Documents You Need to Register a Pharma Wholesale Business
Starting a pharmaceutical wholesale business in India can be a rewarding venture, but it comes with regulatory responsibilities. One of the most crucial steps in establishing such a business is obtaining a Wholesale Drug License. This license ensures that your business is legally authorized to distribute and sell drugs in bulk to retailers, hospitals, or other licensed entities. To obtain this license, a well-prepared documentation set is essential. Here’s a detailed look at the documents you’ll need to register a pharma wholesale business in India.
1. Covering Letter and Application Form
You must begin the application process with a formal covering letter addressed to the licensing authority. Along with this, the prescribed Form 19 must be duly filled and signed by the authorized person of the business.
2. Constitution of the Firm
Whether your business is a proprietorship, partnership, private limited company, or LLP, you'll need to submit proof of constitution. This includes:
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Partnership Deed (for partnership firms)
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Certificate of Incorporation (for companies)
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GST Registration Certificate
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PAN Card of the business
3. Premises Documents
You need a commercial premises from where the business will operate. The documents include:
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Ownership proof (like sale deed or electricity bill)
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Rent agreement (if rented)
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Blueprint/Layout of the premises
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Declaration of adequate storage facility, such as air conditioning and refrigeration, especially for temperature-sensitive drugs.
4. Pharmacist/Competent Person Details
It is mandatory to employ a Registered Pharmacist or a competent person who has the required experience (minimum 1 year in drug sales or a diploma in pharmacy). Documents required:
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Pharmacy Registration Certificate
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Appointment Letter
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Educational Certificates
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Experience Letter (if applicable)
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Affidavit for full-time employment
5. Director/Partner KYC Documents
All directors or partners of the business must submit identity and address proof:
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Aadhar Card / PAN Card
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Passport-size photographs
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Residential Address Proof
6. Affidavit and Declarations
You may also need to furnish various declarations and affidavits, such as:
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Declaration of non-conviction under the Drugs and Cosmetics Act
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Affidavit of ownership/control of the premises
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Declaration for the use of premises only for wholesale drug trade
7. Fee Receipt
The government licensing fee must be paid via a challan or through online payment, and its receipt must be submitted along with the application.
Get Expert Help from Agile Regulatory
Navigating through the wholesale drug license registration process can be complex and time-consuming. At Agile Regulatory, we simplify the entire journey for you—from documentation to final approval. With years of experience in pharmaceutical regulatory services, we ensure error-free application filing, timely updates, and end-to-end support. Whether you're starting a new wholesale pharma venture or expanding operations, our experts are here to help you stay fully compliant with India’s drug laws. Reach out to us today to get started