The Narendra Modi government, in an effort to curb unethical practices, has made the new marketing code for pharmaceutical companies mandatory, departing from its previous voluntary status. The Department of Pharmaceuticals announced a new regulation on Tuesday that prohibits pharmaceutical companies from providing gifts, travel perks, and other benefits to doctors or their families. This marketing code, known as the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP), outlines the relationship between pharmaceutical companies and doctors. With the entire process now under government oversight, a new era of accountability and transparency is set to begin in the pharmaceutical industry, according to a top officer of the Modi government, Arunish Chawla, Secretary of the Department of Pharmaceuticals.
It is no longer voluntary; it is mandatory,” stated Chawla. “The entire process will be under government oversight. Now, any government agency or authority can be involved as per relevant statutes.” The department falls under the Ministry of Chemicals and Fertilizers and is responsible for formulating and implementing policies for the regulation of pharmaceuticals in India. Chawla highlighted a provision from the code under the subheading of penalties and references indicating the crucial role of the government in upholding the code.
The initiative to strengthen the UCPMP began in 2019 when Prime Minister Narendra Modi warned India’s top pharmaceutical companies to strictly adhere to marketing ethics and refrain from bribing doctors. This action was prompted by a report released by the NGO Support for Advocacy and Training to Health (SATHI), which revealed that medical representatives (MRs) were offering bribes such as overseas trips, high-end smartphones, and gadgets.
Record-keeping is emphasized in the new regulations, covering various aspects of marketing and promotions. From limiting the distribution of free drug samples to ensuring proper documentation of promotional activities, the code mandates stringent record-keeping by pharmaceutical companies. According to the new rules, samples of products must be distributed by a medical representative directly to the qualified prescriber or an authorized recipient on their behalf. Additionally, the name and address of the healthcare practitioner must be recorded for documentation purposes.
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The code also holds companies responsible for the actions of their employees, including medical representatives, and emphasizes the importance of compliance in employment contracts. While the code permits the use of Continuing Medical Education (CME) by pharmaceutical companies, it imposes restrictions to ensure transparency. CMEs are now limited to domestic locations such as medical colleges, teaching institutions, hospitals, and academic and research institutions, and companies are required to disclose details of such events on their websites.
The code prohibits pharmaceutical companies from offering gifts or travel facilities for personal benefit to healthcare professionals or their families. Hospitality, including hotel stays and expensive meals, can only be provided if the healthcare professional is a speaker at an event. Committees have been established to handle complaints, with each pharmaceutical association required to have an Ethics Committee for Pharma Marketing Practices (ECPMP), chaired by its Chief Executive Officer and approved by the association’s board.
Industry experts and veterans have expressed varying opinions on the implications of the new code. While some view it as expected, others are surprised by its mandatory status. The UCPMP, initially released in 2014 as a voluntary code, aimed to regulate marketing practices for pharmaceutical companies and the medical devices industry. It prohibits pharma firms from gifting sample products to healthcare professionals, with sample packs limited to the prescribed dosage for three patients.
