Cosmetic regulations in India
The cosmetics market has been growing exponentially in India at an accelerating rate, especially in urban areas. This can be attributed to several factors like the influence of western culture, the desire to look attractive, beautiful, etc. Currently, there is an exhaustive range of various types of cosmetic products in the market. Every cosmetic product consists of different types of chemicals and hence it is important for the government of the country to look after the interest of the consumers and ensure that the products are safe to use.
Earlier, there were no strict regulations for cosmetic products but due to the increase in awareness regarding animal cruelty and the harmful effects of chemicals in cosmetic products. Countries today are formulating laws and policies to that effect and are ensuring that stringent steps should be taken for the safe use of these products.
In India, the Central Authority for discharging regulatory functions relating to drugs and cosmetics is the Central Drugs Standard Organization (CDSCO) which is headed by the Drugs Controller General of India. It is a statutory authority established under the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules, 1945.
The primary goal of CDSCO is to ensure the safety, efficiency, and quality of drugs, cosmetics, and medical devices. Every state also consists of a state-level authority known as the SDCA which is the State Drug Control Authority which is responsible for the implementation of the regulations under the Drugs and Cosmetics Act, 1940.
The Bureau of India Standards is another statutory authority in India that is empowered to lay down stands for cosmetics under the Bureau of Indian Standards Act, 1986. Now let us further discuss the Cosmetic regulations in India.
cosmetics products manufacturer
According to the Drug and Cosmetics Act 1940, Cosmetic refers to “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”.
To ensure the safe use of cosmetic products included within this definition, India has laid down the Drug and Cosmetic Act 1940. It rules 1945 which lays down stringent provisions pertaining to the import, manufacturing Sale & distribution of cosmetics. These provisions primarily deal with licenses for imports & manufacturing of cosmetics. The provisions also contain a list of cosmetics that are prohibited by law to be manufactured or imported and most importantly deal with penalties for contravention of any of the provisions under the Drug and Cosmetic Act 1940.
Cosmetic products in India are also regulated by the Bureau of Indian Standards (BIS) which lays down standards for cosmetics products laid down under Schedule ‘S’ of the Drugs and Cosmetics Act Rules 1945 which comprises a list of 30 different types of cosmetics like skin powders, creams, pastes, and tooth powders, hair oil, soaps, shaving creams, etc. Any cosmetics in a finished product form that is included under Schedule-S of D & C Rules should conform to the Indian Standards specifications laid down by BIS from time to time.
Regulatory provisions for manufacturing cosmetics
For the purpose of manufacturing cosmetics, a license needs to be obtained from the state regulatory authority (States foods and Drug Administration) appointed by the state government to manufacture any cosmetic specified under Schedule M-II of the Act for its sale/distribution.
How to obtain the license
The application shall be furnished in Form 31, accompanied by a fee of INR 2,500/- and an inspection fee of INR 1000/-, and in case the number of items exceeds 10, an additional fee shall be deposited. The application shall comprise:
Layout plan of the premise of the factory,
Machines and equipment to be installed,
Documents exhibiting the constitution of the firm,
Documents exhibiting that the premise for the factory is possessed by the applicant, and
Affidavits or any other relevant information required by state drug control authorities.
Before granting the license, the officers of the state regulatory agency shall inspect the premise to find out whether the applicant has provided adequate space for manufacturing, storage of raw materials, packaging, and finished products have adequate equipment and machinery for manufacture, and adequate testing facilities for raw materials & finished form of cosmetics. Based on these observations a detailed report is submitted by the inspectors and whether the license is to be granted or not is decided based on these observations.
Restrictions on the manufacture, sale, and distribution of drugs & cosmetics
As per Section 18 of the Drugs and Cosmetics Act, any cosmetic which is not of standard quality or is adulterated, misbranded or spurious is prohibited from manufacturing, sale, and distribution. The restriction also extends to a patent or proprietary drug, which by any statement, device, or statement accompanies it or it is claimed to prevent or mitigate or cure any ailment or disease or which has any other harmful effect as prescribed under the act. The restriction is also applicable to any cosmetic which contains an ingredient that is harmful for use as per the directions indicated on the label and any other drug or cosmetic which is in contravention of any provision of the chapter dealing with the manufacture, sale, and distribution of drugs & cosmetics.
The terms spurious, misbranded, adulterated, or standard quality under the restrictions on the manufacture, sale, or distribution provision have the same meaning under the provisions for the import of drugs or cosmetics products.
In the case of Pratap Sharma Private Limited v. Union of India[1], the Supreme Court held that if a drug is not in compliance with the prescribed standards and has the potential to cause injury to or endanger the life of a person, the prohibition of such a drug if not expressly prohibited under the Act will be implicit and the accused shall be held liable.
cosmetics manufacturer
Introduction
As per the Gazette notification GSR 426 (E) dated 19th May 2010 (see here) issued by the Government of India, the Drugs and Cosmetics Rules 1945 have been amended, and the new
Amendment provides for the registration of import of cosmetics into the country. All the products which are imported for sale in India now are required to be registered with the CDSCO i.e. Central Drugs Standard Control Organization which has been appointed as the licensing authority specifically for this purpose. The purpose of this registration requirement is mainly to regulate
irregular/indiscriminate import of cosmetics products by traders with no accountability for their content and no mechanism to cater to customers who are not satisfied with the quality. The main goal of having a registration requirement for imports is to check the sub-standard sale of cosmetic products in India.
An application is to be filed for the import of cosmetics into India by:
A manufacturer with a registered place of business in India, by his authorized agent, or by any of his subsidiaries in India, is authorized by the manufacturer or any other importer.
Documents required for filing the application for registration
The application should be applied via Form-42 which requires details of the manufacturing sites of the products. The application requires the following:
Challan indicates payment of registration fee of USD 2000 or its equivalent to Indian rupees for each brand of the cosmetics product and USD 50 for each variant,
Power of attorney in case the application is submitted by an authorized agent of the manufacturer. The Indian embassy of the country of the manufacturer is required to legalize the document,
Details of the brand and cosmetic products with respect to the chemical composition and safety,
Details of the actual manufacturer and in cases where the manufacturer is not the brand owner, a label stating ‘Manufactured in ZYX country’,
License for manufacturing is to be attested in the English language. In case of multiple manufacturers for the same product, all manufacturers need to provide these documents,
- Specifications of the cosmetics products like details of ingredients used, quality, etc, and testing protocols,
- A list of countries wherein permission for import has been granted or registration has been granted,
- Product specifications that go into packaging have to be provided and information about any potential allergic reaction or side effects has to be duly informed.
- All the requisite documents along with the application are required to be submitted to the Drugs Controller General (I), CDSCO, FDA Office, Delhi.
- Timeline of processing the application: The registration certificate for the import of cosmetics shall be issued within 90 days from the date of submission of the application form and other required documents as discussed above.
- Validity of the registration certificate: The registration certificate for the import of cosmetics is valid for three years from the date of issuance.
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