Wholesale Drug License | Form 20B - 21B
A Wholesale Drug License in India is a legal requirement for entities involved in the wholesale distribution of drugs and medicines. The Permiso team will provide comprehensive assistance, starting from the project’s paperwork through its successful completion.
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A Wholesale Drug License is a legal requirement for any person or business involved in the Sale, Stock, Exhibit or Distribution of pharmaceutical products, including drugs and medicines. The Wholesale Drug License also known as Form 20B and Form 21B is provided by the respective State Drug Control Authority viz. Food and Drug Administration. The firm can additionally apply license for the sale of Homeopathic Medicine which is also known as Form 20D.
To obtain a wholesale drug license, an individual must have a firm, such as a sole proprietorship, partnership, LLP, private limited company, or public limited company. Once the business is constituted, the individual can apply for a wholesale drug license in the company’s name. The wholesale license is a government license that is required when purchasing and selling allopathy, homoeopathy, schedule X, and restricted pharmaceuticals. The wholesale license is also an important document required by customs when importing or exporting pharmaceuticals. The license is issued to business owners who comply with the requirements of The Drugs And Cosmetic Act, 1940, and the Rules, 1945.
Procedure for Obtaining a Wholesale Drug License in India:
- Obtaining Login credentials: To obtain a Drug License, a person must first register in an online portal and create a Login ID and Password, which will be sent to them through SMS on the mobile phone.
- Documentation: The applicant must produce documents and upload them online accordingly. All documents must meet the rules of The Drugs And Cosmetic Act, 1940
- Fees: The applicant must pay the required fees online by the requirements as per The Drugs And Cosmetics Act, 1940, The Drugs And Cosmetics Rules, 1945 or The Medical Devices Rules, 2017.
- Inspection: Following the submission of documentation, the Drug Inspector visits the premises where the drug license is to be obtained to authenticate the location and verify the documents.
- Issue of Drug License: Post Inspection by the Drug Inspector, the licensing authority verifies the documents and inspection report submitted by the Drug Inspector and will grant or reject the license
Pre - Requisites / Documents required for Wholesale Drug License:
- Area: The minimum area required is 10 Sq. Mtr. If combined with Retail then 15 Sq. Mtr. The premise should have a separate and exclusive entrance
- Qualified Person: Services of a Competent Person (Preferably a graduate with more than 2 years of experience in drug procurement and selling) or a Registered Pharmacist. His Appointment letter, ID proof, Experience Letter and final year mark sheet are also required.
- Storage Facility: A refrigerator is only essential if the company sells products that require cold storage. Cupboards, racks, and other furniture are necessary for drug storage.
- Firms Constitution Documents: Photo ID / Partnership Deed & ROF registration receipt / Certificate of Incorporation / Trust Registration / HUF Deed / Society Registration depending on the type of constitution
- Details of proprietor/partner/ Director/Trustee etc.: Details of proprietor/director/trustee etc. mentioning their Name, Qualification, DOB, Phone number, and Email ID.
- ID Proof: Pan card and Aadhar card of proprietor/partners/directors
- Agreement: Sale Agreement or Registered Rent Agreement
- Premises ownership documents: Electricity Bill and Property tax Receipt
- Plan Layout: Plan layout drawn as per FDA rules
A wholesale drug license is issued by the State Drug Controller. As a result, if you wish to undertake pharmaceutical business in several states, you’ll need a separate license for each one. Once the wholesale license is established the company needs to follow the rules and regulations as mentioned in The Drugs and Cosmetics, Act. The State FDA also performs frequent inspections of wholesale premises to avoid malpractice by implementing the Food and Drug Act
Obtaining a Wholesale Drug License can be time-consuming and the licensing procedure consists of steps that require a clear and thoughtful method. Any blunder during the registration procedure may result in the applicant being denied the license. We reduce the likelihood of application rejection and ensure that licenses are issued quickly and without complications
You can apply for a Fresh Wholesale Drug License / Renewal of Wholesale Drug License / Change in Constitution / Change in Premises / Additional License / Name Addition as a Technical Person / Duplicate License or Surrender of License through M/s. The Permiso and obtain the application reference number within 2 days. If you have any issues or facing any difficulty with the application, you can call +91 8104691667 or email us at info@thepermiso.com
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Wholesale Drug License Registration Procedure
