What Is a Wholesale Drug License?
A wholesale drug license allows businesses to buy pharmaceutical products in bulk from manufacturers and sell to retail pharmacies, hospitals, and other licensed businesses — without selling directly to patients. It is issued under Form 20B (for Schedule G, H, H1 drugs) and Form 21B (for Schedule C, C1 drugs).
Eligibility for Wholesale Drug License
- Entity Type: Any individual, proprietorship, firm, LLP, or private limited company can apply.
- Premises: Minimum 10 sq metres in most states (some states require more — Maharashtra typically requires 15 sq metres).
- Competent Person: Must have a B.Sc. degree (Biology/Chemistry) OR a degree/diploma in pharmacy, medicine, or related science with experience.
- Storage: Adequate clean shelving and a dedicated refrigerator for Schedule C/C1 heat-sensitive drugs.
Complete Document Checklist
- Application form (Form 19/19A as per state portal)
- Identity and address proof of owners/directors (PAN, Aadhaar)
- Business constitution documents (Partnership deed / MOA-AOA / GST registration)
- Premises ownership deed or registered lease agreement (minimum 3 years)
- Site plan of premises (drawn to scale and signed by authorized person)
- Competent Person appointment letter, educational proofs, and affidavit
- Drug list proposed to be stocked and distributed
- Affidavit and undertaking in state-prescribed format
Step-by-Step Application Process
From start to finish, the process requires thorough preparation: conducting a premises readiness check (area, storage, refrigeration), verifying Competent Person documentation, completing state portal forms, paying government challan fees, and handling physical inspection by State FDA officers until Form 20B/21B issuance.
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