Jubaraj Singha

The use of cosmetics as substances for the purpose of embellishing, perfuming, restoring and rituals dates back to prehistoric era. Nowadays fitness, vigour, good looks and the way of presenting oneself are being considered as qualities of personality. In present times people are reckoned on these elements. Hence today it becomes pertinent to give more attention towards beauty and looks for professional success.

The evidence of cosmetic usage spans at least 6000 years of human race and found in almost every part on earth. Cosmetics are the agents used to improve beauty and attractiveness of a person. It includes skin care, lotions, powders, nail polish, lipsticks, eye liner, hair colour, baby product, bath oils, facial makeup and many other products. A makeup which is a subset of cosmetics refers mainly to coloured products intended to change the user’s appearance.

In India the term cosmetic was combined with the Drugs Act and the name was changed to the Drugs and Cosmetic Act, 1940 by an Act in 1962. According to the Drugs and Cosmetic Act, 1940 and Rules 1945, cosmetic is defined as any article intended to be rubbed, poured, sprinkled or sprayed on or introduced into or otherwise applied to human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance of any article intended for use as a component of cosmetic. In the Act, soap was introduced in 1982 as toilet preparation under the definition of cosmetic.

In 1980, the journey of ‘cosmeceuticals’ began with the use of natural fruit hydroxyl acids as exfoliants against wrinkles. In 1961 the term was first coined by Raymond Reed, a founder member of United States Society of Cosmetic Chemists. In 1971 a formula was developed by Dr Albert Kligman for skin damaged and wrinkled by UV light using retinoic acid as cosmeceutical. Cosmeceutical is the novel approach where wellness meets beauty in cosmetics. Cosmeceutical is a portmanteau of the word cosmetic and pharmaceutical. Some products can be both cosmetic and drug. For example, shampoo is a cosmetic because it is used to clean the hair and its anti-dandruff treatment is due to the pharmaceutical active ingredient. These products meet both the standards for cosmetics and drugs. Like cosmetics, cosmeceuticals are also applied topically but they contain ingredients which influence the biological functions of skin. Phytochemicals, antioxidants enzymes, vitamins, essential oils may contain in cosmeceuticals as purported substances. Some cosmetics companies use the term cosmeceuticals to refer their products that have therapeutical benefits. FDA does not recognize the term cosmeceutical. A product can be a cosmetic, pharmaceutical drug or combination of both but the term has no meaning under the law.

The fast growing cosmetics industry is estimated to be worth of Rs 14 billion. Out of which Rs 7 billion is in the unorganized sector and the rest with the organized sector. The total cosmetic market is growing annually at the rate of 20% while the market for herbal products at the rate of 70% per annum. The Indian cosmetics industry is segmented on the line of product categories and premium segment. Before 1962, no law was there in India to regulate the import, manufacturing and sale of cosmetics. However, it became necessary to prevent manufacturing and sale of misbranded and spurious products. A cosmetic company sometimes sells its products without FDA approval. FDA urges the cosmetic makers to go for necessary tests to prove their safety. The cosmetic makers must label their product indicating the warning that it has not been through safety testing – the safety of this product has not been determined. Proper labelling is an important aspect of putting a cosmetic product on the market. The cosmetic products in India are regulated by the Act of 1940 and the labelling declaration by the Bureau of Indian Standard (BIS). The standards of cosmetics are maintained by the BIS under Schedule ‘S’ of the Drugs and Cosmetic Rules of 1945. The Indian standard specification are laid down by the BIS for various cosmeceuticals from time to time. For example, the BIS provided IS 6608:2004 and IS 9875:1990 specifications for skin creams and lipsticks. According to IS 6608:2004, all the raw materials requiring test for heavy metals have been tested and comply with the requirement, but then the manufacturer may not test the finished cosmetics for heavy metals and arsenic. The BIS classifies the raw materials as GRAS (generally recognized as safe) and GNRAS (generally not recognized as safe). Rule 134 has laid down some restrictions on the use of cosmetics containing dyes, colours and pigments other than those specified by the BIS. Rule 145 prohibits the use of lead and arsenic compounds in cosmetic preparations for the purpose of colouring. Rule 135 prohibits the import of cosmetics containing lead and arsenic. Rule 145D and 135A prohibit the import and manufacture of cosmetics which may contain mercury compounds. Like drugs, the import of cosmetics is also regulated by the rules which do not require licence. However, misbranded and spurious cosmetics are prohibited from import under Section 10 of the Drugs and Cosmetic Act. The quality control must be with respect to certain criteria.

Various innovative terms for cosmeceuticals are being introduced in the market like beauty cosmetic, bioactive cosmetic, performance cosmetic, phyto-cosmetic, functional cosmetic, dermaceuticals, skin cosmetic, cosmetic drug, etc. Because of the multi-functionality and lesser side effects, more and more cosmeceuticals are being used as cosmetics.

Today’s market is overflowing with a large numbers of cosmeceuticals products such as anti-wrinkle, sunscreen lotions, hair growth, stimulants, moisturizers, skin care, hair care, hair cream, anti-dandruff, etc. Some cosmetic manufacturers are trying to evade the safety guidelines of FDA. As technology advances, the cosmeceuticals predominantly occupy the market with more and more products but the risk factors cannot be ignored. The lack of harmonization of regulation of cosmeceuticals creates problems. Hence, there should be utmost necessity of uniform regulations and safety concerns.