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Mon, Jan 19 2026
Raju Karn
If you want to start a wholesale medicine business in Mumbai, you must get a wholesale drug license.This license is required if you plan to store, supply, or distribute medicines to retailers, hospitals, clinics, or other wholesalers.
Without a valid drug license, handling medicines is illegal in India. This rule is made to protect public health and ensure that medicines are stored and sold safely.
This blog explains the wholesale drug license requirements in Mumbai in very simple language, step by step, so you can clearly understand what is needed and how the process works.
A wholesale drug license allows a business to sell medicines in bulk instead of directly to patients.It is issued under the Drugs and Cosmetics Act, 1940 by the Food and Drug Administration (FDA), Maharashtra.
For wholesale businesses, licenses are issued in:
Form 20B – for drugs other than Schedule C and C1
Form 21B – for Schedule C and C1 drugs
These forms are commonly referred to as Form 20 and 21 drug license for wholesale purposes.
You need a wholesale drug license if you are:
➤ Supplying medicines to medical shops
➤ Distributing medicines to hospitals or clinics
➤ Operating as a pharmaceutical distributor
➤ Running a medicine stockist or warehouse
➤ Supplying medicines to government or private institutions
If medicines are part of your business, a drug license is compulsory.
⁃ Legal permission to deal in medicines
⁃ Builds trust with manufacturers and hospitals
⁃ Avoids penalties and legal trouble
⁃ Helps in business expansion
⁃ Required for government and bulk supply contracts
To apply for a wholesale drug license in Mumbai, the following basic conditions must be met.
Your business must be legally registered as:
GST registration is also required.
Minimum area: 10 square meters
The premises should be clean and suitable for medicine storage
Proper racks, cupboards, and ventilation are needed
Unlike retail licenses, a pharmacist is not mandatory, but you must appoint a competent person who has:
➜ Minimum 1 year experience in drug distribution, OR
➜ Degree or diploma related to pharmacy or science (as accepted by FDA)
Here are the common documents required:
→ Business registration certificate
→ GST certificate
→ PAN card of firm/directors
→ Address proof of premises (rent agreement or ownership proof)
→ Premises layout plan
→ Appointment letter of competent person
→ Educational and experience certificates
→ Affidavit as per FDA format
→ Identity proof of applicant
All documents must be clear and up to date to avoid delays.
The application is submitted online through the FDA Maharashtra portal.Forms 20B and 21B are filled along with document uploads.
Government fees are paid online based on the type of license applied for.
A drug inspector may visit the premises to:
Verify storage conditions
Check documents
Confirm competent person details
If everything is found correct, the wholesale drug license is approved and issued.
In most cases:
After approval:
‣ Applying without a qualified competent person
‣ Improper storage arrangements
‣ Missing or incorrect documents
‣ Ignoring renewal deadlines
‣ Avoiding these mistakes saves time and money.
Starting or running a wholesale medicine business involves rules, documents, and inspections—and it’s normal to feel unsure about the process.If you want clear guidance, correct documentation, and support at every step, PSR Compliance is here to help.
We explain everything in simple words, handle the paperwork carefully, and stay with you until your drug license is approved.
📞 Call or WhatsApp: 7065883416Let’s make your drug license process smooth, stress-free, and fully compliant.
A competent person must be a Pharmacy graduate with at least 1 year of drug-dealing experience or an SSC/Matriculation pass with a minimum of 4 years of relevant experience.
The premises must have a minimum area of 15 sq. meters, adequate height, proper storage facilities, and refrigeration (AC or fridge) for temperature-sensitive drugs.
Documents include Form 19 application, ₹3,000 fee challan, affidavits, ownership or rent proof, site plan, identity/address proofs, and educational and experience certificates of the proprietor and pharmacist.
A Wholesale Drug License is typically issued within 15–30 working days and remains valid for 5 years, after which renewal is required.
No, retailers must obtain a separate Wholesale Drug License (WDL) to legally conduct wholesale drug sales.