Drug License
DRUG LICENCE & PHARMACEUTICAL COMPLIANCE
Drug License Registration for Pharmaceutical Businesses
Get the Right Drug License for Your Business
Professional assistance for retail, wholesale, manufacturing and other applicable drug licensing requirements,
including documentation, application filing and regulatory support.
Retail Drug
License
Wholesale Drug License
Manufacturing License
Application Assistance
Find the Right Drug License for Your Business
Retail Drug License
For businesses selling medicines directly to consumers, subject to the applicable regulatory requirements.
Wholesale Drug License
For businesses selling, stocking or distributing medicines to retailers, institutions or other eligible entities.
Manufacturing License
For businesses manufacturing drugs for sale or distribution.
Import License
For businesses importing regulated drugs into India, subject to the applicable central regulatory requirements.
Businesses That May Require Drug Licensing
Pharmacies
Wholesale Distributors
Drug Manufacturers
Importers
Hospitals & Institutions
How Drug License Registration Works
Identify the Licence
Check
Eligibility
Prepare Documents
Submit Application
Licence Issuance
Drug License Assistance From Application to Approval
License Identification
Eligibility Assessment
Document Preparation
Application Filing
Inspection Preparation
Regulatory Support
Premises Specifications & Conditions
The specifications and conditions of the premises are crucial for obtaining a pharma license.
| Eligibility Criteria | For Retail Drug License | For Wholesale Drug License |
|---|---|---|
| Type of Premises | May be located in a Mixed Land Use Area or a Commercial Place. | It must be located in a Commercial Place only. |
| Minimum Area | The minimum carpet area is 10 square meters with a height of 2.75 meters. | The minimum carpet area is 10 square meters with a height of 2.75 meters. |
| Approach Road | The road must face a minimum width as the local municipality prescribes for mixed land use. | Should be on a road/street broad enough for easy loading and unloading, ideally facing a road with a minimum width of 18 meters. |
| Furniture | Requires racks, almirah for storage, and a table and chair. | Requires racks, almirah for storage, and a table and chair. |
| Equipment | Computer systemPrinter for invoices Refrigerator (essential for storing certain drugs, especially vaccines, in a low-temperature zone) | Computer systemPrinter for invoicesRefrigerator (essential for storing certain drugs, especially vaccines, in a low-temperature zone) |
Frequently asked questions
Is a drug license mandatory for every pharmaceutical business?
Not every business needs the same license. Businesses involved in regulated activities such as selling, stocking, distributing, manufacturing or importing drugs may require the applicable license under the Drugs and Cosmetics regulatory framework.
What types of drug licenses are available?
Depending on the activity, licenses can include retail sale, wholesale sale, manufacturing, import and other specialized licenses. The official ONDLS lists multiple license/application categories.
Do I need a separate license for retail and wholesale?
The applicable license depends on the nature of the sale/distribution activity and the relevant regulatory requirements. Retail and wholesale applications are separately represented in the ONDLS system.
Is a pharmacist required?
For applicable retail operations, qualified personnel requirements apply. The exact qualification and competent-person requirements should be determined according to the license category and applicable rules.
Is inspection required?
Depending on the license and application, the licensing authority may conduct inspection/scrutiny of the premises and compliance arrangements.
Can I apply for a drug license online?
Yes. The Online National Drugs Licensing System (ONDLS) provides online processing for various drug manufacturing and sales license applications and related services.