In India, the market of cosmetics is growing at an accelerating rate. The demand for cosmetics products has augmented, especially in the urban areas in the past few years. Several factors contributing to the craze is the influence of the western culture, the increase in the purchasing power, desire to look attractive and beautiful etc.
In India, there were no such strict regulations regarding the cosmetic products earlier. But due to the growing awareness, cosmetics is slowly coming under strict regulations. Presently, the governing legislation in case of cosmetics in India is the Drugs & Cosmetics Act, 1940.The procedure to be followed in order to manufacture cosmetics and getting cosmetic license in India has been laid down under the Drugs and Cosmetics Rules, 1945. Schedule M-II classifies cosmetics into 11 broad product categories like powders, creams, lotions emulsions, pastes, cleansing milks, shampoos, pomade, brilliantine, shaving creams, hair oils, nail Polishes and nail Lacquers, lipsticks & lip Gloss, depilatories, preparations used for eyes, aerosol, alcoholic Fragrance Solutions (Cologne), hair Dyes, tooth Powders and Tooth Pastes, toilet Soaps.
How to apply for manufacturing license for cosmetics in India?
The manufacture of cosmetics is regulated under a system of inspection and licensing by each state drug control department as per the provisions of Drugs and Cosmetics Act, 1940 and Rules. It varies from state to state. The application for a license is submitted though the website of each state in India. Specific procedures vary from state to state.
- Submission of Form 31, along with a license fee of Rs. 2500 and an inspection fee of Rs. 1000.
- The license in Form no 32 that is issued for manufacturing cosmetics for sale or distribution and filing of the application in Form no 31.
- The license in Form 32-A that is issued for loan license for manufacturing cosmetics for sale for distribution, and the application is filed in form no 31-A.
- The license on Form 37 is issued for grant or renewal of approval for carrying out tests on cosmetic or raw material used in the manufacturing thereof on behalf of license for manufacture for sale of cosmetics. The manufacturer has to ensure that the production is done in the presence of a competent and qualified technical staff and at least one of the staff persons should possess the following educational requirements:
- Holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948; or is registered under the Pharmacy Act, 1948.
- Has passed the intermediate examination with Chemistry as one of the subjects or any other examination as recognized by the Licensing Authority as equivalent to it.
- The Licensing Authority needs to inspect the whole premises where cosmetic production operations are to be carried out before the grant or refusal of the license.
What are the requirements for factory premises for the manufacturing of cosmetics in India?
The factory premises for the manufacturing of cosmetics need to follow conditions as per Schedule M-II. Some of the general requirements are as follows:
- Location and vicinity of the premises: Location of the area in which the factory or manufacturing facility of cosmetics and the surroundings is hygienic with proper sanitary conditions. No production should take place within or around a residential area.
- Building: The building in which the production is to be carried should be free from rodents, insects, etc. The height of the rooms of the building should be at least 6 feet from the floor. The construction of the building must be smooth, waterproof, and capable of being kept clean. Concerning floors, the same should be smooth, washable, even and dust-free.
- Proper disposal and drainage of water used in the premises: Careful and proper disposal or discharge of waste water in the production.
- Staff: The appointed staff persons should be regularly screened for health issues and not suffering from any infectious or communicable disease. Staff must be provided with safety tools such as masks, hand gloves, uniforms, etc. Management must ensure the availability of the first aid facility inside the factory premises.
Why CliniExperts?
CliniExperts has an experienced team of regulatory experts for cosmetics who are well versed with cosmetic regulation in India. We can help you with any queries related to the cosmetic business in India.
References
- How to Apply for Manufacturing License of Drugs and Cosmetics.docx. Available at: http://fsdaup.gov.in/writereaddata/images/HowtoApplyforManufacturingLicenceofDrugsandCosmetics.pdf .Accessed on September 21, 2020.
