The regulation of cosmetic products in India is in the development stage while cosmetic market in India serves for USD 6.5 billion and increasing continuously with 25% CAGR rate. Due to the competitive marketplace, companies indulge in irrational and false marketing of a cosmetic with a drug claim or by marketing a drug as if it were a cosmetic not complying the requirements of the drug.
Whether a product is a cosmetic or a drug under the law is determined by that product’s intended use. This article will focus cosmetic product registration depending on the intended use.
What is a Cosmetic?
According to Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles 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 the appearance”.
Examples are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. Cosmetics in India are broadly categorized into skin care, hair care, nail and cuticle products, and oral care products, etc.
How can a product be both a cosmetic and a drug?
Sometimes cosmetic products match both cosmetics and drugs. It can happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Antidandruff shampoo is also categorized under cosmetics. But if the shampoo claims to decrease hyper-seborrhoea or allows hair to regain energy and health then it cannot be registered under cosmetic.
For example, a cosmetic product is considered as soap
- If the bulk of the nonvolatile matter in the cosmetic product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds
- It follows the labelling requirements of India and then sold
If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug.
For example:
If a product consists of detergents, primarily made of alkali salts of fatty acids, and is intended not only for cleansing but also for other cosmetic uses. It is regulated as a cosmetic.
If a product consists of detergents, primarily of alkali salts of fatty acids, and is intended not only for cleansing but also to cure, treat, or prevent disease, or to affect the structure or any function of the human body. It is regulated as a drug, or possibly both a drug and a cosmetic. Examples include antibacterial cleansers and cleansers that are also intended to treat acne.
If a product
- is intended solely for cleansing the human body,
- has the characteristics consumers generally associate with soap, and
- does not consist primarily of alkali salts of fatty acids
It will be labeled as soap and regulated as a cosmetic.
Cosmetic Manufacturers must be cautious about making tall claims. The Central Drug Standard Control Organization (CDSCO) is the principal authority to manage activities relating to cosmetic products in India. CDSCO should take proper regulations to integrate the cosmetic regulatory compliance in India.
References
- Cosmetics: Regulatory and market scenario for us and India. Available at: http://www.thepharmajournal.com/archives/2018/vol7issue6/PartC/7-6-3-701.pdf.Accessed on 23.06.2020.
- Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).Available at: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap.Accessed on 23.06.2020.
