Drug License Gujarat: Food and Drug License

If you want to sell medicines or food products in Gujarat, you will need a valid drug license. This applies to both retail pharmacies and wholesale distributors. This blog explains who needs the license, what’s required, how to apply, associated costs and why staying licensed matters. 

What Counts as a Drug License in Gujarat?

A drug license in Gujarat gives legal permission to a person or business to sell, stock, exhibit, or distribute any drug or medicine as defined by the Drugs and Cosmetics Act. For food-related products—such as nutraceuticals, health tonics, or fortified foods you may also need a food license under FSSAI. This guide focuses on drug licenses covering steps for both retail and wholesale.

Who Needs a Retail Drug License?

You must get a retail drug license if you operate:

• A pharmacy or chemist shop that sells medicines directly to consumers
• A clinic pharmacy which is located in a hospital or nursing home
• An online medicine store with delivery to addresses in Gujarat
• A nutraceutical or health tonic shop—if the products fall under drug classification

You must also have a qualified pharmacist on staff, registered with the Pharmacy Council of India.

Who Needs a Wholesale Drug License?

You must hold a wholesale drug license if your business involves:

• Selling medicines to other chemist shops or hospitals
• Supplying drugs to distributors within Gujarat
• Importing or exporting drugs through Gujarat ports
• Repacking or re-labeling medicines before sale

A wholesale license requires a competent person with at least one year’s experience and suitable storage facilities.

Read More  What is the Process of Drug License Renewal

When Do You Need FSSAI License

Gujarat food license is applicable in cases when you manufacture, store or market food resources that have got the drug nature such as energy drinks or supplements. In case these items pose drug claims, you will require a drug license and FSSAI license. The nature of the product and its purpose determine the licensing of that product

Eligibility Criteria for Drug License Gujarat

For Retail License:

• Premises with minimum 10 sq. m space
• Appointment of a full-time registered pharmacist
• Secure storage area with shelving and basic security (locks)

For Wholesale License:

• Office or warehouse space with at least 20 sq. m
• A competent person appointment who a has diploma or degree in pharmacy
• Proper facilities like counters and separate storage
• Temperature control for sensitive drugs

Drug License Gujarat Tip: Your premises must comply with local building and municipal rules.

Documents Required (Retail & Wholesale)

Both types require similar documents:

1. Application Form – Form 19 (retail) or Form 20 (wholesale); filled and signed
2. Ownership or rental proof – papers of property or lease agreement
3. No Objection Certificate (NOC) from landlord
4. Pharmacist’s registration and appointment letter (retail)
5. Competent person appointment (wholesale)
6. Certificate of qualifying person
7. Pharmacist’s qualification certificate
8. Key plan layout of premises
9. Rent proof or electricity bill
10. Photographs – internal and external
11. Affidavit on stamp paper
12. Drug list you intend to sell

Digital copies should be in PDF or JPEG format and clearly legible.

Read More FSSAI License

Step-by-Step Application Process

1. Create User Account

Visit Gujarat’s Drugs Control Department portal. Register through your details and create a login

2. Choose License Type

Select Retail (Form 19) or Wholesale (Form 20) and start your application

3. Fill Application Form

Enter your shop information, qualified staff details and upload documents

4. Submit Fee

Pay license fee online using the generated challan. Rates vary by license type

5. Schedule Inspection

After submission a designated officer visits your shop or warehouse to verify premises and staff qualifications

6. Deploy Qualified Person

Ensure your pharmacist (retail) or competent person (wholesale) is on-site at the time of inspection

7. Get License

After successful inspection the license is issued digitally. You must print and display it prominently.

Processing time ranges from 15 to 30 working days depending on your documents and inspection scheduling

Fee Structure for Gujarat Drug License

Fees cover initial application and one-time facility inspection. Renewal costs are similar but may slightly increase with additional schedules.

Validity & Renewal Requirements

Drug licenses issued in Gujarat are generally valid for 5 years. To renew your license:

• Submit renewal application at least 30 days before expiry
• Provide documents like pharmacist’s letter or competent person update
• Pay renewal fees similar to initial charges
• Pass renewal inspection (if required by the department)
• Late renewal may attract fines or permit cancellation.

Post-License Compliance Guidelines

Once licensed, you must adhere to strict rules:

• Operate only from licensed premises
• Maintain sales and purchase records daily
• Sell drugs only through invoices
• Avoid expired or unapproved drugs
• Display license and staff documentation
• Cooperate with surprise inspections by officials
• Keep temperature control and security in place

Final Take

Starting a pharmacy or drug distribution business in Gujarat means you must follow the law. A drug license from the Drugs Control Department is no longer optional—it’s mandatory and necessary for ethical business.

If you want to open a medical store or want to expand into wholesale. It is the perfect time to act. Let Agile Regulatory make your license process fast and accurate.

Get in touch today to ensure your Gujarati pharmacy business is legally compliant, professionally equipped, and ready to serve the community.