Pharmaceuticals play a significant part in the management of sickness and disease in human life, and in this context, medical practitioners are tasked with prescribing the different drugs necessary for various ailments/illnesses in order to treat and cure them appropriately. In this post, we’ll look at how India controls pharmaceutical promotion and marketing to ensure that customers aren’t tricked into taking hazardous medications.

Unethical marketing and advertising practices have long been a source of concern for both the government and patient advocacy organizations. The pharmaceutical industry has been accused of dubious practices in the sale of its drugs on several occasions. Suspicious activities involving pharmaceutical corporations and healthcare practitioners/providers (“HCPs”) have gotten the most attention in this area. Unethical practices used by pharmaceutical enterprises are a source of worry, according to the Draft Pharmaceutical Policy, 2017. “All-expense-paid vacations, generally disguised as ‘educational conferences,’ and other such incentives are used to induce doctors to advocate a specific brand,” it claims. While the Drugs and Magic Act prohibits any drug promotion, such “educational” gatherings are used to circumvent the law. These costs are added to the overall cost of the medicine. It has gotten out of hand and has to be dealt with as part of the new pharmaceutical policy.”

We’ve seen commercials for a range of drugs on television. Consumers, on the other hand, continue to have doubts about the advertising’ credibility. This section looks at the Drugs and Cosmetics Act of 1940, the Drugs and Cosmetics Rules of 1945, the Drugs and Magic Remedies (Objectionable Advertisement) Act of 1954, the Drugs and Magic Remedies (Objectionable Advertisements) Rules of 1955, and legal precedents.

DMRA and DMR Rules

The DMRA’s Section 3 bans the marketing of new medications for the treatment of specific illnesses and illnesses. The DMRA schedule includes a list of illnesses for which advertising is forbidden.

This rule prohibits any advertisement relating to a drug used for:

• The procurement of miscarriage in women; or the prevention of conception in women.
• The preservation or increase of a person’s sexual enjoyment capacity; or the treatment of menstrual abnormalities in women; or
• The diagnosis, cure, mitigation, treatment, or prevention of any illness, affliction, or condition listed in the schedule.

Deceptive drug ads are prohibited under Section 4 of the DMRA if they:

• Give a deceptive impression regarding the drug’s real nature, either directly or indirectly, or
• Make a fraudulent drug claim; or
• Are untrue or misleading in any other material regard.

The DMRA prohibits the direct or indirect advertising of magical remedies for the treatment of certain disorders that claim to be beneficial for any of the objectives stated in Section 3.

JUDICIARY’S TAKE ON PHARMACEUTICAL ADVERTISING:

The main aim and goal of the DMRA, according to the Supreme Court in the HAMDARD DAWAKHANA CASE, is to prevent individuals from self-medicating for a variety of ailments. Self-medication for serious diseases stated in the DMRA and DMR Rules is harmful to community health and is likely to harm people’s well-being. Following the discovery that some pharmaceuticals tended to lead individuals to self-medicate as a consequence of excessive advertising, it was agreed that, in the interests of public health, commercial puffing be put to an end and makers be obliged to route their goods through recognized channels.

The Supreme Court further stated that the DMRA as a whole not only prohibited advertising for medications and drugs connected to disorders specifically mentioned in Section 3 of the Act, but also prohibited all disagreeable and immoral advertising that encourages self-medication or self-treatment.

The following forms of advertisements are permissible under Section 14 of the DMRA:

• Any signboard or notice put on the premises of a registered medical practitioner that details the treatment for any of the diseases, ailments, or conditions stated in Section 3.
• Any treatise or book dealing with any of the themes stated in Section 3 from a true scientific or social stance.
• Any confidential advertisement for a drug sent to a licensed medical practitioner.
• Any drug advertising printed or published by the government.
• Any medication advertising that has been printed or published with the permission of the government.

Different notifications from the Ministry of Health and Family Welfare have allowed for the advertising of certain types or categories of drugs.

The central government has issued a notification that the provisions of Section 3 clause (a) in relation to the prevention of conception in women, as well as Section 6, will not apply to or in relation to any advertisement for contraceptives, provided that the advertisement only refers to government-approved contraceptives.

Advertisements of the following sorts are permitted, but only under certain conditions:

• Leaflets or other materials are included in drug packaging.
• Advertisements for drugs can be seen in medical, pharmaceutical, scientific, and technical journals.
• Drug manufacturers, importers, and distributors with valid licenses issue price lists or therapeutic indexes.
• Drug makers, importers, and distributors hire officially licensed medical detailers to deliver medical material.

In Mahesh Ramnath Sonawane vs. Union of India, a petitioner sought to have the advertisements for Tablet D’ Cold complete, Syrup D’ Cold and Cough, Gelusil MPS antacid, Glycodin Cough Syrup, and Benadryl Cough Formula removed from various television stations. The Drugs & Cosmetics Act of 1940’s Section 2(b) definition of “drug” was ruled to be an inclusive term having a broad reach. As a result, it isn’t restricted to any certain sort of treatment or medication. As a result, no drug marketing may be utilized to encourage self-medication or self-treatment.

First, the authorities must establish if all medications or medications may be marketed on these channels, and if so, what material should be included in such commercials. The contents must not be in contravention of the 1954 Act’s Sections 3 and 4. If advertisements are permitted, the fact that they encourage self-medication or self-treatment must be considered, and appropriate safeguards may be required. The writ petition was granted, and the requisite orders were delivered to regulatory bodies.

Conclusion

All drug advertisements are prohibited unless permitted by the central government, licencing authorities, or exempted from the application of the Drugs & Cosmetics Act, 1940, Drugs & Cosmetics Rules, 1945, and Drugs and Magical Remedies (objectionable) Act 1954, based on a combined reading of the Drugs & Cosmetics Act, 1940, Drugs & Cosmetics Rules, 1945, and Drugs and Magical Remedies (objectionable) Act 1954.

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