Summary: Cosmeceuticals are topical products with biologically active ingredients that blur the line between cosmetics and pharmaceuticals. Such products have gained significant market traction in India, yet occupy a regulatory grey zone with no independent legal status under the Drugs and Cosmetics Act, 1940. This ambiguity forces businesses to strategically navigate compliance by carefully crafting product claims to remain within the “cosmetic” category while avoiding the stricter regulatory requirements applicable to “drugs” or “medical devices”.
Between Beauty and Therapy: What Are Cosmeceuticals?
Cosmetics in India and the world are undergoing transformation on interpretation, classification and then, accordingly, regulation. “Cosmeceuticals” may be characterised as topical products combining cosmetic and pharmaceutical attributes. Formulated using biologically active ingredients, these exert pharmaceutical activity but are safe for use on normal or near-normal skin. In practice, these cosmetic‑pharmaceutical hybrids, which incorporate actives like retinoids, peptides, niacinamide, alpha‑hydroxy acids, antioxidants, and botanical extracts in sophisticated delivery systems, claim to enhance appearance and are marketed for conditions such as ageing, hyperpigmentation, acne, or hair loss.[1]
The United States Food and Drug Administration does not recognise “cosmeceuticals” as a legal category of regulated products, but the term is widely used by dermatologists, marketers, and consumers across the world and in India. A working description that aligns with this practice is a cosmetic product with drug‑like or therapeutic claims, positioned as offering more than temporary beautification but less than full‑fledged medicinal treatment.
On the Vanity Shelf: Prevalent Indian Cosmeceuticals
In the Indian market, cosmeceuticals cut across formats, price points, and channels, from dermatologist-dispensed ranges to direct-to-consumer (“D2C”) “skin science” brands amplified on social media. Some prominent product types include:
Advanced Facial Masks and Patches
Sheet masks, hydrogel masks, and under‑eye/spot derma patches are widely sold for hydration, brightening, anti‑ageing, and targeted repair, often incorporating concentrated actives, peptides, or acids in serum‑soaked substrates. Valued at about USD 451 million in 2024, India’s facial masks market is projected to grow steadily through 2030.s
LED/Red-light face masks and light-based devices
LED face masks using red, blue, or multi‑spectrum light have entered the Indian consumer and clinic segment, positioned for anti‑ageing, anti‑acne, and skin rejuvenation.
Daily-use “dermocosmetics” and clinic-backed brands
Dermatologist‑associated or “dermocosmetic” lines include cleansers, serums, sunscreens, and moisturisers with high‑performance actives and clinical‑style claims (barrier repair, pigment correction, acne control). These often blur into prescription skincare, with products recommended as part of long‑term regimens for chronic conditions like acne or melasma.
Hair and scalp cosmeceuticals
Anti‑hair‑fall serums, peptide‑based scalp tonics, caffeine‑infused shampoos, and densifying leave‑on products present themselves as non‑drug alternatives or complements to minoxidil and finasteride, promising thicker, fuller hair via cosmetic‑adjacent mechanisms.
Pigmentation, “brightening”, and anti-ageing lines
Vitamin C, niacinamide, alpha‑arbutin, kojic acid, and retinol‑based serums have become staples in Indian urban skincare, often framed as corrective treatments for photo-ageing and dyschromia rather than mere “fairness” products.
The common thread across these formats is the therapeutic framing of what regulators still treat as cosmetics.
Regulating the In-Between: Legal Framework in India
Despite their market prominence, “cosmeceuticals” have no independent legal status in India. The key features of the current framework are:
Drug or cosmetic?
The Drugs and Cosmetics Act, 1940 (“D&C Act”), separately defines “drug” and “cosmetic”, and cosmetics are defined to mean “any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic”. The intention of cosmetics, therefore, is to neither affect the structure or functions of the body nor provide any treatment, mitigation, or prevention of any disease. Drugs, by contrast, include articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease or those intended to affect the structure or function of the body.
Cosmeceuticals, which serve as an in-between application, may attract legal interpretation under the definition of both “drug” and “cosmetics” under the D&C Act.
Cosmetics and medical device regime (including cosmeceuticals)
Cosmetics, which in practice includes most products marketed as cosmeceuticals, are regulated under the D&C Act, the Cosmetics Rules, 2020, and Bureau of Indian Standards (“BIS”) specifications.
The Cosmetics Rules, 2020, define “new cosmetics” to mean “a cosmetic which contains a novel ingredient which has not been used anywhere in the world or is not recognised for use in cosmetics in any National or International literature”. The Cosmetics Rules, 2020, consolidate provisions on manufacture, import, sale, labelling, and quality and heavily rely on BIS standards for product-specific requirements.
Cosmeceuticals and medical devices are increasingly converging in the Indian skincare and wellness ecosystem, but they sit on very different legal foundations. Most so‑called cosmeceuticals, i.e., serums, derma patches, sheet masks, and “clinical” creams, are regulated as “cosmetics” under the D&C Act and the Cosmetics Rules, 2020, even when they adopt quasi‑therapeutic narratives around barrier repair, pigmentation, acne, or hair loss.
Conversely, products achieving their primary effect through physical or biophysical action on the body, such as LED/red‑light masks, microcurrent devices, or certain home‑use skin rejuvenation gadgets, may fall within the ambit of the Medical Devices Rules, 2017, depending on their intended use and labelling, and require device registration, quality‑management systems, and post‑market surveillance. This divergence means that two products sold side‑by‑side, for example, a peptide serum promising “wrinkle correction” and a red‑light mask marketed for “collagen stimulation”, may in fact be subject to entirely different regulatory pathways, compliance burdens, and enforcement risks, making careful claim‑crafting and product classification a central and strategic question for brands operating in this blurred “beauty-therapy-device” continuum.
Line between drug claim and cosmetic claim
Indian law does not carve out an intermediate statutory bucket for cosmeceuticals. Instead, products are characterised as either cosmetics or drugs based on composition, intended use, and representations made, including labels, advertising, and promotional material.
The Central Drugs Standard Control Organisation (“CDSCO”) in its frequently asked questions on registration and import of cosmetics in India explicitly states that a cosmetic with a “drug claim” cannot be registered as a cosmetic; products making therapeutic claims that fall within the definition of “drug” must comply with drug regulatory pathways instead.[2] This creates practical friction for cosmeceuticals, where marketing teams push toward curative or disease‑adjacent language, but regulatory and legal teams must keep claims safely on the cosmetic side of the line to retain the lighter regime.
Compliance and enforcement touchpoints
Given increasing reports of contact dermatitis and other adverse reactions linked to cosmetic use, commentators have called for stronger “cosmetovigilance”, i.e., systematic surveillance of cosmetic products and adverse events. In parallel, tightening norms around labelling, ingredient disclosure, claims substantiation, and animal testing have been progressively raising the compliance bar for manufacturers and importers.
Conclusion
Cosmeceuticals in India illustrate the pressures that consumer demand and innovation place on binary regulatory architectures. On the ground, dermatology clinics, D2C brands, and multinational “dermocosmetic” divisions rely on the language and logic of cosmeceuticals to differentiate products and command pricing premiums. In the statutory framework, however, those products must still be anchored in the familiar categories of drugs and cosmetics, requiring the compliance consequences that follow. For businesses, the strategic challenge is to design portfolios, ingredient decks, and claim matrices that harness genuine scientific innovation without inadvertently tipping a product into the drug or medical device bucket or inviting enforcement around misleading or unsubstantiated claims. For regulators, the policy question is whether incremental tightening of cosmetic and advertising norms, plus more robust cosmetovigilance, will suffice, or whether India will eventually follow global experiments in articulating a more nuanced middle category for this increasingly significant slice of the personal‑care market.
[1] https://pubmed.ncbi.nlm.nih.gov/31334943/.
[2] https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/cosmetics/FAQs-Cosmetics_New.pdf.