Context: Ministry of Chemicals and Fertilizers has notified the Uniform Code for Pharmaceutical Marketing Practices, 2024 to curb unethical marketing of drugs and ban medical representatives from using inducements to access healthcare professionals. Before this, pharmaceutical industry was following UCPMP 2015 which was voluntary in nature. However, the new UCPMP 2024 is quasi-judicial in nature.
SALIENT FEATURES OF UNIFORM CODE FOR PHARMACEUTICAL MARKETING PRACTICES 2024
- According to 'Ethical Criteria for Medicinal Drug Promotion, 1988' of WHO, '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 drugs.
- Promotion of a drug must be consistent with the terms of its marketing approval and a drug must not be promoted prior
Medical Representatives
- Medical Representatives are sales representatives and other company representatives who call on healthcare professionals, pharmacies, hospitals or healthcare facilities in connection with promotion of drugs.
- Medical representatives must not employ any inducement or subterfuge to gain an interview. They must not pay, under any guise, for access to a healthcare professional.
- Companies are responsible for the activities of their employees, including the medical representatives, for ensuring compliance of this Code.
Brand Reminders
Brand Reminders are permitted in two categories
- Informational and education items including books, calendars, diaries, journals (including digital), dummy device models and clinical treatment guidelines for professionals used in healthcare settings value of which does not exceed Rs 1000 (One thousand) per item. Such items should not have an independent commercial value for healthcare professionals
- Free samples provided by the companies to medical professionals:
- Free samples of drugs shall not be supplied or directly handled to a who is not qualified to prescribe such a product.
- Such samples should be provided only for creating awareness about treatment options and for acquiring experience in dealing with the product.
- Such samples should be limited to prescribed dosage for not more than three patients for the required course of treatment.
- Each sample should be marked 'free medical sample not for sale' or bear another legend of analogous meaning.
- Each sample should not be larger than the smallest pack present in the market.
- Sample of a drug which is hypnotic, sedative or a tranquilizer should not be given.
- Each company should maintain details such as product name, doctor name, quantity of samples, date of supply of free samples to healthcare professionals etc.
- Monetary value of samples distributed should not exceed 2% of domestic sales of the company per year.
Continuing Medical Education
- Engagement of pharmaceutical industry with healthcare professionals for Continuing Medical Education (CME), Continuing Professional Development (CPD) or otherwise for conference, seminar, workshop etc. should only be allowed through a well-defined, transparent and verifiable set of guidelines.
- Conduct of such activities in foreign locations is prohibited.
- All pharmaceutical companies should share details of such activities on their website and may be subject to independent, random or risk-based audit.
Support for Research
Pharmaceutical companies can provide rational support and encouragement to research and innovation through industry-academia linkage subject to following conditions:
- The research study should have requisite approval from competent authority (ICMR, DCGI, Ethics Committee, Institutional Authority, NMC etc.) and is conducted at a recognised site or location.
- Engagement of healthcare professionals in consultant-advisory capacity shall be for bonfide research services, under a consultancy agreement involving a consultancy fee or an honorarium-based payment.
- Expenditure on research by pharmaceutical companies is an allowable expenditure subject to provisions of Income Tax Act, 1961.
Relationship with Healthcare Professionals
- No gifts should be offered or provided or promised for personal benefit of any healthcare professional or family members by any pharmaceutical company or its agents.
- No travel facilities inside or outside the country should be extended to healthcare professionals or their family members by pharma companies or their representatives except the person is a speaker for a CME or a CPD program.
- No hospitality like hotel-stay, expensive cuisine, resort accommodation etc. should be extended to healthcare professionals or their family members by pharma companies and their representatives except when the person is a speaker for a CME or a CPD program.
- No cash or monetary grant should be extended to any healthcare professional or their family members under any pretext.
Compliance of UCPMP 2024 by Pharmaceutical Associations
- All complaints related to an activity of breach of the Code should be made within six months of the alleged of the breach of the Code, with an additional delay of 6 months. Complainant should identify himself, the pharma company and details of breach of the Code.
- A non-refundable amount of Rs 1,000 is to be deposited by the complainant along with complaint.
- All Indian Pharmaceutical Associations will form a committee for handling complaints as 'Ethics Committee for Pharma Marketing Practices (ECPMP), in each Association to be chaired by its Chief Executive Officer. The Committee will have 3-5 members and its composition will be approved by the Board of Association.
- ECPMP will conduct enquiry and decisions of the committee should be taken by majority
- Penalties: Once it is established that a breach of UCPMP 2024 has taken place by an entity, the ECPMP can propose one of the following against the erring entity:
- Suspend or expel the entity from the Association
- Reprimand the entity and publish full details of such reprimand.
- Require the entity to issue a corrective statement in the same or other suitable media.
- Ask the entity to recover money or items, given in violation of Code from the concerned person/s.
- In cases where disciplinary, penal or remedial action lies within the domain of any agency or authority of Government in accordance with statute, the ECPMP may send its recommendations to such agency or authority through the Department of Pharmaceuticals.
- Appeal against UCPMP 2024
- If a party to the complaint is dissatisfied with the decision of ECPMP, it may file an appeal before the Apex Committee for Pharma Marketing Practices (ACPMP) to be headed by Secretary, Department of Pharmaceuticals, having a Joint Secretary and a Finance Officer as its members.
- Appeals against the order of ECPMP must be ordinarily filed within 15 days with an additional 15 days of reasonable time delay permitted for reasons to be recorded in writing



