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Tue, Apr 07 2026
Raju Karn
If you are planning to open a medical store or start a wholesale medicine business in Gujarat, getting a drug license is the first and most important step. Whether you are in Ahmedabad, Surat, Vadodara, Rajkot, or any small town, you cannot legally sell medicines without a valid license. This license is required by law and ensures that medicines are sold safely and properly.
Many people in Gujarat want to start a pharmacy because the demand for medicines is always high, and healthcare services are growing fast. However, beginners often feel confused about the process, documents, and approvals. This guide is written in simple language to help you clearly understand how to get a drug license in 2026 without any confusion.
A drug license is an official permission from the government that allows a person or business to sell, store, or distribute medicines legally. It is not just a piece of paper; it shows that the business follows all the rules for handling medicines safely. Without a drug license, running a medical store, pharmacy, or wholesale medicine business is illegal, and the owner could face serious penalties.
The main purpose of a drug license is to protect both the seller and the customer. It ensures that medicines are stored properly so they remain effective and safe to use. It also prevents expired or harmful medicines from being sold and makes sure that safety, hygiene, and quality standards are strictly followed. In simple terms, a drug license is a guarantee that the medicines you buy are safe, reliable, and trustworthy.
If you are planning to start any business involving medicines in Gujarat, you must have a drug license. This is required by law to ensure that medicines are sold safely, stored properly, and meet government standards. Without a license, running a pharmacy or medicine business is illegal, and you could face fines or legal action.
You should apply for a drug license if you are planning to:
• Open a medical store for retail customers
• Start a wholesale medicine business
• Supply medicines to hospitals or clinics
• Sell medicines through a clinic
• Run an online pharmacy
• Distribute pharmaceutical products across the state
Even in smaller towns and cities of Gujarat, proper licensing is now mandatory due to strict inspections and government monitoring. This ensures that all medicines sold are safe, genuine, and handled properly, protecting both the business owner and the customers.
In Gujarat, different businesses need different types of drug licenses depending on how they sell or distribute medicines. These licenses ensure that all medicines are stored and sold safely, protecting both the business owner and the customers.
If you are opening a medical store and selling medicines directly to customers, you need a Retail Drug License.
For businesses that supply medicines in bulk or sell to other retailers or hospitals, a Wholesale Drug License is required.
These forms are part of the official license process. Most retail medical stores need both forms:
By getting the right license and forms, you can legally run your medical store or wholesale business without facing penalties.
In Gujarat, the Gujarat Food and Drug Control Administration (FDCA) is the main authority that issues drug licenses. This department ensures that all businesses selling or distributing medicines follow the rules and maintain safety standards.
Before issuing a license, the FDCA checks several important things:
➤ Storage conditions – Medicines must be stored properly to remain safe and effective.
➤ Documents – All required documents and forms must be complete and correct.
➤ Safety compliance – The business must follow government rules for handling and selling medicines.
The FDCA also conducts inspections of your premises before giving final approval. This ensures that your store or wholesale business operates legally and safely, protecting both customers and business owners.
Getting a drug license in Gujarat is simple if you follow the steps carefully. This license allows you to legally sell, store, or distribute medicines. Here is the process explained step by step:
The first step is to register on the ONDLS portal (Online Drug Licensing System). You need to create your login details and fill in your business information, such as store name, address, and type of business.
Choose the type of license you need:
Choosing the wrong license type is a common mistake, so make sure you select the correct one.
Upload all the required documents carefully. This includes proof of identity, address, pharmacy qualification, and premises details. Any incorrect or missing document may lead to rejection of your application.
After submitting your application, a drug inspector will visit your shop or warehouse. They check the area size, storage setup, and availability of a refrigerator for medicines that require cold storage.
If everything is correct, your application will be approved. You can then download the drug license copy from the ONDLS portal and start your business legally.
Following these steps carefully ensures that your drug license application in Gujarat is processed smoothly and without delays.
To get a drug license, you need to submit some important documents. These help the authorities verify your identity, business, and storage setup. Submitting incomplete or wrong documents is one of the biggest reasons for delays in approval.
The key documents required are:
→ Aadhaar card – Proof of identity.
→ PAN card – For financial and tax verification.
→ Shop rent agreement or ownership proof – Shows that you have the legal right to operate the premises.
→ Shop layout plan – A simple diagram of your store showing shelves, storage, and other facilities.
→ Pharmacist registration certificate – Proof that a registered pharmacist is available in your store (mandatory for retail stores).
→ Refrigerator bill – If you have cold storage for medicines that require it.
→ GST certificate – For tax compliance.
→ Affidavit – A declaration that all information provided is true and your business will follow the rules.
Make sure all documents are correct, complete, and up-to-date to avoid any delays in your drug license approval.
After your drug license is approved, you can easily download and verify it online. This ensures that you have proof of legal authorization to sell or distribute medicines.
➜ Login to the ONDLS portal using your account credentials.
➜ Download the drug license copy in PDF format.
➜ Verify your license status online to make sure it is active and correct.
It is recommended to keep a printed copy of your license at your shop at all times. This is very useful during inspections by the drug authorities or for any official verification.
A drug license in Gujarat is valid for 5 years. To continue your business legally, you must renew it before it expires. Renewal is simple if you follow the right steps.
▪ Apply for renewal – Submit your application on the ONDLS portal before the license expires.
▪ Pay the renewal fee – The fee is similar to the original license fee.
▪ Update documents – Ensure all documents like shop proof, pharmacist certificate, and GST are current and valid.
⚠ The license may expire, and your business can face legal issues.
⚠ You cannot legally sell or distribute medicines until the license is renewed.
It is important to track your license expiry date carefully and start the renewal process in advance to avoid any interruptions in your business.
Setting up your shop or warehouse properly is very important to get a drug license in Gujarat. Authorities check your premises carefully before approving your application, so meeting the minimum requirements is essential.
– Retail shop area: At least 10 square meters.
– Wholesale shop area: At least 15 square meters.
– Refrigerator: Required for storing temperature-sensitive medicines.
– Shelves and cupboards: Proper storage facilities for medicines.
Temperature-sensitive medicines, such as certain vaccines and injectable drugs, must be stored under the correct temperature.
Many applications are rejected because of poor storage setup or insufficient shop area, so it is important to prepare your premises according to these standards before applying.
Many businesses in Gujarat face challenges when applying for a drug license. Understanding these common problems can help you avoid delays or rejections.
⨯ Wrong license category selection – Choosing retail instead of wholesale, or vice versa.
⨯ Missing pharmacist details – Not having a registered pharmacist listed for retail stores.
⨯ Small shop area – Not meeting the minimum size requirement for retail (10 sq.m) or wholesale (15 sq.m).
⨯ Improper storage – Poor shelving, cupboards, or lack of refrigeration for temperature-sensitive medicines.
⨯ Incorrect form submission – Submitting forms with missing information or wrong labels.
Example: Some applicants in Rajkot submit documents without checking label details or the shop layout. This leads to rejection and delays.
Mahesh Patel from Ahmedabad wanted to open a medical store near his home. He rented a small shop and applied for a drug license, but during inspection, the officer rejected his application because the shop area was smaller than required and a refrigerator for medicines was missing.
Mahesh contacted PSR Compliance, and our team helped him redesign the shop layout, install proper storage and a refrigerator, and ensure all documents were complete and accurate. After making these corrections and reapplying, he received his drug license within 25 days, showing how expert guidance can prevent delays and make the process smooth.
Mahesh Patel, Retail Medical Store, Ahmedabad"PSR Compliance helped me open my medical store smoothly. My first application was rejected because the shop area was small and the refrigerator was missing. With their guidance, I corrected the issues and got my drug license in just 25 days. Their support made the whole process stress-free."
Jignesh Shah, Wholesale Medicine Distributor, Surat“We planned to start a wholesale medicine business in Surat but did not understand the ONDLS process. The team guided us in preparing documents and setting up our storage area correctly. Because of their help, our license was approved without delays. It made the process much easier for us.”
Neha Desai, Retail Pharmacy, Vadodara"I wanted to open a retail pharmacy in Vadodara, but I was confused about forms, documents, and premises requirements. PSR Compliance helped me organize everything correctly and prepared me for inspection. I received my license quickly, and now my pharmacy is running legally without any issues."
If you are applying for a drug license in Gujarat, following a few practical tips can help you avoid rejection and save time.
✓ Select the correct license type – Retail or wholesale, based on your business.
✓ Ensure proper shop area – Retail shops should be at least 10 sq.m and wholesale shops 15 sq.m.
✓ Hire a registered pharmacist – Mandatory for retail pharmacies.
✓ Install a refrigerator before inspection – For medicines that require cold storage.
✓ Double-check documents – Make sure all forms and certificates are complete and accurate.
✓ Keep digital copies ready – For online submission and future reference.
Following these simple steps increases your chances of smooth approval and helps you start your medical business without delays.
PSR Compliance can guide you through the complete drug license process without confusion.
📞 Call: 7065883416📧 Email: support@psrcompliance.com
Applicants must be Indian citizens, over 21, with a pharmacy degree and Gujarat Pharmacy Council registration.
Shops must have at least 10 sq.m area, proper storage, refrigerator, and good sanitation.
Documents include pharmacist affidavit, shop ownership/rent proof, and a site plan.
Yes, manufacturing licenses use the iDMLA portal; sales licenses have online procedures too.
Yes, Schedule X drugs and some medical devices require specialized licenses.
Retail, wholesale, and manufacturing licenses, each specific to the location and business type.
Yes, each location requires its own license.
No, it is valid only within Gujarat; other states require separate licenses.
Operating without a license is a legal offence and can lead to fines or closure.
Fees vary by license type: retail, wholesale, or manufacturing.
Yes, pharmacies selling certain products may also need an FSSAI license.
GMSCL provides guidance on tenders, procurement, and online license applications.