9. Advertising Aspects

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9. Advertising Aspects

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Drugs
India

This section provides information on regulations on advertising and if there are any restrictions or approval processes.

9.1 Applicable Advertising Regulation

1. Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. [1]

2. The Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1955 [2]

3. The Drugs and Magic Remedies (Objectionable, Advertisements) Amendment Act, 1963 No.42 of 1963 [3]

The Act describes:

Prohibition of advertisement of certain drugs for treatment of certain diseases and disorders.
Prohibition of misleading advertisements relating to drugs
Prohibition of advertisement of magic remedies for the treatment of certain diseases and disorders
Prohibition of import into, and export from, India of certain advertisements
Penalties

4. The Drugs and Cosmetics Act, 1940, and Drugs and Cosmetic Rules 1945 (as amended up to 2016) [4]

The Drugs and Cosmetic Rules, 1945 provides for certain diseases as mentioned under schedule J which a drug may not purport or claim to prevent and cure. It further provides that no drug may claim, purport, prevent, or assist in procuring miscarriage in women. Other diseases and conditions as set out in Schedule J include genetic diseases, diabetes, AIDS, obesity, cataracts, improvement in vision, etc.

5. Cable Television Network Regulation Act 1995 [5]

6. Cable Television Network Rules 1994, GSR 729(E) [6]

Section 6, Chapter II of the Cable Television Networks (Regulation) Act prohibits a person from transmitting or re-transmitting any advertisement through a cable network if such advertisement is not in conformity with the prescribed code.

7. Consumer Protection Act, 2019 [7]

Consumer Protection Act, 2019 is to inquire or cause an inquiry or investigation to be made into violations of consumer rights and institute complaints/prosecution, order recall of unsafe goods and services, order discontinuation of unfair trade practices and misleading advertisements, impose penalties on manufacturers/endorsers/publishers of misleading advertisements.

9.2 Specific Restrictions on Advertising

The Drugs and Cosmetics Act of 1940 prohibits advertisements for any drug or cosmetic from using reports of tests or analysis of the Central Drugs Laboratory or by a government analyst. This act also requires the advertisement of certain medicines to be made in a prescribed manner [4].

No advertisement of the drugs specified in Schedule H, Schedule H1, and Schedule X shall be made except with the previous sanction of the Central Government. [No reference shall be made to any other license number granted by any authority outside India on any label or container or in any covering in which the container is packed or in any other matter or advertisement enclosed therewith].

Position under the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 (“DMRA”), and the Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1955 (“DMR Rules”) [1]

Section 3 of the DMRA prohibits the advertisement of certain drugs for the treatment of specific diseases and disorders. The Schedule of the DMRA also provides a list of diseases for which any advertisement is prohibited.

This section prohibits any advertisement referring to any drug used for:

the procurement of miscarriage in women or prevention of conception in women; or
the maintenance or improvement of the capacity of human beings for sexual pleasure; or
the correction of menstrual disorders in women; or
the diagnosis, cure, mitigation, treatment, or prevention of any disease, disorder, or condition specified in the schedule.

Section 4 of the DMRA prohibits misleading advertisements of drugs if they:

directly or indirectly gives a false impression regarding the true character of the drug, or
make a false claim for the drug; or
are otherwise false or misleading in any material particular.

Section 5 of the DMRA prohibits the advertisement of magic remedies for the treatment of certain diseases, claiming directly or indirectly to be efficacious for any of the purposes specified in Section 3.

Judicial Precedents: The Supreme Court (SC) in the Hamdard Dawakhana case1 held that the main object and purpose of the DMRA is to prevent people from self-medicating with regard to various diseases. Self-medication to treat serious diseases mentioned in the DMRA and the DMR Rules has a deleterious effect on the health of the community and is likely to affect the well-being of the people. Having thus found that some medicines have a tendency to induce people to resort to self-medication because of elated advertisement, it was thought necessary in the interest of public health that the puffing of advertisements is put to a complete check and that the manufacturers are compelled to route their products through recognized sources to be properly tested and considered by expert agencies.

The SC further held that the DMRA read as a whole, does not merely prohibit advertisements relating to drugs and medicines connected with diseases expressly mentioned in Section 3 of the Act but also covers all advertisements that are objectionable and unethical and are used to promote self-medication or self-treatment.

Section 6 of the DMRA prohibits import into and export from India of certain advertisements.

No person shall import into or export from the territories, any document containing any advertisement of the nature referred to in the above Sections 3,4 and 5, and any document containing any such advertisement shall be deemed to be goods of which the import or export has been prohibited under Section 19 of the Sea Customs Act, 1878.

Examples of cases:

In the matter of Cipla Ltd Vs State of Tamil Nadu5 decided in 2018 by the Madras High Court, Cipla was prosecuted for the advertisement of EK Pill, an emergency contraceptive. The drug contained Levonorgestrel 1.5 mg whereas the notification dated 30.04.1992 of MHFW permitted the advertisements of the drugs viz., Levonorgestrel 0.15 mg. The petitioner was granted approval from DCGI which was later withdrawn. However, the approval of DCGI was in force on the date of the offense, so the petitioners were given relief.

In the matter of Mahesh Ramnath Sonawane Vs The Union of India6, a PIL filed by a petitioner sought action against the advertisement of Tablet D' Cold total, Syrup D' Cold and Cough, Gelusil MPS antacid, Glycodin Cough Syrup, Benadryl Cough Formula on various TV channels. It was held that Section 2(b) of the Drugs & Cosmetics Act, 1940 which defines ‘drug', is an inclusive definition that has got a very wide sweep. It, therefore, does not restrict itself to any particular type of medicine or drugs. Thus, advertisements cannot be used to promote self-medication or self-treatment of any drug.

Advertisement of Ayurveda Drugs

The Central Government amended the Drugs & Cosmetics Rule, 1945, and Rule 170 is inserted in Part XIX to prohibit the advertisement of Ayurveda, Siddha, and Unani drugs unless a unique identification number is obtained from the licensing authority. The following advertisements were UPHELD.

Actions taken by the Advertising Standards Council of India (ASCI):

ASCI upholds Complaints against 193 Advertisements out of 290 in February 2018 [8]. The following advertisements were considered to be, prima facie, in violation of The Drugs & Magic Remedies Act1954 and were referred to CDSCO regulators (Sr. No. Brand / Product Claims):
1. Shri Kalyan Ayurvedashra M / Cure Leucoderm and Safed Dag Mitao Abhiyan
2. Berry Skin Care (Leuco Kit) / Only brand delivery, with optimal mixture of herbs that ensures a therapeutic outcome
3. Vaidya Ashwani Kumar / Cure Leukoderma and Vitiligo
ASCI upholds complaints against 299 out of 489 advertisements, 151 ads withdrawn in July 2019 [9]
ASCI upholds complaints against 190 advertisements in Jun 2019 [10]

Lotus Herbals Ltd was held liable for promoting its product Lotus Herbals Youth RX which claimed to provide ten times more geneplex youth compounds that can reverse aging and make one look younger.

Section 14 of the DMRA provided exemptions to the following kinds of advertisements [1]:

Any signboard or notice displayed by a registered medical practitioner on his premises indicating the treatment for any disease, disorder, or condition specified in Section 3.
Any treatise or book dealing with any of the matters specified in Section 3 from a bonafide scientific or social standpoint.
Any advertisement relating to any drug sent confidentially to a registered medical practitioner.
Any advertisement relating to a drug printed or published by the government.
Any advertisement relating to a drug printed or published by any person with the previous sanction of the government granted prior to the commencement of the Drugs and Magic Remedies.

(Objectionable Advertisements) Amendment Act, 1963 (42 of 1963) [3] provides that the government may for reasons to be recorded in writing, withdraw the sanction after giving the person an opportunity to show cause against such withdrawal.

The following classes of advertisement are permitted subject to certain conditions [11]:

Leaflets or literature accompanying the packing of drugs
Advertisement of drugs in medical, pharmaceutical, scientific and technical journals
Price Lists or Therapeutic indexes published by manufacturers, importers, or distributors of drugs duly licensed
Medical Literature distributed by medical detailers appointed by manufacturers, importers, or distributors of drugs, duly licensed
Advertisement of chemical contraceptives for oral use only if the advertisement relates to chemical contraceptives for oral use having the following composition per tablet:
- DL-Norgestrel 0.30 mg. Ethinyl Estradiol 0.30 mg; or
- Levo-norgestrel 0.15 mg. Ethinyl Estradiol 0.03 mg; or
- Centchroman 30 mg.

Penalty for Violation

Financial or other sanctions for breach of advertising and promotional controls for medicinal products [1]:

Breach of the DMR Act provisions is punishable by up to six months imprisonment or with a fine or both. There is up to one year of imprisonment or a fine or both for a repeated offense. (Section 7 of DMRAct )
Section 29 & Section 30 Penalty for use of Government Analyst‘s report for advertising.—Whoever uses any report of a test or analysis made by the Central Drugs Laboratory or by a Government Analyst, or any extract from such report, for the purpose of advertising any drug [or cosmetic], shall be punishable with fine, which may extend to five hundred rupees [4].
Whoever, having been convicted of an offense under section 29 is again convicted of an offense under the same section shall be punishable with imprisonment which may extend to [two years, or with fine which shall not be less than ten thousand rupees], or with both.

9.3 Advertising Approval

All drug advertisements should be approved by The Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. It is the National Regulatory Authority (NRA) of India - the central government, licensing authority.

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

The Central Government revised Rules 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.

According to Rule 74(p), Rule 74A(i), Rule 74B(7), Rule 78(q), and Rule 78A(8) of Drug and Cosmetic Rules, advertisement of the drugs specified in Schedule H, Schedule H1, and Schedule X shall not be made except with the previous sanction of the Central Government [12].

The above rule is only applicable to manufacturers. However, the approval procedures are not defined under the said Regulations.

Discussion

Even though the above provisions mandate obtaining approval from the Central Government In the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules 1945, and Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. The Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1955, there are no specific provisions/sub-rules pertaining to approval procedures for the Advertising of drugs.

SCHEDULE A of the Drugs and Cosmetics Rules 1945 defines/lists of all the Forms pertaining to Licencing, certifications, etc. (Form 1 to Form 50 from pages 199 to 281) but a specific set of Forms is not defined under Schedule A [4].

Cost

No cost is mentioned since cost details for advertisement approval are not defined under the DAC Act or DMRA Acts and the approval process is not defined per the functions of CDSCO. [1-4, 13]

Note: Central Drug Standard Control Organization (CDSCO) - In the User Manual for SUGAM (An e-Governance solution for CDSCO), online payment does not make any reference related to advertisements. [14]

9.4 Other Notes or Requirements for Advertising

The Central Government had published a set of guidelines in December 2014 called the “Uniform Code of Pharmaceutical Marketing Practices” (“UCPMP”) as guidance to the industry for the promotion and marketing of drugs and medical devices. These guidelines are voluntary and do not have the force of law, at present, but are a guide for industries that they can follow [15].

Example of The UCPMP Code - which is a self-regulatory code - prescribing any of the following penalties in the event of a breach:

Suspension or expulsion of the company from the pharmaceutical association;
Reprimanding the company and publishing the details of the reprimand;
Requirement of the company to issue a corrective statement in the media used for promotion; or
Requirement of the company to recover items given in violation of the UCPMP Code from the concerned persons and provide details of the action to the ECPMP or the AECPMP.

As for the ASCI Code, it is framed by the Advertising Standards Council of India (ASCI), which is a voluntary self-regulatory body and not a Government body. The ASCI Code aims to regulate the content of promotions or advertisements. This Code applies to advertisers, advertising agencies, media, and others such as market research companies who are members of ASCI. This Code has also been accepted by individuals, corporate bodies and associations engaged in or otherwise concerned with the practice of advertising with the ASCI Code serving as the basic guidelines [16].

Under the ASCI Code, the responsibility for its observance lies with all those who commission, create, place, or publish any advertisement or assist in the creation or publishing of any advertisement. Under the provisions therein, all advertisers, advertising agencies, and media are expected not to commission, create, place, or publish any advertisement that is in contravention of the ASCI Code. The ASCI Code applies to advertisements read, heard, or viewed in India even if they originate or are published abroad so long as they are directed to consumers in India or are exposed to a significant number of consumers in India. It may be noted, though, that the orders of ASCI are not enforceable through the court enforcement mechanism.