Drug License Registration in India: Complete Guide

A Drug License is mandatory to operate any pharmacy or medical store in India. Here's the complete process.

Types of Drug Licenses

  • Form 20 & 21: Retail drug license (for selling medicines to consumers)
  • Form 20B & 21B: Wholesale drug license (for selling to retailers/hospitals)
  • Form 20C: Restricted license (for sales by general merchants in rural areas)

    • Who Can Apply?

    The applicant must have a Competent Person:

  • Registered Pharmacist (D.Pharm or B.Pharm holder)
  • Graduate with 1+ year drug-dealing experience (with restrictions)

    • Step-by-Step Application Process

    Step 1: Prepare the Premises

  • Minimum 10 sq.m for retail
  • Refrigerator (glass door) installed
  • Furniture and fixtures ready
  • Proper signage

    • Step 2: Gather Documents

    DocumentDetails |----------|---------| Application Forms 19, 20, 21Available at State Drug Control Dept. Site Plan (Key Plan)Blueprint showing dimensions AffidavitProprietor + Pharmacist Pharmacist CertificateKSPC/MSPC registration Rental AgreementIf rented premises Refrigerator BillAs proof Fee ChallanAs per state norms

    Step 3: Submit Application

    Karnataka: Apply online at [drugs.kar.nic.in](https://drugs.kar.nic.in) or visit the district drug control office.

    Step 4: Inspector Visit

    A Drug Inspector visits your premises to verify:

  • Area dimensions
  • Refrigerator presence
  • Pharmacist's presence
  • Proper storage conditions

    • Step 5: License Issued

    After successful verification, the license is issued within:

  • 30–60 days (if all documents complete)
  • Can take up to 90 days for any corrections

    • Drug License Fees (Approximate)

    StateRetail License Fee |-------|-------------------| Karnataka₹5,000–₹15,000 Maharashtra₹5,000–₹12,000 Telangana₹5,000–₹10,000

    License Renewal

    Drug licenses must be renewed every 5 years (or as specified by state).

    FAQ

    Q: What is Form 20 and 21 in drug license? A: Form 20 is for Schedule H & H1 drugs, Form 21 is for Schedule C/C1 and other drugs. Both are required for a complete retail pharmacy.

    Q: How long is a Drug License valid? A: 5 years in most states.

    Q: Can I apply online for a drug license in Karnataka? A: Yes, Karnataka has an online portal at drugs.kar.nic.in.

    Q: Do I need a pharmacist to be present always? A: Yes, for Schedule H drugs, a Registered Pharmacist must be present during business hours.

    Q: Can I apply for a drug license in a different state than where I studied? A: Yes, but you need to first register with that state's Pharmacy Council.