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Drug License Registration

LegalInfinix offers professional assistance for drug licence registration online, pharmacy registration, and drug licence renewal online across India. Contact LegalInfinix today for fast and hassle-free drug licence registration..

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Drug Licence Registration Apply Online – Process, Documents & Fee Structure

If you are planning to manufacture, sell, distribute, import, or export medicines, or you want to open a pharmacy / medical store, obtaining a Drug Licence registration is mandatory in India. Operating any business related to medicines or cosmetics without a valid medical drug licence is a punishable offence.

The Government of India has strengthened drug licensing regulations to ensure that safe, genuine, and quality medicines are accessible to everyone. The entire process—from manufacturing to sale—is governed under the Drugs and Cosmetics Act, 1940.

What Is a Drug Licence?

A Drug Licence is a legal authorization issued by the Drug Control Department that allows an individual or business to manufacture, sell, distribute, import, or export drugs and cosmetics in India.

This licence ensures that medicines available in the market meet quality, safety, and regulatory standards. Once issued, a drug licence must be renewed every 5 years to remain valid.

Apply for drug licence renewal online with LegalInfinix and stay compliant.

Types of Drug Licence Registration in India

Depending on your business activity, you must apply for the appropriate licence.

1. Drug Manufacturing Licence

Required for companies manufacturing:

  • Allopathic medicines
  • Ayurvedic products
  • Homeopathic medicines
  • Cosmetics and pharmaceutical formulations

2. Drug Sale Licence

Wholesale Drug Licence
For businesses supplying medicines in bulk to hospitals, pharmacies, and institutions.

Retail Drug Licence
Required for medical stores, pharmacies, and Ayurvedic shops selling directly to consumers.

3. Loan Licence

For businesses that market drugs manufactured at another company’s licensed manufacturing facility.

4. Drug Import Licence

Required to import drugs or pharmaceutical raw materials into India (regulated by CDSCO).

5. Drug Export Licence

Mandatory for exporting pharmaceutical products outside India.

6. Multi-Drug Licence

Allows businesses dealing in multiple drug categories (allopathic, ayurvedic, homeopathic) under a single registration.

Call LegalInfinix now for pharmacy registration apply or renewal support.

Drug Licence Application Forms

Licence Type Application Form Purpose
Drug Manufacturing Licence Form 25, Form 28 Manufacturing medicines legally
Wholesale Drug Licence Form 20B, Form 21B Bulk sale of medicines
Retail Drug Licence Form 20, Form 21 Sale to consumers
Loan Licence Form 24A Marketing drugs manufactured elsewhere
Drug Import Licence Form 10, Form 11 Import of drugs/raw materials
Drug Export Licence Product-specific Export compliance

How to Apply for Drug Licence Registration Online?

Step 1: Preparation

Identify correct licence type, ensure premises compliance, gather all documents.

Step 2: Online Application

Visit State Drug Control/FDA portal, register, upload documents, pay fees.

Step 3: Inspection

Drug Inspector visits premises and verifies compliance.

Step 4: Licence Issuance

Approval by authority and download certificate.

LegalInfinix also assists with pharmacy registration renewal online.

How Can LegalInfinix Help You?

Drug licence registration involves multiple departments, inspections, and strict compliance. A small mistake can delay or reject your application.

LegalInfinix Offers:

  • Drug licence apply online
  • Pharmacy registration & renewal
  • Wholesale & retail drug licence
  • Manufacturing & import licences
  • End-to-end documentation & inspection support

We also assist with:

  • Private Limited Company Registration
  • LLP Registration
  • NITI Aayog Registration
  • RERA Agent Registration
  • Trademark Registration

Choose LegalInfinix for stress-free business compliance.

Other Services from Legal Infinix

We manage complete business setup and compliance across India.

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FAQs – Drug Licence Registration