Overview

Drug & Cosmetic License

The Central Drugs Standard Control Organisation (CDSCO) regulates the import, manufacture, distribution, and sale of drugs and cosmetics in India. This is done through a licensing system that ensures that all drugs and cosmetics meet the required quality standards. The CDSCO also has the power to issue notifications under Section 26B of the Drugs and Cosmetics Act, which allows them to control and regulate or restrict drug manufacture in the public interest.

Drug and Cosmetic License

A drug license is required for any person or entity involved in selling, purchasing, or manufacturing drugs in India. This includes manufacturers, retailers, and traders. The Drugs Controller General of India (DCGI) or the Central Drugs Standard Control Organisation (CDSCO) issued the drug license.

There are two types of drug licenses:

• Retail
• Wholesale

A retail drug license is required to run a chemist shop. In contrast, a wholesale drug license is required to sell drugs and pharmaceutical products.

Documents Required

The applicant must submit an application form to the DCGI or CDSCO and the required documents to obtain a drug license. The documents required may vary depending on the type of license being applied for.

Common documents required include:

• Proof of identity and address
• Proof of ownership or lease of the premises where the drugs will be sold or manufactured
• A certificate from a registered pharmacist
• A fee

Cosmetic License

A cosmetic license is required for any person or entity that manufactures or imports cosmetics in India. The CDSCO issues the cosmetic license. The applicant must submit an application form to the CDSCO and the required documents to obtain a cosmetic license.

Common documents for cosmetics include:

• Proof of identity and address
• Proof of ownership or lease of the premises where the cosmetics will be manufactured or stored
• A list of ingredients used in the cosmetics
• A stability test report
• A fee

Classification of Drugs License

Manufacturing Drug License

This license is required for any person or entity that manufactures drugs in India. Requirements include:

• Suitable location with adequate space and equipment.
• Compliance with Good Manufacturing Practices (GMP).
• Competent technical staff (Pharmacy graduate with 18 months experience).
• Separate testing arrangements for strength, quality, and purity.
• Separate licenses for factories in different locations.

Import Drug License

Requirements for importers:

• Proper storage accommodations to preserve drug properties.
• Retail sale containers for patent medicines.
• Invoices with manufacturer name, address, and drug quantities.
• Declarations for drugs not covered under mandatory licensing.

Other Licenses

• Multi-Drug License: For entities operating in multiple states; separate license per location.
• Sale Drug License: Categories include Wholesale, Retail, and Restricted licenses for general stores.
• Loan Drug License: For those using another licensed manufacturer's premises. Valid for one year.

Indian cosmetic market is growing rapidly, leading to the increase in demand for skincare, haircare, makeup, and personal care products. Setting up your cosmetic business needs approval from the regulatory authority.

What Is A Cosmetic License?

A cosmetic license is a legal document that gives businesses the permit to manufacture, import, distribute, or retail beauty products in the market. This license is issued by the State Licensing Authority & regulated by the Central Drugs Standard Control Organization in India.

Registration Process: Step-By-Step

1. Identify License: Select Import License (Form COS-1) or Manufacturing License.
2. Appoint Agent: Foreign manufacturers must appoint an Authorized Indian Agent.
3. Prepare Documents: Compile Power of Attorney, FSC, Formulation details, and Label artwork.
4. Sugam Portal: Submit application online through CDSCO portal.
5. Government Fee: USD 250 per product variant for imports.
6. CDSCO Review: Authorities review accuracy and clarity.
7. Grant (Form 43): Issued upon approval; valid for 5 years.

Rules & Labelling

Important Rules

• Drugs and Cosmetics Rules, 1945: Core regulation for storage and licensing.
• Medical Devices Rules, 2017: Standards for quality and safety of devices.
• Cosmetics Rules, 2020: Specific requirements for registration and safety.
• Drugs (Prices Control) Order, 2013: Specifies Maximum Retail Price (MRP).

Imported Cosmetic Labelling Requirements

Must display:

• Registration certificate number (CDSCO).
• Name and address of certificate holder and manufacturer.
• Clear product name and list of ingredients in descending weight.
• Manufacture and Expiry dates.
• Adequate directions and warnings.

FAQs