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How to Apply for a Medical Store License in India- by PSR Compliance
Drug License

Sat, Jan 31 2026

Raju Karn

How to Apply for a Medical Store License in India? Step by Step Guide

If you are planning to open a medical store or pharmacy, one of the first things you need to figure out is how to apply for a medical store license. Most people get stuck here because the process is not clearly explained anywhere. There are drug laws to follow, government approvals to take, and terms like CDSCO, drug license verification, and renewal timelines that can feel confusing at first.

The good news is that applying for a medical store license is not as complicated as it sounds—once you understand the steps. With the right documents, a qualified pharmacist, and proper setup, the license can be obtained smoothly. This guide explains the complete process in a simple and practical way, so you know exactly what is required and what to expect at each stage.

What Is a Medical Store License?

A medical store license is officially known as a drug license. It is issued under the Drugs and Cosmetics Act, 1940, and allows you to legally sell medicines, drugs, and pharmaceutical products.

Without a valid drug license, selling medicines is illegal in India—even if the medicines are genuine. This license ensures that medicines are stored, handled, and sold safely to protect public health.

In simple terms:

  • Customers get safe medicines
  • Authorities control misuse of drugs
  • Businesses operate legally

Who Issues the Medical Store (Drug) License?

Drug licenses are issued by the State Drug Control Department, while overall regulation and policy guidance come from CDSCO (Central Drugs Standard Control Organization).

You may often hear terms like CDSCO login or CDSCO portal, but for a retail medical store, the actual license is granted at the state level through the Drugs Control Office.

Types of Drug Licenses for Medical Stores

Before applying, it is important to know which type of drug license you need.

1. Retail Drug License

This is required if you want to sell medicines directly to customers from a shop or pharmacy.

2. Wholesale Drug License

This is required if you plan to supply medicines to other pharmacies, hospitals, or distributors.

Some businesses apply for both retail and wholesale licenses, depending on their business model.

Basic Requirements to Apply for a Medical Store License

To apply for a drug license, certain basic conditions must be fulfilled.

Premises Requirement

➔ Minimum area of 10 sq. meters for retail OR wholesale

➔ 15 sq. meters if both retail and wholesale are applied together

➔ Proper storage with refrigerator for medicines

Qualified Person Requirement

➔ A registered pharmacist is mandatory for retail medical stores

➔ For wholesale, a competent person with relevant experience is required

➔ These requirements are checked during inspection.

Advantages of Having a Medical Store License

Having a valid medical store (drug) license is not just a legal formality. It gives long-term benefits to your pharmacy business:

– Legal permission to sell medicines
A drug license allows you to sell all approved medicines without risk of penalties or closure.

– Trust among customers and doctors
Customers feel safer buying medicines from a licensed pharmacy, especially prescription drugs.

– Eligibility to stock branded and scheduled drugs
Many pharmaceutical companies supply medicines only to licensed medical stores.

– Smooth drug license verification and inspections
A valid license helps you pass inspections easily and avoid legal notices from authorities.

– Business expansion and online sales
A drug license is mandatory if you plan to expand, open another branch, or sell through online platforms.

– Easy drug license renewal
Once registered correctly, renewal becomes simple and stress-free.

Step-by-Step Process to Apply for Medical Store License

This is the section most people look for. Below is a realistic and practical explanation of how the process works.

Step 1: Prepare Your Documents

Before applying, keep all documents ready. Missing documents are the most common reason for application delay.

Step 2: Online Application Submission

The application for a medical store license is submitted online through the State Drug Control portal. In some cases, details may also be linked with CDSCO systems for verification.

At this stage, you will:

  • Fill application forms
  • Upload documents
  • Pay government fees

Step 3: Drug Inspector Inspection

After submission, a Drug Inspector visits the shop premises. They check:

  • Shop size and layout
  • Storage conditions
  • Refrigerator availability
  • Presence of registered pharmacist

This inspection ensures medicines will be stored and sold safely.

Step 4: Grant of Drug License

If everything is found correct, the drug license is issued. Once issued, you can legally start selling medicines from your store.

Documents Required for Medical Store License

Some commonly required documents include:

→ Identity proof of applicant

→ Address proof of premises

→ Rent agreement or ownership proof

→ Pharmacist registration certificate

→ Appointment letter of pharmacist

→ Refrigerator purchase bill

→ Shop layout plan

→ Affidavit as per drug rules

Keeping documents clear and correct helps in faster approval.

Drug License Verification – Why It Matters

After receiving the license, drug license verification becomes important.

Customers, suppliers, and authorities can verify your license details online to ensure:

‣ The license is genuine

‣ It is active and valid

‣ It belongs to the correct premises

Regular verification helps avoid misuse or compliance issues.

Drug License Renewal 

A drug license is not permanent. Drug license renewal must be done before expiry to continue business legally.

If renewal is delayed:

‣ Penalties may apply

‣ Business operations may be stopped

It is always safer to apply for renewal well before the expiry date.

Common Mistakes People Make

Many applicants face delays because of simple mistakes such as:

⚠ Applying without a registered pharmacist

⚠ Incorrect premises size

⚠ Incomplete documents

⚠ Not preparing for inspection

⚠ Missing renewal timelines

Avoiding these mistakes saves time and money.

Need Help in Medical Store License?

Applying for a medical store license can be confusing when you are dealing with documentation, pharmacist requirements, inspections, and online portals. Even a small mistake can delay approval.

PSR Compliance helps you through the complete process—from understanding eligibility and preparing documents to application filing, follow-ups, and guidance on drug license verification and renewal. Our focus is to make the process clear, compliant, and stress-free for you.

📞 Call PSR Compliance at 7065883416 to get practical guidance for your medical store license.

Frequently Asked Questions (FAQs)

1. Who can apply for a drug license?

Any individual, company, partnership firm, or LLP can apply for a drug license. However, the applicant must employ a registered pharmacist or a competent person to supervise drug sales.

2. What are the qualifications required for a pharmacist?

A pharmacist must hold a Bachelor of Pharmacy (B.Pharm) or Diploma in Pharmacy (D.Pharm) and be registered with the State Pharmacy Council.

3. What is the minimum area required for a medical store?

A retail medical store must have a minimum carpet area of 10–15 square meters, as prescribed by drug control authorities.

4. Are air conditioning (AC) and a refrigerator mandatory?

Yes, both AC and a refrigerator are mandatory to maintain proper storage conditions for medicines, especially temperature-sensitive drugs such as vaccines and insulin.

5. Which forms are required to apply for a drug license?

The following forms are commonly required:

  • Form 19 – Retail drug license application
  • Form 20 – License for sale of general drugs
  • Form 21 – License for sale of prescription drugs (Schedule H, H1, and X)
6. Is a separate drug license required for different locations?

Yes, drug licenses are location-specific. A separate license is required for each premises, even if owned by the same person or entity.

7. Can a residential property be used to open a medical store?

Generally, a commercial premises is required. However, in some areas, mixed land-use premises may be permitted, subject to local municipal and zoning regulations.

8. How long does it take to get a drug license?

The drug license approval process typically takes 30–45 days, depending on inspection schedules and processing timelines of the state drug authority.

9. Can Ayurvedic or Homeopathic medicines be sold under a standard drug license?

No, separate and specialized licenses are required to sell Ayurvedic or Homeopathic medicines. A standard drug license does not cover these categories.

10. What are the consequences of operating without a drug license?

Operating a medical store without a valid license is illegal under the Drugs and Cosmetics Act and may result in heavy fines, prosecution, and imprisonment.

11. Is GST registration mandatory for a drug license?

Yes, a GST registration certificate is generally required as part of the drug license application process.

12. Can a drug license be renewed?

Yes, a drug license is valid for five years and can be renewed before its expiration by submitting a renewal application.

13. What is the process for transferring a drug license if the shop location changes?

Since drug licenses are site-specific, a fresh application must be filed and the existing license must be surrendered if the shop location is changed.

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