In a significant move to promote transparency and ethical conduct within the pharmaceutical sector, the Union government recently enacted the Uniform Code for Pharmaceutical Marketing Practices (UCPMP). This comprehensive code aims to rein in unethical practices while fostering a culture of integrity and accountability among pharmaceutical companies.
Stakeholders say that pharma manufacturers have traditionally induced doctors to prescribe their products in this fragmented market. Most recently, in the US, Purdue Pharma was found be bribing doctors to promote its opioid product Oxycontin. It was promoted as a non–addictive pain medication. This product is considered to be among the prime culprits behind America’s opioid crisis, which has killed over 4,50,000 people in the past two decades.
What are the new pharma marketing rules?
On March 12, 2024, the Department of Pharmaceuticals (DoP) issued a policy communication to all pharmaceutical associations, enclosing the Uniform Code for Pharmaceutical Marketing Practices 2024 (UCPMP 2024).
Regarding advertisements, the rules prohibit inflated claims and comparison of products and distortion of facts. In. The term "safe" mandates contextual qualification, while absolute assertions regarding absence of side effects, toxicity, or addiction risk are prohibited. Comparative analyses between products must uphold factual accuracy, fairness, and verifiability, avoiding distortion, undue emphasis, omissions, or similar misleading tactics, the rules state. Use of brand names from other companies in comparisons requires prior consent, and direct or implied disparagement of competitors or their offerings is strictly prohibited.
Regarding marketing of products to healthcare professionals, “Companies or their representatives, or any person acting on their behalf, should not extend hospitality like hotel stay, expensive cuisine, resort accommodation etc., to healthcare professionals or their family members," the government said in the notification issued on March 12. It added that travel facilities inside or outside the country, including rail, air, ship, cruise tickets, paid vacations, etc. were also not permitted.
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Free samples of drugs shall not be supplied to any person who is not qualified to prescribe such a product, according to the new rules. If such samples are provided, they should be marked "free medical sample not for sale" and should not be larger than the smallest pack present in the market
On December 12, 2014, the central government had released the Uniform Code of Pharmaceutical Marketing Practices to be voluntarily adopted and complied by pharma industries with respect to marketing practices. It said that if the code is not found to be effectively implemented by pharma associations/companies, the government may consider making it a statutory code.
What are the duties of industry associations and company managements?
All Indian Pharmaceutical Associations will publish the UCPMP on their websites, including the procedure for lodging complaints, linked to the Department of Pharmaceuticals' UCPMP portal. Each association will form an "Ethics Committee for Pharma Marketing Practices (ECPMP)" chaired by its CEO, with three to five members. Complaint details, such as nature, company accused, current status, and actions taken by the ECPMP, will be shared on association websites for five years. Violators face suspension, expulsion, or a public reprimand.
Additionally, for more severe lapses, the association can request the concerned government ministry to take action. “In cases where disciplinary, penal, or remedial action lies within the domain of any agency or authority of the Government, in accordance with the statute, the Committee may send its recommendations to such agency or authority through the Department of Pharmaceuticals,” the notification reads.
The chief executive officer of the pharmaceutical company will be responsible for adherence to the code. He must submit an annual self-declaration form to associations or directly to the government's UCPMP portal.
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How has the industry reacted?
Industry associations and analysts have welcomed the move to end freebies in the sector. “It is a step towards industry advancement, prioritising superior patient care and adhering to established norms,” said Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance.
The Association of International Pharmaceutical Producers also expressed hope in the new rules. “The emphasis on informational and educational items, with a capped value, represents a balanced approach that prioritises knowledge dissemination and enhancement,” said Anil Matai, Director General, Organisation of Pharmaceutical Producers of India, (OPPI). The association added that it looks forward to the development of well-defined guidelines for engagements such as Continuing Medical Education and conferences as the guidelines would underscore the importance of transparent collaboration between the industry and healthcare professionals for better patient care.
However, analysts note that there are still a few grey areas in the rules. “While the Code largely retains the contents of the previous code with certain modifications, it additionally addresses crucial topics such as brand reminders, CMEs, and support for research. Nonetheless, further clarity may be necessary regarding its interplay with other regulations,” wrote analysts at Deloitte.
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