Drug License Registration

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.

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.

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

Mandatory for selling medicines and divided into:

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

Why Is Drug Licence Registration Important?

A drug licence is not just a legal requirement—it protects public health.

Key Reasons:

• Consumer Safety: Ensures medicines are stored and sold under hygienic conditions

• Prevents Fake Drugs: Stops counterfeit and substandard medicines

• Legal Accountability: Fixes responsibility on the licence holder

• Standardised Operations: Uniform rules for pharmacies across India

LegalInfinix helps you apply drug licence for medical store without errors.

Importance of Getting a Drug Licence

• Legal authority to operate your pharmacy or drug business

• Direct purchase from authorized manufacturers

• Increased customer trust and credibility

• Quality control through regulated storage

• Higher profitability and business stability

If you are searching “how to apply wholesale drug licence”, our consultants are ready to assist.

Eligibility Criteria for Drug Licence Registration

Legal Requirements

• Minimum age: 21 years

• Business must be legally registered as:

  • Sole Proprietorship

  • Partnership Firm

  • LLP

  • Private Limited Company

Premises Requirements

• Retail or Wholesale: Minimum 10 sq. meters

• Retail + Wholesale: Minimum 15 sq. meters

• Permanent structure (brick & mortar)

• Mandatory refrigerator and air-conditioning

• Proper racks and storage facilities

Documents Required for Drug Licence Registration

Common Documents (All Licences)

• Application form (Form 19 / applicable form)

• Government fee receipt

• Business registration documents (MOA, AOA, LLP deed, etc.)

• PAN card of firm/company

• ID & address proof of proprietor/directors

• Premises ownership or rent agreement

• Site plan & key plan

• Affidavit of non-conviction

Additional Documents by Licence Type

Retail Drug Licence

• Pharmacist degree/diploma (D.Pharm / B.Pharm)

• State Pharmacy Council registration

• Appointment & joining letter

• Full-time employment affidavit

• Electricity bill, AC & fridge invoices

Wholesale Drug Licence

• Educational qualification certificates

• Experience certificate (1–4 years)

• Appointment & joining letter

• Premises documents

Drug Manufacturing Licence

• Technical staff list & qualifications

• Site Master File (SMF)

• Pollution Control NOC

• Fire Safety NOC

• Factory layout plans

• Machinery list & SOPs

• Quality control lab details

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 and fill application form

• Upload documents

• Pay government fees

Step 3: Inspection

• Drug Inspector visits premises

• Verifies storage, documents & compliance

Step 4: Licence Issuance

• Approval by authority

• Download drug licence certificate

• Display licence at business premises

LegalInfinix also assists with pharmacy registration renewal online.

Drug Licence Fees & Penalty Structure (Indicative)

Fees vary based on:

• Drug category (Schedule C, C1, X, etc.)

• Retail / Wholesale / Restricted licence

• State rules

Late renewal attracts monthly penalties, and operating without a valid licence can lead to cancellation or prosecution.

Contact LegalInfinix for exact fee calculation as per your state.

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.

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