The Uniform Code of Pharmaceutical Marketing Practices 2024 (UCPMP 2024) is a set of ethical guidelines issued by India's Department of Pharmaceuticals (DoP) to govern the marketing and promotion of pharmaceutical products to healthcare professionals and consumers in the country. It aims to ensure transparency, accuracy, and integrity in pharmaceutical advertising while preventing misleading claims, unethical inducements, and conflicts of interest. The code outlines standards for interactions with healthcare professionals, restrictions on promotional gifts, ethical advertising practices, and responsible patient education. Similar regulatory frameworks exist globally, including the PhRMA Code in the United States and the EFPIA Code of Practice in the European Union.
The UCPMP is an extension of the Uniform Code for Pharmaceuticals Marketing Practices 2015 (UCPMP 2015), which took effect on 1 January 2015. Although there were long-standing expectations that the 2015 Code would be legally enforced, it remained a voluntary guideline for pharmaceutical companies to follow in their marketing practices. [1]
In March 2024, DoP released the Uniform Code of Pharmaceutical Marketing Practices 2024. [2] [3]
In September 2024, the code was expanded to include medical device manufacturing companies. [4] [5]
The Ethics Committee for Pharma Manufacturing Practices (ECPMP) is responsible for handling violations of the UCPMP, with penalties ranging from suspension to corrective actions. Appeals can be made to an Apex Committee under the DoP, which has the authority to uphold, modify, or overturn decisions. Also, the May 2024 circular issued by the DoP, confirmed that the self-declaration form applies to the 2024–25 fiscal year (FY25), effectively granting these guidelines a quasi-statutory status. [7]
Pharmaceutical marketing is a branch of marketing science and practice focused on the communication, differential positioning and commercialization of pharmaceutical products, like specialist drugs, biotech drugs and over-the-counter drugs. By extension, this definition is sometimes also used for marketing practices applied to nutraceuticals and medical devices.
In drug development and production, good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.
Continuing medical education (CME) is continuing education (CE) that helps those in the medical field maintain competence and learn about new and developing areas of their field. These activities may take place as live events, written publications, online programs, audio, video, or other electronic media. Content for these programs is developed, reviewed, and delivered by faculty who are experts in their individual areas. Similar to the process used in academic journals, any potentially conflicting financial relationships for faculty members must be both disclosed and resolved in a meaningful way. However, critics complain that drug and device manufacturers often use their financial sponsorship to bias CME activities toward marketing their own products.
A medical writer, also referred to as medical communicator, is a person who applies the principles of clinical research in developing clinical trial documents that effectively and clearly describe research results, product use, and other medical information. The medical writer develops any of the five modules of the Common Technical Document. The medical writers also ensure that their documents comply with regulatory, journal, or other guidelines in terms of content, format, and structure.
The Association of the British Pharmaceutical Industry (ABPI) is the trade association for over 120 companies in the UK producing prescription medicines for humans, founded in 1891. It is the British equivalent of America's PhRMA; however, the member companies research, develop, manufacture and supply medicines prescribed for the National Health Service.
Marketing ethics is an area of applied ethics which deals with the moral principles behind the operation and regulation of marketing. Some areas of marketing ethics overlap with media and public relations ethics.
The ethics involved within pharmaceutical sales is built from the organizational ethics, which is a matter of system compliance, accountability and culture. Organizational ethics are used when developing the marketing and sales strategy to both the public and the healthcare profession of the strategy. Organizational ethics are best demonstrated through acts of fairness, compassion, integrity, honor, and responsibility.
Fee splitting is the practice of sharing fees with professional colleagues, such as physicians or lawyers, in return for being sent referrals.
Sun Pharmaceutical Industries Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) in more than 100 countries across the globe. It is the largest pharmaceutical company in India and the fourth largest specialty generic pharmaceutical company in the world. The products cater to a vast range of therapeutic segments covering psychiatry, anti-infectives, neurology, cardiology, diabetology, gastroenterology, ophthalmology, nephrology, urology, dermatology, gynecology, respiratory, oncology, dental and nutritionals.
Medical education agencies are a specialty subset of advertising agencies that develop educational content for the Healthcare, Life Science and Biotechnology industries. Medical education agencies are divided into two categories:
Medical ghostwriters are employed by pharmaceutical companies and medical-device manufacturers to produce apparently independent manuscripts for peer-reviewed journals, conference presentations and other communications. Physicians and other scientists are paid to attach their names to the manuscripts as though they had authored them. The named authors may have had little or no involvement in the research or writing process.
PharmedOut (PhO) is a Georgetown University Medical Center project founded in 2006. It is directed by Adriane Fugh-Berman. The stated mission of the organization is to advance evidence-based prescribing and educate healthcare professionals about pharmaceutical marketing practices.
Pharmaceutical fraud is when pharmaceutical companies engage in illegal, fraudulent activities to the detriment of patients and/or insurers. Examples include counterfeit drugs that do not contain the active ingredient, false claims in packaging and marketing, suppression of negative information regarding the efficacy or safety of the drug, and violating pricing regulations.
Kenneth John Harvey AM is an Australian public health doctor, currently Honorary Adjunct Associate Professor at the Institute for Evidence-Based Healthcare in Bond University. Described by The Age as an "anti-quackery crusader", Harvey is an advocate of evidence-based medicine and a critic of pharmaceutical marketing and unproven diet products. He is the president of Friends of Science in Medicine. In 2017, Harvey was awarded a Member of the Order of Australia (AM) for his "significant service to community health and the pharmaceutical industry”.
The medical–industrial complex (MIC) refers to a network of interactions between pharmaceutical corporations, health care personnel, and medical conglomerates to supply health care-related products and services for a profit. The term is derived from the idea of the military–industrial complex.
Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP) (transl. Prime Minister’s Indian Public Medicine Scheme) is a campaign and public welfare scheme of the Government of India, launched in 2008 as the Jan Aushadhi Scheme by the Ministry of Chemicals and Fertilizers. The initiative was rebranded in 2016 as the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) to expand its scope and strengthen its mission of providing quality generic medicines at affordable prices to the public.
MedPage Today is a medical news-focused site owned by Ziff-Davis, LLC. It is based in New York City, and is geared primarily toward medical and health professionals.
Innovative Medicines Canada (IMC) is a national association of pharmaceutical companies that represents the interests of the research-based pharmaceutical industry in Canada. Its membership includes biopharmaceutical companies, vaccine developers, and manufacturers of medical devices, and works with government agencies, insurance companies, healthcare professionals and other stakeholders in the regulation and promotion of medicines.
The Pharmaceutical Advertising Advisory Board (PAAB) is a Canadian not-for-profit organization based in Pickering, Ontario. Acting as a pseudo-regulatory body, PAAB offers review and pre-clearance services recognized by Health Canada to pharmaceutical companies and marketing agencies who wish to advertise directly to consumers and/or healthcare professionals. It is financed on a fee-for-service basis.
Harshit Jain is a physician and entrepreneur. He is the founder and Global CEO of Doceree, a company that operates physician-only platforms for programmatic marketing.
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