Government notifies new code to curb unethical practices by pharma companies

The Centre has 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 issued by the Department of Pharmaceuticals also bans supply of free samples to those who are not qualified to prescribe such a product.

Information about drugs must be balanced, up-to-date, verifiable, must not mislead either directly or by implication, accurately reflect current knowledge or responsible opinion, and must be capable of substantiation, which must be provided without delay, at request of members of the medical and pharmacy professions, including members of other professions employed in the pharmaceutical industry, it said. 

The guidelines which prohibit pharma companies from offering gifts to healthcare professionals state: “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.” 

It also adds, no pecuniary (relating to or consisting of money) 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 agents.

The guidelines state, medical representatives must not employ any inducement or subterfuge to gain an interview. “They must not pay, under any guise, for access to a healthcare professional. 

The code also says, companies or their representatives, shall not extend travel facilities inside or outside the country to healthcare professionals for attending conferences, seminars, workshops etc., unless the person is a speaker. 

“Companies or their representatives, or any person acting on their behalf, should not extend hospitality like hotel stay, expensive cuisine, resort accommodation, etc., to healthcare professionals or their family members (both immediate and extended) unless the person is a speaker for a CME or a CPD program,” it further adds. 

Brand Promotion Activities 

The guidelines state, 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,” or said. 

The code mentions that free samples so provided should only be for the purpose of creating awareness about treatment options and for acquiring experience in dealing with the product; sample packs should be limited to prescribed dosage for not more than three patients for the required course of treatment and no company should offer more than 12 such sample packs per drug to any healthcare practitioner per year. 

Each  sample should be marked “free medical sample not for sale” or bear another legend of analogous meaning 

Pharmaceutical companies have been told not to supply samples of a drug which is a hypnotic, sedative, or a tranquilizer.

 Companies have been asked  to maintain details such as product name, doctor name, quantity of samples given, date of supply of free samples to healthcare practitioners, etc, and the monetary value of samples so distributed should not exceed two per cent of the domestic sales of the company per year.

Claims and Comparisons 

Pharma companies have been told that  claims of usefulness of a drug must be based on 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 newly mentioned guidelines state. 

Similarly, there are restriction on the use of the word “new”. 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.