Summary: This article explores the regulatory challenges surrounding acne and transdermal patches in India. An acne patch that promises to “reduce a blemish overnight” and a nicotine patch that delivers a measured dose through the skin look worlds apart. Yet under Indian law, both sit on the same unresolved line. Their classification determines whether a company needs only a cosmetic registration or a full drug license backed by clinical data, with any misclassification carrying serious risks.
Two boxes, no bridge
The governing statute, the Drugs and Cosmetics Act, 1940 (“D&C Act”), sorts every product into two mutually exclusive categories. A “cosmetic” is any article intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance. A “drug”, by contrast, includes substances intended for the diagnosis, treatment, mitigation or prevention of disease, or intended to affect the structure or function of the body.” There is no statutory middle-ground. The Central Drugs Standard Control Organisation (“CDSCO”) has clarified that a product carrying a drug claim falls outside the definition of “cosmetic” and cannot be registered as one, regardless of its formulation.
Courts have repeatedly been asked to referee this binary distinction, particularly in tax and excise disputes where the classification determines the rate of duty, but the underlying test has been extrapolated with broader connotations. The clearest articulation was the Supreme Court’s reasoning in Ciens Laboratories (2013), where the presence of curative ingredients, not their proportion, mattered; availability without a prescription did not rescue a product from drug status; and the operative question was whether the product’s primary function was “care” or “cure”. Applying the same substance-over-label logic in 2024, the Telangana High Court held that salicylic acid content was sufficient to give a “Heat Powder” a genuinely medicinal character, notwithstanding its packaging as a talc-style powder. By contrast, an earlier Supreme Court decision in Alpine Industries (2003)found a product manufactured under a drug license to be, in commercial parlance, a product intended for the “care”, not “cure”, of the skin, for the purposes of determining custom duty.
Acne Patches: A Claims-driven Approach
For a hydrocolloid acne patch with no active pharmaceutical ingredient, classification may depend largely on what the label says. A patch that claims only to “absorb impurities” or “reduce the appearance of blemishes” reads as a cosmetic. However, when marketed as one that “treats” or “cures” acne, the same patch has made a drug claim, which removes it from the cosmetic definition altogether, regardless of the chemical’s characteristics.
The analysis is less simple once the formulation incorporates an active ingredient. Salicylic acid, a keratolytic used in most acne patches on the market, is not an ingredient that automatically triggers classification as a drug. The Cosmetics Rules, 2020, expressly permit its usage in cosmetics up to defined concentration limits. The CDSCO’s 2025 enforcement action cancelling several imported cosmetic registrations, after detecting concentrations as high as 30 per cent, reinforces that the operative trigger is concentration and claim, not the mere presence of the ingredient. A company can, in principle, sell a compliant cosmetic acne patch containing salicylic acid within these limits, provided the marketing never crosses into a disease-treatment claim.
The Indian regulatory framework is yet to envisage an intermediate “cosmeceutical” category of products that would let a genuinely active but low-risk patch carry a modest, regulator-verified efficacy claim without being pushed into full drug licensing.
Separately, the CDSCO clarified that cosmetics may never be delivered by injection precisely because the definition only encompasses products applied externally. As a result, a potential micro-needling acne patch adds another layer of complexity. Designed to pierce through the skin’s outer layer with tiny dissolvable needles that push an active ingredient deeper into the skin, a micro-needling patch, prima facie, appears to move out of the “cosmetics” boundary. The Medical Devices Rules, 2017, separately define an “invasive device” as one that penetrates the body, in whole or in part, through the skin’s surface or a body opening. The rules grade such devices starting at a moderate risk class even for brief use, moving higher still where the device is meant to be absorbed by the body or to deliver a medicinal product in a potentially hazardous way. It is arguably never a cosmetic at all, however mild its marketing language, because the mechanism itself takes it outside the “cosmetic” definition.
The Transdermal Problem
A transdermal patch designed to deliver an active ingredient systemically, such as a nicotine patch, is not primarily a labelling problem. Nicotine patches are licensed drug products in India, illustrating that a settled transdermal drug category can be regulated coherently. What remains unsettled is what happens when a patch combines a genuine drug-delivery mechanism with device-like housing, or when the active ingredient itself sits in a regulatory grey zone. Take the case of a transdermal melatonin patch. Section 22 of the Food Safety and Standards Act, 2006, permits health supplements and nutraceuticals to be sold, provided they are not drugs under the D&C Act and are formulated in listed oral dosage form. The Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2022, regulate melatonin’s permitted levels. None of these provisions, however, extend to transdermal formats. FSSAI permits products intended only for oral consumption, whereas CDSCO approvals for melatonin products are currently limited to tablets with fixed dosages.
Cross-jurisdictionally, South Korea’s Cosmetics Act creates a third tier of products, the “functional cosmetic”, for products claiming specific, ministry-recognised effects such as whitening, wrinkle reduction, or acne relief. Historically, anti-acne preparations were regulated as “quasi-drugs” under Korea’s pharmaceutical law before several categories were reassigned to functional cosmetics.
Industry Implications
The practical exposure to companies is, perhaps, concentrated on labelling and advertising, not formulation. A conservatively worded, concentration-compliant cosmetic patch may be defensible. The same formulation marketed with therapeutic language and exaggerated intended use may cross over to the definition of “drug”. In the absence of a fixed classification guidance from CDSCO on transdermal or combination-format patches, companies may encounter issues in seeking approvals under a uniform regulatory pathway. Ingredient-specific gaps, such as a transdermal melatonin or novel enzyme patch, compound this risk further, as these could place the product simultaneously within and outside CDSCO’s drugs or medical device classifications.
For regulators, the future may revolve around a cost–benefit analysis of considering an intermediate category, balancing product safety with a company’s compliance burden. Until that changes, the patch category, spanning an acne dot to a systemically active transdermal delivery system, will keep testing the limits of a regulatory framework built for a simpler product world.
For further information, please contact:
Biplab Lenin, Partner, Cyril Amarchand Mangaldas
biplab.lenin@cyrilshroff.com
