last update.

Mailings and ads must transparently be promotional, especially in journals sponsored by pharmaceutical companies.
Promotions in journals, regardless of editorial control, must adhere to these guidelines if sponsored by the product’s company.
Promotions must conform both in text and illustration and also respect the professional nature of the audience, avoiding offensive content.
Using healthcare professionals’ names or photos in promotions is not allowed.
Promotions must not copy other companies’ slogans or designs in a misleading or confusing manner.
The printing or review date should be included in technical and informational materials, aiding in the proper registration and tracking of medical device information through SUGAM.
Public mailings must not contain advertising visible to non-professionals or inappropriate content.
Audio-visual materials need printed support to ensure compliance with this Code’s requirements.

4. Medical Representatives

The term “medical representative” means sales representatives (including personnel retained by way of contract with third parties) and other company representatives who call on healthcare professionals, pharmacies, hospitals, or healthcare facilities in connection with promotion of drugs.
Medical representatives must maintain high ethical standards and adhere strictly to this Code.
Representatives should not use incentives or deceit to secure appointments, nor should they pay for access to healthcare professionals.
Companies must ensure their representatives, including those contracted, follow this Code, reinforced by contractual obligations.
External parties, like joint ventures or licensees working on pharmaceutical promotions, must also understand and comply with this Code.

5. Brand Reminder Guidelines

Brand Reminders are permitted in the following two categories, (i) Informational and education items and (ii) Free samples
Informational and Education Items: Includes books and guidelines for healthcare use, valued under Rs. 1000, without commercial benefit to professionals.
Free Samples: (i) For qualified prescribers (ii) When samples are handed over to qualified prescribers – name and address of this professional must be maintained
Accepting brand reminders does not constitute professional endorsement.
Both parties must comply with the Income Tax Act, 1961, for financial declarations and deductions.

6. Continuing Medical Education

Pharmaceutical interactions with healthcare professionals for Continuing Medical Education (CME), Continuing Professional Development (CPD) must follow transparent, auditable guidelines.
Key guidelines include:
- Location Restrictions: Events must not be held abroad.
- Authorized Organizers: Only specified medical institutions, professional bodies, and pharmaceutical entities (alone or in collaboration).
- Transparency: Companies and organizers must publicly report event details and finances, subject to audits.
- Tax Compliance: All involved must adhere to the Income Tax Act 1961.

7. Guidelines for Research Support

To provide research and innovation through industry-academia collaborations, pharmaceutical interactions with healthcare professionals are subject to the following:

Approval and Compliance: Research must have necessary approvals (e.g., ICMR, DCGI) and adhere to directives from bodies like the NMC, conducted at recognized venues.
Consultation Engagements: Healthcare professionals can serve as consultants for genuine research, under agreements that ensure patient interests and professional integrity, with payments compliant with the Income Tax Act 1961.
Research Expenditure: Pharmaceutical companies’ research spending is permissible under the Income Tax Act 1961.

8. Relationship with Healthcare Professionals

Relationships with healthcare professionals are subject to strict regulations:

Gifts: No personal gifts, monetary gains, or benefits in kind should be given to healthcare professionals or their relatives by pharmaceutical entities or their intermediaries.
Travel: Provision of travel accommodations for healthcare professionals or their families for attending events is prohibited unless they are speakers at CME or CPD programs.
Hospitality: Offering luxurious hospitality to healthcare professionals or their families is not allowed, except for speakers at educational programs.
Monetary Grants: Direct financial incentives to healthcare professionals or their families are strictly forbidden.

9. Ethics Committee for Pharma Marketing Practices

Indian Pharma Associations will post the UCPMP and complaint procedures online, linking to the Department of Pharmaceuticals’ portal.
An “Ethics Committee for Pharma Marketing Practices (ECPMP)” will be established in each association, led by the CEO, with 3-5 members vetted by the board and listed on the website.
Complaints unrelated to an association’s members will be transferred to the appropriate association.
Complaints against non-member companies, or those in multiple associations, are handled by the initially contacted association, with potential guidance from the Department of Pharmaceuticals.
Associations will publicly detail complaints, actions taken, and outcomes on their websites and the UCPMP portal for five years.

10. Filing Complaints Overview

Complaints about Code breaches must be directed to the Ethics Committee for Pharma Marketing Practices (ECPMP)”, “Chief Executive Officer”, “Name of Association”.
Complaints should be consolidated and filed within six months of the breach, with a six-month extension for justified delays.
Written complaints require:
- The complainant’s identification and contact information.
- Identification of the alleged breaching company and involved personnel or products.
- Detailed account of the breach, including dates, violated Code sections, and evidence.

A non-refundable fee of Rs. 1,000 must accompany the complaint, with payment instructions available on the association’s website. Pseudonymous, anonymous, or unpaid complaints will not be processed.
Complaints from pharmaceutical companies must be officially signed by a senior executive.
Public media reports of breaches, except for editorial letters, can initiate a complaint process, with the Ethics Committee possibly seeking more information.
Complaints received by the Department of Pharmaceuticals may be redirected to the relevant association for action, potentially leading to a special audit.

11. Handling of Complaints

The Ethics Committee for Pharma Marketing Practices (ECPMP) handles enquiry processes, with decisions made by majority.
If potential breaches are identified, the implicated company’s CEO will be asked for a detailed response.
The Committee may guide the company on necessary supporting materials to ensure comprehensive responses within set deadlines.
Professional auditors may assist associations for thorough and unbiased evaluations.
Companies must respond with comments and evidence within 30 days of notification.
Even if believing there’s no breach, companies should provide evidence.
Decisions are made within 90 days, with written notifications sent to involved parties.
If no breach is found, or the issue falls outside the Code, the complainant is informed and directed to the appropriate forum.
For confirmed breaches, both complainant and company are informed in writing, including required corrective actions.
Without appeals within the designated period, ECPMP’s decision is final, with compliance necessary for association membership. Decisions will be published online.

12. Penalties and Reference:

Once it has been established that a breach of the code has occurred, the following actions can be undertaken by the committee:

Suspension of the entity from the Association.
Reprimand the entity and publish the details
Obligation to publish a corrective statement in the same and additional appropriate media, pending Committee approval.
Must retrieve any items or funds given in violation and report the action to the Committee.
For actions under government agency jurisdiction, recommendations are forwarded through the Department of Pharmaceuticals.

13. Appeal

Dissatisfied parties (complainant or respondent) can appeal ECPMP decisions (including no decision or delays) to the Apex Committee for Pharma Marketing Practices (ACPMP), led by the Department of Pharmaceuticals Secretary with a Joint Secretary and Finance Officer as members.
Appeals must be filed within 15 days, with an extra 15-day grace period for justified delays, documented in writing.
ACPMP notifies involved parties, conducts a fair hearing, and delivers a final verdict within six months.
The ACPMP has the authority to impose penalties or refer the matter to government agencies, as outlined in section 12.
The ACPMP’s appeal decision is final and obligatory for all parties.

14. Miscellaneous

The Department of Pharmaceuticals can issue updates or clarifications, integrated into the Code.
Applies also to medical devices and related businesses, excluding exemptions or specific modifications.
A recognized panel of auditors will be established for compliance assessment.
CEOs must annually affirm compliance, submitting a declaration to their association or directly to the UCPMP portal.

Conclusion

The Uniform Code for Pharmaceuticals Marketing Practices 2024, issued by the Department of Pharmaceuticals, sets guidelines for ethical pharmaceutical marketing, covering medical representatives, brand reminders, free samples, Continuing Medical Education (CME), and interactions with Healthcare Professionals (HCPs). It prohibits CMEs in foreign locations, mandates transparency in HCP research engagements, and forbids personal benefits to HCPs. Morulaa can assist companies in adhering to these guidelines, ensuring ethical marketing strategies and compliance with regulations. Contact us for more details on our registration and regulatory services, including guidance on MD-14, SUGAM, and CDSCO compliance for medical devices. Reach out at [email protected] or Click Here to know more.