Kumar Sujit and Gupta R N
Accepted Abstracts: Pharmaceut Reg Affairs
Introduction: Cosmetic is defined 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. Cosmetic industry is the fastest growing personal care industry in the world. In India it is growing at an average rate of almost 20% annually. Objective: The objective of the present study was to carefully analyze the lacunae in the legislation and propose suitable regulatory guidelines in Indian Scenario. Methods: 1. Study of cosmetics formulation in the market: This was done by visiting different medical and cosmetic shops in the market at wholesale and retail points. 2. Study of the related books and journals: For this Drugs and Cosmetics Act 1940 and Rules 1945, BIS publications on cosmetic products, Drugs and Magic Remedies (Objectionable Advertisement) Act 1954, Code of Advertising Standards by Advertising Standards Council of India (ASCI), Court judgments and orders, EU Cosmetic Directive 76/768/EEC, United States Food, Drugs & Cosmetics Act, The Canadian Food & Drugs Act, Australian Therapeutic Goods Act, 1989, ASEAN Cosmetic Directive 2007, National and International journals on the subject etc. were studied. 3. Discussion with consumers and dermatologists: This was done to know their opinions regarding the safety and claims on the products. Discussion: The purpose of cosmetic ingredient labelling is to enhance the safety of the consumers by making available to users valuable information concerning the composition of cosmetics. This provides information to the consumers to avoid those products which may cause adverse reaction. Most of the cosmetic manufacturers do not mention the colour on their products. Even the nomenclature of the ingredients is not as per international norms. Various brands of herbal hair dyes are mixed with p-phenylenediamine. An adulterated cosmetic for the purpose of import is not defined in the Act. Limit for lead and arsenic has been fixed for synthetic and natural colours in the Drugs and Cosmetics Act Rules 1945. No limit has been fixed for inorganic colours. USFDA has set a limit for lead in candy i.e., 0.1ppm. There is no limit for heavy metals in the lipstick, nail polishes etc. Canada has issued ?Guidelines for Cosmetic Labelling Claims?. ASEAN Cosmetic Directive also deals with claim guidelines. BIS stipulates that manufacturers list key ingredients but does not define ?key ingredients?. It is left to the manufactures to decide as to what are key ingredients. Sunscreens/fluoridated tooth pastes are marketed in India as both drugs and cosmetic products. Conclusion: Suitable amendments are suggested in the Drugs and Cosmetics Act and Rules regarding the definition, nomenclature, heavy metals content, quality of cosmetics and claims etc for cosmetic products in Indian scenario.
Pharmaceutical Regulatory Affairs: Open Access received 471 citations as per Google Scholar report