BRIEF:
Advertising of pharmaceuticals and medical equipment to consumers is strictly regulated. The “Uniform Code of Pharmaceutical Marketing Practices” (UCPMP) is a set of regulations that the Central Government published in December 2014 to provide advice to the pharmaceutical and medical device industries. These recommendations, however, are not already binding laws and are voluntary.
The government is considering creating a unique regulation called the Uniform Code for Medical Device Marketing Practices (UCMDMP) to regulate the marketing of medical devices. The code hasn’t been finished, though. The UCPMP should be regarded as the official policy for medical device promotion by medical device businesses up until the UCMDMP is formally issued.
ISSUES:
- What are the specific laws that govern the marketing aspects of the materials in the pharma sector and whether is it codified?
- What are the separate marketing requirements for advertising materials, brochures, videos, and slogans in the Indian pharmaceutical sector?
APPLICABLE LAW:
Currently, there is no explicit regulation in India that governs how businesses can advertise and market their products to healthcare professionals (HCPs). Contrarily, the promotion of medications and medical devices to consumers is closely regulated. The “Uniform Code of Pharmaceutical Marketing Practices” (UCPMP) is a set of regulations that the Central Government published in December 2014 to provide advice to the pharmaceutical and medical device industries. These recommendations, however, are not already binding laws and are voluntary.
SOLUTIONS OFFERED:
- For marketing promotional materials
The following information must be given clearly so that the persons qualified to prescribe or supply the promotional material have had sufficient knowledge about that material, which includes: the relevant drug, the name, and address of the holder of the authorization of the drug or the business name and address of the part of the business responsible for the marketing of such drugs.
A statement stating that more information is available upon request; adverse reactions; warnings and precautions for usage; and pertinent contraindications of the product; the date on which the aforementioned material was created or last updated. Advertising in journals and other promotional materials such as mailings cannot be disguised as something else. Promotional content that a pharmaceutical corporation purchase obtains, or arranges for its publication in journals must not resemble editorial content. Regardless of editorial control over the content, any promotional materials appearing in journals whose publication is paid for, secured, or organized by a firm and referencing by brand name any product of that company must comply with (the standards immediately above) as necessary.
Promotional materials must be written and illustrated in a manner that complies with good taste standards, respects the receivers’ profession, and avoids any situations where they might be offensive. In promotional materials, healthcare practitioners’ names or images are not permitted to be utilized. Promotional materials cannot include devices, phrases, or general layouts used by other businesses in a way that could confuse or lead to misinformation. The date of printing or the time of the most recent examination of promotional materials must be provided when appropriate (for instance, in technical and other instructive information). Anything that the general public might interpret as advertising must not be included on postcards, other exposed mailings, envelopes, or wrappers.
- For the purpose of Brochures containing general information
A drug cannot be advertised before receiving the appropriate authority’s marketing approval, which permits its sale or supply. The terms of the marketing approval must be followed when promoting a medicine. Information concerning drugs must be accurate, current, and based on responsible knowledge of current events. Information about drugs must be truthful, objective, fair, and balanced, and it cannot inadvertently or overtly mislead. Information needs to be able to when members of the medical and pharmacy professions, including those who work in the pharmaceutical sector, request evidence under the aforementioned provision, that evidence must be delivered right away.
- For the purpose of samples
No one who is not licensed to prescribe the medicine in question may receive free samples of it. When a medical representative gives out product samples, the sample must be given directly to the person who is qualified to prescribe the product or to the person who has been designated to accept the sample on their behalf. Samples must be given in the following circumstances to a person licensed to prescribe the product: These samples are only given in extraordinary circumstances and are given so that recipients can gain experience working with the product in question. Such sample packets shall only contain the prescribed dosages for the necessary course of treatment for three individuals; the size of each sample pack must not exceed that of the smallest pack currently on the market. Each sample shall be accompanied by a copy of the most recent Product Information (as required by the Drug and Cosmetic Act, 1940) relevant to that product. Each sample shall be marked “free medical sample – not for sale”. The provision of a sample of an antidepressant, hypnotic, sedative, or tranquilizer by a pharmaceutical business is prohibited. The companies will keep records of information like the product name, the doctor’s name, the number of samples delivered, the date of the free samples were distributed to healthcare professionals, etc.
Pharmaceutical industry regulations are subject to frequent change, so it is up to businesses to fully comprehend how these changes affect their marketing strategies when they advertise to the general public. The rules governing promotional materials are intended to protect consumers by ensuring that they receive accurate information that enables them to make wise health decisions and to promote an equitable market in general.
NAGARJUN.S
Intern at Aggarwals & Associates, S.A.S. Nagar, Mohali
