In brief: India's 2024 Code prescribing Marketing Practices for the Pharma Industry

published on 24 April 2024 | reading time approx. 2 minutes

In March 2024, India introduced the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024. It updates regulations for pharmaceutical marketing, emphasizing executive accountability, setting limits on promotional items and samples, outlining guidelines for engagement with medical practitioners, and establishing an Ethics Committee for handling complaints. Pharmaceutical associations are expected to enforce the Code strictly, prompting businesses to align their practices accordingly.

In March 2024, the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024 (“Code”) was notified to pharmaceutical associations in India. The Code applies to manufacturers, agents, wholesalers, and distributors of medicinal drugs as well as medical devices, unless specifically exempted.

While the Code is substantially similar to the UCPMP notified in the year 2014, it appears to clarify aspects of the pharma industry’s relationship with medical practitioners to correspond with obligations from the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 governing registered medical practitioners in India.

Notably, the Code makes the executive head of a company responsible for its adherence and a self-declaration to that effect is required to be submitted at the close of every financial year by every company falling in the purview of the Code.

The Code can be divided into four major sections as follows for ease of understanding:

The opening section deals with claims on the usefulness of a drug and comparisons of drugs as well as textual and audio-visual promotional material. The provisions are intended to ensure that promotion of a drug is consistent with the terms of its marketing approval.
Next, the Code deals with medical representatives and distribution of brand reminders by them. It specifies who shall be construed as medical representatives, the standard of their conduct, and holds the companies engaging them responsible for the activities they carry out. Particularly, the Code here introduces that the value of any informational and educational items distributed as brand reminders shall not exceed INR 1,000.00 per item, while having no independent commercial value for the medical practitioner receiving it. It also introduces a distribution limit of twelve sample packs per drug to a medical practitioner in a year as well as a monetary value limit on sample distribution being 2 percent of the domestic sales of the company per year.
Further, the Code specifies the framework for engagement of the pharma industry with medical practitioners for continuing medical education, support for research through industry-academia linkage, and relationship with medical practitioners in terms of extending travel and hospitality facilities. It prohibits monetary and non-monetary gifts as well as monetary grants under any pretext for personal benefit to a medical professional or their immediate and extended family member.
In the final section, the Code establishes the complaints procedure. It provides for the formation of an Ethics Committee for Pharma Marketing Practices (ECPMP) in each pharma industry association in India which shall decide complaints alleging breach of the Code. The ECPMP is mandated to give its decision in a timebound manner, and the Code provides actions that it can take against an erring entity. An appeal from its decision rests with the Apex Committee for Pharma Marketing Practices (ACPMP) which shall be headed by the Secretary of the Department of Pharmaceuticals of the Government of India.

The Code is expected to be disseminated and implemented strictly by pharmaceutical associations in India. As a result, businesses are recommended to ascertain areas of concern, and prioritize review of their marketing policies, promotional material, contracts with medical representatives, etc. to comply with the Code.