Applying for a drugs license is a critical step for anyone involved in the pharmaceutical, healthcare, or retail drug business. But the truth is, many applications get rejected due to avoidable mistakes. If you're planning to apply—or if you've already faced a rejection—this guide will walk you through the top reasons why drug license applications get denied, how to apply for a drug license, and how to get your application approved successfully.
1. Incomplete Documentation
The most common cause of rejection. Missing even a single form or proof can lead to denial.
Fix: Double-check with the state drug department’s official checklist.
2. Improper Premises Setup
Authorities inspect for hygiene, storage, refrigeration, and spacing.
Fix: Follow the minimum standards set by the Drug Control Department.
3. Unqualified or Unregistered Pharmacist
Only a registered pharmacist or an approved competent person is eligible.
Fix: Make sure the pharmacist's certificate is valid and not already linked with another license.
4. Incorrect License Type
Applying under the wrong category (e.g., retail instead of wholesale) can lead to rejection.
Fix: Understand your business model and select the right license.
5. Errors in the Application Form
Spelling mistakes, inconsistent address details, or incorrect document uploads can lead to delays.
Fix: Review and proofread your form before submission.
6. Non-payment or Missing Fee Receipt
Failure to pay the fee or upload proof can result in rejection.
Fix: Always save and upload the correct fee payment proof.
7. Zoning or Location Issues
Licenses may not be granted in areas not approved for commercial or pharma activities.
Fix: Confirm zoning rules before renting or buying a location.
Getting a drugs license involves several steps that vary slightly depending on your country or state. Here’s a quick overview of the general process:
Eligibility Requirements
1. Register on the State Drug Control Portal
Every state in India (and most countries) has an online portal for drug license applications.
2. Choose License Type
Select whether you need a retail, wholesale, or manufacturing license.
3. Fill Out the Application Form (Form 19, 20, etc.)
Forms vary depending on license type and jurisdiction.
4. Upload Required Documents
5. Pay the Prescribed Fee
Submit the government fee online and attach the challan or payment proof
6. Inspection by Drug Inspector
Authorities will inspect your premises to ensure it meets regulatory standards.
7. Get Approval
If everything is in order, your license will be issued within 15–60 days.
Pro Tip: Always refer to the latest state-specific guidelines. Some states now offer fully online processes, while others still require physical submission of certain documents.
Getting your drugs license approved the first time is all about preparation. By understanding the common mistakes and following the correct procedure, you can save weeks of delay and avoid costly back-and-forth with the authorities.
To learn more about drugs license in India, we recommend you to visit Metacorp as it solves legal and compliance issues of new and established businesses.
Q: How long does it take to get a drugs license approved?
A: It usually takes 15–60 days depending on your state and the completeness of your application.
Q: Can I reapply if my application is rejected?
A: Yes, once you fix the issues, you can resubmit or appeal.
Q: Do I need a separate license for online sales?
A: Yes, online pharmacies must comply with additional e-commerce and drug laws.
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