1. Introduction

Opening a medical store in India is more than just a business opportunity—it’s a responsibility that directly impacts public health. As the demand for affordable and accessible medicines grows across urban and rural India, retail pharmacies and standalone medical shops are increasingly vital in the healthcare ecosystem.

But before you can legally stock and sell medicines, you must obtain a drug licence for medical store from your respective state’s drug control department. This licence is mandatory under the Drugs and Cosmetics Act, 1940, and is a legal requirement for anyone planning to open a pharmacy, drugstore, or chemist shop.

Whether you’re setting up a small pharmacy in a residential area or planning a chain of medical outlets, getting a pharmacy licence is non-negotiable. It certifies that your store meets the necessary safety, staffing, and infrastructure standards required to dispense medicines to the public.

Operating without a valid drug licence for a medical store is a serious offence. It can lead to heavy fines, product seizure, business suspension, or even criminal prosecution. Regulatory authorities are increasingly strict about compliance, and regular inspections are part of maintaining your licence.

This blog is your comprehensive guide to understanding how to apply for a medical shop licence in India. You’ll learn:

• What types of drug licences exist for medical stores
   
• Who is eligible to apply
   
• The complete list of documents required
   
• The step-by-step application process
   
• Costs, validity, and renewal guidelines
   
• Common mistakes to avoid
   
• Legal requirements to stay compliant
   

Whether you’re a first-time entrepreneur, a healthcare professional, or a business owner expanding into pharmaceuticals, this article will help you navigate the drug licensing process with confidence.

Let’s begin by understanding the different types of drug licences required for a medical store in India.

2. Types of Drug Licences for Medical Stores

Before you apply for a drug licence for medical store, it’s essential to understand which type of licence your business needs. India’s drug regulatory system issues different licences based on the kind of medicines you plan to sell and the nature of your operations—whether retail, wholesale, or specialized.

Below are the main types of drug licences issued for pharmacies and medical shops:

A. Retail Drug Licence (Form 20 and Form 21)

This is the most common licence for anyone opening a standard medical store or pharmacy.

• Form 20: Required for selling general (non-schedule) allopathic medicines over the counter and via prescription.
   
• Form 21: Required for selling prescription-based drugs, including Schedule H and H1 drugs.
   

Who needs it?

• Standalone medical stores
   
• Pharmacies attached to clinics or hospitals
   
• Retail chains or franchise outlets selling medicines
   

To get this pharmacy licence, your store must have:

• At least 100 sq. ft. of space
   
• A registered pharmacist employed full-time
   
• Proper storage facilities including refrigeration
   

B. Wholesale Drug Licence (Form 20B and Form 21B)

This is for businesses involved in distributing medicines in bulk to retailers, hospitals, or other wholesalers.

• Form 20B: For general drug distribution
   
• Form 21B: For prescription drug distribution
   

It is not typically required for small retail shops but is essential if you’re planning to stock and supply to other medical outlets or practitioners.

C. Restricted Drug Licence (For Rural Areas)

In certain Indian states, restricted licences are issued for:

• Selling OTC (over-the-counter) medicines in remote or rural areas
   
• Locations where registered pharmacists are not available
   

These are only given under special circumstances and come with limited selling permissions.

D. Schedule X Drug Licence (Form 20F and 21F)

If your pharmacy plans to sell narcotics or habit-forming drugs (like morphine, codeine-based syrups, or sleeping pills), you need additional authorization.

• Form 20F: For retail sale of Schedule X drugs
   
• Form 21F: For wholesale distribution of Schedule X drugs
   

These licences require:

• Separate, lockable storage
   
• Detailed sales records
   
• Stricter inspection processes
   

E. Multi-Outlet Licences for Chains

If you operate a pharmacy chain or multiple stores, you must apply for a separate drug licence for each outlet. There are no transferable licences between locations, even if operated by the same company.

F. Additional Licences (FSSAI, Cosmetic, AYUSH)

Depending on your product range, you may also require:

• FSSAI licence (for nutraceuticals or food supplements)
   
• Cosmetic sale licence
   
• AYUSH licence (for Ayurvedic or herbal medicines)
   

3. Eligibility Criteria for a Medical Store Licence

To apply for a drug licence for medical store in India, you must meet certain eligibility conditions set by the Drugs and Cosmetics Act, 1940 and enforced by the State Drug Control Department. These conditions ensure that only qualified individuals operate pharmacies, and that medicines are stored and dispensed safely.

Here’s a breakdown of the key eligibility criteria for obtaining a medical store licence:

A. Premises Requirements

To qualify for a retail pharmacy licence, your store must meet the following physical standards:

• Minimum area:
   
  • 100 sq. ft. for a retail medical store
     
  • 150 sq. ft. if applying for both retail and wholesale under one roof
     
• Zoning:
   
  • The premises must be located in a commercial area or an approved location as per your local municipal norms.
     
• Storage infrastructure:
   
  • Proper ventilation, cleanliness, and pest control
     
  • Refrigerator for cold-chain medicines (vaccines, insulin, etc.)
     
  • Lockable storage for controlled substances (Schedule X drugs)
     

B. Pharmacist Requirement (For Retail Licence)

A registered pharmacist is mandatory for applying for a drug licence for medical store. The pharmacist must:

• Hold a D.Pharm or B.Pharm degree from a recognized institution
   
• Be registered with the State Pharmacy Council
   
• Be employed full-time by your store
   
• Provide an appointment letter, registration proof, and a signed affidavit confirming their full-time role
   

If your pharmacist resigns or is unavailable during inspections, your licence can be suspended.

C. Qualified Person (For Wholesale Licence)

If you’re applying for a wholesale drug licence, you can appoint a person who is either:

• A registered pharmacist, or
   
• A graduate with at least 1 year of experience in drug sales in a licensed pharmaceutical firm (must provide an experience certificate)
   

D. Ownership and Legal Structure

To apply for a medical store licence, you must operate through a registered business entity. Acceptable structures include:

• Sole proprietorship
   
• Partnership or LLP
   
• Private Limited Company
   

Documents like PAN, GST registration, and Shop & Establishment certificate are mandatory.

E. Age and Citizenship

The applicant must be:

• At least 18 years old
   
• An Indian citizen with valid government-issued ID proof

F. Additional Notes for Chain Pharmacies

If you operate multiple locations:

• Each outlet must meet the same eligibility requirements
   
• You need a separate drug licence for each branch
   

Meeting all these eligibility conditions is the foundation for a successful and legally compliant application for a drug licence for medical store in India.

4. Documents Required to Get a Drug Licence for Medical Store

Applying for a drug licence for medical store requires submitting a complete and accurate set of documents to the State Drug Control Department. Missing or incorrect documentation is one of the most common reasons for application rejection or delays.

Below is a detailed checklist of all the documents required to apply for a medical store licence in India:

A. Applicant and Business Proof

• PAN Card of the proprietor/partners/company
   
• Aadhaar Card or other government-issued ID
   
• GST Registration Certificate
   
• Shop and Establishment Licence issued by the local authority
   
• Partnership Deed / MOA & AOA / LLP Agreement (based on business type)
   
• Certificate of Incorporation (for Pvt. Ltd. or LLP entities)
   

B. Premises-Related Documents

• Rent agreement or ownership proof of the premises
   
• No Objection Certificate (NOC) from the landlord (if rented)
   
• Site layout plan of the store (showing storage, counter, refrigerator, etc.)
   
• Photographs of the exterior and interior of the pharmacy
   
• Proof of refrigerator purchase or invoice for cold storage setup
   
• Declaration of storage facility availability (as per Schedule N norms)
   

C. Pharmacist or Qualified Person Documents

For retail stores:

• Pharmacy degree certificate (D.Pharm/B.Pharm)
   
• Pharmacist Registration Certificate from the State Pharmacy Council
   
• Appointment letter on company letterhead
   
• Affidavit declaring full-time employment
   
• Recent passport-size photograph and valid ID
   

For wholesale stores:

• Degree certificate (if pharmacist) or
   
• Experience certificate (1+ years in drug sales if not a pharmacist)
   
• Affidavit of full-time engagement
   

D. Licence Application Forms & Affidavits

• Form 19 – Application for retail or wholesale licence
   
• Covering letter addressed to the State Drug Licensing Authority
   
• Self-declaration of cold chain and hygienic storage
   
• Affidavit of non-conviction under the Drugs and Cosmetics Act
   
• Power of Attorney (if signed by a person other than business owner)
   

E. Additional Documents (If Applicable)

• Form 20F/21F for Schedule X drug application
   
• FSSAI registration (for nutraceuticals or supplements)
   
• Cosmetic sale permission (if applicable)
   
• Website declaration if medicines will be sold online
   
• Copies of previous licences (for renewal or transfer cases)
   

Pro Tip:

Ensure that all documents are self-attested, scanned clearly, and submitted in the format required by your state’s online portal. Notarization may be required for affidavits or power of attorney, depending on the state guidelines.

5. Step-by-Step Process to Apply for a Drug Licence for Medical Store

Once you’ve finalized your location, hired a qualified pharmacist, and gathered all the necessary documents, you’re ready to apply for a drug licence for medical store. The process is largely handled by the State Drug Control Department, and many states now accept online applications through their dedicated portals.

Here’s a detailed breakdown of the step-by-step process:

Step 1: Register Your Business

Before applying for the pharmacy licence, ensure your business is legally recognized. You must have:

• A registered business entity (Sole Proprietorship, Partnership, LLP, or Pvt. Ltd.)
   
• GST registration and Shop & Establishment certificate
   
• Business PAN and TAN
   

Step 2: Prepare Your Premises

Your store must comply with minimum space and infrastructure requirements:

• 100 sq. ft. area for retail, 150 sq. ft. for retail + wholesale
   
• Air-conditioned storage, refrigerator, and clean shelving
   
• Secure cabinet for Schedule H or Schedule X drugs
   
• Basic fire safety and pest control measures
   

Take photographs and create a site layout to attach to your application.

 

Step 3: Hire a Full-Time Pharmacist or Qualified Person

• For retail: Appoint a registered pharmacist
   
• For wholesale: Appoint either a pharmacist or a person with 1+ year drug sales experience
   

Ensure all their documents, ID, appointment letter, and affidavit are ready.

Step 4: Create an Account on Your State’s Drug Portal

Each state has its own drug control department portal.

Log in or create a user ID, then begin filling Form 19 for retail/wholesale pharmacy licence.

Step 5: Upload Documents and Pay Fees

Upload scanned copies of:

• Identity proof
   
• Pharmacist certificates
   
• Rent agreement and shop layout
   
• All affidavits and declarations
   

Pay the required fee online (₹3,000–₹10,000 depending on state and licence type). Save the payment receipt.

Step 6: Premises Inspection by Drug Inspector

The State Drug Inspector will schedule a visit to:

• Verify your premises, equipment, and pharmacist availability
   
• Confirm compliance with Drugs and Cosmetics Act provisions
   
• Cross-check storage conditions and refrigeration
   

Step 7: Receive Your Drug Licence for Medical Store

If all is in order:

• You’ll receive your Retail Drug Licence (Form 20/21) or Wholesale Drug Licence (Form 20B/21B)
   
• Some states offer digital download, others issue a hard copy certificate
   

Once issued, you can legally start operating your pharmacy and dispensing medicines.

Timeline:

• Typical approval time: 15 to 45 working days, depending on state efficiency and inspection scheduling.
   

6. Fees, Validity & Renewal Process of Drug Licence for Medical Store

Once you’ve submitted your application for a drug licence for medical store, you’ll need to understand the financial and regulatory timelines involved. This includes the licensing fee, the validity period of your licence, and the renewal process to keep your medical store legally operational without interruptions.

A. Government Fees for Drug Licence for Medical Store

The government fee varies depending on:

• Whether it’s a retail or wholesale licence
   
• Whether you’re applying for Schedule X drugs
   
• Your state’s specific fee structure
   

Below is an approximate fee guide:

Licence Type	Government Fee (Approx.)
Retail Drug Licence (Form 20/21)	₹3,000 – ₹5,000
Wholesale Drug Licence (Form 20B/21B)	₹3,500 – ₹6,000
Schedule X Drug Licence (Form 20F/21F)	₹7,500 – ₹10,000
Drug Licence Renewal Fee	₹3,000 – ₹5,000

Note: States may also charge portal usage fees, inspection fees, or stamp duty charges.

B. Validity of a Medical Store Licence

• A drug licence for medical store is typically valid for 5 years from the date of issuance.
   
• After the 5-year period, you must renew it before expiry.
   
• In case of business changes (ownership, address, pharmacist), you must apply for an amendment with the licensing authority.
   

C. Renewal Process

To renew your drug licence:

1. Apply at least 90 days before expiry through the same state drug control portal
    
2. Submit updated documents such as:
    
   • Pharmacist’s recent employment proof
      
   • Latest rent agreement or property ownership certificate
      
   • Renewal affidavit and declaration
      
   • Payment receipt of the renewal fee
      
3. The drug inspector may conduct a fresh inspection if necessary
    
4. After approval, you will receive a renewed licence certificate
    

Delays in renewal can:

• Incur penalty charges
   
• Lead to temporary suspension
   
• Force a reapplication from scratch (in severe cases)
   

D. When Renewal Is Not Enough (Apply Fresh Licence)

You must apply for a new drug licence (instead of a renewal) if:

• You shift the store to a new address
   
• There’s a complete change in ownership or legal entity
   
• You wish to add Schedule X drugs to your existing licence
   

Pro Tip:

Set a reminder system or use compliance software to track your licence expiry and renewal timelines. It’s easier to maintain continuity than to recover from an expired licence suspension.

7. Common Mistakes to Avoid During Application

Getting a drug licence for medical store involves more than just submitting forms and uploading documents. Even minor oversights can result in application rejection, delays, or compliance issues down the line. Avoiding these common mistakes can make the process smoother and help you get approved on the first attempt.

Here are the most frequent errors to watch out for:

1. Incomplete or Mismatched Documentation

Missing documents, blurry scans, or inconsistent business information are among the top reasons applications are rejected.

How to avoid it:

• Double-check that your pharmacist registration details, business name, and premises address match across all forms and affidavits
   
• Ensure all documents are self-attested, valid, and up to date
   
• Use proper PDF formats as required by your state’s drug licensing portal
   

2. Appointing a Pharmacist on Paper Only

Some applicants list a pharmacist just to meet requirements, even though that person won’t work full-time.

Why this fails:

• The Drug Inspector may conduct surprise visits or require real-time attendance tracking
   
• If your registered pharmacist is not present during inspections, your licence may be suspended
   

Tip: Always appoint a dedicated, full-time pharmacist, and retain signed employment contracts and affidavits.

3. Using a Non-Commercial or Unapproved Premises

Your application will be rejected if your store:

• Operates from a residential space (unless locally permitted)
   
• Shares space with unrelated businesses (e.g., grocery store or salon)
   
• Lacks essential infrastructure like a refrigerator or secure shelving
   

Ensure your premises meets:

• Zoning guidelines
   
• Minimum area requirement (100 sq. ft. or more)
   
• Clean and professional retail conditions
   

4. Ignoring Additional Licences for Other Products

Planning to sell:

• Ayurvedic supplements? → You’ll need an AYUSH licence
   
• Nutraceuticals or protein powders? → FSSAI registration required
   
• Skincare or cosmetic products? → May need a cosmetic sale licence
   

Avoid penalty or seizure by understanding the full scope of your product offerings and their licensing requirements.

5. Applying Under the Wrong Licence Type

Some applicants mistakenly apply for a wholesale licence when they only plan to operate a retail pharmacy, or vice versa.

Fix: Understand the difference between Form 20/21 (retail) and Form 20B/21B (wholesale) before you begin. If you plan to distribute drugs beyond your shop, you’ll need the correct wholesale documentation.

6. Not Following Up Post-Submission

After submitting your application, some states require:

• A manual visit to the Drug Office for document verification
   
• A follow-up call or appearance during inspection scheduling
   

Always monitor your application dashboard, email, or SMS alerts. Delayed follow-up can pause your application indefinitely.

8. Legal Compliance After Getting the Drug Licence for Medical Store

Receiving your drug licence for medical store is a major milestone—but it’s only the beginning of your responsibilities. To maintain your licence and operate legally, you must follow a set of ongoing compliance requirements as mandated by the Drugs and Cosmetics Act, 1940 and enforced by the State Drug Control Department.

Failing to comply can result in licence suspension, penalties, or even permanent closure of your pharmacy.

Here’s what you must consistently do after receiving your medical store licence:

1. Maintain Proper Drug Storage and Cold Chain Standards

• All medicines must be stored according to manufacturer guidelines
   
• Refrigerated items like insulin, vaccines, and hormone-based drugs must be kept at 2°C–8°C
   
• Temperature logs or cold chain monitoring is highly recommended
   
• Schedule X or narcotic drugs must be stored in lockable cabinets
   

Tip: Regularly inspect your storage setup and keep it audit-ready.

2. Keep Batch-Wise Sales and Purchase Records

You are legally required to:

• Maintain stock registers for all incoming and outgoing medicines
   
• Record batch number, expiry date, MRP, and quantity sold
   
• Use GST-compliant invoices for all transactions
   
• For Schedule H and X drugs, maintain separate registers as per format
   

Retention Period: Keep records for at least 2 years, or as per state rules.

3. Ensure Pharmacist Presence During Business Hours

• Your appointed pharmacist must be present full-time
   
• His/her name, photograph, and registration number should be displayed prominently inside the pharmacy
   
• Biometric or attendance logs may be required in some states (e.g., Delhi, Maharashtra)
   

If your pharmacist resigns:

• Immediately inform the licensing authority
   
• Submit new appointment documents and update your licence
   

4. Display Mandatory Information Inside the Store

• Valid drug licence copy (framed or laminated)
   
• Pharmacist’s registration certificate
   
• Helpline or emergency contact details
   
• GST number (if applicable)
   

5. Handle Expired or Recalled Medicines Properly

• Maintain a separate shelf or area for expired stock
   
• Never sell or display expired medicines
   
• Return them through authorized channels (reverse logistics or destruction as per norms)
   

Improper handling of expired drugs can result in legal action.

6. Renew Your Licence Before It Expires

• A drug licence for medical store is valid for 5 years
   
• Start the renewal process at least 90 days in advance
   
• Submit all updated documents and fees online
   
• If delayed, you may face penalties or forced reapplication
   

7. Prepare for Surprise Inspections

Drug inspectors may visit your pharmacy unannounced to:

• Check records, stock, and invoices
   
• Verify pharmacist presence
   
• Inspect your premises for hygiene and safety
   

Always maintain audit-ready documentation and ensure your store meets all norms.

9. FAQs About Drug Licence for Medical Store

If you’re planning to open a medical store in India, you likely have questions about the legal process, eligibility, and day-to-day responsibilities after getting a drug licence for medical store. Here are answers to some of the most common queries:

Q1. Can I open a medical store without being a pharmacist?

Yes. You can own the store, but you must employ a full-time registered pharmacist to obtain and maintain your drug licence for medical store. Their physical presence is mandatory during business hours.

Q2. How long does it take to get a pharmacy licence in India?

It usually takes 15 to 45 working days, depending on your state’s processing system, documentation, and inspection timelines. Delays can happen if documents are missing or inspections are rescheduled.

Q3. What is the minimum area required for a medical store?

As per licensing norms:

• 100 sq. ft. for a standalone retail pharmacy
   
• 150 sq. ft. if you plan to operate both retail and wholesale from the same premises
   

The premises must be clean, secure, and legally approved for commercial use.

Q4. Do I need a new licence for each medical store if I own a chain?

Yes. Each outlet must apply for and receive a separate drug licence. You cannot operate multiple pharmacies under one licence—even if they share the same name or ownership.

Q5. Can I sell cosmetics, health supplements, or Ayurvedic products under this licence?

For additional product categories, you may need:

• FSSAI licence for nutraceuticals or protein powders
   
• AYUSH licence for Ayurvedic medicines
   
• Cosmetic licence for bulk cosmetic products
  
  Some OTC cosmetic sales are allowed without a separate licence, but confirm with your state FDA.
   

Q6. Is online medicine sale allowed with a retail drug licence?

Yes, but:

• You must have a valid retail drug licence for medical store
   
• Orders must be fulfilled by a licensed pharmacist
   
• Medicines must be stored, labeled, and delivered in compliance with all guidelines
  
  Some states may require additional online sale declarations.
   

Q7. Can I transfer my medical store licence to a new location?

No. Drug licences are location-specific. If you change your store address, you must apply for:

• A fresh licence at the new location
   
• And surrender the existing one
   

Q8. Can I get a pharmacy licence if I only plan to sell over-the-counter (OTC) medicines?

Even if you’re only selling OTC drugs, you still need a retail drug licence. Only in select rural or remote areas can a restricted licence be issued without a pharmacist—but this is rare and location-dependent.

10. Conclusion

Obtaining a drug licence for medical store is a non-negotiable step for anyone planning to start a pharmacy in India. It not only legitimizes your operations but also ensures that you’re contributing to public health in a safe, regulated, and compliant manner.

Throughout this guide, we’ve covered everything you need to know to get started—from understanding the different types of drug licences to the eligibility requirements, documentation, step-by-step application process, compliance norms, and common pitfalls to avoid.

Let’s recap the essentials:

• A drug licence is mandatory under the Drugs and Cosmetics Act, 1940
   
• You need a qualified pharmacist, a commercial premises, and a clear set of documents to apply
   
• Application must be submitted to the State Drug Control Department, usually online
   
• Your licence is valid for 5 years and must be renewed proactively
   
• Maintaining compliance after approval is crucial to avoid penalties or suspension
   

Whether you’re launching your first standalone pharmacy or scaling a retail network, this licence is the foundation of your business. Without it, you’re not just operating illegally—you’re risking customer safety and your long-term reputation.

By staying informed, organized, and compliant, you’ll not only obtain your drug licence for medical store faster but also build a trustworthy and sustainable healthcare business.