in a constantly evolving landscape Drug marketingTransparency, honesty and accountability stand as guiding stars. Striking a balance between reaching goals healthcare professionals It can be challenging to effectively provide services to consumers and consumers while maintaining ethical practices. Uniform Code Pharmaceutical marketing addresses some of these and has been in force voluntarily since 2014, Indian Government Recently the Uniform Code for Pharmaceutical Marketing Practices 2024 (‘the New Code’) has been notified, making it mandatory for pharma companies to establish compliance.

The new code covers important areas such as conduct Medical Representativeprovision of brand reminders and free samples, continuing medical education, links with healthcare professionals and a more streamlined complaint redressal mechanism. It also covers medical device manufacturers and distributors within its scope.

In this article, let us look at the key differences between the 2024 and 2014 Codes and their impact on the industry:

The 2014 Code emphasizes truthful claims with the most recent analysis of all available data for accurate and ethical promotion of prescription drugs. Information should be “balanced,” according to the updated guidelines. Deceptive tactics such as calling drugs completely “new” after being promoted for a year on the market are discouraged, and fair comparisons with other drugs are encouraged to avoid negativity for competing products.

Additionally, the guidelines introduce ‘brand reminders’, which include informational and educational items, such as books, calendars, diaries, journals etc., valued up to Rs 1000, provided these items have no independent commercial value. Suppliers and recipients of brand reminders should maintain logs on delivery and receipt of goods transacted and also keep track of their values and comply with relevant tax provisions.

Companies will now have to note down the names and addresses of their customers. Qualified Health Care Practitioner Those who receive free samples must also maintain accurate records of the name of the product, name of the doctor, quantity of the sample, date of supply and monetary value of the free samples, with a maximum limit of 2 per cent of the company’s annual domestic sales. Companies must ensure that sample packs are given to a maximum of 3 patients, with an annual limit of 12 for each. Healthcare ProfessionalsThe earlier requirement of obtaining signed and dated requests for supply of sample packs has been abolished.

Pharmaceutical companies are now allowed to incur expenditure for CME or conferences through well-defined, transparent and verifiable guidelines. Earlier, pharmaceutical companies were prohibited from incurring travel-related expenditure for conferences, etc. for healthcare professionals and their families. The new code allows companies to provide travel and accommodation for healthcare professionals invited to speak at CME or CPE events. However, these events cannot be held at foreign locations. Organisers of such events must clearly state the process followed in selecting participants, display details of funding sources and expenses on their website, and may be subject to special audits for this purpose. Companies must ensure that such expenditure complies with applicable tax provisions.

The new Code also details the responsibilities of pharmaceutical associations in the formation of an Ethics Committee on Pharmaceutical Marketing Practices (‘ECPMP’) for handling complaints, an Apex Ethics Committee on Pharmaceutical Marketing Practices (‘ECPMP’) for appeals against ECPMPs, and various penalty provisions. All complaints relating to violations must be clubbed together, made within six months, and addressed to the ECPMP along with a fee of Rs 1000. The complainant, the violating company, and any specific products or activities relating to the violation must be clearly identifiable. Any complaint made by a pharmaceutical company must be signed or authorized in writing by the KMP of the company. For any complaint arising from media reports, the Committee may request further information from the relevant publication

All Indian Pharmaceutical Association And the UCPMP portal will display details of all complaints on its website for five years. The previous requirement to confirm discontinuation of promotional activities or recovery of goods distributed in violation of the 2014 Code within five days of the decision has been removed. For violations, the Committee may propose public reprimand, issuance of corrective statements in the media, suspension from the association or recovery of money or goods in addition to applicable disciplinary and punitive consequences.

way forward

The new code is an important step ethical behavior Strong investment in the pharma industry compliance programPrioritizing data-driven marketing and fostering genuine conversations with healthcare professionals will be crucial for compliance. With the help of technology and AI, pharmaceutical companies can customize their conversations, 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. In addition, companies should revise the terms of appointment of medical representatives to make it compliant with the code. By promoting transparency and discouraging deceptive 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 medicines, ultimately creating a more responsible and trustworthy healthcare ecosystem.