On the television at night, it is almost impossible to miss the advertisements for products to gain height, lose weight, control drug addiction, and a plethora of other such purposes. The question to be addressed is whether such advertising is allowed in India or are there certain hurdles.
Drug advertising is regulated by the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. The preamble of the act clearly indicates that all the provisions apply to drugs only.
Under section 2(b)(ii) of the act, “drug” includes “any substance intended to be used for or in the diagnosis, cure, mitigation, treatment or preventing of disease in human beings or animals”. Section 2(b)(iii) specifically excludes food, clarifying that “drug” refers to “any article, other than food, intended to affect or influence in any way the structure or any organic function of the body of human beings or animals”.
Under section 3, “no person shall take any 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 – (a) the procurement of miscarriage in women or prevention of conception in women; or (b) the maintenance or improvement of the capacity of human beings for sexual pleasure; or (c) the correction of menstrual disorder in women; or (d) 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 may be specified in the rules made under this Act”.
A division bench of Karnataka High Court in The State of Karnataka v RMK Sivasubramanya Om (1978) held that: “The publication of an advertisement, to amount to any offence, should have reference to a drug and that drug should have been suggested as a cure for certain ailments mentioned in Clauses (a) to (d) of Section 3. Since the contravention of Section 3 is made punishable, it is necessary to construe the Section strictly.”
Subsequently, Bombay High Court in Kantirani Jaynarayan Mangal v State of Mahrashtra (1982) reiterated that a drug as defined in section 2 of the act must purport to being curative. A similar view was taken by Delhi High Court in Amit Singh v The State and M/s HT Media Ltd v The State (2012).
From the above, it is clear that any “drug” is definitely regulated by the act. We now examine whether “food” can be regulated under the act.
Under the Food Safety and Standards Act, 2006 (FSSA), the definition of “food” has become very exhaustive. Under section 3(j) read with section 22 of the FSSA, food includes items such as proprietary and novel food.
Section 22 of the FSSA provides that: “Save as otherwise provided under this Act and regulations made thereunder, no person shall manufacture, distribute, sell or import any novel food, genetically modified articles of food, irradiated food, organic foods, foods for special dietary uses, functional foods, neutraceuticals, health supplements, proprietary foods and such other articles of food which the Central Government may notify in this behalf.”
Section 22(1)(b)(i) provides that “foods for special dietary uses or functional foods or nutraceuticals or health supplements” includes products that are labelled as food for special dietary uses, functional foods, nutraceuticals or health supplements or similar products, which are not represented for use as a conventional food – formulated in the form of powders, granules, tablets, capsules, liquids, jelly and other dosage forms but not parenterals.
Section 22(1)(b)(iii) provides that such a product cannot claim to cure or mitigate any specific disease, disorder or condition, except for such health benefits or promotion claims as may be permitted by the regulations made under the FSSA.
Thus, while “food” as such is not under the purview of the Drugs and Magic Remedies (Objectionable Advertisements) Act and the authorities cannot exercise jurisdiction under that act, food for special dietary uses, functional foods, nutraceuticals, health supplements and similar products are regulated by the FSSA, which prohibits any claim to cure or mitigate any disease or disorder.
Therefore, manufacturers, sellers, importers and distributors of such food products should be cautious in their advertisements as claims to cure any disease listed in the schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Act may bring in the prohibition of advertising under that act. However, the larger question which is yet to be decided by any court is whether once any such a product is granted product approval under the FSSA regulations and is defined as a food, will the Drugs and Magic Remedies (Objectionable Advertisements) Act, still be applicable to the product as that act specifically excludes “food” or will any penal action need to be taken under the FSSA.
Sidhartha Srivastava and Gurmeet Kainth are partners at DH Law Associates.
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