India’s pharmaceutical and cosmetic industries are among the fastest-growing sectors in the country. However, before manufacturing, importing, or selling any drug or cosmetic product, it is mandatory to obtain a Drug and Cosmetic License. This license is regulated under the Drugs and Cosmetics Act, 1940, and the Rules, 1945, to ensure that products meet safety, efficacy, and quality standards for consumers.

Types of Drug and Cosmetic Licenses

1. Manufacturing License
   This license is required by companies that intend to manufacture drugs or cosmetic products. It is divided into:

   • Drug Manufacturing License for Allopathic Medicines (Form 25/28)

   • Cosmetic Manufacturing License (Form 27/28)

2. Wholesale License
   A wholesale license allows businesses to trade in drugs without manufacturing them. This is generally issued as Form 20B under the Drugs and Cosmetics Rules.

3. Retail License
   Pharmacists or retail sellers of drugs and cosmetics need a retail license (Form 21C) to legally sell products to end consumers.

4. Import License
   Any individual or company importing drugs or cosmetics into India must obtain an import license (Form 10) from the Central Licensing Authority (CLA).

Eligibility Criteria

• The applicant must be an Indian citizen or a registered company in India.

• The premises must comply with Good Manufacturing Practices (GMP) for drugs or safety standards for cosmetics.

• Qualified personnel, such as a pharmacist or a technical officer with required educational qualifications, must be appointed.

• Proper storage facilities, such as temperature-controlled areas for drugs and hygiene-compliant storage for cosmetics, are mandatory.

Application Process

1. Documentation – Submit identity proof, company registration, list of products, premises details, and qualifications of technical staff.

2. Online Submission – The CDSCO SUGAM portal allows applicants to file for licenses digitally.

3. Inspection – Authorities conduct a physical inspection of the premises to verify compliance.

4. License Issuance – Once approved, the applicant receives the valid Drug and Cosmetic License with a specified validity period, typically 5 years for manufacturing and renewable thereafter.

Importance of a Drug and Cosmetic License

Obtaining this license is crucial for legal operations, consumer safety, and market credibility. It helps prevent counterfeit products, ensures adherence to quality standards, and protects businesses from legal penalties.

Agile Regulatory Support

At Agile Regulatory, we provide end-to-end assistance for Drug and Cosmetic License in India. From document preparation and online filing to inspection guidance and compliance management, our experts ensure a smooth and hassle-free licensing process. Whether you are starting a new pharmaceutical unit or expanding your cosmetic business, Agile Regulatory offers personalized consultancy to help you stay compliant and focus on growth.