Cosmetic Manufacturing in India: Key Legal Compliance and Licensing Requirements
Introduction
Cosmetics have become a daily necessity for people, whether in urban or rural areas, leading to the rapid expansion of the cosmetic market in India. To establish a cosmetic business, manufacturers or importers must adhere to legal requirements, including obtaining proper cosmetic registration. The industry is regulated under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetic Rules, 1945. A cosmetics manufacturing license is essential for businesses looking to produce cosmetics, and it remains valid for five years from the date of issue. Companies seeking to produce and market cosmetic products in India can apply for the following licenses:
Manufacturing License in India
Cosmetic manufacturing is regulated by authorities appointed by the State Governments under the Drugs and Cosmetics Act, 1940. The Central Licensing Authority (CLA), appointed by the Central Government, oversees the import of cosmetic products through a registration system.
Distribution License
Manufacturers may apply for licenses to produce up to 10 products per cosmetic category listed in Schedule MII of the Rules. The application requires a fee of Rs. 2,500, plus Rs. 1,000 for each inspection.
License for Approval
Manufacturers must submit Form 36 to the state licensing authority, along with an inspection fee of Rs. 1,500, to have their products tested.
Importing License
Entities importing and reselling cosmetics in India, but not producing them, require a cosmetic importer’s license. Importers must file Form 42 (application for a registration certificate), while Form 43 is used to issue registration certificates for importing cosmetics into India.
Rules and Regulations
Before issuing a Cosmetic Manufacturing License, the State Licensing Authority (SLA) will conduct a thorough inspection of the facility. Based on the inspection officer’s report, the Licensing Authority will decide whether to grant the license. Cosmetic manufacturers must also comply with the following regulations as outlined in the Rules.
Qualification Criteria for Staff
Manufacturers must ensure production occurs under the supervision of qualified technical staff, with at least one person meeting the following qualifications:
- A Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948.
- Registration under the Pharmacy Act, 1948.
- Passing an intermediate examination with Chemistry as a subject, or an equivalent qualification recognized by authorities.
Labelling Rules
Cosmetic manufacturers must ensure the following labelling standards:
- Clearly display all ingredients on the outer label.
- Include batch numbers, with manufacturing batches starting with “M” and separate batch numbers for each product starting with “B.”
- Clearly state the product name on both inner and outer labels. For small containers, the primary location and pin code are acceptable.
- Include usage instructions and any necessary warnings on the inner label.
Process for Obtaining a Cosmetic Manufacturing Licence
- Application Submission:
The applicant must submit the necessary documents through COS-5 to apply for a cosmetic manufacturing license. Our team will handle the preparation and filing process for you. - Document Submission:
Once the application is submitted, email us all the required paperwork, and we will compile and submit them to the authorities on your behalf. - Inspection:
After the application is submitted, the relevant authorities will inspect the facility and documentation. - License Issuance:
If the authorities are satisfied with the inspection and documentation, the cosmetic manufacturing license will be issued in Form COS-8, and the license will be delivered to you.
Conclusion
To boost sales and strengthen their market position, cosmetic manufacturers should continuously innovate and experiment with advanced products. However, it is essential to comply with all relevant laws and regulations to ensure a smooth operation in India’s cosmetic industry.