The Department of Pharmaceuticals notified a new code which prohibits pharma companies from offering gifts and travel facilities to healthcare professionals or their family members.
The Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) 2024 also bans supply of free samples to those who are not qualified to prescribe such a product.
“No gift should be offered or provided for personal benefit of any healthcare professional or family member (both immediate and extended) by any pharmaceutical company or its agent i.e. distributors, wholesalers, retailers, etc,” the UCPMP guidelines read.
Similarly, no pecuniary advantage or benefit in kind may be offered, supplied, or promised to any person qualified to prescribe or supply drugs, by any pharmaceutical company or its agent (eg: distributors, wholesalers, retailers, etc).
Information about drugs must be balanced and up-to-date, ensuring that it does not mislead either directly or by implication, and must be capable of substantiation, which must be provided without delay, at the request of medical and pharmacy professionals.
Brand Promotion Activity guidelines:
The guidelines state that free samples of drugs shall not be supplied to any person who is not qualified to prescribe such a product.
“Where samples of products are distributed by a medical representative, the sample must be handed directly to the person qualified to prescribe such product, or to a person authorised to receive the sample on their behalf, and the name and address of the healthcare practitioner noted for records,” it said.
Additionally, the code specifies that free samples if provided should only be to create awareness about treatment options and acquiring experience in dealing with the product and should be limited to a dosage for not more than three patients for the required course of treatment. no company should offer more than 12 such sample packs per drug to any healthcare practitioner per year. Moreover, samples of drugs which are hypnotic, sedative or tranquilizing should not be supplied.
Each sample should be marked “free medical sample not for sale” or bear another marking of identical meaning. Moreover, companies have been ordered to maintain details (product name, doctor name, quantity of samples given, etc) and the monetary value of the samples so as to not exceed two per cent of the domestic sales of the company per year.
Claims:
Pharma companies have also been told that claims of usefulness of a drug must be founded on an up-to-date evaluation of all available evidence. ““The word “safe” must not be used without qualification, and it must not be stated categorically that a medicine has no side-effects, toxic hazards, or risk of addiction,” the new guidelines state.
There is a similar restriction on the word “new”. As the guidelines say, it “must not be used to describe any drug which has been generally available or any therapeutic intervention which has been generally promoted in India for more than a year.”
Brand names of products of other companies must not be used in comparison unless the prior consent of the companies concerned has been obtained, the guidelines mandated.
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