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.
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Table of Content
- Overview Drug & Cosmetic License
- Documents Required
- Classification or Types of Drugs License
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What is a Drug License?
A drug license is a legal permit that government authorities issue to a person or company. It allows you to manufacture, sell, distribute, or import drugs and cosmetics. Governed by the Drugs and Cosmetics Act of 1940, this licensing system is crucial for controlling the quality and distribution of pharmaceuticals, ensuring all medicines available to the public are safe and effective. The type of license required depends on your specific business activities, and it typically has a validity of five years, after which it must be renewed.
Types of Drug Licenses
You must choose the correct license for your pharmaceutical business:
1. Drug Manufacturing License
This license is required for companies that produce pharmaceutical products, including allopathic, ayurvedic, and homeopathic medicines. It confirms that the manufacturing site follows government-mandated quality and safety practices, i.e., Good Manufacturing Practices (GMP).
2. Drug Sale License
- Wholesale Drug License: Required for businesses that supply medicines in bulk to retailers, hospitals, or other institutions. The premises must meet specific size and storage standards.
- Retail Drug License: Pharmacies, Ayurvedic shops, and medical stores that sell medicines directly to consumers must obtain a retail license. A qualified pharmacist is usually required to manage operations.
3. Loan License
This license is issued to businesses that market their drug brands but do not own a manufacturing unit. Instead, they manufacture products using another company’s approved facility.
List of Application Forms for Drug Licenses
| License Type | Application Form(s) | Purpose |
| Drug Manufacturing License | Form 25, Form 28, etc. | To legally manufacture pharmaceutical products under regulated quality and safety norms. |
| Wholesale Drug License | Form 20B, Form 21B | To sell drugs in bulk to retailers, hospitals, or institutions. |
| Retail Drug License | Form 20, Form 21 | To sell drugs directly to consumers through pharmacies or medical stores. |
| Loan License | Form 24A | To market drugs manufactured by another licensed manufacturer. |
| Drug Import License | Form 10, Form 11 | To import pharmaceutical products or raw materials compliant with national standards. |
| Drug Export License | Depends on the product/destination | To export pharmaceutical products meeting the regulatory requirements of India and other countries. |
Related Business Registrations
In addition to registration or incorporation, a business may require other registrations depending on the business activity undertaken. Talk to an Advisor to find out registrations your business may require post registration.
