DoP releases new UCPMP for pharma and medical devices companies
The Department of Pharmaceuticals (DoP) has issued a new Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024, 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 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 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 1000 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 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.
Each association should set up ECPMP and update its website and the DoP’s UCPMP portal on the details of the complaints. A non-refundable amount of Rs. 1,000 is to be deposited by the complainant while filing a complaint against violation of the code. Action can also be taken based on media reports under which the source or the correspondent of the publication may be treated as the complainant.
The committee should render a decision within 90 days of the receipt of complaint and the party dissatisfied with the decision of the ECPMP can appeal before the Apex Committee for Pharma Marketing Practices (ACPMP) headed by the Secretary of Department of Pharmaceuticals, having a joint secretary and finance officer dealing with the subject as its members, in 15 days or t a maximum of 30 days. The Apex Committee shall give final decision within six months and it can prescribe any penalties mentioned under the code.
The DoP will notify a panel of auditors, either audit firms of standing empanelled by the CAG or commercial audit firms of repute having an experience of dealing with such matters, it added.
It may be noted that the Federation of Medical and Sales Representatives Association of India (FMRAI) had approached the Supreme Court a couple of years back seeking establishment of a Statutory Code of ethical marketing for the pharmaceutical industry with provisions for penal actions against violators. Amidst legal proceedings, the government in September, 2022 formed a five-member high-level committee headed by NITI Aayog member (health) V K Paul to study a legal mechanism to regulate the marketing and promotional activities of the pharmaceutical industry in the country.
While the UCPMP was introduced in 2014 and implemented since January 1, 2015, it was not enforceable under any law or statute of the government, said the Department during the time.
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