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Documents Required for Wholesale Drug License in India (2026): Complete Step-by-Step Guide

Legal Disclaimer: This article provides general informational guidance about wholesale drug license documentation in India. Regulations may vary by state. Always consult a qualified regulatory expert, legal advisor, or your State Drug Control Department before submitting a license application.

Planning to start a pharmaceutical wholesale business in India? Whether you want to supply medicines to retail pharmacies, hospitals, clinics, or government institutions – you cannot legally operate without a Wholesale Drug License. But here's the challenge: The documentation requirements can be overwhelming, and even minor errors can lead to application rejection or delays. Many first-time applicants struggle with understanding exactly which documents are required for wholesale drug license approval. In this comprehensive guide, we'll provide the complete checklist of documents required for wholesale drug license in India, explain each requirement in detail, and share expert tips to get your application approved quickly.

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What is a Wholesale Drug License?

A Wholesale Drug License is an official authorization issued by the State Drug Control Department that permits a business to purchase, stock, and sell pharmaceutical products in bulk quantities to other licensed entities.

Key Points About Wholesale Drug License

Governing Law	Drugs and Cosmetics Act, 1940 & Rules, 1945
Issuing Authority	State Drug Control Department / State FDA
License Forms	Form 20B (Non-Schedule drugs) & Form 21B (Schedule C, C1, X drugs)
Application Form	Form 19
Who Can Sell To	Retail pharmacies, hospitals, clinics, other wholesalers, government institutions
Direct Sale to Public?	NO – Wholesale license does NOT permit direct sales to individual patients/consumers
Validity Period	Typically 5 years (varies by state)

What Can You Sell with a Wholesale Drug License?

✅ Allopathic medicines (tablets, capsules, syrups, injections)
✅ Surgical items and medical devices (with appropriate license)
✅ OTC (Over-the-Counter) medicines
✅ Schedule H and H1 drugs (prescription medicines)
✅ Vaccines and biologicals (with cold chain facilities)
✅ Schedule C, C1 drugs (sera, vaccines, etc. – requires Form 21B)
✅ Schedule X drugs (controlled substances – requires additional permissions)

💡 Important: To sell Schedule C, C1, and X drugs, you need Form 21B license in addition to Form 20B. Schedule X drugs (narcotics, psychotropics) require additional permissions from the Narcotics Control Bureau.

Why is a Wholesale Drug License Mandatory?

Operating a pharmaceutical wholesale business without a valid drug license is illegal in India and carries serious consequences:

Legal Requirements

Consequence of Operating Without License	Penalty Under Drugs & Cosmetics Act
First Offense	Imprisonment up to 3 years + Fine up to ₹5,000 or both
Second Offense	Imprisonment up to 5 years + Fine up to ₹10,000
Selling Spurious/Adulterated Drugs	Imprisonment up to 10 years to life + Fine up to ₹10 lakh or 3x value of drugs
Business Closure	Immediate sealing of premises and seizure of stock

Business Benefits of Having a Wholesale Drug License

✅ Legal Protection: Operate your business without fear of legal action
✅ Business Credibility: Gain trust from manufacturers, retailers, and hospitals
✅ GST Compliance: Required for proper tax filing and input credit
✅ Bank Financing: Essential for business loans and credit facilities
✅ Government Tenders: Mandatory for supplying to government hospitals and institutions
✅ Quality Assurance: Ensures proper storage and handling of medicines
✅ Manufacturer Partnerships: Pharma companies only supply to licensed distributors

Types of Wholesale Drug License (Form 20B & 21B)

There are two main types of wholesale drug licenses in India, based on the categories of drugs you want to sell:

License Type	Form Number	Drugs Covered	Who Needs It
Wholesale Drug License (General)	Form 20B	• All drugs EXCEPT Schedule C, C1, and X • General allopathic medicines • OTC products • Schedule H & H1 drugs	All pharmaceutical wholesalers
Wholesale Drug License (Schedule C, C1, X)	Form 21B	• Schedule C drugs (biological/special storage) • Schedule C1 (sera, vaccines, toxins) • Schedule X (controlled substances – additional permits needed)	Wholesalers dealing with vaccines, sera, biologicals, controlled substances

✅ Recommendation: Most pharmaceutical wholesalers apply for both Form 20B and Form 21B together to have flexibility in the products they can distribute. You can apply for both simultaneously.

Eligibility Criteria: Who Can Apply for Wholesale Drug License?

Before preparing the documents required for wholesale drug license, ensure you meet the eligibility criteria:

Business Entity Eligibility

Business Type	Eligible?	Documents Required
Sole Proprietorship	✅ Yes	Proprietor's ID proof, GST registration
Partnership Firm	✅ Yes	Partnership deed, all partners' ID proof
Limited Liability Partnership (LLP)	✅ Yes	LLP agreement, MCA registration certificate
Private Limited Company	✅ Yes	MOA, AOA, Board resolution, Director ID proofs
Public Limited Company	✅ Yes	MOA, AOA, Board resolution, Director ID proofs
Individual (without business entity)	❌ No	Must register as at least a proprietorship

Technical Staff Requirement

The most important eligibility requirement is having a Competent Person to supervise wholesale drug operations:

Competent Person Qualification	Acceptable?	Notes
Registered Pharmacist (B.Pharm)	✅ Preferred	Must be registered with State Pharmacy Council
Diploma in Pharmacy (D.Pharm)	✅ Yes	Must be registered with State Pharmacy Council
Graduate with 1+ year experience	⚠️ Some States	Rules vary by state; check with local Drug Controller
Matric + 4 years experience in drug dealing	⚠️ Some States	Older provision; may not be accepted in all states

⚠️ Important: Most states now prefer or mandate a registered pharmacist for wholesale drug license. We strongly recommend hiring a B.Pharm or D.Pharm holder registered with the State Pharmacy Council to avoid application rejection.

Premises Requirements

✅ Minimum area as specified by state (usually 10-15 sq. meters minimum)
✅ Proper ventilation and lighting
✅ Clean, hygienic conditions
✅ Adequate storage racks and shelving
✅ Refrigerator/cold storage if dealing with cold chain products
✅ Not located in residential area (depends on state rules)
✅ Accessible for inspection

Complete Documents Required for Wholesale Drug License (Master Checklist)

Here is the comprehensive list of documents required for wholesale drug license in India. This checklist covers both Form 20B and Form 21B applications:

📋 Documents Required for Wholesale Drug License – Complete Checklist

Sr. No	Document	Details	Format
1	Application Form (Form 19)	Prescribed application form for drug license; must be filled completely and signed by applicant	Original + 2 copies
2	Covering Letter	Formal letter addressed to Drug Controller stating business intent, declaration of compliance, and requesting license issuance	Original on letterhead
3	Treasury Challan / Fee Receipt	Proof of payment of prescribed government fees (online or bank challan)	Original
4	Applicant's Identity Proof	Aadhaar Card / Voter ID / Passport / Driving License of proprietor or all partners/directors	Self-attested copies
5	Applicant's Address Proof	Aadhaar Card / Voter ID / Passport / Utility bill showing residential address	Self-attested copies
6	PAN Card	PAN of individual (proprietorship) or firm/company PAN	Self-attested copy
7	Passport Size Photographs	Recent photographs of applicant and competent person	4-6 photos each
📁 BUSINESS CONSTITUTION DOCUMENTS
8	Partnership Deed	For partnership firms – registered partnership deed	Notarized copy
9	LLP Agreement	For LLPs – LLP agreement and incorporation certificate	Certified copy
10	MOA & AOA	For companies – Memorandum and Articles of Association	Certified copy
11	Certificate of Incorporation	For companies and LLPs – MCA issued certificate	Certified copy
12	Board Resolution	For companies – resolution authorizing application and nominating authorized signatory	Original on letterhead
13	GST Registration Certificate	GST registration for the business	Self-attested copy
🏢 PREMISES DOCUMENTS
14	Ownership Proof	Sale deed / Registry / Property ownership documents (if owned premises)	Certified copy
15	Rent Agreement	Registered/notarized rent agreement (if rented premises)	Original or certified copy
16	Landlord NOC	No Objection Certificate from landlord for running drug business (if rented)	Original on stamp paper
17	Electricity Bill	Recent electricity bill for the premises (last 3 months)	Copy
18	Property Tax Receipt	Latest property tax paid receipt	Copy
19	Site Plan / Layout Drawing	Detailed layout plan showing office area, storage zone, racks, refrigerator placement, etc.	Architect certified or self-drawn clear plan
20	Photographs of Premises	Clear photographs showing exterior, interior, storage area, refrigerator (if applicable)	Color prints (4-6 photos)
👨‍🔬 TECHNICAL STAFF / COMPETENT PERSON DOCUMENTS
21	Educational Qualification Certificate	B.Pharm / D.Pharm degree or diploma certificate	Attested copy
22	Pharmacy Council Registration	Valid registration certificate from State Pharmacy Council	Attested copy
23	Appointment Letter	Letter of appointment/employment as competent person	Original on company letterhead
24	Undertaking/Consent Letter	Written consent from pharmacist to act as competent person for this establishment	Original
25	Bio-data / Resume	Detailed resume of the competent person	Original
26	Experience Certificate	Work experience certificate from previous employer (if applicable)	Original or attested copy
27	Competent Person's ID Proof	Aadhaar Card / PAN Card / Voter ID	Self-attested copy
28	Competent Person's Photographs	Passport size photographs	4-6 photos
📝 DECLARATIONS & ADDITIONAL DOCUMENTS
29	Affidavit / Declaration	Notarized affidavit declaring no conviction under Drugs & Cosmetics Act and commitment to comply with rules	Original on stamp paper
30	List of Proposed Drugs	List of categories/types of drugs proposed to be stocked and sold	On letterhead
31	Equipment List	List of equipment including refrigerator, AC, racks, computer systems	On letterhead
32	Bank Account Details	Bank account statement or cancelled cheque in firm's name	Copy
33	Fire Safety NOC	Certificate from Fire Department (required in some states)	Original or copy
34	Municipal / Trade License	Local body trade license if applicable	Copy

💡 Pro Tip: Always prepare 3 sets of all documents – one for submission, one for the inspector, and one for your records. Keep all originals safe for verification during inspection.

📥 Download: Documents Required for Wholesale Drug License Checklist

📋 Want a Printable Checklist? DOWNLOAD FREE CHECKLIST (PDF) →

Premises & Infrastructure Requirements

The premises where you'll operate your wholesale drug business must meet specific standards set by the Drug Control Department:

Minimum Space Requirements

License Type	Minimum Area	Notes
Wholesale Drug License (Form 20B)	10-15 sq. meters (varies by state)	Covered area excluding toilet
With Cold Storage (Form 21B)	15-25 sq. meters (varies by state)	Additional space for refrigeration units

Infrastructure Checklist

Requirement	Details	Inspector Checks
Storage Racks/Shelving	Proper racks for organized storage of medicines	Adequate capacity, clean, organized
Refrigerator/Cold Room	For medicines requiring 2-8°C storage (if dealing with such products)	Working condition, temperature records
Temperature Control	AC or proper ventilation to maintain storage conditions	Room temperature below 25-30°C
Lighting	Adequate lighting for inspection and handling	No dark corners, proper illumination
Ventilation	Proper airflow to prevent moisture buildup	Windows, exhaust fans, or AC
Cleanliness	Clean floors, walls, and surfaces	No dust, pest-free, hygienic conditions
Security	Lockable premises for Schedule H/X drugs	Proper locks, restricted access
Record Keeping Area	Desk/table for maintaining registers and records	Purchase/sale registers, inspection books
Fire Safety	Fire extinguisher (required in most states)	Valid, accessible fire equipment

Site Plan Requirements

Your site plan should clearly show:

✅ Total area dimensions
✅ Office/administrative area
✅ Drug storage area
✅ Location of storage racks
✅ Refrigerator/cold storage location
✅ Entry/exit points
✅ Toilet location (if within premises)
✅ Fire extinguisher placement

Technical Staff & Competent Person Documents

The Competent Person is one of the most critical requirements for wholesale drug license. Here's a detailed breakdown:

Who is a Competent Person?

A Competent Person is a qualified individual who supervises the drug wholesale operations, ensures compliance with drug laws, and is responsible for proper storage and handling of medicines.

Competent Person Qualifications

Qualification	Registration Required	Acceptance
B.Pharm (Bachelor of Pharmacy)	State Pharmacy Council Registration	✅ Universally Accepted
D.Pharm (Diploma in Pharmacy)	State Pharmacy Council Registration	✅ Universally Accepted
M.Pharm (Master of Pharmacy)	State Pharmacy Council Registration	✅ Accepted (overqualified for role)
Pharm.D (Doctor of Pharmacy)	State Pharmacy Council Registration	✅ Accepted
Graduate + 1 year experience	No formal registration	⚠️ State-specific; verify with Drug Controller

Competent Person Documents Checklist

Document	Purpose	Format
Degree/Diploma Certificate	Proof of pharmacy qualification	Attested photocopy
State Pharmacy Council Registration	Proof of valid registration as pharmacist	Attested photocopy (must be current/renewed)
Appointment Letter	Formal employment as competent person	Original on firm's letterhead
Undertaking/Consent Letter	Declaration to act as competent person	Original signed by pharmacist
Resume/Bio-data	Professional background information	Original
Experience Certificate	Previous work experience proof (if any)	Original or attested copy
ID Proof (Aadhaar/PAN)	Identity verification	Self-attested copy
Photographs	For license records	Passport size (4-6 nos.)

💡 Important: The Competent Person must be physically present at the premises during working hours. If the same pharmacist is registered at multiple establishments, it may lead to license rejection or cancellation.

Step-by-Step Application Process

Here's how to apply for a Wholesale Drug License in India:

Step 1: Gather All Documents

Collect all documents required for wholesale drug license as per the checklist above. Ensure:

✅ All documents are complete and up-to-date
✅ Photocopies are clear and readable
✅ Documents requiring attestation are properly attested
✅ Affidavits are notarized on proper stamp paper

Step 2: Prepare the Premises

Set up your wholesale premises with:

✅ Proper storage infrastructure
✅ Refrigerator (if required)
✅ Clean, organized layout
✅ Signage and display board

Step 3: Register on State Drug Portal

Most states now have online application systems:

State	Portal/Website
Maharashtra	fdamfg.maharashtra.gov.in
Gujarat	fdca.gujarat.gov.in
Delhi	gnctd.gov.in (Health Department)
Karnataka	drugscontrol.karnataka.gov.in
Tamil Nadu	tnhealth.tn.gov.in
Other States	Check respective State Drug Control Department website

Step 4: Fill Application Form (Form 19)

Complete Form 19 with:

✅ Accurate business details
✅ Premises information
✅ Competent person details
✅ List of drug categories to be dealt with
✅ Declaration of compliance

Step 5: Upload/Submit Documents

Upload all documents in prescribed format (PDF, usually under 2MB per file) or submit physical copies as required.

Step 6: Pay Application Fees

Pay the prescribed government fees through:

✅ Online payment (most states)
✅ Treasury challan
✅ Demand draft (some states)

Step 7: Application Review

The Drug Control Department reviews your application and documents. They may:

Request additional documents
Ask for clarifications
Schedule inspection

Step 8: Premises Inspection

A Drug Inspector will visit your premises to verify:

✅ Premises matches the submitted layout
✅ Infrastructure is adequate
✅ Competent person is present and qualified
✅ Storage conditions are appropriate
✅ All documents are genuine

Step 9: License Issuance

Upon successful verification, the Drug Controller issues:

✅ Form 20B – For general drugs
✅ Form 21B – For Schedule C, C1, X drugs (if applied)

Application Timeline

Stage	Typical Duration
Document Preparation	1-2 weeks
Application Submission	1 day
Initial Review	7-15 days
Inspection Scheduling	15-30 days
License Issuance	7-15 days after inspection
Total Time	30-60 days (if no deficiencies)

License Fees & Validity

Wholesale Drug License Fees

License Type	New License Fee	Renewal Fee	Validity
Form 20B (Wholesale)	₹3,000 - ₹6,000	₹2,500 - ₹5,000	5 years (varies by state)
Form 21B (Schedule C, C1)	₹3,000 - ₹6,000	₹2,500 - ₹5,000	5 years (varies by state)
Both (20B + 21B)	₹6,000 - ₹12,000	₹5,000 - ₹10,000	5 years
Late Renewal Penalty	Additional fees + possible show-cause notice

Note: Fees vary significantly by state. Check with your State Drug Control Department for exact amounts.

Common Mistakes That Cause Application Rejection

Avoid these frequent errors that delay or reject wholesale drug license applications:

Common Mistake	Why It's a Problem	How to Avoid
❌ Incomplete Form 19	Missing fields or incorrect information	Double-check every field before submission
❌ Missing Signatures	Unsigned forms are invalid	Ensure applicant signs all required places
❌ Unattested Documents	Photocopies without attestation are not accepted	Self-attest or notarize as required
❌ Expired Pharmacy Registration	Competent person must have valid registration	Renew pharmacy council registration before applying
❌ Incorrect Site Plan	Layout doesn't match actual premises	Prepare accurate, to-scale layout plan
❌ Unregistered Rent Agreement	Some states require registered agreements	Register rent agreement with local authority
❌ Missing Landlord NOC	Landlord permission is mandatory for rented premises	Obtain NOC on proper stamp paper
❌ Pharmacist at Multiple Locations	Same pharmacist cannot be registered at multiple establishments	Hire a dedicated pharmacist for your premises
❌ Incomplete Affidavit	Missing declarations or wrong format	Use prescribed format on proper stamp paper
❌ Poor Premises Condition	Fails inspection due to hygiene/infrastructure issues	Set up premises completely before applying

✅ Pro Tip: Have your application reviewed by a regulatory consultant or experienced pharmacist before submission. A small investment in expert review can save weeks of rejection-related delays.

License Renewal: Documents Required

Wholesale drug licenses must be renewed before expiry. Here are the documents required for wholesale drug license renewal:

Renewal Documents Checklist

#	Document	Notes
1	Renewal Application Form	Form 19 marked for renewal
2	Existing License Copy	Current Form 20B/21B
3	Treasury Challan / Fee Payment	Renewal fee payment proof
4	Updated Rent Agreement	If previous agreement expired
5	Updated Pharmacy Council Registration	Must be valid/renewed
6	Competent Person Documents	If changed since original application
7	Affidavit/Declaration	Confirming continued compliance
8	No Conviction Declaration	Declaring no drug law violations during license period

⚠️ Important: Apply for renewal at least 3 months before expiry. Operating with an expired license is illegal and can result in penalties and business closure.

Frequently Asked Questions

1. What documents are required for wholesale drug license in India?

The main documents required for wholesale drug license include: Application Form 19, identity and address proofs, business constitution documents (partnership deed/MOA-AOA), premises documents (ownership/rent agreement, layout plan), competent person's pharmacy qualification and registration, GST certificate, affidavit, photographs, and fee payment receipt. The complete checklist contains 30+ documents depending on your business type.

2. Is a pharmacist mandatory for wholesale drug license?

Yes, a registered pharmacist (B.Pharm or D.Pharm) with valid State Pharmacy Council registration is mandatory in most states. This person is called the "Competent Person" who supervises drug wholesale operations. Some states may allow graduates with relevant experience, but a registered pharmacist is strongly recommended.

3. What is the cost of wholesale drug license in India?

Government fees for wholesale drug license range from ₹3,000 to ₹12,000 depending on the state and license type (Form 20B and/or 21B). Additional costs include documentation, premises setup, pharmacist salary, and consultant fees if you take professional help.

4. How long does it take to get a wholesale drug license?

Typically, it takes 30-60 days from application submission to license issuance, provided all documents are complete and there are no deficiencies. Delays can occur due to incomplete documents, inspection scheduling, or high application volumes.

5. Can I operate a wholesale drug business without a license?

No. Operating without a valid wholesale drug license is illegal under the Drugs and Cosmetics Act, 1940. Penalties include imprisonment up to 3-5 years and fines. Unlicensed premises can be sealed and stock seized.

6. What is the difference between Form 20B and Form 21B?

Form 20B is for wholesale dealing in general drugs (excluding Schedule C, C1, and X). Form 21B is required additionally for dealing in Schedule C drugs (biologicals), C1 drugs (sera, vaccines, toxins), and Schedule X (controlled substances). Most wholesalers apply for both.

7. What are the premises requirements for wholesale drug license?

Premises must have minimum 10-15 sq. meters covered area (varies by state), proper storage racks, adequate ventilation and lighting, refrigerator for cold chain products, clean and hygienic conditions, and be accessible for inspection. A detailed layout plan must be submitted with the application.

8. Can I apply for wholesale drug license online?

Yes, most states now have online application portals. You can register on your State Drug Control Department website, fill Form 19 online, upload documents, and pay fees electronically. Physical submission may still be required in some states.

9. What is the validity of a wholesale drug license?

Wholesale drug licenses are typically valid for 5 years (may vary by state). Renewal must be applied for before expiry to continue operations legally. Late renewal attracts penalties and may require fresh application.

10. Can the same pharmacist work at multiple wholesale establishments?

No. A pharmacist can only be registered as a Competent Person at one establishment at a time. If an inspector finds the same pharmacist registered at multiple locations, licenses can be cancelled. Each wholesale business needs its own dedicated pharmacist.

Why PowerNosh.com Advocates Proper Licensing

PowerNosh strongly recommends obtaining proper licensing before engaging in any pharmaceutical trading or distribution activity:

✅ Legal Protection: Protects your business from legal action and penalties
✅ Business Credibility: Builds trust with manufacturers, retailers, and healthcare institutions
✅ Quality Assurance: Ensures proper storage and handling of medicines
✅ GST Compliance: Required for proper tax filing and input credit claims
✅ Business Growth: Essential for partnerships with pharma companies and government tenders

🏪 Need Help with Wholesale Drug License Documentation? PowerNosh offers expert regulatory guidance for drug license applications, document preparation, and compliance support. GET LICENSE ASSISTANCE → 📞 Call: +91-8003467285 | 💬 WhatsApp: +91-8003467285 ✅ Document Review | ✅ Application Support | ✅ Inspection Guidance | ✅ Faster Approval

Conclusion

A Wholesale Drug License is the foundation of any legal pharmaceutical distribution business in India. Understanding the complete list of documents required for wholesale drug license and preparing them correctly from the start ensures smooth approval and avoids costly delays. Key Takeaways:

📋 Prepare all 30+ documents as per the checklist before applying
👨‍🔬 Hire a registered pharmacist as your Competent Person
🏢 Set up premises to meet all infrastructure requirements
📝 Fill Form 19 accurately and completely
✅ Double-check all documents to avoid common rejection mistakes
⏰ Apply well in advance and allow 30-60 days for processing
🔄 Plan for renewal 3 months before license expiry

For expert help with license preparation, document review, or application support, explore the regulatory services offered by PowerNosh.com.

Contact PowerNosh for License Assistance

🌐 Website: www.powernosh.com
📧 Email: care@powernosh.com
📞 Phone: +91-8003467285
💬 WhatsApp: +91-8003467285
🕐 Working Hours: Monday to Saturday, 9 AM – 6 PM

📝 Disclaimer: This article provides general informational guidance about wholesale drug license documentation in India. Regulations may vary by state and are subject to change. Always consult the official State Drug Control Department website, a qualified regulatory consultant, or legal advisor before submitting your license application. PowerNosh.com is not responsible for any application outcomes based on this information.

References

Drugs and Cosmetics Act, 1940
Drugs and Cosmetics Rules, 1945
Central Drugs Standard Control Organization (CDSCO) – cdsco.gov.in
State Drug Control Department Websites
Pharmacy Council of India – pci.nic.in

Documents Required for Wholesale Drug License in India (2026)