Procedure to Obtain Licence to Sell, Stock, Exhibit or Offer for Sale, or Distribute Drugs by Retail

Deepti Mudgal

Deepti Mudgal

Published on: Dec 31, 2025

Shreya Jain

Updated on: Dec 31, 2025

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A retail license is required for the retail sale of drugs. A retail sale means the sale of drugs or cosmetics for the consumption of the end consumer. Retailers can sell it to a dispensary, hospital, educational, medical, or research institute. Retailers engaged in pharmaceuticals, cosmetics, stand-alone pharmacists, ayurvedic shops, etc. need this license.

Applicable Provisions : Rule 59(2), 65, 67E of Drugs Rules, 1945

Who can apply?

Any applicant who satisfies the following conditions can apply :

1. Area of the outlet to verify the compliance with the statutory limits (Minimum 100 sq. feet for Retail) and (Minimum 150 sq. feet for both).
2. Capabilities to provide good storage conditions of the drugs stocked in the premises such as racks, refrigerator (for cold storage drugs) etc.
3. Premises should be RCC structure and located on ground floor for Retail shop.

Mandatory Documents

1. Form 19 A
2. Schedule C (Biological and Special Products), C1 (Other Special Products) and X
3. Declaration by the Proprietor / Partner / Director / Competent Persons / Registered Pharmacist with proof of residential address (Present and Permanent) for proof of residential address Aadhar Card, Passport, Driving License, Voter ID
4. Partnership deed in case of partnership firm / List of Directors downloaded from MCA website signed by Company Secretary / Managing Director (in case of company)
5. In case of company an Affidavit under Section 34 of Drug and Cosmetics Act, 1940 on INR 20/- stamp paper signed by one of the Directors of the company in prescribed proforma
6. Declaration by the Registered Pharmacist regarding acceptance of job on INR 20/- non-judicial stamp paper in prescribed proforma duly signed by Public Notary
7. Declaration by the Proprietor regarding full time engagement of Pharmacist on INR 20/- non-judicial stamp paper in prescribed proforma duly signed by Public Notary
8. Declaration by the Proprietor-cum-Pharmacist on INR 20/- non-judicial stamp paper in prescribed proforma duly signed by Public Notary. (If the Pharmacist himself is a proprietor)
9. Declaration by the Proprietor regarding non-conviction under Drugs & Cosmetics Act & Rules on INR 20/- non-judicial stamp paper in prescribed proforma duly signed by Public Notary
10. Declaration by the owner of the premises regarding No Objection for conducting the business of Retail drugs on INR 20/- non-judicial stamp paper in prescribed proforma duly signed by Public Notary
11. Self-attested copy of Registered Pharmacist certificate (renewal up to date) affixed with latest original photograph and signature of the candidate / original to be produced to the Drug Inspector at the time of inspection for endorsement
12. Self-attested copy of qualification certificate of the Registered Pharmacist
13. Plan of the proposed premises indicating the carpet area (specifying length and breadth in meters and area in sqm) with the signature of owner of the premises and the applicant (Pro / partner / Authorized signatory / Managing Director, etc.) in a legal-size paper
14. Declaration by owner of premises (Photograph of the building owner with self-attestation) in prescribed proforma. Self-attested photocopy of the document showing the proof of ownership of the premises to be licensed (Legal / Revenue records showing the present ownership)
15. Copy of the Rent / Lease deed in case of rental premises
16. Invoice of the newly purchased Refrigerator in the name of shop / proprietor
17. Sketch map showing the location of the premises

Process for Application

Applicant shall make application for the grant of a restricted license to sell, stock or exhibit or offer for sale, or distribute drugs by retail by dealers who do not engage the services of a registered pharmacist, other than those specified in Schedule C (Biological and Special Products), C1 (Other Special Products) and X in Form 19A accompanied by a fee of rupees five hundred (Rs. 500).

Process for Renewal

Applicant shall make an application for renewal of a restricted licence to sell, stock or exhibit or offer for sale, or distribute drugs by retail by dealers who do not engage the services of a registered pharmacist, after its expiry but within six (06) months of such expiry accompanied by an additional fee.

Validity of License

License issued shall remain valid, if licensee deposits a license retention fee before the expiry of a period of every succeeding five (05) years from the date of its issue, unless it is suspended or cancelled by the licensing authority.