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 the advertising and marketing of pharma
products to ensure consumers don�t get duped into having harmful medicines.
Both the government and patient advocacy organizations have long been concerned
about unethical marketing and advertising practices. At various times, the
pharmaceutical business has been accused of questionable practices in the sale
of its products. In this context, suspicious practices involving pharmaceutical
companies and healthcare practitioners/providers (HCPs) have received the
According to the Draft Pharmaceutical Policy, 2017, unethical practices utilized
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 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 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:
- The procurement of 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
- 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 fraudulent drug claim; 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.
The 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 harms community health and is likely
to harm people's well-being. After discovering that some drugs tended 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 those producers be forced to route their products through
The SC further argued that the DMRA as a whole not only banned advertising for
medicines and medicines 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 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 of Section 6, will not apply to or concerning 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
- Drug packaging includes leaflets or materials
- Drug advertisements in medical, pharmaceutical, scientific, and
- Price lists or therapeutic indexes published by lawfully licenced drug
makers, importers, or wholesalers.
- Medical literature is distributed by duly licenced 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 violate 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
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 licencing
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, 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.