DoP Orders Medical Devices Industry to File Self-Declaration under UCPMP by June 30

The directive, issued on May 28, requires pharmaceutical companies to ensure compliance with the UCPMP for the financial year 2024-25.

The Department of Pharmaceuticals (DoP) has mandated that the medical devices industry submit a self-declaration in a prescribed format per the new Uniform Code for Pharmaceutical Marketing Practices (UCPMP) by June 30, 2024. 

The directive, issued on May 28, requires pharmaceutical companies to ensure compliance with the UCPMP for the financial year 2024-25.

Reportedly, the self-declaration, to be signed by the executive head of each company, must confirm adherence to the provisions of the UCPMP 2024 and commit to supporting authorities in enforcing the Code. 

This requirement follows a standing order issued to medical devices industry associations on May 30, extending the original deadline.

The new UCPMP 2024, introduced in March, permits pharmaceutical companies to provide brand reminders and free samples to medical professionals, with specific restrictions on sample packs and total value. 

Brand reminders and expenditures on continuing medical education (CME) and research projects are subject to provisions of the Income Tax Act of 1961.

What Does the New Code Say?

Under the new Code, companies can offer brand reminders in two categories: informational and educational items and free samples. Informational and educational items include books, calendars, diaries, journals (including e-journals), dummy device models, and clinical treatment guidelines for professional use. 

Further, the value of these items must not exceed INR 1,000 per item and should not have independent commercial value for healthcare professionals.

Additionally, free drug samples can only be supplied to qualified prescribers. The Code limits sample packs to prescribed dosages for no more than three patients and restricts companies from offering more than 12 sample packs per drug to any healthcare practitioner per year. 

The total monetary value of samples distributed should not exceed 2% of the company's annual domestic sales.

Insight into UCPMP Provisions

The DoP has urged all industry associations to form an Ethics Committee for Pharmaceutical Marketing Practices (ECPMP), set up a dedicated UCPMP portal on their websites, and take necessary steps towards implementing the Code. 

The provisions of the Code apply to medical devices and entities involved in their manufacturing, sale, and distribution unless exempted or modified by standing orders.

The Code also details the pharmaceutical industry's engagement with healthcare professionals for CME, Continuing Professional Development (CPD), and research activities. These engagements must adhere to transparent, verifiable guidelines and cannot be conducted in foreign locations. 

Furthermore, CME and CPD meetings can be organized by accredited institutions and must be disclosed on the companies' websites, with expenditures subject to audit.

Interactions between pharmaceutical companies and healthcare professionals are permitted to support research and innovation, provided they comply with consultancy agreements and relevant Income Tax Act provisions. 

Also, the Code prohibits gifts, financial advantages, or travel facilities to healthcare professionals, except when the professional is a speaker at a CME or CPD program.

The DoP's directive to file a self-declaration under the UCPMP 2024 by June 30 is a significant step towards enhancing compliance and ethical practices in the medical devices industry. 

The new Code aims to regulate interactions between the industry and healthcare professionals, ensuring transparency and accountability in marketing practices.