Many countries across the globe have specific laws and regulations that regulate the promotional and marketing activities like the Physicians Payment Sunshine Act (US), Association of the British Pharmaceutical Industry (ABPI) Code of Practice and French Sunshine (Loi Bertrand) Act that require transparency in reporting payments made to healthcare professionals or the US FCPA and UKBA which mandates ethical business practices. There are publicly accessible databases for disclosing details of payments and other benefits in kind made to Healthcare Professionals (HCP)s like the Open Payments Data in the U.S. and Disclosure UK by ABPI.
With the objective of ensuring ethical marketing practices, the Ministry of Chemicals, and fertilizers Department of Pharmaceuticals in India, has notified the Uniform Code for Pharmaceutical Marketing Practices 2024 (UCPMP or ‘The Code’) to all Pharmaceutical Associations for circulating the same to their members for strict compliance to the Code. The provisions of this Code, unless exempted, shall also apply to Medical Device organisations. Further, the Code also prompts compliance by the organisations who are not members of any association.
The Code regulates inter-alia product promotion, conduct of agents as well as medical representatives and interaction with healthcare professionals or their family members (both immediate and extended). Organisations who are part of global groups and some domestic organisations might have their own strict ethical policies, but it is imperative to restructure the policies, as required, and maintain adequate controls to ensure adherence to UCPMP.
This is a monumental change in the Indian pharmaceutical landscape. Hence, adherence to the Code should not be considered as just a regulatory obligation to avoid penalties and damages but a unique opportunity to showcase the industry’s commitment to ethical and responsible market practices, ensuring the protection of consumers and the credibility of the industry. Consequently, the tone the leadership sets is of paramount importance.
We have put together a document which captures key guidelines that have to be adhered by the pharmaceutical organisations and what they should be doing to be compliant towards the code. To know more, download the copy now.
Navigating the new regulatory terrain
The Department of Pharmaceuticals has notified the Uniform Code for Pharmaceutical Marketing Practices 2024 to all Pharmaceutical Associations.