Pharmaceutical Advertisements in India: Whether Prohibited or Regulated?
Drugs plays crucial part in our life. With providing cure for any known illness to providing ailment, drugs have formed an essential part of our daily routines. Any the medical practitioners are made duty bound to prescribe various drugs required for curing the illness, depending on the respective illness.
Table of Contents
- Regulation of Pharma Advertisement in India
- Purpose of Restriction on Advertisement of Medicines
- Hamdard Dawakhana (Wakf) Lal Kuan, Delhi & Another V. Union of India & Others
- Advertisement Ban for Specified Medicines
- Restrictions on Advertisement of Medicines at the premises of Medical Practitioner
- Cipla Ltd. v. State of Tamil Nadu
- Mahesh Ramnath Sonawane v. Union of India
- Advertisement of Ayurveda Drugs
- Amit Singh & Anr. v. State
- Conclusion
However, drugs being in different category from those of other consumer products, are subject to regulations on the pretext of advertising and marketing.
Regulation of Pharma Advertisement in India
The Act which is responsible for maintaining system of checks and balance on advertisement of drugs is Drugs and Magical Remedies (Objectionable Advertisement) Act, 1954. Any advertisement pertaining to the drug used for diagnosis, cure, mitigation, treatment or prevention of any disease is subject to scrutiny of Section 3(d) of the Drugs and Magical Remedies Act.
As per Section 3(d) of the Act, “no person shall take part in the publication of any advertisement referring to any drug in terms which suggest or are calculated to lead to the use of that drug for the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule, or any other disease, disorder or condition (by whatsoever name called) which maybe specified in the rules made under this Act.”
Purpose of Restriction on Advertisement of Medicines
Supreme Court in the case of Hamdard Dawakhana (Wakf) Lal Kuan, Delhi & Another V. Union of India & Others, clarified the position regarding the Drug and Medical Remedies Act, and held that “The object of the Act as shown by the scheme of the Act is the prevention of self-medication and self-treatment and a curb on such advertisements is a means to achieve that end.“
Taking serious note of the self-medication Supreme Court remarked that “self-medication for serious conditions listed in DMRA has negative impact on community health and is likely to have negative impact on people’s well-being as well. It went to comment that after discovering some drugs that had a tendency to drive people to self-medicate as a result of exaggerated advertising, it is important in the interest of public health to put a stop to these puffing commercials.”
Thus, from the definition provided in the Act and interpretation of Supreme Court, it is clear that the purpose of this Act is to regulate the advertisement of medical drugs, by prohibiting the advertisement of any drug, which might suggest its use to be to cure, mitigate, treat or prevent any disease specified under the Act.
Advertisement Ban for Specified Medicines
Advertisement of which drugs are banned under the Act?
- Drug used for procurement of miscarriage of women;
- Prevention of conception of women;
- Preservation or enhancement of person’s capability for sexual pleasure;
- Treatment of women’s menstruation disorder;
Furthermore, Section 4 of the Act forbids advertisement of drugs if;
- They tend to create a deceptive impression of drug’s genuine nature, either directly or indirectly;
- Or make a claim regarding fraudulent nature of the drug;
- Or make claim in any other material respect, which is false or misleading.
Restrictions on Advertisement of Medicines at the premises of Medical Practitioner
However, this Act not only forbids the advertisement of medical drugs. Section 14 of the Act permits advertisement pertaining to:
- Signboard or notice posted on the premises of certified medical practitioner outlining treatment of a disease, ailment or condition;
- Any book from a genuine scientific standpoint, dealing with topics listed in Section 3 of the Act;
- Advertisement of drug submitted to registered to medical practitioner in confidence;
- Government advertisement pertaining to a drug;
- Or, any advertisement published with prior permission of the Government;
Various cases have came before various courts across the country, where the question involved was whether the advertisement of a specific drug can be allowed or not?
In the case of Cipla Ltd. v. State of Tamil Nadu, Madras High Court resolved the query pertaining to advertisement of Ek Pill, an emergency contraceptive by holding that the petitioners were granted prior permission of DCGI, which was later on rescinded. However, High Court held that since on the day of advertisement, the permission of DCGI was in effect, the petitioners were not under default under the Drugs and Magical Remedies Act.
In another case of Mahesh Ramnath Sonawane v. Union of India, Supreme Court clarified the scope of drug under the Drugs and Magical Remedies Act and held that “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.
Advertisement of Ayurveda Drugs
The Drugs & Cosmetic Rules, 1945 provides for the advertisement of Ayurveda products and holds that under Rule 170 of the Act, advertisement of Ayurveda, Siddha and Unani drugs are restricted unless a unique identification number is obtained from a proper licensing body.
Even Delhi High Court in the case of Amit Singh & Anr. v. State, held that “an attempt to bring to the notice of public at large about the new technology which had been innovated.., the same in no manner can be termed as an advertisement to the sale and use of any particular drug,”.
CONCLUSION
The Drugs and Magical Remedies Act was brought in force in order to control the advertisement of drugs in order to prohibit advertisement which promotes self-medication.
Even the courts across the country have time and again clarified the position regarding advertisement of drugs and reiterated time and again the damages in has to public health.