Company Registration
NGO Registration
Virtual business address
Startup Registration
Shop Act Registration
BIS Registration main
CDSCO Registration
Star Rating Certification
WPC Registration
Brand Registration
Legal Metrology Certification
CPCB Approval
PESO certification
Fire NOC
AERB Certification
PSARA License
Fssai License
RCMC Certification
Import Export Registration
China Food Export
RNI Certification
NSIC Registration
ISO Certification Main
ICEGATE Registration Main
Income tax Filing
Annual Compliance
Trade License Registration
Factory License Registration
Tue, Jan 06 2026
Raju Karn
Starting or running a pharmaceutical business in Karnataka without a valid drug license is not just risky-it can shut down your operations overnight. Whether you are a wholesaler in Bengaluru, a retailer in Mysuru, or a manufacturer supplying across India, drug license registration is legally mandatory under the Drugs and Cosmetics Act. Yet, many businesses still struggle with drug license verification, Form 20 and 21 applications, CDSCO login issues, and renewal timelines.
If you are searching for a clear, step-by-step guide for drug license in Karnataka (2026)-covering CDSCO online, ONDLS CDSCO, CDSCO Sugam portal, documents, fees, validity, and compliance-this guide will help you make the right decisions from day one.
PSR Compliance assists businesses across Karnataka and India with drug license registration, renewal, and CDSCO approvals, ensuring your business remains compliant and growth-ready.
A drug license is a legal authorization issued by the State Drug Control Department or CDSCO (Central Drugs Standard Control Organization) that allows a business to:
Without a valid license, any activity involving drugs is considered illegal under Indian law.
CDSCO full form: Central Drugs Standard Control Organization
CDSCO is India’s national regulatory authority responsible for:
➜ Approval of new drugs and medical devices
➜ Regulation of clinical trials
➜ Import/export permissions
➜ Oversight of drug manufacturing and quality
Businesses in Karnataka must comply with both State Drug Control Department regulations and CDSCO guidelines.
Depending on your business model, you may need one or more of the following:
● Retail Drug License
For medical stores and pharmacies selling directly to consumers.
● Wholesale Drug License
For distributors, stockists, and suppliers selling to retailers, hospitals, or clinics.
● Manufacturing Drug License
For companies producing medicines or pharmaceutical formulations.
● Loan License
For businesses manufacturing drugs using another company’s facilities.
● Import / Export Drug License (CDSCO Online)
For companies importing or exporting pharmaceutical products.
Form 20 Drug License
Form 21 Drug License
Both forms are issued by the State Drug Control Department in Karnataka after verification of premises, staff qualifications, and compliance standards.
Holding a valid drug license is not just a legal formality-it directly impacts business credibility and growth.
– Legal authorization to operate
– Eligibility to supply hospitals, clinics, and government tenders
– Business expansion across states
– Easy drug license verification by partners and authorities
– Builds trust with customers and distributors
– Required for CDSCO approved drug distribution
You must apply for a drug license if you are:
➝ A medical store owner
➝ A pharmaceutical wholesaler or distributor
➝ A drug manufacturer
➝ A hospital or clinic with in-house pharmacy
➝ An online pharmacy
➝ An importer or exporter of medicines
Business Documents
• Certificate of Incorporation / Partnership Deed / Proprietorship Proof
• PAN Card
• GST Registration
• Address proof of business premises
Premises Documents
• Rental Agreement or Ownership Proof
• Site plan / layout of shop or warehouse
• Storage facility details (refrigeration if required)
Staff & Technical Documents
• Qualification certificates of registered pharmacist / competent person
• Appointment letter
• Experience certificates (for wholesale)
Compliance Documents
• Affidavit of compliance
• Declaration of drug categories
• Application forms (Form 20 / Form 21 / Manufacturing forms)
Step 1: Determine the License Type
Identify whether you need retail, wholesale, manufacturing, or CDSCO import/export license.
Step 2: Prepare Documents
Compile all business, premises, and technical documents.
Step 3: Online Application
Apply through the state drug control portal or CDSCO online system where applicable.
Step 4: Site Inspection
Drug inspectors verify:
Step 5: Approval & Issuance
After successful inspection, your drug license certificate is issued.
CDSCO Online
Used for approvals related to imports, exports, medical devices, and new drugs.
ONDLS CDSCO (Online National Drug Licensing System)
A centralized digital platform for application, tracking, and compliance.
CDSCO Sugam Portal
For:
You can track applications using:
➤ CDSCO login
➤ CDSCO MD online system
➤ CDSCO Sugam portal dashboard
A drug license is not permanent-it must be renewed before expiry.
Renewal Process
▪ Update documents
▪ Submit renewal application
▪ Pay government fees
▪ Undergo re-inspection if required
Why Renewal Is Critical
▪ Avoid penalties and cancellation
▪ Prevent disruption in supply chain
▪ Maintain eligibility for tenders and partnerships
PSR Compliance handles drug license renewal with complete follow-ups and documentation support.
Government Fees (Approx.)
Retail / Wholesale License: ₹3,000 – ₹10,000
Manufacturing License: ₹10,000 – ₹50,000+(Fees may vary based on category and state rules)
Timeline
Application Processing: 15–30 working days
Inspection & Approval: 7–15 days
Validity
Typically 5 years
Renewal required before expiry
In 2025, Mr. Suresh Reddy, who operates a pharmaceutical distribution firm in Yelahanka, Bengaluru, approached PSR Compliance after one of his hospital clients asked for drug license verification and found that his Form 21 license was close to expiry. Due to a missed renewal deadline, his distributor registration was temporarily blocked, and two large supply orders were put on hold.
Our team immediately reviewed his compliance status, prepared renewal documentation, updated records on the ONDLS CDSCO system, and coordinated with the Drug Control Department. We also ensured his business details were properly reflected on the CDSCO Sugam portal. Within a short period, his drug license renewal was approved, and hospital contracts were reinstated. Today, his operations run smoothly with proper compliance and digital verification in place.
PSR Compliance provides end-to-end drug licensing services for businesses across Karnataka and India.
Our Services Include:
☑ Drug license registration (Retail, Wholesale, Manufacturing)
☑ Form 20 and 21 application handling
☑ CDSCO online filing & ONDLS management
☑ Drug license verification assistance
☑ Renewal, modification & compliance support
☑ Import/export drug license & CDSCO approvals
We handle everything-from documentation to inspections-so you can focus on growing your pharmaceutical business.
1️⃣ What is a drug license?
A drug license is a legal authorization to manufacture, sell, or distribute pharmaceutical products in India.
2️⃣ What is the CDSCO full form?
CDSCO stands for Central Drugs Standard Control Organization, India’s national drug regulatory authority.
3️⃣ What are Form 20 and 21 drug licenses?
Form 20 is for retail sale, while Form 21 is for wholesale distribution of drugs.
4️⃣ Is drug licesne mandatory in Karnataka?
Yes. Operating without a valid drug license is illegal and punishable under the Drugs and Cosmetics Act.
5️⃣ How can I verify a drug license?
Drug license verification can be done through the state drug control portal or CDSCO platforms using the license number.
6️⃣ What is CDSCO Sugam portal?
It is an online system for drug approvals, imports, exports, and regulatory submissions.
7️⃣ How long does drug license approval take?
Typically 3–6 weeks depending on inspection and document verification.
8️⃣ What is the validity of a drug license?
Usually valid for 5 years, after which renewal is required.
9️⃣ Can I apply for drug license online?
Yes. Applications can be submitted through state portals and CDSCO online / ONDLS CDSCO systems.
🔟 How can PSR Compliance help?
PSR Compliance provides complete support for registration, renewal, verification, and CDSCO compliance across Karnataka and India.