Retail Drug License - Form 20 and 21

A Retail Drug Licence is an official licence issued by the Drug Control Authority that permits a business to sell prescription and over-the-counter (OTC) pharmaceuticals. The Permiso team will provide comprehensive assistance, starting from the project’s paperwork through its successful completion.

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A retail drug license, also known as a pharmacy license or a drugstore license, is an official license or permit granted by the State Drug Control Authority that allows a business to sell prescription and over-the-counter (OTC) pharmaceuticals, as well as other pharmaceutical items to the general public. A pharmacist or a medical store typically obtains a retail drug license since they offer medicine directly to end customers.

A Retail Drug License is also a legal requirement for any person or business involved in the Sale, Stock, Exhibit or Distribution of pharmaceutical products, including drugs and medicines. The Retail Drug License also known as Form 20 and Form 21 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 20C.

To obtain a retail 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 retail drug license in the company’s name. It is a government license that is required when purchasing and selling allopathy, homoeopathy, schedule X, and restricted 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 Retail Drug License in India:

  • check icon 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.
  • check icon Documentation: The applicant must produce documents and upload them online accordingly. All documents must meet the rules of The Drugs And Cosmetic Act, 1940
  • check icon 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.
  • check icon 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.
  • check icon 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 Retail Drug License:

  • check icon Area: The minimum area required is 10 Sq. Mtr. If combined with wholesale then 15 Sq. Mtr. The premise should have a separate and exclusive entrance
  • check icon Registered Pharmacist Person: A Registered Pharmacist is compulsory for a Retail Store. His PPP Card, Last year's mark sheet, Pharmacy Registration Certificate, Appointment letter, and ID proof are also required.
  • check icon Storage Facility: A refrigerator is compulsory for a retail drug store. Cupboards, racks, and other furniture are necessary for drug storage.
  • check icon 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
  • check icon Details of proprietor/partner/ Director/Trustee etc.: Details of proprietor/director/trustee etc. mentioning their Name, Qualification, DOB, Phone Number, and Email id.
  • check icon ID Proof: Pan card and Aadhar card of proprietor/partners/directors.
  • check icon Agreement: Sale Agreement or Registered Rent Agreement
  • check icon Premises ownership documents: Electricity Bill and Property tax Receipt
  • check icon Plan Layout: Plan layout drawn as per FDA rules

A retail 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 retail 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 retail drug stores to avoid malpractice by implementing the Food and Drug Act.

Obtaining a Retail 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 Retail Drug License / Renewal of Retail 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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Retail Drug License Registration Procedure

Registration Procedure