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DoP asks industry to file self-declaration under UCPMP for FY 2024-25
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Gireesh Babu, New Delhi
May 30 , 2024
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The Department of Pharmaceuticals (DoP) has directed the industry to file a self-declaration in a prescribed format in accordance with the procedure in the recently published new Uniform Code for Pharmaceutical Marketing Practices (UCPMP) within June 30, 2024.
The self-declaration should be signed by the executive head of the company regarding compliance to the UCPMP for the financial year 2024-25.
The format prescribes the executive head of the company that the official undertakes to comply with the provisions of the UCPMP 2024 and extend all required assistance to authorities for the enforcement of the Code.
It may be noted that the DoP issued the new UCPMP 2024, in the first half of March, permitting pharma companies to provide brand reminders such as informational and education items and free samples to medical professionals with restrictions on sample packs and total value.
The brand reminders, expenditure on continuing medical education and on research projects are subject to the relevant provisions of the Income Tax Act, 1961, says the Code which is now for strict compliance by the members of all industry organisations. It has also mandated a fee of Rs. 1,000 to be remitted by the complainant while making a complaint against a company alleging violation of the Code.
Publishing the new version of the Code almost nine years after its first implementation, the Department requested all associations to constitute an Ethics Committee for Pharmaceutical Marketing Practices (ECPMP), set up a dedicated UCPMP portal on their website, and take further necessary steps towards implementation of the Code. The provisions of the Code, unless exempted or modified by standing orders, will also apply to medical devices and entities manufacturing or dealing with the sale and distribution of such products.
The new code permits the companies to offer brand reminders to the healthcare professionals in two categories - informational and education items and free samples. Informational and educational items as per the code mean books, calendars, diaries, journals including e-journals, dummy device model and clinical treatment guidelines for professional use in healthcare settings. Value of these items should not exceed Rs. 1,000 per item and such items should not have an independent commercial value for the healthcare professionals, it says.
Free samples of drugs shall not be supplied to any person who is not qualified to prescribe such a product. Apart from limiting the sample packs to prescribed dosage to not more than three patients for the required course of treatment, it adds that no company should offer more than 12 such sample packs per drug to any healthcare practitioner per year.
"The monetary value of samples so distributed should not exceed two percent of the domestic sales of the company per year," stipulates the Department.
"Receipt of brand reminders from pharmaceutical companies by healthcare practitioners may not be construed as endorsement activity if it does not amount to recommendation or issuance of a statement by a healthcare professional with regard to use of the respective brand," it added. The giver and recipient of brand reminders should comply with the relevant provisions of the Income Tax Act, 1961 with respect to deductions and reporting of income.
Another area in which the new Code elaborates the ethics further from the previous UCPMP, introduced for the first time in late 2014, include the engagement of pharmaceutical industry with the healthcare professionals for Continuing Medical Education (CME), Continuing Professional Development (CPD), or otherwise for conference, seminar, workshop etc and research activities in collaboration with educational institutions.
These engagements should be allowed through "a well-defined, transparent, and verifiable set of guidelines based on which the pharmaceutical industry may undertake such expenditures".
Conducting such activities in foreign locations is prohibited, while CME and CPD meetings can be conducted by medical colleges, teaching institutions, universities, hospitals, professional associations of doctors and specialists, NIPERs, laboratories of ICMR, DBT, CSIR etc., pharma colleges and other academic and research institutions. Pharmaceutical companies, including their trusts or associations either alone or in collaboration with professional bodies, and the institutions listed, are allowed to conduct such meetings.
All pharmaceutical companies should share the details of such events conducted by them, including the expenditures incurred thereupon, on their website, and may be subject to independent, random, or risk-based audit for this purpose.
Interaction between pharmaceutical companies and healthcare professionals to provide rational support and encouragement to research and innovation through the industry-academia linkage is allowed subject to certain conditions. Engagement of healthcare professionals in consultant-advisory capacity shall be for bona-fide research services, under a consultancy agreement involving a consultancy fee or an honorarium-based payment, subject to the relevant provisions of the Income-Tax Act, 1961.
Pharma and medical devices companies should not provide gifts or pecuniary advantage or benefits to healthcare professionals and should not extend travel facilities, or hospitality unless the person is a speaker for a CME or a CPD programme.
The Federation of Medical and Sales Representatives’ Associations of India (FMRAI), which approached the Courts for preparation of the new Code, alleged that the new Code is “old wine in a new bottle” and may be used to legitimise the various questionable promotional activities of the pharma companies.
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