While intended as an upgrade from the 2014 guidelines, many perceive the UCPMP as akin to its predecessor, lacking statutory enforcement and remaining voluntary in nature.
These guidelines are designed to regulate marketing practices within the Indian pharmaceutical industry. (Creative Commons)
The Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilisers, has introduced the new Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024.
These guidelines are designed to regulate marketing practices within the Indian pharmaceutical industry, with a focus on promoting ethical engagement between pharmaceutical companies and healthcare professionals to ensure responsible marketing practices.
The UCPMP prohibits practices such as offering gifts, travel facilities, or free samples to healthcare professionals.
While intended as an upgrade from the 2014 guidelines, many perceive the UCPMP as akin to its predecessor, lacking statutory enforcement and remaining voluntary in nature.
These new guidelines have been formed after the 2022 Supreme Court judgement where the government had asked to upgrade them, after bringing everyone to the discussion table.
However, the new guidelines, except for adding a few provisions, have kept them similar to the previous one.
The new guidelines stipulate that no gifts should be offered or provided for the personal benefit of any healthcare professional or their family members (both immediate and extended) by any pharmaceutical company or its agents, such as distributors, wholesalers, or retailers, according to the UCPMP guidelines.
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 agents.
Furthermore, companies or their representatives, or any person acting on their behalf, are prohibited from extending travel facilities, whether within or outside the country, including rail, air, ship, cruise tickets, or paid vacations, to healthcare professionals or their family members for attending events like conferences, seminars, and workshops.
Additionally, companies or their representatives should refrain from providing cash or monetary grants to any healthcare professional or their family members (both immediate and extended) under any pretext, as per the UCPMP code.
The Department of Pharmaceuticals has urged all associations to establish an Ethics Committee for Pharmaceutical Marketing Practices (ECPMP), set up a dedicated UCPMP portal on their website, and take further necessary steps towards the implementation of this Code, addressing associations of drug firms in a notification.
Moreover, the promotion of a drug must align with the terms of its marketing approval, and a drug must not be promoted prior to receiving marketing approval from the competent authority authorising its sale or distribution, according to the code.
The guidelines also emphasise that information about drugs must be balanced, up to date, verifiable, and must not mislead — either directly or by implication.
Additionally, it should accurately reflect current knowledge or responsible opinion, and must be capable of substantiation, which must be provided without delay, upon request of members of the medical and pharmacy professions, including members of other professions employed in the pharmaceutical industry.
The new additions to UCPMP 2024 have introduced a few new key guidelines and procedures to enhance ethical practices within the Indian pharmaceutical industry.
The document specifies that claims about a drug’s usefulness must be based on current evidence, prohibits unqualified use of “safe,” and restricts labelling drugs as “new” after being available for over a year. It mandates fair, factual, and substantiated comparisons between drugs.
The guidelines permit brand reminders — such as diaries, calendars, and journals — in informational and educational items and free samples with specific conditions on their distribution, quantities, and value limits of ₹1,000.
It clarified: “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 w.r.t. use of the respective brand.”
Also, the guideline has asked the giver and recipient of brand reminders to comply with the relevant provisions of the Income Tax Act, 1961, with respect to deductions and reporting of income.
The UCPMP 2024 encourages research support by ensuring studies have the necessary approvals and details are uploaded on the UCPMP portal for five years.
In 2022, the Federation of Medical and Sales Representatives Association of India (FMRAI) filed a petition in the Supreme Court, requesting the enforcement of a legal code for the marketing of medicines, aiming to make the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) statutory rather than just a rule.
However, the Union Government stated that the UCPMP is functioning adequately within the provisions of the Code.
Nevertheless, the Supreme Court directed the government to reconsider and frame the code again, this time with consultation from all stakeholders.
“The government asserted that they had established a panel to address the matter. However, they claimed that the panel had only consulted certain parties, excluding those who had expressed concerns. Specifically, they stated that the panel had neglected to involve individuals with grievances, instead opting to consult the association of pharmaceutical management. Consequently, they deemed the panel’s efforts as more of a superficial gesture rather than a genuine attempt at resolving the issues at hand,” President of FMRAI Ramesh Sundar R told South First.
He added that there has been no discernible change from the previous guidelines.
“We contended that the code should be made statutory, rather than remaining voluntary. We advocated for the inclusion of punitive clauses, yet similar to its predecessor, the current code only threatens expulsion from the association as a form of punishment,” he said.
“This approach feels akin to being told it’s our responsibility if we fail to wear a helmet while riding a bike. We believe there should be appropriate legal consequences. Our committee is scrutinising the situation, and if deemed necessary, we are prepared to escalate the matter to the Supreme Court through an appeal,” said Ramesh.
Malini Aisola, Co-convenor of All India Drug Action Network (AIDAN), told South First that the new guidelines are derived through one-sided consultations with the pharma industry.
“None of the loopholes have been plugged, rather legitimizes many problematic incentives/payments/honorariums through which pharma promotion takes place,” she said.
(Edited by Shauqueen Mizaj)
May 03, 2024
May 03, 2024
May 01, 2024
May 01, 2024
Apr 30, 2024
Apr 30, 2024
