THE LAW ON DRUG PROMOTION AND MARKETING IN INDIA

INTRODUCTION

Drugs play a very important role in the treatment of diseases and disorders in a person's life and, in this context, professionals are responsible for the implementation of a number of drugs that are required for the various diseases/conditions, adequately treated and cured. In this article, we will see how, in India that regulates the advertising and marketing of pharmaceutical products, in order to ensure that the consumer will not be disappointed by the harmful chemicals.

Both the government and the rights of the patient's advocacy have long been interested in the ethics of advertising and marketing practices. At the time, the pharmaceutical company has been accused of questionable marketing practices for its products. In this regard, most of the attention has been given to wrongdoing in connection with the pharmaceutical companies and health care professionals ("HCPs") have received the greatest attention. In accordance, with the Draft Pharmaceutical Policy, 2017 unethical practices utilized by pharmaceuticals business are a subject of concern. Doctors are enticed to recommend a particular brand through all-expense-paid excursions typically disguised as educational conventions, and other such incentives it says. While the drug and magic act forbids any advertising of a drug such educational conferences are utilized to get around the law. These expenses add to the drug's overall costs. It has grown to dangerous proportions, and it should be considered as part of the new pharmaceutical policy.

In electronic media, we have seen commercials for a variety of medications. Consumers on the other hand continue to have reservations about the legitimacy of these commercials. The Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules 1945, the Drugs and Magic Remedies (objectionable advertisement) Act 1954, the drugs and magic remedies (objectionable advertisement) rules, 1955, and judicial precedents are all examined in this section.

STATUS UNDER DMRA:

Section 3 of the DMRA does not allow the sale of a new drug for the treatment of specific diseases and medical conditions. The list of offenses for which the promotion is prohibited and is included in the DMRA Schedule.

All the ads that can be assigned to the drug are used for: 

•     The procurement of miscarriage in women; or

•     The prevention of conception in women is prohibited under this provision

•     whether for the treatment of menstrual disorders in women, or

•     have any illness, disease, or condition that is specified in a schedule for the diagnosis, treatment, mitigation, treatment, or prevention 

The DMRA’s Section 4 forbids deceptive drug advertisement if they:

•    create a false impression of the essential nature of the drug, either directly or indirectly, 

•    make a drug and claim that is fraudulent; or

•     any other material respect is false or misleading

Section 5 of the DMRA doesn't allow magical cures of various diseases that are directly or indirectly a claim to be effective for the purposes set out in article 3. 

STANCE OF THE JUDICIARY:

The intent and purpose of the DMRA according to the Supreme Court in the Hamdard Dawakhana case which is to get people to forbid self-healing of various diseases on their own. Self-medication for serious medical conditions indicated in the DMRA and DMR Rules and regulations will have a negative effect on our health, and it is likely to have a negative impact on the well-being of the people. Recognizing that some of the drugs have a tendency to encourage people to self-medicate, resulting in an excess of publicity, it was decided that it is in the best interest of public health, it is necessary to completely stop the wind, advertising, and the strength of the manufacturers to focus on their products on the authorized channel.

Supreme court further argued that the DMRA as a whole not only banned advertising for medicines related to disease expressly referred to in Section 3 of the act, but also came with the ads that are unethical, rather than ethics, and the promotion of self-medication or self-treatment.

According to Section 14 of the DMRA, the following types of advertisements are permitted:

•     Any sign, or notice, is posted on the premises of a certified medical practitioner outlining the treatment for any disease, ailment, or condition given in section 3. 

•     Any treatise or book from a genuine scientific or social standpoint dealing with any of the topics listed in Section 3.

•    Any form of advertising of medicinal products which are to be submitted by a registered medical practitioner in confidence. 

•    Any government-printed or published advertisement referring to a drug.

•     Any advertising of a drug that has been printed or published with the government’s prior permission.

THE MINISTRY OF HEALTH AND FAMILY WELFARE HAS ISSUED DIFFERENT NOTIFICATIONS ALLOWING ADVERTISING OF SPECIFIC TYPES OR GROUPS OF MEDICATIONS:

The Central government has issued a notification that the provisions of clause (a) of section 3 in connection to the prevention of conception in women, as well as those od sections 6 will not apply to or in relation to any advertisement for contraceptives, provided that the advertisement solely refers to contraceptives that are approved by the government.

Types of Advertisements are allowed but under specific circumstances:

•     Drug packaging includes materials

•     Drug advertisement in medical, pharmaceuticals, scientific and technical publications

•     Price lists published by lawfully licensed drug makers, importers, or wholesalers

•     Medical literature distributed by duly licensed medical detailers engaged by drug manufacturers, importers, or distributors.

CONCLUSION

Thus, based on a combined reading of the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics, Laws of 1945, and the Drugs and Magic of Product (objectionable) Act of 1954, all of the drugs are banned, unless it has been authorized by the central Government, the licensing authority, or is exempt from the application of the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics, Laws of 1945, and the Drugs and Magical Remedies (objectionable) Act, 1954. 

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Author:

Damini Nagar
Indore
B.A LLB from Indore institution of Law