Advertising of medical devices in India

Medical technology is thriving amid the pandemic. But thorny questions arise over the advertising of medical equipment and devices in India, where the government is understandably concerned about unethical marketing, to protect the public from exploitation.

In an attempt to better understand and untangle this legal minefield, let’s examine the various provisions and pitfalls.

The Code for the Self-Regulation of Advertising Content in India (ASCI code), published by the Advertising Standards Council of India, does not set any standard for medical device advertisements.

Ashutosh Upadhyaya
Senior partner
Anand and Anand

However, the provisions of the Drugs and Magical Remedies (Improper Advertising) Act of 1954 (DMRA), the main legislation governing the advertising of medical devices, contain many reasons for a more careful examination of legality.

Before evaluating the limits of advertising, it is imperative to first understand how medical devices are legally defined?

Section 2 of the DMRA defines drugs, among other things, as a “medicine” for internal or external use of human beings or animals, but also “any substance” intended for use in the diagnosis, cure, the alleviation, treatment or prevention of disease in humans or animals. It further defines drugs as “any article”, other than a food or “any article intended for use as a component” of any drug, substance or article as mentioned in this section.

The terms “any article” and “any substance” are broad enough to cover medical devices. In addition, the Department of Health and Family Welfare updated its regulations on February 11, 2020, adding various medical devices and appliances to the definition of medicines under section 3 of the Medicines Act 1940. medicines and cosmetics.

Considering that the DMRA dates back to 1954, a bigger question now arises whether said definition of drugs includes modern medical devices and equipment.

From a jurisprudential point of view, consider the judgment of the Supreme Court of Judge YV Chandrachud (November 25, 1975) in the case Zaffar Mohammad ZM Sarkar vs West Bengal State. This clarified the law, considering that a machine is a tangible thing that can be both seen and felt – and as such meets the description of an article within the meaning of section 2 of the DMRA .

Essentially, this brackets modern medical equipment and devices under the DMRA’s generalized definition of “drugs,” which brings us to the central issue of various deliberations, which is Section 3 of the DMRA.

This section prohibits the advertising of drugs for the treatment of certain diseases and disorders. It states that no one should take part in the publication of an advertisement for “any medicine” (reminding that this includes medical devices or equipment), which suggests or is calculated to lead to the use of that medicine for diagnosis , the cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule – or any other disease, disorder or condition specified in the Rules under this Act.

This list contains a fairly comprehensive list of 54 diseases, conditions or disorders, ranging from fever, diabetes and cancer to disorders of the brain and optical system.

The DMRA prohibits any form of advertising for the diagnosis, cure, mitigation, treatment, or prevention of the aforementioned diseases, disorders, or conditions. Such advertisements may violate the provisions of the DMRA and the ASCI code.

The objective of the DMRA was clarified in the judgment of the Supreme Court of India of Hamdard Dawakhana (Wakf) against Union of India and Golds (1959). While partially upholding the constitutionality of the DMRA, the Supreme Court said the law’s purpose was to prevent “objectionable” and “unethical” advertising, to discourage self-medication and self-medication.

Let caution prevail

This brings us to our conclusion that an advertisement of any drug (including medical devices or equipment) for the diagnosis, cure or alleviation of any disease or disorder is subject to challenge under the provisions of the DMRA. . However, whether said advertising is unethical or objectionable is a moot point.

It would be wrong not to mention that there are certain safety nets. For example, informational videos such as user manuals or video guides do not fall into the category of advertisements, nor in any way promote the diagnosis, cure, mitigation, treatment, or disease prevention. However, caution should prevail, as such guarantees can only be determined after reviewing the precise content of an informative video.

Ashutosh Upadhyaya is a Senior Partner at Anand and Anand

patent Pravin Anand, Managing Partner, Anand and Anand

Anand and Anand
B-41, Nizamuddin East,
New Delhi 110013, India

Contact details:
Tel: +91 120 405 9300
E-mail:

ashutosh@anandandanand.com

www.anandandanand.com

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