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Drug License Checklist for Small Pharmacies (2026)
Drug License

Thu, Jan 22 2026

Raju Karn

Drug License Checklist for Small Pharmacies (2026)

If you are planning to open a small medical store or pharmacy, getting a drug license is the first and most important step. Many people get confused about what documents are needed, who should apply, and what rules must be followed.

This checklist explains everything in simple words so you can prepare properly and avoid delays or rejection.

Type of Drug License You Need

Before applying, first understand which license is required:

  • Retail Drug License – For selling medicines directly to customers
  • Wholesale Drug License – For supplying medicines to other shops or hospitals
  • Retail + Wholesale License – If you plan to do both from the same premises

πŸ‘‰ Most small pharmacies start with a Retail Drug License (Form 20 & 21).

Minimum Space & Premises Checklist

Your shop must meet basic physical requirements:

➜ Minimum 10 sq. meters for retail pharmacy

➜ 15 sq. meters if retail + wholesale

➜ Proper ventilation and lighting

➜ Clean and hygienic condition

Shop must be in a commercial or approved mixed-use area

Storage & Equipment Checklist

Medicines must be stored safely:

⁃ Refrigerator for vaccines and temperature-sensitive medicines

⁃ Air conditioner or proper cooling arrangement

⁃ Shelves and racks to store medicines properly

⁃ No expired or damaged drugs on display

Pharmacist Requirement

This is a mandatory rule:

β–ͺ A registered pharmacist must be appointed

β–ͺ Pharmacist must be registered with the State Pharmacy Council

β–ͺ Pharmacist must be present during working hours

β–ͺ One pharmacist cannot work at two pharmacies

Documents Required 

Keep these documents ready before applying:

β†’ Filled Form 19 application

β†’ Shop ownership proof or rent agreement + NOC

β†’ Site plan & layout of the pharmacy

β†’ Pharmacist qualification certificate

β†’ Pharmacist registration certificate

β†’ Pharmacist affidavit

β†’ Refrigerator purchase invoice

β†’ Owner’s PAN & Aadhaar

β†’ GST registration

β†’ Partnership deed / MOA / AOA (if applicable)

Online Application Process 

● Register on the State Drug Control / CDSCO portal

● Fill the application form online

● Upload all documents

● Pay government fees

● Submit application

After submission, a drug inspector will visit the shop for inspection.

Inspection Readiness Checklist

β€£ During inspection, authorities usually check:

β€£ Shop size and cleanliness

β€£ Refrigerator and storage conditions

β€£ Presence of pharmacist

β€£ Document verification

β€£ Display of license application receipt

Timeline & Validity

  • Approval time: 30–60 days (if documents are correct)
  • License validity: 5 years
  • Renewal must be applied before expiry

Common Mistakes to Avoid

πŸ›ˆ Applying without a registered pharmacist

πŸ›ˆ Wrong shop area or residential location

πŸ›ˆ Missing documents

πŸ›ˆ Improper storage arrangements

πŸ›ˆ Delay in responding to inspection queries

How PSR Compliance Can Help You

Your Pharmacy License, Done the Right Way

PSR Compliance helps small pharmacy owners by:

β˜‘ Explaining rules in simple language

β˜‘ Preparing documents correctly

β˜‘ Filing applications online

β˜‘ Coordinating inspections

β˜‘ Avoiding rejection and delays

πŸ“ž Call PSR Compliance: 7065883416
One conversation today can save months of trouble later.

Frequently Asked Questions (FAQs) – Drug License

❓ What is the minimum area required for a retail pharmacy?

A standalone retail pharmacy requires a minimum of 10 sq. meters, and if applying for both retail and wholesale licenses, 15 sq. meters. The minimum ceiling height must be 2.75 meters.

❓ Is a registered pharmacist mandatory?

Yes, a registered pharmacist is required to operate the pharmacy and must be present during all working hours. If they leave, a replacement must be appointed within 30 days.

❓ What essential infrastructure or equipment is required?

Mandatory equipment includes a refrigerator (2–8Β°C for vaccines/biologics), proper storage racks and locked cupboards, and an independent shop premises. Air-conditioning is recommended for temperature-sensitive drugs.

❓ What documents are required for a new retail drug license (Form 19/20/21)?

Key documents include:

  • Application Form 19
  • Identity & Address Proof of owners
  • Premises proof (rent agreement/ownership document)
  • Layout plan of the premises
  • Pharmacist certificates and appointment letter
  • Affidavits (non-conviction, ownership, full-time employment)
  • Fee receipt and refrigerator purchase bill

❓ How long is the license valid, and how is it renewed?

The license is valid for 5 years. Renewal must be done 30–90 days before expiry to avoid penalties.

❓ Can I operate a pharmacy from my home?

Generally, no. A drug license is not granted for residential plots unless the premises comply with local regulations and have a separate commercial entrance.

❓ What happens after submitting the application and documents?

After submission, a Drug Inspector (DI) will inspect the premises to verify layout, infrastructure, and pharmacist presence before issuing the license.

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