Pharmaceutical Advertising in India: Whether Prohibited or Regulated under Drug Laws In India

Drugs play a very important role in the management of ailment and illness in human life and in this context; medical practitioners are given the responsibility of prescribing the various drugs required for respective ailments/illnesses for the appropriate treatment and cure of the same. Through this article we see how India regulates advertising and marketing of pharma products to ensure consumers donat get duped into having harmful medicines.

Fri Jul 01 2022 | Business Law | Comments (0)

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Both the government and patient advocacy organisations have long been concerned about unethical marketing and advertising practices. On various occasions , the pharmaceutical business has been accused of questionable practises in the sale of its products. In this context, suspicious practices involving pharmaceutical companies and healthcare practitioners/providers ("HCPs") have received the greatest attention. According to the Draft Pharmaceutical Policy, 2017, unethical practises utilised by pharmaceutical businesses 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 Drugs 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 cost. It has grown to dangerous proportions and must be handled as part of the new pharmaceutical policy.

In electronic media, we've 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 Advertisements) Rules, 1955, and judicial precedents are all examined in this section.

Status under the (DMRA) and (DMR Rules)

Section 3 of the DMRA prohibits the marketing of novel drugs for the treatment of certain diseases and disorders. A list of disorders for which advertising is prohibited is included in the DMRA schedule.

Any advertisement referring to a medicine used for:

  • conducting miscarriage in women; or
  • the prevention of conception in women is prohibited under this provision.
  • the preservation or enhancement of a person's capability for sexual pleasure; or
  • the treatment of women's menstruation disorders; or
  • any disease, ailment, or condition indicated in the schedule's diagnosis, cure, mitigation, treatment, or prevention

The DMRA's Section 4 forbids deceptive drug advertisements if they:

  • create a deceptive impression about the drug's genuine nature, either directly or indirectly, or
  • make a drug claim that is fraudulent; or
  • In any other material respect, are false or misleading.

Section 5 of the DMRA forbids the advertising of magical cures for the treatment of certain ailments that claim to be efficacious for any of the purposes listed in Section 3 directly or indirectly.

Stance of the Judiciary: The major intent and objective of the DMRA, according to the Supreme Court in the Hamdard Dawakhana case, is to prohibit people from self-medicating for various maladies. Self-medication for serious conditions listed in the DMRA and DMR Rules has a negative impact on community health and is likely to have a negative impact on people's well-being. After discovering that some drugs had a tendency to drive people to self-medicate as a result of exaggerated advertising, it was decided that, in the interests of public health, the puffing of commercials be put to a complete stop and that producers be forced to route their products through recognised channels.

The SC further argued that the DMRA, as a whole, not only banned advertising for medicines and  medicine related to diseases expressly referred to in Section 3 of the Act, but also came up with all advertising that is objectionable and unethical and which promotes self-medication or self-treatment.

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

  • Any signboard or notice posted on the premises of a certified medical practitioner outlining the treatment for any disease, ailment, or condition listed 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 advertisement for a drug submitted to a registered medical practitioner in confidence.
  • Any government-printed or published advertisement referring to a drug.
  • Any advertisement for a drug that has been printed or published with the government's prior approval.

The Ministry of Health and Family Welfare has issued different notifications allowing advertising:

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 of Section 6, will not apply to or in relation to any advertisement for contraceptives, provided that the advertisement solely refers to contraceptives that are government approved.

The following types of advertisements are allowed, but only under particular conditions:

  • Drug packaging includes leaflets or material.
  • Drug advertisements in medical, pharmaceutical, scientific, and technical publications
  • Price lists or therapeutic indexes published by lawfully licensed drug makers, importers, or wholesalers
  • Medical literature distributed by duly licensed medical detailers engaged by drug producers, importers, or distributors.

Cipla was charged with advertising the EK Pill, an emergency contraceptive, in the case Cipla Ltd vs State of Tamil Nadu, which was resolved by the Madras High Court in 2018. The medicine included Levonorgestrel 1.5 mg, but the MHFW's notification dated 30.04.1992 allowed for the advertising of medications containing Levonorgestrel 0.15 mg. DCGI granted the petitioner approval, which was later rescinded. However, because the DCGI approval was in effect on the day of the offence, the petitioners were granted relief.

A PIL filed by a petitioner in the case of Mahesh Ramnath Sonawane vs. Union of India sought to stop the advertising of Tablet D' Cold complete, Syrup D' Cold and Cough, Gelusil MPS antacid, Glycodin Cough Syrup, and Benadryl Cough Formula on various television stations. The definition of "drug" in Section 2(b) of the Drugs & Cosmetics Act, 1940, was found to be an inclusive definition with a broad scope. As a result, it is not limited to any single type of medicine or drug. As a result, marketing for any substance cannot be used to promote self-medication or self-treatment.

The authorities must first determine if all pharmaceuticals or medicines can be advertised on such channels, and if so, what content should be included in such advertisements. The contents must not be in violation of Section 3 or Section 4 of the 1954 Act. If ads are allowed, the fact that they encourage self-medication or self-treatment must be considered, and suitable precautions may be necessary in this regard. The writ petition was granted, with regulatory agencies being given the required instructions.

Position under the 1940 Drugs and Cosmetics Act and the 1945 Drugs and Cosmetics Rules:

The Central Government revised Rule 74 and 78 of the Drugs & Cosmetic Rules, stating that no advertisement for Schedule H, H1 or X can be issued without prior approval from the Central Government.

Advertisement of Ayurveda Drugs

The Drugs & Cosmetics Rule, 1945 was changed by the Central Government, and Rule 170 was added to Part XIX to restrict the advertisement of Ayurveda, Siddha, and Unani drugs unless a unique identification number is obtained from the licensing body.

Conclusion

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

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