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Labelling of Drugs & Cosmetics: Indian Soaps & Toiletries Makers Association v. Ozair Husain & Ors. (2013)
Citation: (2013) 3 SCC 641
Date of judgement: 07/03/2013
Facts:
Ozair Husain, a public-spirited individual, filed a PIL before the Delhi High Court claiming the fundamental right of a consumer to know about the source of ingredients in drugs and cosmetics. The preliminary issue being, the lack of labelling on drugs and cosmetics as to the origins of their ingredients. A Division Bench of the High Court by an order dated 13/11/2002 upheld the contentions and remarked non-labelling to be violative of Articles 19(1)(a), 21 and 25. An interim order was passed directing the packaging of cosmetics to be done in a way similar to food items. Moreover, all drugs, except for life-saving ones, were asked to be marked with a red label to connote the presence of non-vegetarian content and green for vegetarian. It also directed the Director-General of Health Services to issue a list of drugs that could be deemed life-saving to avail the exception.
Aggrieved by the order, Indian Soaps & Toiletries Makers Association (appellants) filed an appeal before the Supreme Court challenging the inherent difficulties posed by the impugned judgement dated 13/11/2002.
Issues:
- Whether a consumer has the right to know whether a particular drug or cosmetic is vegetarian or non-vegetarian
- Whether labelling the source of ingredients for drugs and cosmetics was practical
- Whether the High Court had jurisdiction to direct the Centre to amend Rules.
Arguments advanced:
The appellants placed on record that the direction was impracticable and wouldn’t serve any purpose. The distinction between “vegetarian” & “non-vegetarian” was usually related to the notion of food and ingestion. They also raised the issue that drugs and cosmetics were made up of a plethora of ingredients and it would be difficult to trace the origins and specific chemical or medicinal component of each.
The requirement would impose severe technological and research-based costs on local manufacturers. Unlike food products, there was a large influx of drugs and cosmetics from international markets and this would put Indian manufacturers at an economic disadvantage.
The respondent’s (Ozair Husain) contention was based on the idea that about 60% of Indians were vegetarian, 50% were illiterate and over 90% couldn’t read English. He claimed that it was the fundamental right of each consumer to know whether a product had vegetarian or non-vegetarian produce as it would influence his purchase choice. It was added that the purpose of the petition was to safeguard the interests of those who didn’t know and effectively communicate to them by means of universal symbols. Through this communication, one could fulfill and stand true to one’s beliefs on vegetarianism. Article 25 was also raised as a way of enforcing one’s particular belief or opinion about a category of product.
Judgement:
- Classification of life-saving drugs:
The Court recognized that the impugned judgement was formed by placing drugs at par with the food products. The first aspect under consideration was the exception of life-saving drugs. The appellants furthered that there was no definition in pharmacology for a “life-saving drug” and the same would be subjective to a particular stage of a disease or infirmity. The Court thus rejected the impugned order’s view as the classification sought was generic, and the fact that each drug was life-saving in its own way. In addition to these, the Court upheld the fact that the power to determine and consequently direct such labelling would be vested with the Drug Technical Advisory Board constituted under Section 5 of the Drugs & Cosmetics Act.
- Labelling under the Prevention of Food Adulteration Act:
It is pertinent to note that the entire course of events unfolded before the enactment of the Food Safety and Standards Act, 2011 and thus relied on the provisions, and orders under the Act of 1954.
The learned judges referred to the concept of labelling and packaging brought about by the Prevention of Food Adulteration (Fourth Amendment) Rules, 2001 that effectuated symbolism and colour codes to categorize food products. The same was enshrined under Rule 32(b) that established guidelines to be followed while packaging food. This made it mandatory for manufacturers to declare the contents of food. However, the concept of labelling was still within the ambit of the Act of 1954 whereas the Drugs and Cosmetics Act, 1940 imposed no such prerequisite.
- Labelling under the Drugs and Cosmetics Act, 1940:
Section 5 of the Act dealt with the constituting of a Drug Technical Advisory Board for advising both the Centre & State on technicalities based on the provisions of the Act. The Hon’ble Apex Court then referred to Part XV of the Drugs and Cosmetics Rules, 1945 which encompassed the manner for the labelling and packing of cosmetics and medicines. However, the Rules did not prescribe any requirement as to the use of any labels for vegetarian or non-vegetarian. Neither the Rules nor the Act imposed any responsibility on manufacturers to make any such specification.
- Right to receive information and the practicality of labelling:
The provisions of the Act of 1945 made it evident that any decision or amendment could be made by the Central Government only in consultation with the Drug Technical Advisory Board. Reference was made to the outcome of a meeting of the Board concerning labelling based on the ingredients included. The Meeting dated 8/07/1999 concluded with an answer in the negative as such as a proposal was neither practical nor relevant.
While delving into the contention of the right to information, the court upheld the well-established principle that freedom of speech under Article 19(1)(a) included the right to receive information. Decisions such as those in State of U.P. v. Raj Narain & Ors., (1975) 4 SCC 428 and P.V. Narasimha Rao vs. State, (1998) 4 SCC 626, upheld that state had the duty to ensure its citizens’ received information. Nonetheless, this right could be exercised and claimed only to a practical extent while also ensuring that it wouldn’t infringe upon the rights of others.
Relying on the appellant’s submissions and the previous views of the Board on labelling, the learned judges upheld the contention that classification would not be plausible. It was also added that the option of deciding whether or not to consume a drug merely based on its vegetarian quotient could not be left with a patient whose life depended on it.
Individuals’ food habits were acknowledged to be extremely subjective with each having a belief and liking for his own. Instances such as the practice in Jainism whereby vegetarians do not consume food grown below the ground and other situations wherein vegetarians consume only eggs. There would be a subdivision even amongst non-vegetarians who would not consume beef/pork due to religious beliefs. Thus, it was substantiated that a requirement for labelling would serve no effective purpose due to the plethora of beliefs and sub-divisions within a category and the additional costs it would impose.
- High Court’s power to issue a mandamus to the Central Government:
Judgements such as those in A.K. Roy v. Union of India & Ors., (1982) 1 SCC 271 and Supreme Court Employees’ Welfare Association v. Union of India & Anr., (1989) 4 SCC 187, have consistently upheld the view that a court cannot issue a mandamus directing enactments. Such a power would vest with the Legislature alone or the Executive through delegated legislation and courts do not have the power to compel. The learned judges then referred to the view in Bal Ram Bali & Anr. v. Union of India, (2007) 6 SCC 805, that reiterated policy power to vest with the appropriate government alone and the incapability of Courts to direct other organs to bring about a particular law.
The Division bench of the Supreme Court hence permitted the appeal as it penned that the High Court of Delhi had no power to award an interim arrangement and set aside the impugned order.
Conclusion:
The right to receive information is indubitably a facet of freedom of speech under Article 19(1)(a). Despite having a noble intent for labelling drugs and cosmetics, the same could not be upheld due to the various difficulties inherent in the process and its effectivity. The flaw with classification boils down to the extremely subjective food habits of individuals which would essentially make all classification worthless if not clearly communicated. Furthermore, courts did not have the power to direct either the Executive or Legislature to enact statutes or bring about amendments as it would result in the overstepping of jurisdiction. The verdict established that the right to receive information could be availed only if it was practical and didn’t infringe upon the rights of others.
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