DoP Again Extends Deadline For Self-Declaration By Companies

New Delhi: The Department of Pharmaceuticals (DoP) has again extended the deadline for self-declaration scheme under the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) for industry to September-end. Extending the time from the first published date of June 30 the self-declaration is to be signed by the executive head of the company regarding compliance to the UCPMP for the financial year 2024-25.

The UCPMP is a set of rules that regulate the interactions between pharmaceutical companies and healthcare professionals and is aimed at providing a set of guidelines to ensure transparency, integrity, and accountability in the marketing of pharmaceutical and medical device products across India.

The updated UCPMP was introduced by the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals in March 2024.

Under the latest set of guidelines pharma companies have been issued restrictions on sample packs and total value provided as brand reminders. Also expenditure on continuing medical education and on research projects are subject to the relevant provisions of the Income Tax Act, 1961 and has mandated a fee of ₹1,000 to be remitted by the complainant while making a complaint against a company alleging violation of the Code. 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 monetary value of samples distributed should not exceed two percent of the domestic sales of the company per year. 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 about use of the respective brand. 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,’’ the order states.

On Continuing Medical Education (CME), Continuing Professional Development (CPD), (conference, seminar, workshop etc. and research activities in collaboration with educational institutions) the Code notes that 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, hospitals etc.

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, it added.

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