In an ever-evolving landscape of pharmaceutical marketing, transparency, integrity, and accountability stand as the guiding stars. Striking a balance between reaching healthcare professionals and consumers effectively while maintaining ethical practices can be challenging. While the Uniform Code of Pharmaceutical Marketing addresses some of these and is voluntarily applicable since 2014, the Indian government recently notified the Uniform Code for Pharmaceutical Marketing Practices 2024 (the ‘New Code’), making it mandatory for pharma companies to establish compliance.
The New Code covers critical areas such as conduct of medical representatives, provision on brand reminders and free samples, continuing medical education, relationships with healthcare professionals and a more streamlined grievance redressal mechanism. It also covers medical device manufacturers and distributors within its ambit.
In this article, let’s look at key differences between the 2024 and 2014 codes and implications for the industry:
The 2014 Code emphasised on truthful claims with most recent analysis of all available data for accurate and ethical promotion of prescription drugs. The updated guidelines requires the information to be “balanced.” Misleading tactics like calling medications completely “new” after being promoted for a year in the market are discouraged and fair comparisons with other drugs avoiding negativity for competing products, are encouraged.
Additionally, the guidelines introduce ‘Brand Reminders’ which include informational and educational items i.e., books, calendars, diaries, journals, etc. capped at Rs. 1000, provided these items have no independent commercial value. Suppliers and receivers of Brand Reminders should maintain logs on delivery and receipt of goods transacted along with their values and comply with relevant tax provisions.
Companies are now required to note the names and addresses of qualified healthcare practitioner who receive free samples. They will also have to maintain accurate records of product name, doctor name, sample quantity, supply date, and monetary value of free samples, capped at 2 per cent of company’s annual domestic sales. Companies should ensure that sample packs are given for up to 3 patients with an annual cap of 12 for each healthcare practitioner. The earlier requirement of procuring a signed and dated request for supply of sample packs has been done away with.
Pharmaceutical companies are now permitted to incur expenditure for CME or conferences through well-defined, transparent, and verifiable guidelines. Previously, pharmaceuticals companies were prohibited from incurring travel related expenses for healthcare professionals and their families for conferences, etc. The New Code allows companies to provide travel and accommodation for healthcare professionals invited to speak at CME or CPE programmes. However, these programmes cannot be held in foreign locations. Organisers of such events should explicitly spell out the procedure followed in selection of participants, display a statement of funding sources and expenses on their website, and may be subject to special audit for this purpose. Companies must ensure that such expenses comply with applicable tax provisions.
The New Code also details the responsibilities of Pharmaceutical Associations in constituting the Ethics Committee for Pharmaceutical Marketing Practices (‘ECPMP’) for handling the complaints, Apex Ethics Committee for Pharmaceutical Marketing Practices (‘ACPMP’) for appeal against ECPMP and various penalty provisions. All complaints regarding a breach should be clubbed together, made within six months, and addressed to the ECPMP with a fee of Rs. 1000. The complainant, the company in breach, and any specific products or activities regarding the breach should be clearly identifiable. Any complaint made by a pharmaceutical company should be signed or authorised in writing by the company’s KMPs. For any complaints emanating from media reports, the committee may request the concerned publication for further information, and the source or the correspondent may be treated as the complainant.
All the Indian Pharmaceutical Associations and UCPMP portal will display the details of all complaints on their website for five years. The earlier requirement of affirming the cessation of promotional activities or retrieval of items distributed in violation of the 2014 Code within five days of decision has been removed. For violations, the Committee can propose public reprimand, issuance of corrective statements in media, suspension from the Association or recovery of money or items in addition to applicable disciplinary and penal consequences.
Way forward
The New Code marks a significant stride for ethical conduct in pharma industry. Investing in robust compliance programs, prioritising data-driven marketing, and fostering genuine interactions with healthcare professionals will be key to compliance. With the help of technology and AI, pharmaceutical companies can tailor their interactions, presenting relevant clinical trial opportunities, treatment options backed by the latest research, and educational content targeted to the HCP’s expertise.
This personalised approach can lead to more meaningful conversations and ultimately improve engagement between pharma and HCPs. Further, companies should modify the terms of appointment of medical representatives to bring it line with the code. By promoting transparency and discouraging misleading tactics, the New Code fosters a culture of trust with patients and the public. Furthermore, it creates a fair and level playing field for companies, encouraging them to focus on innovation and development of effective medications, ultimately building a more responsible and trustworthy healthcare ecosystem.
