Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024
The Department of Pharmaceuticals, Government of India released the Uniform Code for Pharmaceutical Marketing Practices (UCPMP). These guidelines aim to regulate the marketing and promotion of pharmaceutical products in India, ensuring fair practices and protecting public health.
Applicability of UCPMP
- It is applicable to promotion and marketing activities undertaken by pharmaceutical and medical device companies manufacturing or dealing with the sale and distribution of such products. (Provision 14.2)
- Third parties working for or on behalf of the pharmaceutical companies, including those acting on their behalf (such as joint ventures and licensees), that are commissioned to engage in activities are covered by this Code, and should also have a sound working knowledge of this Code. (Provision 4.5)
- The Chief Executive Office of the company is responsible for adherence of the code. In such pursuit, he/she is obligated to submit the self-declaration form (Annexure to UCPMP 2024) regarding the compliance of the code within two months after the end of every financial year to the association, or directly on the UCPMP portal of the DoP, if not a member of such association or any other associations. (Provision 14.4)
Key Highlights
|
Features |
Brief Description |
| Brand Reminders |
The UCPMP 2024 allows companies to offer brand reminders of their products to Healthcare Professionals (HCPs) under two categories: (i) Informational and educational items, (ii) Samples.
Pharmaceutical companies can offer doctors informational items like e-journals and dummy models as brand reminders, but each item’s value can’t exceed Rs. 1000. They must also keep records of all samples given, including product name, doctor’s name, quantity, date, and total value. The value should not exceed 2% of the annual domestic sales.
|
| Continuing Medical Education |
The Code mandates that expenditure by the pharmaceutical industry on Continuing Medical Education (‘CME’), Continuing Professional Development (‘CPD’), conference, workshop, etc., should only be through a well-defined, transparent and verifiable set of guidelines
|
| Support for Research |
Engagement of healthcare professionals in consultant-advisory capacity shall be for bona-fide research services, under a consultancy agreement involving a consultancy fee or an honorarium-based payment, subject to the relevant provisions of the Income-Tax Act, 1961.
|
|
Relationship with HCPs |
The Code strictly prohibits pharmaceutical companies and their agents (i.e. distributors, wholesalers, retailers, etc.) from offering or providing gifts for personal benefit of any HCPs or their family members (both immediate and extended). Similarly, it prohibits the offering, supplying, or promising of any pecuniary advantage or benefit in kind to any person qualified to prescribe or supply drugs.
|
| Sample Packs |
A company may offer a doctor up to 12 sample packs of medicines each year. However, these sample packages should be properly marked as ‘not for sale.’ The monetary value of samples distributed by a company should not exceed 2% of its domestic sales.
|
| Claims and Comparisons of Drugs
|
The claims and comparisons of drugs must be factual, fair, and capable of substantiation. |
| Ethics Committee for Pharma Marketing Practices
|
It is mandatory for all Indian Pharmaceutical Associations to upload the UCPMP on their website along with the detailed procedure for lodging of
Complaints. The UCPMP website of the associations must be linked to DoP’s UCPMP portal.
|
| Ethics Committee for Pharma Marketing Practice |
The code provides for constitution of an “Ethics Committee for Pharma Marketing Practices (ECPMP)”, to be chaired by the Chief Executive Officer (CEO) of every association.
|
Conclusion
The UCPMP 2024 is a crucial step towards regulating the pharmaceutical industry, which currently wields significant influence over public health. In addition to meeting its ethics mandates, Companies will now also have to ensure audit readiness.
Disclaimer: This is an effort by Lexcomply.com, to contribute towards improving compliance management regime. User is advised not to construe this service as legal opinion and is advisable to take a view of subject experts.
