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Cosmetovigilance in India: Need of the Day!

#CosmetovigilanceinIndia

Section 3(aaa) of Drugs and Cosmetics Act defines “cosmetics” as “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”.


Cosmetics are regulated in India under the Drugs and Cosmetics Act of 1940 and the Rules of 1945. Part XIII (regulates the importation and registration of cosmetics), Part XIV (the production of cosmetics for sale or distribution) and Part XV (regulates the labelling, packaging and cosmetics standards). The use and import of arsenic and lead containing compounds is prohibited by Rules 145 and 135. In compliance with the provisions of rules 135A and 145 D, cosmetics containing mercury are forbidden. Law 134-A forbids the importation of a cosmetic containing hexachlorophene. Rule 134 specifies that, as defined by Schedule Q and the Bureau of Indian Standards, cosmetic products should contain colour, dye or pigment. Notification Gazette G.S.R 426(E) divides cosmetics into 4 main categories: skin products (it is further subdivided into 10 subcategories: skin care products, cleansing products, body hair removal products, body hair bleach, body odour corrective products, shaving products (pre or after shaving), make-up products, perfumes, sun and self-tanning products and others), hair and scalp products (4 sub-categories: cleansing and treatment products, hair colouring products, hair styling products and other hair and skin care products), nail and cuticle products (nail varnish and remover, nail care and nail hardening products, nail glue remover products and other nail and cuticle care products) and oral hygiene products (tooth care, tooth whiteners, mouthwash and breathing products). Sometimes, however, the distinction between drugs and cosmetics is not apparent. Adverse effects of cosmetics are widely found, much like medications. In a retrospective study of 1609 participants, 12.2% experienced adverse effects from cosmetics and toiletries over a 5-year period, of which 63.3% were female and 36.7% were male. Itching (70.9 percent), skin dryness (63.3 percent), and skin burning sensation (50 percent) were the most common complaints. The skin signs varied to no apparent changes from rhagades, scales, blisters, streaks, and redness. Other complaints were eye irritation as manifested by burning and watery eyes, shortness of breath following perfume spray, swelling of the local lymph node after deodorant use, sneezing after application of aftershave, and nausea following application of perfume.


The most commonly affected area was the face and hands. Tenderness, swelling, scratching, and bumps were the most common adverse drug reaction (ADR) following permanent makeup procedure in the United States. The period of pain varied between 5.5 months and 3 years. The rate of sensitization to many allergenic components has increased with the increased use of cosmetics. As one of the most common causes of contact dermatitis in India, hair dye is mentioned. In the southern part of India, Kumkum dermatitis was extremely prevalent. An significant risk factor for contact dermatitis incidence is also found to be the use of sticker bindi. Certain ingredients in cosmetic products are also involved in adverse reactions after the use of cosmetics, in addition to the active component. Although many ADRs exist at the level of the population, reporting to the regulatory authority is very limited. In a study of patients with contact dermatitis, adverse reactions to cosmetic products were documented in most patients. In their research , they found that the patch test for cosmetics showed positive results in many patients with contact dermatitis, and concluded that cosmetics are significant etiological factors for the incidence of contact dermatitis. Identification and review of adverse effects associated with cosmetic products is largely motivated by industry. While manufacturers make several attempts, the results could be influenced by possible conflicts of interest.


Misbranded and spurious cosmetics, similar to narcotics, are not rare. In accordance with the 1940 Drugs and Cosmetics Act and the 1945 Drug and Cosmetics Law, misbranded and spurious cosmetics are specified. When it contains an unprescribed colour, incorrect labelling, or contains false / misleading product information, cosmetics are considered misbranded. When the name resembles another cosmetic, cosmetics are branded as spurious; the product resembles another cosmetic or if information from the manufacturer is misleading / fictitious or does not exist, which may disappoint consumers.

In India 's market, spurious cosmetics are widely mentioned. Spurious cosmetics was found to be sold to parlours and salons in packaged bottles. Officials confiscated tonnes of cosmetic items with no licence number on the label in one raid by the Food and Drug Administration in beauty parlours in Pune. In many cosmetic products, a high level of lead is identified. In many cosmetic products (lipsticks, lip gloss, eyeshadow and henna hair dye), impurities such as high levels of heavy metals (lead, zinc, and cadmium) are identified. An analysis by Shah et al. shows that 43% of the sindoor samples in India exceeded the sindoor lead content limit compared to US samples. In order to ensure that lead-adulterated sindoors are not available for sale, public health measures should concentrate on primary prevention. It is noticed that even widely used "kajal" contains high levels of lead. Minimum (Pb3O4) and galena (PbS) are the numerous lead-containing compounds present in kajal. Zincite (ZnO), magnetite (Fe3O4), and amorphous carbon are other identified compounds. High levels of these substances , especially in pregnant women, may be harmful to the human body.


India's population is enormous and the cosmetics market is similar. Touch dermatitis and other dermatosis are prevalent in India and the same is involved in cosmetics. Adverse reactions to conventional agents, such as kajal and kumkum dermatitis, are also widely mentioned. As per section 135 B of the Drugs and Cosmetics Act, the importation of cosmetics tested on animals is prohibited in India. Like other illnesses, cosmetic-related disorders often result in pharmaco-economic failure. Therefore, in addition to proper control of these agents, a proper vigilance system is also required to protect the Indian population's health. Proper use of cosmetovigilance, according to Vigan and Castelain, 2014, will help to monitor or rule out dangerous ingredients in cosmetics and thus increase our faith in the use of these agents.


Written By: Ms. Shreyaska Panda, Final Year Student, BBA LLB, Symbiosis Law School, Hyderabad, Law Intern at S. Bhambri & Associates (Advocates), Delhi


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