Regulatory Provisions for Cosmetics in India
Kavya, Himmat Singh Chawra
The cosmetics industry is undergoing significant transformations all over the world. Cosmetics regulation in regulated markets is significantly stricter in terms of quality, safety, nomenclature, and labelling in order to govern the use of cosmetic items. Cosmetic safety is governed by a variety of regulatory agencies around the world, i.e. countries with their own set of rules and regulations. According to a recent study, cosmetic regulations in India differ significantly from those in regulated markets such as the United States, the European Union, and Australia. India's cosmetics market is growing at a rate of roughly 20% per year, which is twice as fast as the US and European markets. Even though India's cosmetic standards are complicated and time-consuming, they are required for pre- and post-market approvals. The existing Indian cosmetic regulations include serious flaws, such as the following: Multiple and complex regulations under different bodies, lack of Central Drug Standard Control Organization implementation guidelines, BIS Cosmetics issues that require standard development and amendment, non-uniform licencing approvals between states, and a divergent approach across authorities in interpreting a certain issue are all issues that must be handled. India's cosmetic industry is governed by the Drug and Cosmetic Act of 1940 and the Rules of 1945. In India, cosmetics are held to high standards and are governed by strict rules. This paper discusses the overall cosmetics scenario, as well as the regulations for cosmetics import and manufacture registration.
Cosmetic is a very diverse product, such as cream, perfumes, lotions, skin cleansing products, and decorative cosmetics sector.1 The word cosmetic comes from the Greek word "kosmtikos," which means "to be able to arrange and decorate".2 The origin of cosmetics was related to looking, fighting, faith, and superstitious notion and later related to medication.3 The global cosmetics market was $460 billion in 2014 and is expected to reach $675 billion by 2020 at an estimated growth rate of 6.4% per year.4,5
This growing industry necessitates ongoing multifaceted management, including the monitoring of harmful chemicals and microbiological contamination (i.e., chemical and biological contamination). The use of forbidden or restricted compounds in hazardous cosmetics puts consumers at danger, according to current cosmetic rules. Contamination of cosmetic items is also a health danger for consumers. According to the European Commission's (EC) Rapid Alert System (RAPEX), 62 cosmetic goods were recalled between 2008 and 2014 owing to microbial contamination. 14 nations were notified of the recalled products, with the number of recalls increasing in 2013 and 2014.6,7
India's cosmetics market is growing at a rate of roughly 20% per year, which is twice as fast as the US and European markets. Even though India's cosmetic standards are complicated and time-consuming, they are required for pre- and post-market approvals. It is therefore important for a cosmetic manufacturers, distributers and importers to understand the differences in the regulatory system in India when compared to the regulated countries like U.S, Europe, Australia countries. Various regulatory authorities around the world govern the safety of cosmetic goods, each with their own set of laws and regulations. The comparison between the Indian market and other regulated markets is addressed in this paper.8 In India, the cosmetic product is categorized as skincare, haircare, oral care, color cosmetic sections, fragrances, and more. The cosmetic market in India is currently USD 6.5 billion it is anticipated to reaching up to USD 20 billion with a compound annual growth rate of 25% by 2025. Moreover, on the other side expected to reach USD 450 billion with a compound annual growth rate of 4.3% by the global cosmetic market by 2025. India will hand out 5% of the global cosmetic market and it comes under one of the top 5 global markets.8,9
Cosmetic means any article intended to be rubbed, poured, sprinkled, 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, as defined by Section 3(aaa) of the Drugs and Cosmetics Act, 1940 and Rules, 1945, and includes any article intended to be used as a component of cosmetic.10 Cosmetics regulation in regulated markets is significantly stricter in terms of quality, safety, nomenclature, and labelling in order to govern the use of cosmetic items. According to a recent study, cosmetic regulations in India differ significantly from those in regulated markets such as the United States, the European Union, and Australia.8 So, in this review we focus on the way how the cosmetics can be regulated in India and how cosmetic regulation in India can be different from other countries. This paper discusses the overall cosmetics scenario, as well as the regulations for cosmetics import and manufacture registration.
Cosmetic Regulations in India:
The Drugs and Cosmetics Act 1940, rules 1945, and labelling declarations issued by the Bureau of Indian Standards govern cosmetic items in India (BIS). The cosmetic standards are set by the BIS, and it is included under schedule “s” of the Drugs and Cosmetics Rules 1945 and also BIS provides the specification for skin creams and lipsticks in the Indian standards (IS) 6608:2004 and 9875:1990.11,12 According to Indian standard 6608:2004, each raw material must undergo a heavy metals test before being evaluated and meeting the following criteria. If these are tested early, the manufacturer may need not to test the finished cosmetic product for arsenic and heavy metals.13
According to Drugs and Cosmetics Rule 134 Colors, pigments, and dyes, in addition to those listed by the BIS, are subject to specific regulations under the rules, as is schedule Q. The use of arsenic and lead compounds in cosmetic goods for the purpose of colouring is prohibited by D&C Rule 145. Rule 135 forbids the import and production of cosmetics that contain arsenic or lead compounds for colouring, while Rules 145 D and 135 A prohibit the import and manufacture of cosmetics that contain mercury compounds.7,14
Table 1: Summary of cosmetic regulation15
Rules and Regulations
Food, Drug and Cosmetic Act
Council Directive 76/ 768/EEC
Drugs and Cosmetics Act
Pre- market Approval
Not required by Cosmetic Directive
Required under state government licensing
Should follow the FD&C and FP&L guidelines.
Based on Council Directive 76/768/EEC
Part XV of the D&C regulations from 1945 should be followed.
No date required
Date of minimum durability is <30 months. Period after opening if durability is >30
Indicated as “Use Before Date”.
Post marketing reporting system
Yes (Voluntary Cosmetic Registration Program)
Licensing General Controller of Drugs (India) Cosmetics are regulated through a system of inspection and licensing by State Licensing Authorities designated by state governments. Under the requirements of the Drugs and Cosmetics Act, 1940, it serves as the Licensing Authority, which gives the registration certificate and regulates the import of cosmetics in India by Gazette notice G.S.R 426(E).16,17
Fig. 1: CDSCO's Cosmetics Division Organogram 17
Central Drugs Standard Control Organization (CDSCO):
· The manufacture of cosmetics is governed by the State Licensing Authorities chosen by the different State Governments, while the import of cosmetics is regulated by the Central Licensing Authorities established by the Central Government.
· The office of the Drugs Controller General (India), also known as the Central Drugs Standard Control Organization [CDSCO], serves as the Central Licensing Authority, issuing registration certificates and regulating cosmetics imports in India under the provisions of the Drugs and Cosmetics Act 1940 and Rules promulgated thereunder.15-17
· Examination of applications for registration of cosmetic items for importation into the country, as required under the Drugs and Cosmetics Act 1940 and its Rules, 1945.
· Examining a variety of NOC/Clarification applications related to the import of cosmetic products.
· Preparation of draft replies to RTI, court cases, VIP references and Parliament Question related to cosmetics.
· Replying to Government correspondences/ BIS as and when required.
· Responding to public inquiries and hearings on the cosmetic import registration process, as well as providing guidance.
· Handling of public/NGOs/Consumer forums complaints/grievances regarding standards of cosmetics products.17-18
Indian regulatory requirement for cosmetic product:
· Location and surroundings- The manufacturing premises can be positioned in hygienic conditions, and sanitary areas must be maintained on the premises. The manufacturing area must be well ventilated and clean.19
· Buildings- To carry out the activities, the walls of the manufacturing space must be up to 6 feet from the floor. It needs to be smooth, waterproof, and easy to clean.20
· Water supply and disposal of water- The manufacturer should use drinking water for production reasons. Wastewater disposal must be properly planned.21
· Staff health, clothing, and sanitary conditions- All employees must be free of infectious or communicable diseases. Wherever necessary, they must be provided with clean uniforms, gloves, and masks. 22
· Cosmetic license for manufacturer- Regulatory examination of product details such as quality, safety, and BIS compliance is required.23
The manufacturer should get a cosmetic license according to the drugs and cosmetics act 1940.
· A licence to manufacture cosmetics for sale or distribution is given using Form No. 32.
· The application is filed using Form No. 31. If no item in any category exceeds ten, the application must be accompanied by a cost of Rs. 2500 and an inspection charge of Rs. 1000.24
The following documents are attached to the application:
· Layout plan of the factory premises
· A list of all the equipment and gear that will be installed
· A document describing the firm's structure.
· A document, such as a rent receipt, demonstrating the applicant's possession of the proposed factory premises.
· Form no. 32A is used to apply for a loan license for cosmetic manufacturing for sale or distribution, and form no. 31A is used to file the application.
· Form no. 37 for the issuance or renewal of a licence for the manufacture and sale of pharmaceuticals and cosmetics.25-26
Labelling requirements for imported cosmetics in India:
All packaged items must contain the following information on their labels:
· Name and address of the importer
· Generic or common name of the commodity packed
· Net quantity in terms of a standard unit of weights and measures
· Month and year of packing in which the commodity is manufactured or packed or imported.
· Maximum retail sales price (MRP) of the packaged commodity at which the commodity will be sold to the end consumer.27
The MRP includes:
· Freight transport charges,
· Commission payable to dealers,
· All charges towards advertising, delivery, packing, and forwarding.27
Specific information about cosmetic items must be clearly stated on both the inner and exterior labels:
· Name of the cosmetic.
· The name of the manufacturer and the complete address of the manufacturer's facility where the cosmetic was made.
· The names of ingredients in the order of percentage of content.27
On the outer label:
· A declaration of the net contents expressed in terms of weight for solids/ semi-solids, fluid measure for liquids.
· The names of ingredients in the order of percentage of the content.27
On the inner label:
· Words indicating the presence of a hazard.
· Adequate instructions for safe usage, including a warning, caution, or special instruction that the user must follow while using the product.
· The names and quantities of any potentially dangerous or deadly compounds must be mentioned.
· The names of the ingredients in order of their percentage of the total content.
· The batch number begins with the letter "B."
· Instead of a batch number, soap labels must include the month and year of manufacture.
· A number preceded by the letter "M" denotes a manufacturing license.27
Regulatory Provisions Relating to Import of Cosmetics in India:
The Import of Drugs and Cosmetics is covered under Chapter III of the Drug and Cosmetic Act. The following cosmetics are now forbidden from being imported under section 10 of the Act and regulations 134A, 135, 135A of the Drug and Cosmetic Rules 1945:
· Any cosmetic this is not of Standard Quality.
· Any cosmetic this is misbranded or spurious.
· A cosmetic containing ingredient which render it injurious or harmful or unsafe to use.
· A cosmetic whose import is prohibited by rule.
· Any cosmetic containing hexachlorophene.
· Any cosmetic in which lead or arsenic compound used for coloring purpose.
· Any cosmetic which contains mercury compounds.12-15
The Indian government The Ministry of Health and Family Welfare amended the Drug and Cosmetic Rule, 1945 in Fed 2007, requiring cosmetics to be registered under Rule 129D by a licensing authority nominated by the Central Government under Rule 21 before being imported into India. The Licensing Authority is typically the Drug Controller General of India. For one or more cosmetics created by the same producer, a single application should be submitted. And, if it is not revoked, the registration certificate is valid for three years. In India, the maker, his agent, or the importer must submit an application for registration. According to rule 43A, cosmetics can only be imported into India through the following ports.
· Firozpur Cantonment and Amritsar Railway Stations.
· Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva and Kandla by Sea route.
· Ahmedabad, Chennai, Delhi, Hyderabad, Kolkata, and Mumbai by Air.
· Raxaul by Road/Railway lines connecting in India.12-15
Imported cosmetics registration in India:
In Indian market there are so many imported brands are selling/marketing, which have good quality & efficacy as per claim but in terms of safety few cosmetics are very dangerous and harmful for human health as per their own countries testing procedures or regulations and due to lack of strict guidelines or there is a Checklist for Pre Screening of Applications for Grant of Registration Certificate in Form 43 under the provisions of the Drugs and Cosmetics Rules and sanctioned by CDSCO in India. The dossier must be presented to the authority in accordance with the following conditions before it may be commercialised in India: For example, the applicant's covering letter, Form 42, Treasury Challan, POA, Schedule D III, Original copy of Label, FSC/MAletter and product specification and testing protocol, Mfg. License, list of countries that have been given market authorization, import permits, or registration was granted, Soft copies of brand, product, and manufacturer information are included in the pack insert.For each Brand, a charge of USD 250 or its equivalent in Indian rupees will be required with each application. The following types of cosmetics, however, are restricted from entering the country: Cosmetics of poor quality, as well as those containing potentially toxic or dangerous substances. Such as Misbranded cosmetics (meaning cosmetics which contain colors other than those prescribed or are not labeled in the prescribed manner or make any false or misleading claims). Spurious cosmetics (meaning cosmetics which are substitutes for other cosmetics or resemble other cosmetics).28,29,30
Cosmetics are imported via ports, according to Rule 43 of the Drugs and Cosmetics Act. 28 Cosmetics can be imported into India by the following.
· The manufacturer must have a registered office in India
· The authorized agent of the manufacturer
· It is a subsidiary agent of the manufacturer.
· Any other importer.29,30
Time duration for grant of import license:
If the application is submitted correctly, the CLA will grant an import license in Form 10, within 3 months from the date of acceptance of an application.31
Guidance for submitting an application for Form 43 registration certification to import cosmetics.
· Covering letter
· Power of attorney
· Schedule D III
· List of ingredients
· Labels of proposed products
· Package inserts
· Manufacturing licenses
· Free sale certificates
· Non-animal testing declaration
· Declaration for heavy metal and hexachlorophene content 31-32.
· Application form-42
· Fee (Bharatkosh online payment) 33
Adulterated, Misbranded and Spurious Cosmetics:
The Federal Food, Drug, and Cosmetic Act forbids the interstate sale of contaminated or misbranded cosmetics.
"Adulteration" refers to product composition breaches, which can be caused by materials, contaminants, processing, packaging, or shipping and handling. A cosmetic is adulterated under the FD&C Act if it contains the following ingredients:
a) "it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual" (with an exception made for coal-tar hair dyes);
b) "it consists in whole or in part of any filthy, putrid, or decomposed substance";
c) "it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health";
d) "its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health"; or except for coal-tar hair dyes, "it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a)" of the FD&C Act. (FD&C Act, sec. 601).10,34
“Misbranding” refers to offences involving products that are mislabeled or packaged falsely. A cosmetic is misbranded under the FD&C Act if it contains the following ingredients:-
a) “Its labeling is false or misleading in any particular”;
b) “Its label does not include all required information”;
c) “The required information is not adequately prominent and conspicuous”;
d) “Its container is so made, formed, or filled as to be misleading”;
e) “It is a color additive, other than a hair dye, that does not conform to applicable regulations issued under section 721 of the FD&C Act”; and
f) “Its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.” (FD&C Act, sec. 602).10,35-36
For the purposes of this Chapter, a medicine is considered spurious if it contains the following ingredients:
a) if it is imported under the name which belongs to another cosmetic; or
b) if the label or the container bears the name of an individual or company purporting to be the manufacturer of the cosmetic, which individual or company is fictitious or does not exist; or
c) if it is a copy of, or a substitute for, another cosmetic, or resembles another cosmetic in a deceptive manner, or bears the name of another cosmetic on it or on its label or container, unless it is plainly or conspicuously marked to reveal its true character and lack of identity with such other cosmetic; or if it is a knockoff or a replacement for another cosmetic, or if it closely resembles another cosmetic in a way that is likely to deceive, or
d) if it purports to be the product of a manufacturer of whom it is not truly a product.10,37-38
According to a thorough investigation, cosmetic regulations in India differ significantly from those in regulated markets such as the United States, the European Union, and Australia in terms of applicable acts, regulations, guidelines, listed ingredients, heavy metals specifications, mandatory labelling, and notification procedures to competent authorities within a specified time frame. In India, it is critical to increase the safety information and cosmetics control requirements. The primary goal of all of these regulations in India is to ensure the safety, quality, and efficacy of cosmetic goods so that they can be sold to customers with safe components and labelling.
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Received on 29.04.2022 Accepted on 02.06.2022
Accepted on 30.06.2022 ©A&V Publications all right reserved