The Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024 was released by the Ministry of Chemicals and Fertilisers, Department of Pharmaceuticals, in March 2024. The UCPMP has been released to prevent unethical practices and ensure transparency, integrity, and accountability in the marketing of pharmaceutical and medical devices throughout India. In this sense, the UCPMP 2024 is successor to the UCPMP 2014, which was the government's first attempt to allow self-regulation within the industry. Although fundamentals of the 2024 Code are still the same as those of the 2014 code, there have been some minor adjustments made to the latter that have raised issues and worries in the industry.
Main Points of the 2024 Code
Promotion of drugs According the UCPMP, '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.
A drug cannot be promoted before receiving marketing approval from the competent authorities, who authorise its sale or distribution. Promotion of a medicine must comply with the conditions of that approval.
Drug-related information has to be fair, up-to-date, verifiable, readily available, and free from implicit or direct deception. It further needs to accurately reflect current knowledge or responsible opinion and be able to be substantiated, which needs to be made available without any delay upon request from members of medical and pharmaceutical professions. Claims for usefulness should be based on evidence, and safety claims should be qualified.
Promotional materials must adhere to the 2024 Code and provide information to the healthcare professionals (HCPs) for making correct decisions. The information should include drug names, generic names, authorisation holder’s names, active ingredients, recommended dosages, methods of use, adverse reactions, and warnings. Promotional materials must not resemble editorial material and should be in good taste, without using the names or photographs of HCPs. It should not contain advertising or be unsuitable for public view.
Role of MRs Medical representatives (MRs), including sales and company representatives, must not use inducement or subterfuge to gain interviews or pay for access to healthcare facilities under any guise. Pharmaceutical companies must ensure compliance of the 2024 UCPMP by including appropriate employment contracts with MRs and holding regular training sessions on the code for their HCPs. Even third parties working for pharmaceutical companies, including joint venture partners and licensees, must possess sound knowledge about the UCPMP 2024. Third parties must also undergo appropriate training to ensure compliance, with undertaking in contracts covering such relationship.
Brand reminders to HCPs The UCPMP 2024 permits companies to provide brand reminders of their products to HCPs in two categories: (i) informational and educational items and (ii) samples. As informational and educational items, HCPs could be provided with books, calendars, diaries, journals, dummy devices, and clinical treatment guidelines, etc., with a value cap of Rs 1,000 per item, by the pharmaceutical companies. Such reminders should not have an independent commercial value for healthcare providers. Similarly, samples can be provided to raise awareness about treatment options and gain experience with the product, subject to certain specific conditions. Companies should provide samples to HCPs in order to raise awareness about the treatment options and experience with the product. Samples should categorically be marked as ‘Free medical sample not for sale’. No samples for hypnotics, sedatives, or tranquilisers. The monetary value of the samples should not exceed two per cent of annual domestic sales of the company. Both the giver and the receiver should act as per the applicable tax laws. Samples should be handed over directly to qualified HCPs or the authorised to receive on their behalf. Companies should maintain accurate records of HCPs names, samples details, supply dates and address of HCPs. Brand reminders to HCPs may not be considered endorsements unless they provide a recommendation. Sample size should be as per the smallest pack available in the market.
Educational and developmental events Pharmaceutical companies could engage with HCPs for continuing medical education (CME) or continuing professional development (CPD) programmes or events. However, they have to follow clear, transparent, and verifiable guidelines. CME/CPD organisers include medical colleges, hospitals, professional associations, research institutions, pharmaceutical companies, and laboratories. Companies must have transparent guidelines for permissible expenditure, disclose event details on their website, disclose participant and speaker selection procedures, funding sources expenditure. Organisers have to comply with the Income Tax Act, 1961. Companies could not hold CME/CPD events at foreign locations.
Pharmaceutical companies and their agents are prohibited from offering gifts to HCPs, including their family members and providing monetary benefits to qualified drug prescribers or suppliers. Pharmaceutical companies and their representatives are not allowed to provide cash or monetary grants to HCPs or their family members under any pretext. Furthermore, travel facilities for conferences, seminars, workshops, and paid vacations should not be extended to HCPs or their family members, except for speakers for CME/CPD programmes. Hospitality facilities for speakers for a CME/CPD programme could be provided.
Research collaborations between companies and HCPs require approval from competent authorities, conducted at recognised sites and under consultancy agreements. HCP engagement is bona fide and companies could claim research expenditure as allowable.
Complaint procedure Indian pharmaceutical associations are required to upload the UCPMP and complaint procedures on their websites. They should link them to the Department of Pharmaceuticals' UCPMP portal. The Code establishes an Ethics Committee for Pharma Marketing Practices (ECPMP), chaired by the CEO, for handling violations under the UCPMP 2024. The ECPMP is required to have a strength of three to five members and the member strength has to the approved by the association's board. Pharma associations are required to maintain complaint and related information for five years on their website and upload it to the UCPMP portal of the Department of Pharmaceuticals. Complaints about companies without affiliations or with multiple affiliations should ordinarily be handled by the specific pharma industry association to whom such complaint is addressed, who could seek guidance from the Department of Pharmaceuticals, if needed. The time limit for registering the complaint is six months which could further be extended for a period of another six months by explaining the delay in writing.
A complaint must be in writing, detailing the complainant, company, products, activities, clauses, and evidence of the breach. It must be accompanied by a non-refundable fee of Rs 1000. The details of how to lodge complaints are provided in the UCPMP 2024. On receipt of the complaint, the ECPMP may request additional information from a media report, excluding editorial letters. It may consider the source or correspondent as the complainant. The ECPMP investigates UCPMP breaches and makes decisions based on a majority vote. The managing director or the CEO of the company against whom a complaint is made has to provide a complete response to the ethics committee within 30 days. The ECPMP has 90 days to take its decision.
In the event of any non-compliance, the ECPMP could propose the following actions against the erring entity:
- Suspend or expel such an entity from the association.
- Reprimand such entity and publish full details of the reprimand.
- Require such entity to issue a corrective statement in the same media.
- To ask such entity to recover money or items given in violation of the code.
- Where it deems any disciplinary, penal, or remedial action falls within the domain of any agency or authority of the government in accordance with statutory provisions, it may send its recommendations to such agency or authority through the Department of Pharmaceuticals.
Appeals against ECPMP decisions Appeals against ECPMP decisions are addressed to the Apex Committee for Pharma Marketing Practices (ACPMP) which is chaired by the Secretary, Department of Pharmaceuticals. The ACPMP could impose penalties or refer matters to governmental bodies. The appeal process is 15 days, with a final decision within six months. The CEO is responsible for adherence to the company's code, submitting a self-declaration form within two months of the end of each financial year to the association or the Department of Pharmaceuticals.
Conclusion
The UCPMP 2024 introduces a framework for regulating interactions between pharmaceutical companies and HCPs, with a focus on preventing undue influence on prescription practices. Despite criticisms, the UCPMP 2024 represents a significant step towards promoting transparency and accountability in pharmaceutical marketing.
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