I. Definition of Cosmeceuticals:
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There is a need to revise the definition of cosmetics in line with our present knowledge of the skin. The definition of cosmetic according to Drug and Cosmetic Act, 1940 is narrow and restricted compared to EU, ASEAN, and Japan. The definitions should recognize that virtually all topical agents have some effect on the structure or function of skin and that the distinction between drugs and cosmetics is better based on risk-benefit analysis, indication for product use, and character of the skin changes resulting from product use. Cosmeceuticals can be defined as topically applied products with both cosmetic and pharmaceutical functionality.
II. Categorization of Cosmeceuticals
The categorization of cosmeceuticals will enable cosmetic companies to market their product. Cosmeceuticals could be characterized based on: a product that has pharmaceutical activity and can be used on normal or near-normal skin. The product should have a defined benefit for minor skin disorders (Cosmetic indication). As the skin disorder is mild, the product should have a very low-risk profile. Cosmeceuticals should be categorized as a subclass of cosmetics or drugs.
III. Dossier Requirements
The regulatory requirements for approval and marketing of cosmeceutical products should contain information based on the qualitative and quantitative composition of the products.
The dossier should be under four major headings:
- An Administrative dossier
- An Ingredient dossier
- A Finished product dossier
- A Post market dossier
The requirements for the above four dossiers are discussed below:
(1) An administrative Dossier
In this dossier, an applicant should submit the trade name of the cosmeceutical product and responsible person in the company, manufacturer name, or distributor name. The dossier should mention the product categories like skin care, hair care, etc. The integral component of the product should be disclosed in the administrative dossier. To ensure safety assessments, a responsible person should be appointed by the company to maintain product files related to the registration of the product. The responsible person shall ensure compliance with guidelines like safety assessment, product information file, good manufacturing practices, sampling and analysis, product notification, restrictions for substances, animal testing, product labeling, product claims, information to the public, and information provided on substances.
For each cosmeceutical product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in the regulations. For an imported cosmeceutical product, each importer shall responsible for the specific cosmeceutical product which he places on the Indian market. In case of distribution of products (distributor) shall be the responsible person, when he places a product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with applicable requirements may be affected. Furthermore, the responsible person shall take necessary corrective measures if the cosmeceutical product fails to deliver and does not conform to the regulations. Further, as a corrective action, the failed product should be withdrawn from the market or recalled, as the case may be.
(2) An Ingredient Dossier
Cosmeceuticals by definition contain ingredients that have an intended pharmaceutical effect, so it should be possible for the manufacturer and ingredient suppliers to prove this. An ingredient dossier should contain detailed information about the identity of ingredient suppliers and the composition of the ingredients supplied. However, the procedure for the registration of new ingredients should be relatively simple. Registrations of a combination of ingredients as well as individual ingredients are recommended. The dossier should have physiochemistry and microbiology of the ingredients including the physiochemical and microbiological inspections. Further, toxicity data including oral, dermal, and inhalation toxicity, local toxicity, like skin irritation, sensitization, photoallergy, and photoirradiation should be included in the dossier when relevant. The dossier should contain repeated dose toxicity data, additional relevant toxicological data. Additionally, the dossier should mention the list of animal tests performed with the ingredients.
(3) A Finished Product Dossier
The finished product dossier should contain details of manufacturing, safety, efficacy, claims, and labeling of cosmeceutical products.
(a) Manufacture of Cosmeceuticals: Applicant should get manufacturing license from a regulatory authority. The manufacturing premises should be inspected by FDA. Even the approval of manufacturing premises should be necessary when located outside the country concerned. To facilitate safe products, GMP of pharmaceutical products must be followed for the manufacture of cosmeceutical products. The respective state FDA shall be made responsible for inspection of compliance with GMP in plants. The complete details about the names, addresses of the directors of the company, and addresses of the manufacturing premises and registered office of the manufacturer should be maintained. A copy of the site master file shall be maintained containing a brief description of the manufacturing process of the cosmeceutical products to be manufactured, details of the standards followed by the company for Good Manufacturing Practices, product evaluation, name, qualification, and experience of technical staff under whose supervision the cosmeceutical products will be manufactured, copies of ISO or any other certifications, if any, obtained by the firm for its manufacturing facility.
(b) Safety of Cosmeceuticals: An important consideration in cosmeceutical development is safety. It is important to recognize that currently, no regulations for cosmeceutical safety are in place. Cosmeceuticals are considered cosmetics by Indian regulatory authorities and, as such, are regulated like cosmetics. As with existing drug and cosmetic groups, cosmeceuticals should have premarket testing requirements. The safety evaluation of cosmeceuticals may, therefore, resemble the safety evaluation of other OTC products. The need of the hour is to define reasonable standards for safety testing to enable regulatory agencies to evaluate cosmeceuticals thoroughly but on time. Before placing the cosmeceutical product on the market, the responsible person shall submit, through electronic means, the following information to the regulatory authorities. The cosmeceutical product safety report should contain the following information:
- The trade name of the product, address of manufacturer or distributor.
- The product information file should state the product category.
- The name and address of the responsible person where the product information file is made readily accessible.
- The country of origin in case of import.
- The member state where the product is placed on the market.
- The contact details of a person for communication, if needed.
- The quantitative and qualitative composition of the product.
- Identity and details of supplier and manufacturer of ingredients.
- Physical /Chemical characteristics and stability data.
- Microbiological tests data.
- Toxicity data including acute oral, dermal, and inhalation toxicity, local toxicity, including skin irritation, eye irritation, sensitization, photo-allergy, and photoirradiation when relevant.
- List of animals tests performed with the finished product.
- Impurities, trace ingredients, and information about packaging material.
Product notification can be made to authority through an online application. Applications shall be processed faster and a timeline should be set. Additional time shall be given to answer queries/objections, if any, raised by a relevant regulatory authority. Submission of Product details (Safety, Quality, and Compliance to Bureau of Indian Standards) at the time of notification should continue as current practice and additional data can be stored as ‘Product information file’ with details maintained at the concerned manufacturing location for the regulator’s review. The product information file should contain the product safety report of cosmeceutical which must be kept up-to-date and shall mention the responsibilities of the manufacturer and the safety assessor.
(c) Cosmeceutical Efficacy: At present, there are no regulations for cosmeceutical safety, even there are no regulations for cosmeceutical efficacy. Typically, human clinical testing should be carried out under the guidance of a research laboratory or dermatologist with defined parameters to substantiate efficacy. To evaluate a new cosmeceutical product that claims a beneficial physiological effect, it is very important to address three issues:
- Can the active ingredient penetrate the stratum corneum and be delivered in sufficient concentrations to its intended target in the skin over a time course consistent with its mechanism of action?
- Does active ingredient have a specific biochemical mechanism of action in the target cell or tissue in human skin?
- Are there published peer-reviewed, double-blinded, placebo-controlled, statistically significant clinical trials to substantiate the efficacy claims?
The laboratory and clinical data should be available for review by the regulatory agencies.
(d) Claim Guidelines for Cosmeceuticals: In the Indian context cosmeceutical claim guidelines are not on records compared to European Union and ASEAN countries. This can be facilitated by the introduction of permissible and non-permissible claim guidelines for cosmeceuticals. Cosmeceuticals are currently defined by the claims that are made about their intended use. A cosmeceutical claim is any public information primarily provided for marketing purposes on the content, the nature, the effect, the properties, or the efficacy of the product. Before claiming an intended use or indication, a manufacturer must hold adequate evidence to support all claims made about a product. The claims on a cosmeceutical product should be supported by information on the finished product itself. Claims should be supported by scientific, relevant, and clear evidence such as experimental studies. Claims must be true, valid, and not misleading. Claims should not lead to unsafe or inappropriate use of a product. The advertising has to be done considering the average consumer. Exaggerated therapeutic claims should be avoided. An example of an anti-aging product is given below.
The acceptable claims for anti-aging cosmeceutical products shall:
- effectively repair the visible signs of the skin’s aging process.
- reduce fine lines.
- minimize fine lines.
- reduce the signs of aging.
- slow appearance /look of aging/premature aging.
- slow signs/the look of aging/premature aging.
- protect against the visible signs of aging.
- fade dark spots.
- cover up to age spots.
- hide age spots.
(e) Labeling/ Product information of Cosmeceuticals offered for Sale: Adequate labeling of cosmeceutical products shall ensure the following details on the label.
- Accurate labeling includes clear placement on the product label of its identity, the name, and the address of the manufacturer or distributor.
- Batch number.
- The nominal content or quantity of the product contained therein (by weight or volume).
- The ingredients are listed in rank order using specific nomenclature and other ingredients.
- Differentiate active ingredients and other ingredients.
- Date of minimal durability if less than 30 months, the period after opening if durability exceeds 30 months.
- Precautions and directions for use: All safety warnings related to the use of the product must be placed prominently on the label.
- Product function.
- Ingredient labeling in International Nomenclature of Cosmetic Ingredients (INCI).
(4) A Post Market Dossier
With the simplification of product licensing procedure, the Indian FDA authority can focus on in-market control of the safety of cosmeceuticals and any unscrupulous practice with shared responsibility by the Industry. In the market, controls can be supported through periodical (yearly) submission of market audit data of cosmeceutical products. The key features of the in-market control system include:
- Avoidance of time-consuming and expensive pre-market licensing/registration of products.
- The company responsible for placing the cosmeceuticals on the market is also responsible for the regulatory compliance, for the safety and efficacy of the product, and must be able to justify this on authority investigation.
- Effective in-market control by competent national authorities monitoring the market to check compliance with regulations. Market surveillance is performed through random control on the market (in retail shops), by routine checks compliance with regulations, or by systematic control of given product categories, if a problem arises, like a consumer complaint.
- In case of non-compliance, there can be penalties of varying strength and if the manufacturer fails to prove that the cosmeceutical product is safe for use, the product shall be withdrawn or recalled from the market.
- It encourages companies to ensure product safety and therefore it offers better health protection benefits.
- Uniform safety standard for consumers.
- It increases the competitiveness of the market.
- It ensures that new products will be available to consumers more quickly.
- It guarantees equal treatment of all companies.
Introduction of Post-marketing Vigilance for Cosmeceutical Products
Post-marketing vigilance systems usually focus on adverse reactions of drugs, recently much consideration is given to medical devices, blood products, biologics, special nutritional and natural products, whereas less attention has been addressed to adverse reactions related to cosmetic or cosmeceutical products. Germany and Sweden are the two countries that have a formal cosmetovigilance system. The well-structured cosmetovigilance system is not only to investigate but also to prevent the risk of adverse reactions through cooperation and coordination among different scientific experts, health authorities, industry/manufacturers, and consumers organizations. This could contribute to increased safety of cosmeceuticals use which is important for the safeguard of public health.
Information accessible to the Public
The cosmetic companies should co-operate with the public by providing information about the products which they are using. The information has to be made to the public on request, but it should not be published. Even the public can access the information by writing to the company, through telephone, and by visiting the company website. The information related to the qualitative and quantitative composition of the products; existing data on undesirable effects on human health resulting from the use of cosmeceutical products should be accessible to the public. The company should answer all the queries and requests in simple language and should maintain the records of all complaints, requests, and answers given by the company.
Advisory body: (Cosmeceutical Consultative Committee)
Cosmeceutical Consultative Committee should be constituted by Central Government to advise the central and state governments on technical matters arising out of the administration. The Cosmeceutical Consultative Committee should be constituted comprising members from industry, consumer activists, the medical profession, academic and regulatory authorities. The members of the Cosmeceutical Consultative Committee may include,
- Member of the cosmetic industry
- Member of Pharmaceutical industry
- A regulatory expert from Indian Pharmaceutical Industry
- An expert from academic institutions involved in basic research of cosmeceuticals.
- A beautician
- Social worker
- Government official (from FDA)
- Representative of Consumer organization
The Cosmeceutical Consultative Committee shall advise on policies to promote the safe and appropriate use of cosmeceuticals and enhance public health and wellness through the use of cosmeceuticals. The advisory board can help the Indian regulatory authority for building workshops for basic understanding of advancements in cosmetic technologies and help big and small scale industries to implement new suggested practices for taking the onus of safety and quality of products.
Looking at the booming Indian cosmeceutical market, it is high time that the Indian regulatory authority should initiate and work for the development of the cosmeceutical category. It is also important that access to beneficial cosmeceutical products should not be delayed by unnecessary constraints, it is equally important to reject cosmeceutical products that are irrational and cause harm to consumers. Further alignment of regulatory frameworks related to cosmeceuticals in the future could contribute to the removal of trade barriers and encourage innovation while ensuring a high level of protection for consumers.
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