Drug License in Rajasthan (2026 Guide): Types, Fees, Documents & Online Application Process

Starting or running a pharmaceutical business in Rajasthan is not possible without a valid drug license. Whether you want to open a medical store, sell medicines wholesale, distribute pharmaceutical products, or manufacture drugs, legal permission from the Drug Control Department is mandatory.

Many business owners face delays because they are unsure which license to apply for, what documents are required, or how the approval process works. In 2026, drug compliance has become stricter across India, and authorities carefully verify storage conditions, pharmacist qualifications, and documentation before issuing approval.

This guide explains everything in simple terms - types of drug licenses, eligibility, required documents, fees, and the step-by-step process to apply for a drug license in Rajasthan.

What is a Drug License?

A drug license is official permission issued by the State Drug Control Department that allows individuals or businesses to manufacture, sell, distribute, or stock medicines and pharmaceutical products legally.

In Rajasthan, drug licenses are issued under the Drugs and Cosmetics Act, 1940 and regulated by the Rajasthan Drugs Control Organization along with guidelines from CDSCO (Central Drugs Standard Control Organization).

Without a valid drug license, selling medicines is illegal and can lead to penalties, shop closure, or legal action.

Who Needs a Drug License in Rajasthan?

You need a drug license if you are involved in:

➔ Medical store or pharmacy business

➔ Wholesale medicine distribution

➔ Online medicine selling

➔ Drug manufacturing

➔ Import or export of pharmaceuticals

➔ Hospital pharmacy operations

Even small retail chemist shops must obtain proper licensing before starting business.

Types of Drug License in Rajasthan

1. Retail Drug License (RDL)

Required for selling medicines directly to consumers through a pharmacy or medical store.

2. Wholesale Drug License (WDL)

Required for businesses supplying medicines to retailers, hospitals, or distributors.

3. Manufacturing Drug License

Required for pharmaceutical manufacturing units.

4. Loan Drug License

For companies manufacturing drugs using another licensed manufacturer’s facility.

5. Import Drug License

Required for importing pharmaceutical products into India.

Choosing the correct license depends on your business activity.

Benefits of Having a Drug License

➤ Legal authorization to sell medicines

➤ Builds trust with customers

➤ Enables wholesale distribution

➤ Required for pharma partnerships

Avoids penalties and legal risks

Eligibility Criteria for Drug License

To apply for a drug license in Rajasthan, you must meet these conditions:

⁃ Registered business entity (proprietorship, partnership, company, etc.)

⁃ Qualified registered pharmacist (for retail license)

⁃ Minimum required storage space

⁃ Proper refrigeration and storage facilities

⁃ Valid GST registration

⁃ Compliance with drug safety standards

Documents Required for Drug License in Rajasthan

Commonly required documents include:

→ Identity and address proof of applicant

→ PAN card

→ Aadhaar card

→ Business registration certificate

→ GST registration certificate

→ Rent agreement or ownership proof of premises

→ Pharmacist qualification certificate

→ Pharmacy council registration

→ Premises layout plan

→ Refrigerator purchase proof

→ Affidavit and declaration forms

Authorities may request additional documents depending on license type.

Minimum Premises Requirement

Authorities inspect the premises before approval.

🗸 Retail drug license → minimum 10 sq. meters

🗸 Wholesale drug license → minimum 15 sq. meters

🗸 Clean, ventilated storage area required

🗸 Refrigerator mandatory for temperature-sensitive medicines

Drug License Fees in Rajasthan (Approx.)

Government fees vary based on license type and category.

• Retail drug license → ₹3,000 to ₹5,000
• Wholesale drug license → ₹3,000 to ₹5,000
• Manufacturing license → depends on product category
• Renewal fees apply periodically

Fees may change as per government updates.

Step-by-Step Process to Apply for Drug License in Rajasthan (2026)

Step 1: Determine License Type

Identify whether you need retail, wholesale, or manufacturing license.

Step 2: Prepare Documents

Collect all required documents and pharmacist details.

Step 3: Submit Online Application

Apply through the Rajasthan Drug Control portal or designated system.

Step 4: Department Verification

Authorities verify documents and business details.

Step 5: Premises Inspection

Drug inspector visits the premises to check storage and compliance.

Step 6: Approval & License Issuance

If all requirements are satisfied, license is granted.

Time Required for Drug License Approval

Approval usually takes:

30 to 60 days, depending on inspection and document verification.

Validity of Drug License

Drug licenses are generally valid for 5 years and must be renewed before expiry.

Failure to renew may lead to suspension of operations.

How to Download Drug License Online?

Once approved, you can download your drug license:

◾ Visit state drug control portal

◾ Login with credentials

◾ Go to approved license section

◾ Download drug license certificate

Role of CDSCO in Drug Licensing

CDSCO regulates drug standards and safety across India.
State authorities issue licenses, but CDSCO guidelines must be followed for:

• Drug quality standards
• Import approvals
• Manufacturing regulations

Penalty for Operating Without Drug License

Operating without a drug license may lead to:

⚠ Heavy financial penalties

⚠ Business closure

⚠ Product seizure

⚠ Legal prosecution

Common Reasons for Application Rejection

✖ Incomplete documents

✖ Unqualified pharmacist

✖ Improper storage facility

✖ Incorrect application details

✖ Failed inspection

Proper preparation prevents delays.

Real Case Example: Drug License Approval in Kota

One of our recent clients, Mr. Mudit Sharma, wanted to open a retail medical store in Kota under the name Sharma Medico Hub. He had rented a shop and arranged a pharmacist, but his application was getting delayed due to incomplete documentation and confusion about storage requirements.

PSR Compliance reviewed his documents, corrected the premises layout, prepared compliance paperwork, and guided him through inspection preparation. After proper submission and verification, his retail drug license was approved within 38 days.

Today, Sharma Medico Hub is running legally with full compliance.

📞 Need Help With Drug License in Rajasthan?

PSR Compliance helps businesses with documentation, application filing, inspection preparation, and approval support.

Call now: 7065883416

FAQs on Drug License in Rajasthan

1. What is a Drug License in Rajasthan?

A Drug License in Rajasthan is a mandatory approval issued under the Drugs & Cosmetics Act, 1940 for manufacturing, selling, or distributing drugs, cosmetics, and medical devices.

2. Who issues the Drug License in Rajasthan?

The Drug License is issued by the Commissionerate, Food Safety and Drug Control, Rajasthan.

3. Is a Drug License mandatory for medical shops in Rajasthan?

Yes, a valid Drug License is compulsory to operate a pharmacy, wholesale business, or manufacturing unit in Rajasthan.

4. What are the types of Drug Licenses in Rajasthan?

The main types are Retail Drug License, Wholesale Drug License, and Manufacturing Drug License.

5. What is the minimum area required for a Drug License in Rajasthan?

A minimum of 10 square meters is required for retail or wholesale, with additional space needed for storage if applicable.

6. Is a registered pharmacist required for a retail Drug License?

Yes, a pharmacist registered with the Rajasthan Pharmacy Council is mandatory for obtaining a retail Drug License.

7. What documents are required for a Drug License in Rajasthan?

Applicant ID proof, premises proof, site plan, firm constitution documents, and qualification proof of the pharmacist or competent person are required.

8. How can I apply for a Drug License in Rajasthan?

Applications must be submitted online through the Rajasthan SSO portal at sso.rajasthan.gov.in.

9. What is the process for obtaining a Drug License in Rajasthan?

The process includes online application, fee payment, document submission, and inspection by the Drugs Control Officer.

10. What is the validity of a Drug License in Rajasthan?

A Drug License is generally perpetual subject to compliance, with periodic renewal and inspections as per regulations.