If you want to start a manufacturing business of cosmetics in India for the sale and distribution of cosmetic products then, the primary need is obtaining a manufacturing license certificate from the Central Drug Standard Control Organization (CDSCO) as per the Drug and Cosmetic Rule, 1945. The license certificate for manufacturing cosmetic products is issued under Form 32 Cosmetic License by applying under Form 31.
Form 32 ensures that the product as well as the manufacturing process is set as per regulatory compliance and helps in providing standard quality, safe, and effective cosmetics in the Indian market for the use of consumers.
What Is Form 32? Â
Form 32 is the cosmetic manufacturing license certificate or legal authorization for manufacturing of cosmetic products which is generally issued by State Licensing authority under the Drug and Cosmetic Act, 1940. This includes all details about manufacturing premises and cosmetic products.
Who Issues The Form 32 Cosmetic License? Â
The Form 32 Cosmetic License is issued by the State Licensing Authority or State Drug Controller appointed by the State Governments of the respective states.
What Is The Need for Form 32 Cosmetic License? Â
Form 32 is essential in cosmetics for the following reasons discussed below:
- For starting a Manufacturing business in India
- For the sale and distribution of cosmetic products in India
- Helps in maintaining cosmetic product safety
- Provide standard quality products to consumers
- Build customer’s trust
- Enhance Brand market reputation and value
Who can Apply for a Form 32 Cosmetic License? Â
- Any manufacturers or Importer who want to start a cosmetic business
- Any Individual
- Any authorized person on behalf of manufacturers or in the case of foreign manufacturers
What Are The Documents Required for Form 32 Cosmetic License?
For the seamless process of getting Form 32 manufacturing License Certificate for manufacturing of cosmetic products in India a list of essential documents along with Form 31 must be submitted to the state licensing authority. The documents are as follows:
- Application Form 31: It contains all the details about manufacturing premises, owner, and product details
- GMP and GLP documents
- Manufacturers personal details
- Documents about Manufacturing premises along with ownership or rental documents
- List of Equipment’s along with its SOPs
- Technical staff details
- Product details along with composition, brand name, and Labelling
- NOC from the Pollution Control Board
- Self-declaration certificate stating compliance with the regulations
- Proof of Fees paid receipt
- Additional documents as per requirements
What is the Procedure For Applying for Form 32 in Cosmetics? Â
The various steps to be followed for getting Form 32 cosmetics manufacturing License Certificate are as follows:
- Fill out Form 31: It is the manufacturing license application form through the SUGAM Portal and is the primary step before starting a manufacturing business
- Submit all the documents along with the Form 31 Application formÂ
- Pay Registration Charges: Make the payment of the application online according to the schedule third of the cosmetics rule.
- Inspection of Manufacturing facilities by State Licensing Authorities: Within 30 days from the day of filling application form SLA visits the Manufacturing site to check GMP (Good Manufacturing Practices) and other parameters that are discussed in Schedule 7
- Verification and Review: After checking the manufacturing site and all other documents, the State Licensing Authority gives a decision 45 days from the day applied.
- Issuance of Form 32 Manufacturing License Certificate by Authorities: If the State Licensing Authority finds all the requirements for getting Manufacturing are according to regulatory guidelines, then the Form 32 manufacturing license certificate is for the sale and distribution of cosmetic products
- Uploading License on the website: Once the certificate is received it must be uploaded for future reference as a record.
What Is the Validity of Form 32 In Cosmetics?Â
The validity of Form 32 in cosmetics is 3 years from the date of issuance. After this period, the license must be renewed to continue manufacturing. For the renewal process of Form 32 renewal application along with updated documents and fees is submitted.
Fees for Form 32 in Cosmetics  Â
- Fees of Rs.10000 for grant or retention of Form 32 manufacturing
license certificate for each category of up to 10 items. - Fees of Rs.500 for grant or retention of Form 32 manufacturing
License certificate for an additional category of cosmetic
Consequences of Not Having Form 32
The potential consequences for manufacturers who do not obtain or renew Form 32 which is the mandatory license for starting manufacturing can lead to several consequences. Which include:
- Monetary Fines and Penalties: The regulatory body imposes fines or penalties on manufacturers who do not have licenses or do not renew licenses in the given time.
- Product Recalls: Any product manufactured without Form 32 is not allowed for marketing or sale. this type of non-compliant products are recalled from the market, leading to Damage to brand reputation and financial loss.
- Legal Action: Non-compliance can result in civil or criminal lawsuits
- Loss of Market Access: Manufacturers are prohibited from selling their products in the market without Form 32. This will stop market growth and Business value.
- Imprisonment: If Manufacturing without form 32 causes any safety issues to consumers then, it will cause imprisonment to the manufacturer for three to five years.
How ELT Corporate Will Assist You in Form 32 In Cosmetics?
Understanding the complex process of obtaining a Form 32 Manufacturing license certificate is quite challenging. At ELT Corporate, we specialise in simplifying the document collection and application process for cosmetic registrations for Manufacturing, Import, sale, or distribution. Our expert team ensures a smooth and hassle-free experience, for meeting the specific regulatory requirements of the licensing authorities.
Frequently Asked Questions (FAQs)
What is the Difference Between Form 31 and Form 32?Â
Form 31 is the application form submitted to the State Licensing Authority for a license to manufacture cosmetics. Form 32 is the license issued after the approval of the Form 31 application, authorizing the production of cosmetics.
Can I Manufacture Multiple Cosmetic Products Under One Form 32 License?Â
Yes, you can manufacture multiple cosmetic products under one Form 32 license, provided all the products are listed in the application and meet the required standards.
What are the Consequences of Manufacturing Cosmetics Without a Form 32 License?Â
Manufacturing cosmetics without a valid Form 32 license is illegal and can result in severe penalties, including fines, imprisonment, and the closure of the manufacturing facility.
