Cosmetovigilance in India: Need of the day.

Cosmetics and Their Adverse Effects

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.”[12]

In India, cosmetics are regulated as per Drugs and Cosmetics Act 1940 and Rules 1945. Part-XIII (regulates import and registration of cosmetics), part-XIV (manufacture of cosmetic for sale or for distribution) and part-XV (regulates labelling, packing and standards of cosmetics). Rule 145 and 135 prohibits the use and import of arsenic and lead containing compounds. Cosmetics containing mercury are prohibited as per provisions of rules 135A and 145 D. Rule 134-A prohibits import of hexachlorophene containing cosmetic. Rule 134 specifies that cosmetic products should contain color, dye or pigment as per specified by schedule Q and Bureau of Indian Standards. Gazette notification G.S.R 426(E) divides cosmetics into 4 gross categories: skin products (it is further subdivided into 10 subcategories: products for skin care, cleansing, removal of body hair, body hair bleach, body odor corrective products, products for shaving (pre or after shave), products for makeup, perfume, products for sun, and self-tanning and others), hair and scalp products (4 subcategories: cleansing and care products, products for hair coloring, hair styling products, and other products for hair and scalp care), nail and cuticle products (nail varnish and remover, products for nail care and nail hardening, product for nail glue removing and other products for nail and cuticle care), and products for oral hygiene (tooth care, tooth whiteners, mouth wash and breath spray and other products for oral hygiene).[2]

However, the distinction between drugs and cosmetics is sometimes not clear.[3] Like drugs, adverse effects of cosmetics are commonly encountered. In a retrospective study with 1609 participants, in a period of 5 years, 12.2% suffered from adverse effects of cosmetics and toiletries, out of which 63.3% were woman and 36.7% were man. Most common complaint was itching (70.9%), dryness of skin (63.3%), and burning sensation in skin (50%). The skin manifestations ranged from rhagades, scales, blisters, spots, and redness to no visible changes. Other complaints were eye irritation as manifested by burning and watery eyes, shortness of breath following perfume spray, local lymph node swelling following deodorant use, sneezing following aftershave application, and nausea following perfume application. Face and hands were the most frequently affected location.[4] Most common adverse drug reaction (ADR) following permanent makeup procedure in unites states were tenderness, swelling, itching, and bumps. The duration of suffering ranged from 5.5 months to 3 years.[5]

With increased use of cosmetics, the rate of sensitization to many allergenic components has increased.[6] Hair dye is reported as one of the most common causes of contact dermatitis in India.[7] Kumkum dermatitis was highly prevalent in southern part of India. Sticker bindi use is also found to be an important risk factor for occurrence of contact dermatitis.[8] Apart from the active product, other ingredients of cosmetic products are also implicated in adverse reactions following the use of cosmetics.[9] Although lots of ADRs occur at the population level, reporting to the regulatory authority is very low. In a study with patients of contact dermatitis cases, most of the patients reported adverse reactions to cosmetic products. In their study, they found that in many patients suffering from contact dermatitis showed positive finding in patch test for cosmetics and they concluded that cosmetics are important etiological factors for occurrence of contact dermatitis.[10] Cosmetic product-related adverse effect identification and analysis is mainly industry driven. Although lots of efforts are made by manufacturers, potential conflict of interest may bias the findings.[3]

Misbranded and Spurious Cosmetics

Similar to drugs, misbranded and spurious cosmetics are not uncommon. Misbranded and spurious cosmetics are defined as per provision of Drugs and Cosmetics Act 1940 and Drug and Cosmetics rule 1945. Cosmetics are called misbranded if it contains an unprescribed color, inappropriate labeling, or contains false/misleading product information.[11] Cosmetics are labeled as spurious when its name resembles another cosmetic; the product resembles another cosmetic or if manufacturer information is misleading/fictitious or does not exist, which can deceive customers.[11]

Spurious cosmetics are commonly reported in Indian market. Spurious cosmetics in branded bottles are found to be sold to parlors and salons. In one Food and Drug Administration raid in beauty parlors in Pune, officials seized lots of cosmetic products with no license number displayed on the label.[12] High level of lead is reported in many cosmetic products.[13] Impurities such as high level of heavy metals (lead, zinc, and cadmium) are reported in many cosmetic product (lipsticks, lip glosses, eyeshadows, and henna hair dye).[13] Hair technicians in saloon and parlor are at risk of chemicals in cosmetics and hand dermatitis is quite common among them. Female hair technicians are at particular risk for fertility disorders and adverse pregnancy outcomes, which is of special concern. Hair technicians are also more prone to development of asthma due to exposure to ammonium persulfate.[14] A study by Shah et al. shows that 43% of the India samples of sindoor exceeded the limit of lead content in sindoor comparative to US Samples. Public health interventions should focus on primary prevention to ensure that lead-adulterated sindoor is not available for sale.[15] Even commonly used “kajal” is found to contain high levels of lead. The different lead-containing compounds found in kajal are minimum (Pb3O4) and galena (PbS). Other compounds reported are zincite (ZnO), magnetite (Fe3O4), and amorphous carbon. High level of these compounds can be harmful to human body, more specifically for pregnant woman.[16]

Cosmetics and Pregnancy

Cosmetic use during pregnancy and its developmental effect is another issue which needs to be dealt carefully. There is no clear-cut answer to this issue. Regarding skin care products, except hydroquinone and topical retinoids, risk of malformations and other adverse effects do not seem to be increased with use of cosmetics.[17] With regard to chemical peeling agents, trichloroacetic and salicylic acid is preferably to be avoided or to be used with caution. Use of botulinum toxin is another controversial area. Sclerotherapy also needs to be used with caution and it is better to avoid during the first trimester and after 36 weeks of pregnancy. Fat transfer procedure and sclerotherapy are not recommended during lactating period.[18] Couto et al. reported an association between first trimester use of hair dye or hair strengthening products and development of acute lymphoblastic leukemia and acute myeloid leukemia in their children.[19] In studies conducted later, no such outcomes were observed, but it is preferable to avoid such treatment during pregnancy.[14]

Cosmetovigilance

Concept of pharmacovigilance is a quite recent one and is different from industry surveillance, the primary aim of which is use of safety information for commercial purpose. Cosmetovigilance is a public health surveillance on cosmetic products with a public health objective.[20]

In European Union, directive 76/768/EEC regulates the monitoring of cosmetics. This directive was first legislated in 1976 and it summarizes that cosmetics should not damage human health when applied in normal or under foreseeable conditions. Later, regulation (EC) No. 1223/2009 created the basis of uniformity in cosmetics regulation and cosmetovigilance.[21]

For cosmetovigilance purpose, causality is defined as analysis of the relation between a cause (cosmetic product) and an effect (manifestation). Several methods are there to determine causality, most of which are based on analysis of evolving semiological and chronological elements. AFSSAPS method calculates semiological and chronological score, and level of causality is categorized into 5 levels: very-likely, likely, not clearly attributable, unlikely, and excluded. Definition by Colipa is slightly different. Colipa method is based on interpretation of symptomatology, chronology of the events, and specific test results and divides level of causality into questionable, likely, and very likely.[20]

Thus, the process of cosmetovigilance is evolving and coming up as a strong regulatory science to protect public health and beauty.

Need of Cosmetovigilance in India

Population of India is huge and similar is the market of cosmetics. Contact dermatitis and other dermatosis are common in India and cosmetics are implicated in the same. Adverse reactions to traditional agents are also commonly reported, for example, kajal and kumkum dermatitis. Import of cosmetics tested in animals is prohibited in India as per se ction 135 B of Drugs and Cosmetics Act. Like other diseases, disorders related to cosmetics also lead to pharmacoeconomic loss. Hence besides proper regulation of these agents, a proper vigilance system is also required to protect health of Indian population. Going with words of Vigan and Castelain, 2014,[20] proper use of cosmetovigilance can help to control or rule out hazardous ingredients in cosmetics and thus improve our confidence on use of these agents.