If you’re planning to open a pharmacy, wholesale distribution business, or manufacturing unit in Mumbai (Bombay), you must have a drug license.
This license ensures your business complies with the Drugs and Cosmetics Act, 1940, and all safety standards.
In this guide, you’ll learn step by step how to apply for a drug license in Mumbai, including the required documents, fees, and important tips.
What is a Drug License?
A drug license is official permission from the Food and Drug Administration (FDA) Maharashtra, allowing you to legally sell, stock, distribute, or manufacture medicines.
Without this license, operating any medicine-related business is illegal.
Types of Drug Licenses in Mumbai
Choose the right license based on your business type:
| License Type | Who Needs It? | ||
|---|---|---|---|
| Retail Drug License | Pharmacies, chemist shops, medical stores | ||
| Wholesale Drug License | Distributors selling medicines to hospitals, clinics, or other retailers | ||
| Manufacturing License | Units making drugs or cosmetics | ||
| Loan License |
| ||
| Homeopathy/Ayurveda License | Sellers of traditional medicines |
Wholesale businesses must apply with Form 20B and Form 21B.
Steps to Apply for a Drug License in Mumbai
Follow this process carefully:
Step 1: Register Your Business
Set up your business as:
You will also need:
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Shop & Establishment Certificate
Step 2: Prepare Your Premises
Your shop or warehouse must:
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Be at least 10 sq. meters (retail) or 15 sq. meters (wholesale)
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Be located in a commercial area
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Have a refrigerator and proper storage facilities
Step 3: Appoint a Qualified Person
Depending on your license type:
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Retail: A registered pharmacist
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Wholesale: A person with 1 year of experience in drug sales
Step 4: Create an Account on FDA Maharashtra Portal
Visit:
https://fda.maharashtra.gov.in
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Register your account
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Fill in your business details
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Select the appropriate forms (20, 21, 20B, 21B)
Step 5: Upload All Required Documents
Make sure your scans are clear and properly named (check the document list below).
Step 6: Pay the Application Fee
You can pay securely online through the portal.
Step 7: Premises Inspection
A Drug Inspector will visit your premises to verify compliance.
Step 8: License Issuance
If everything is in order, your license will be issued within 30–45 working days.
It is valid for 5 years.
Documents Required for Drug License in Mumbai
Here’s an easy checklist:
Business Documents:
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GST Registration Certificate
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Company incorporation or partnership deed
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Ownership proof or rent agreement
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Latest electricity bill
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Premises layout/blueprint
Personal Documents:
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PAN and Aadhaar of the proprietor or directors
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Qualification certificate of the pharmacist or experienced person
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Registration certificate of the pharmacist
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Experience certificate (for wholesale)
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Two passport-size photos
Other Documents:
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Refrigerator purchase invoice
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Affidavit of no criminal conviction
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NOC from the landlord (if rented)
Drug License Fees in Mumbai (2025)
| License Type | Approximate Fees |
|---|---|
| Retail License | ₹3,000 – ₹5,000 |
| Wholesale License | ₹5,000 – ₹7,500 |
| Manufacturing License | ₹10,000+ |
| Renewal | ₹2,500 – ₹5,000 |
Important Compliance Rules
Once your license is issued:
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Display it prominently in your shop
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Keep updated records of all purchases and sales
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Store temperature-sensitive medicines properly
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Renew the license before expiry
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Do not sell prescription drugs without a valid prescription
Tips for Smooth Approval
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Make sure your premises meets all size and location requirements
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Ensure your Qualified Person is available on inspection day
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Name your documents clearly before uploading
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Save your application reference number
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Take professional assistance if you are unsure about any step
Areas We Assist in Mumbai (Bombay)
We help applicants in all parts of Mumbai, including:
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Andheri
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Bandra
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Borivali
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Dadar
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Goregaon
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Malad
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Navi Mumbai
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Thane
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Mulund
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Chembur
Final Thoughts
Getting a drug license in Mumbai is mandatory to run your pharmacy, wholesale, or manufacturing business legally.
Although the process is online, it can be complex if you’re applying for the first time.
At PSR Compliance, we assist you in preparing documents, applying online, and coordinating with FDA authorities so you don’t face delays or rejections.
👉 Need Help Applying for a Drug License in Mumbai?
We guide you through:
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Choosing the correct license type
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Preparing and submitting documents
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Following up on inspections
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Answering authority queries
✅ Professional Support
✅ Faster Processing
✅ Complete Transparency
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