Just send us your questions or concerns by starting a new case &
we will give you the help you need. Start Here...
CDSCO License
Tue, Dec 30 2025
Raju Karn
Types of Drug Licenses in India – Forms & Categories
In India, the sale, distribution, and manufacture of drugs and pharmaceuticals are strictly regulated to ensure the safety and quality of medicines. Any business dealing with drugs must obtain the appropriate drug license under the provisions of the Drugs and Cosmetics Act, 1940.
The licensing process involves applying for different forms, each catering to a specific type of drug activity. This blog explains the main types of drug licenses and the forms used for each purpose.
What is a Drug License?
A drug license is an official permission granted by the State Drug Control Department or Central Drugs Standard Control (CDSCO), allowing an individual or entity to legally.
Types of Drug Licenses & Their Forms
| Drug License Type | Purpose | Applicable Forms | Who Needs It? |
|---|---|---|---|
| Retail Drug License | Allows the retail sale of drugs to end consumers. | Form 20: General retail sale of allopathic drugs Form 21: Retail sale of drugs specified in Schedule C and C1 | Chemists, Pharmacies, Medical shops |
| Wholesale Drug License | Permits the sale of drugs to retailers, hospitals and other institutions. | Form 20B: Wholesale of general drugs Form 21B: Wholesale of drugs listed in Schedule C and C1 | Wholesale distributors, Stockists, Supply chain companies |
| Manufacturing Drug License | Authorizes the manufacture of drugs, including applicable repackaging and processing activities. | Form 25: Manufacture of non Schedule C/C1 drugs Form 28: Manufacture of Schedule C and C1 drugs | Pharmaceutical manufacturers, Repackaging units |
| Loan License | Allows a manufacturer to use another manufacturer's manufacturing premises when it does not own its own facility. | Form 25A: For non Schedule drugs Form 28A: For Schedule C and C1 drugs | Manufacturers using another licensed manufacturer's facility |
| Import License | Required for importing drugs and applicable pharmaceutical products into India. | Form 10: License to import drugs Form 41: Import license for new drugs and investigational drugs | Drug importers, Pharmaceutical importers |
| Restricted License | Allows certain entities to sell specified drugs without the supervision of a registered pharmacist, subject to applicable restrictions. | Form 20A: Restricted license for general drugs | Businesses eligible for restricted drug sale |
Note: Drug license forms and applicability can vary depending on the drug category, activity, premises and applicable rules. Verify the exact form requirements before applying.
Important Note on Schedules
Schedule C and C1 include biological products such as:
- Sera
- Vaccines
- Insulin
- Other injectable preparations
These require stricter controls and specialized forms.
Key Considerations
All licenses are issued under the Drugs and Cosmetics Act, 1940.
Applicants must meet infrastructure, storage, and personnel qualifications.
Licenses must be renewed periodically and displayed prominently on the premises.
Compliance with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) is mandatory for relevant licenses.
Conclusion
Understanding the different types of drug licenses and forms is essential for any pharmaceutical business in India. Whether you plan to retail medicines, distribute to hospitals, manufacture formulations, or import products, the correct license ensures legal compliance and safeguards public health.
FAQs
What is a Drug License in India?
A Drug License is a legal authorization required for businesses involved in the sale, distribution, manufacturing or import of drugs in India. The type of license depends on the nature of the business and the category of drugs handled.
What are the main types of Drug Licenses in India?
The main types include Retail Drug License, Wholesale Drug License, Manufacturing Drug License, Loan License, Import License and Restricted Drug License. Each license has specific eligibility requirements and applicable forms.
Which forms are required for a Retail Drug License?
A Retail Drug License generally involves Form 20 for general allopathic drugs and Form 21 for drugs covered under the applicable Schedule C and C1 categories.
Which forms are required for a Wholesale Drug License?
A Wholesale Drug License generally involves Form 20B for wholesale of general drugs and Form 21B for wholesale of drugs covered under the applicable Schedule C and C1 categories.
What is the difference between a Retail and Wholesale Drug License?
A Retail Drug License allows the sale of drugs directly to consumers, while a Wholesale Drug License allows the sale or distribution of drugs to retailers, hospitals, institutions and other eligible businesses.
Which Drug License is required for a pharmaceutical manufacturing business?
A pharmaceutical manufacturing business generally requires a Manufacturing Drug License. Depending on the type and category of drugs manufactured, applicable forms can include Form 25 and Form 28.
What is a Loan Drug License?
A Loan License is applicable when a manufacturer does not have its own manufacturing facility and uses the premises and facilities of another licensed manufacturer for manufacturing activities.
What is an Import Drug License?
An Import Drug License is required for applicable businesses importing drugs into India. The applicable requirements and forms depend on the type of drug and import activity.
Who needs a Wholesale Drug License?
Businesses involved in wholesale distribution or supply of drugs may require a Wholesale Drug License. This can include wholesalers, distributors, stockists and businesses supplying drugs to retailers, hospitals and institutions.
How can I apply for a Drug License in India?
The application process generally involves determining the correct license category, preparing the required documents, submitting the application through the applicable regulatory portal, premises verification where applicable, and obtaining approval from the concerned drug licensing authority.
What documents are required for a Drug License?
Common documents can include premises ownership or rental documents, site plan, details of the competent person or registered pharmacist, educational and registration certificates, identity and address documents, business constitution documents and other documents required by the concerned licensing authority.
How much does a Drug License cost in India?
Drug License fees depend on the type of license, number of forms, drug categories, state requirements and other applicable factors. Government fees and professional assistance charges may be separate.
How long does it take to get a Drug License?
The processing time depends on the license type, state authority, document completeness, premises inspection requirements and other regulatory factors. Applications with complete and accurate documentation can generally be processed more efficiently.
Can a pharmacy operate without a Drug License?
Businesses cannot legally carry out activities requiring a Drug License without obtaining the applicable authorization from the competent drug regulatory authority.
Can I get expert help for Drug License registration?
Yes. Professional compliance consultants can assist with identifying the applicable license, preparing documents, application filing, responding to regulatory requirements and completing the Drug License process.
