DOCUMENTS YOU NEED TO REGISTER A PHARMA WHOLESALE BUSINESS

Documents You Need to Register a Pharma Wholesale Business

Documents You Need to Register a Pharma Wholesale Business

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Starting a pharmaceutical wholesale business in India requires not just an understanding of the market but also compliance with various regulatory requirements. One of the most crucial steps is obtaining a wholesale drug license under the Drugs and Cosmetics Act, 1940. Whether you’re planning to distribute allopathic, ayurvedic, or homeopathic medicines, registering your business legally ensures smooth operations and builds trust with clients and regulatory authorities. Below is a detailed guide on the key documents required to register a pharma wholesale business.

1. Application Form

The first step is to fill and submit Form 19, which is the prescribed form under the Drugs and Cosmetics Rules for applying for a wholesale drug license. This form needs to be submitted to the State Drug Licensing Authority (SLA) in your region.

2. Covering Letter

A formal covering letter addressed to the Drug Licensing Authority should accompany the application, detailing the nature of the application and the list of enclosures.

3. Business Constitution Proof

Submit legal documents depending on the type of business:

  • Proprietorship: Aadhaar, PAN of proprietor

  • Partnership: Partnership deed

  • Company: Certificate of incorporation, MOA, AOA
    This establishes the legal identity of your business.

4. Premises Proof

You must provide proof of premises where the wholesale business will operate. This could include:

  • Rent agreement or ownership deed

  • Property tax receipt

  • Copy of site plan/layout

The premises must meet minimum space requirements (usually 10 square meters) and should comply with storage conditions like temperature control and cleanliness.

5. Pharmacist/Competent Person Details

Every pharma wholesale business must have a qualified person who will supervise the sale and distribution of drugs. Submit:

  • Qualification certificate (D. Pharma or B. Pharma)

  • Registration with the State Pharmacy Council

  • Appointment letter and bio-data

  • Experience certificate (if required)

6. Photographs and Identity Proofs

  • copyright-size photographs of proprietor/partners/directors and pharmacist

  • PAN Card, Aadhaar Card, and address proof for all key persons

7. Affidavit & Declaration

An affidavit on non-judicial stamp paper declaring that the business will comply with all relevant laws and regulations, including proper storage and sale practices, is mandatory.

8. Electricity Bill or Water Bill

This is generally required to verify the existence and operation of the business premises.

9. Cold Storage Equipment Details (If Applicable)

If the business deals in temperature-sensitive products, details of refrigerators or cold chain logistics must be submitted.

How Agile Regulatory Can Help

Navigating the registration process for a pharma wholesale business can be overwhelming, especially with evolving compliance standards. Agile Regulatory offers end-to-end support in obtaining your wholesale drug license—right from preparing documentation to coordinating with the Drug Department for inspections. With a team of licensing experts and years of experience in the pharma regulatory space, Agile Regulatory ensures that your application is accurate, complete, and fast-tracked. Contact us today to get started and make your pharma venture legally compliant from day one

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