Uniform Code for Pharmaceutical Marketing Practices, 2024
On 12th of March, 2024, the Department of Pharmaceuticals released the “Uniform Code for Pharmaceutical Marketing Practices (“Code”). All Indian Pharmaceutical Associations are 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 this Code.
The Code essentially focuses on promotional activities relating to drugs, which include “all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medical drugs.”
The section that applies to medical professionals is similar to the principles in the Medical Council of India, 2002 Regulations and Telemedicine Guidelines with an addition of “ Brand Reminders”, which permits distribution to medical professionals the following:
There is also an exception that allows Pharmaceutical Companies to sponsor travel and hospitality to doctors if they are speakers of a CME or CPD Program. These CMEs are required to be mandatorily conducted in India. This exception did not exist in the 2002 Regulations.
Medical Council of India, 2002 Regulations and TMP Guidelines
MCI (Professional Conduct, Etiquette and Ethics) Regulations, 2002, Clause 6.1.1 banned the “self-aggrandisement” of doctors and has summarised what a doctor can show of themselves in public. In clause 6.8, they have detailed a code of conduct for doctors in their relationship with the pharmaceutical and allied healthcare industry.
The Telemedicine Practice Guidelines in Guideline 5 have placed a ban on doctors participating in platforms that provide ratings including reviews, advertisements and promotion of the doctors by “any means”. Any means includes the manipulation of algorithms and search engines.
Consumer Protection Act, 2019
The Consumer Protection Act, 2019 (“COPRA”) which weighs heavily in the favor of consumers deals with misleading advertisements which i) falsely describes a product or service, ii) gives a false guarantee or is likely to mislead the consumers as to the nature, substance, quantity or quality of a service, iii) conveys an express or implied representation which if made by the service provider would constitute and unfair trade practice and iv.) deliberately conceals important information.
It has also been recommended by the Department of Consumer Affairs that the Indian Standard (IS) 19000:2022’ should be complied with. Essentially these standards prescribe guidelines for online consumer reviews. In November 2023, news reports indicated that the same will be made mandatory and actionable under the Consumer Protection Act, 2019.
Key highlights of the framework relevant to the medical industry include that the reviews on online e-commerce platforms should be published accurately, that the review information should be handled in a secure and confidential manner and the manner of collection of such a review.
For example, while soliciting the review, the invitation should mention who is the person soliciting the review, the details of the product or service for which the review is sought, how the review will be used and what is the exact material that will be published.
Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022
The 2022 Misleading Advertisements Guidelines require advertisements to a) contain truthful and honest representation, b) not mislead consumers by exaggerating the benefits, c) not suggest the claims as universally accepted when there is significant informed view to the contrary, d) to ensure that unsubstantiated claims do not mislead consumers; and e) comply with sector specific rules and regulations.
The guidelines further set regulations for bait advertisements, free claim advertisements and children targeted advertisements. They contain a complete ban on surrogate advertisements.
Guidelines on Dark Patterns
A dark pattern is a User Interface that is craftily designed in order to trick user in order to perform such actions. Guidelines relating to deceptive practices used by e-commerce companies were released by the Central Consumer Protection Authority on the 30th of November, 2023. The Guidelines identify 10 dark patterns which are considered as unfair trade practices under the Consumer Protection Act 2019. The dark patterns identified are false urgency, basket sneaking, confirm shaming, forced action, subscription trap, interface interference, bait and switch, drip pricing, disguised advertisement, nagging, trick question, SAAS Billing and Rogue Malware. An example provided as per the guidelines is as follows:
“While giving a choice to opt, “Do you wish to opt out of receiving updates on our collection and discounts forever?” using phrases like, “Yes. I would like to receive updates” and “Not Now”, instead of the option, “Yes”.
The Drugs and Magic Remedies (Objectionable Advertisements Act, 1954)
One of the older legislations in this list, an amendment was proposed to this particular law in 2020. The Act places a blanket ban on the advertisement of drugs for diseases and disorders such as miscarriage, menstrual disorder, miscarriage or conception and a list of about 54 other diseases
and ailments. Further, section 4, prevents false and misleading claims related to drugs and prevents doctors from taking part in the publication of such advertisements.
Penalties include imprisonment with a fine and are divided on the basis of the number of convictions.
The Advertising Standards Council of India Code and Guidelines
Products of the Advertising Standards Council of India (ASCI), these codes and guidelines are non-binding and no legal action can be taken on this basis. However, adherence to them are considered to be good industry practice in the advertising industry and it is advisable to follow them.
The ASCI Code contains four chapters which deal with truthful and honest representation, non – offensive advertisements, harmful products/situation and fair competition. There are around 17 Guidelines under the ASCI Code which deal with specific situations. Relevant to the medical industry are Guidelines for “advertising of foods and beverages”, “disclaimers made in supporting, limiting or explaining claims made in advertisements”, “validity and duration of claiming new/improved”, “skin lightening or fairness improvement products”, “awards/rankings in advertisements” and “online deceptive design patterns in advertising”.
Please note that the above is only an indicative list of the laws surrounding the advertisement of medical practitioners and institutions. It should not be construed as legal advice. In order for specific legal advice, please contact us.