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Drug Retail License

We specialize in Drug Retail License Registration services to help your retail pharmacy or medical store meet compliance requirements and contribute to sustainable growth. Our services include the following:

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Overview

Drug Retail License in India

A Drug Retail License is a mandatory regulatory approval issued by the State Drug Licensing Authority that allows an individual or business to operate a retail pharmacy, medical store, or drug outlet in India. This license is governed by the Drugs and Cosmetics Act, 1940 and Rules, 1945, and is essential for selling prescription drugs, over-the-counter medicines, and pharmaceutical products to the public.

Operating a pharmacy without a valid drug retail license is a punishable offense under the law. Whether you are opening a new medical store in your locality or expanding your pharmacy chain, obtaining a drug retail license is the first and most crucial step toward running a compliant and trustworthy business.

Drug Retail License Services
Types of Drug License

Types of Drug Retail License in India

Depending on the nature and scale of your pharmacy business, different types of drug retail licenses are available.

Retail Drug License (Form 20/21)

Issued for retail sale of drugs and medicines to the general public. Required for medical stores, pharmacies, and drug outlets.

Wholesale Drug License (Form 20-B/21-B)

Granted for wholesale distribution of drugs to retailers, hospitals, and other institutions. Requires larger premises and storage facilities.

Ayurvedic / Unani Retail License

Issued for retail sale of Ayurvedic, Siddha, Unani, and herbal medicines and formulations.

Cosmetic Retail License

Required for retail sale of cosmetic products along with drugs and medicines.

Who Needs This Service

Is Drug Retail License the right fit for your business?

A drug retail license is required for any individual or business operating a retail pharmacy, medical store, or drug outlet in India.

  • Retail pharmacy owners
  • Medical store operators
  • Hospital pharmacies
  • Drug distributors and wholesalers
  • Ayurvedic and Unani medicine retailers
  • Cosmetic and beauty product retailers
Eligibility Requirements

Who can apply for Drug Retail License?

To be eligible for a drug retail license, the applicant must meet the following criteria:

  • Minimum Age: Applicant must be at least 18 years of age
  • Qualified Pharmacist: Must have a qualified registered pharmacist on staff (B.Pharm or D.Pharm with valid registration)
  • Proper Premises: Must have adequate premises with proper storage facilities, including refrigeration
  • Compliance: Must comply with Drugs and Cosmetics Act, 1940 and Rules, 1945
Documents Required

Documents Required for Drug Retail License

The following documents are required for a drug retail license application:

Application Documents
  • Application form (Form 19/19-A)
  • Affidavit attested by Public Notary
  • Address verification of applicant
  • Two photos of proprietor/partners
Pharmacist Documents
  • Pharmacist affidavit
  • Educational certificates (B.Pharm/D.Pharm)
  • Pharmacy Council registration certificate
  • Appointment and joining letters
Premises Documents
  • Floor plan of premises (3 copies)
  • Ownership or rental proof
  • Refrigerator purchase receipt
  • Site photographs
Step-by-Step Procedure

Process of Drug Retail License

The following is a concise description of the procedure for obtaining a drug retail license.

01
1–2 working days

Connect with First Auditor Team

Get in touch with our experts to discuss your pharmacy business requirements and location.

02
2–3 working days

Document Collection & Verification

Submit all necessary documents including application form, pharmacist credentials, and premises details.

03
3–5 working days

Login Credentials & Registration

Register on the drug licensing portal. After registration, login information is sent to the registered email address or mobile number.

04
3–5 working days

Application Filing

Submit all requisite details, pharmacist information, and upload necessary documents. The application is submitted with required payments.

05
15–30 working days

Inspection

A drug inspector visits the location to authenticate the premises, check the pharmacist's presence, and verify the originality of documents. The inspection report is submitted to DLA.

06
1–3 working days

License Issuance

Based on the inspection report, the final retail license is issued by the Drug Licensing Authority.

Authority, Timeline & Fees

Where the application goes, and what it costs

Government Authority

State Drug Licensing Authority (DLA), Drug Controller General of India (DCGI), Ministry of Health and Family Welfare, Government of India.

Estimated Processing Period

Typically 30 to 60 working days from complete document submission, depending on state and workload.

Certificate Issued

Drug Retail License (Form 20/21) with unique registration number and validity period.

Fee Structure

Government fee varies based on state and application type. Professional fee quoted upfront by First Auditor.

ComponentPaid ToNature of charge
Application Fee State Drug Licensing Authority As prescribed by state rules
Inspection Fee State Drug Licensing Authority As per inspection scope
Professional fee First Auditor Quoted upfront, one-time

Government fees are prescribed by the State Drug Licensing Authority. Our team quotes both components separately before you proceed, with nothing added later.

Validity & Renewal

How long is the Drug Retail License valid?

The drug retail license is typically valid for a period of 5 years, subject to renewal. To maintain the license, businesses must:

  • Apply for renewal before the expiry date
  • Submit updated documents and fees
  • Maintain proper product records and documentation
  • Maintain a qualified pharmacist on staff
  • Comply with all regulatory requirements
  • Maintain proper storage conditions for drugs
  • Submit periodic returns and reports
Common Reasons for Rejection

What causes the Drug Licensing Authority to reject a retail license application

  • Incomplete or incorrect application form submission
  • Missing or invalid pharmacist registration
  • Inadequate premises or storage facilities
  • Non-compliance with GMP requirements
  • Missing required documents
  • Outstanding government fees not paid
  • False information or documents
  • Inspection failure due to non-compliance
How First Auditor Assists

One team, from document collection to license issuance

We manage every step, document, and follow-up with the Drug Licensing Authority so you can focus on running your pharmacy business.

Eligibility & Document Check

We verify your eligibility and ensure all required documents are complete and valid.

Application Preparation

Complete drug retail license application drafting and verification to ensure error-free submission.

Pharmacist Verification

Assistance in verifying pharmacist qualifications and Pharmacy Council registrations.

Premises Inspection Preparation

Guidance on preparing premises for drug inspector visits.

Application Filing

Complete application filing through the drug licensing portal.

Query Handling

We respond to all queries from the Drug Licensing Authority on your behalf.

Timely Follow-up

Regular follow-up with DLA to ensure timely processing of your application.

Post-License Compliance

Assistance with post-license compliance, renewals, and regulatory updates.

Documentation Support

Help with preparing and organizing all required documents for the application.

Frequently Asked Questions

FAQ

It is a regulatory approval issued by the State Drug Licensing Authority that allows an individual or business to operate a retail pharmacy, medical store, or drug outlet in India. The license ensures compliance with the Drugs and Cosmetics Act, 1940 and Rules, 1945.

Any individual or business intending to operate a retail pharmacy, medical store, or drug outlet in India must obtain this license. This includes selling prescription drugs, OTC medicines, and pharmaceutical products.

Form 19 and Form 19-A are commonly required for retail drug licenses, depending on the category of drugs you intend to sell.

Documents include application form, pharmacist qualifications and registration, premises ownership or rental proof, floor plan, and refrigerator purchase receipt. Fees payment proof is also mandatory.

The drug retail license is typically valid for 5 years and must be renewed before the expiry date to continue operations.

Yes, a qualified pharmacist with valid registration with the State Pharmacy Council is mandatory for obtaining and maintaining a drug retail license in India.

First Auditor provides end-to-end assistance for drug retail license applications including document verification, application preparation, portal filing, inspection preparation, and follow-up with the Drug Licensing Authority.

No, a separate drug retail license is required for each retail outlet or pharmacy location. Each license is location-specific and cannot be transferred to another premises.
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Disclaimer: This page is provided for general informational purposes only and does not constitute legal, tax, or professional advice. Government fees, processing timelines, and documentation requirements are prescribed by the State Drug Licensing Authority under the Drugs and Cosmetics Act, 1940 and Rules, 1945 and are subject to change without notice. First Auditor is an independent professional services firm and is not affiliated with, or an agent of, any government department. Please consult our team or a qualified professional for advice specific to your situation before making any registration decision.
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