What is a Drug License?

A Drug License is a legal permit required for businesses involved in the manufacturing, distribution, or sale of drugs and cosmetics. It is issued by the State Drugs Standard Control Organization under the Drugs and Cosmetics Act, 1940.

Operating a pharmacy (Retail) or becoming a medical distributor (Wholesale) without a valid license is a punishable offense. The license ensures that drugs are handled by qualified personnel and stored in proper conditions to maintain their efficacy.

Types of Licenses

  • Retail Drug License: For chemist shops/pharmacies (Form 20/21).
  • Wholesale Drug License: For distributors/stockists (Form 20B/21B).
  • Manufacturing License: For drug production units.
  • Restricted License: For general stores selling household meds.
  • Loan License: Manufacturing using another's facility.

Key Requirements

  • Pharmacist: Mandatory for Retail License.
  • Competent Person: Required for Wholesale (Graduate + 1yr Exp).
  • Space: Min 10 sq. mtrs (Retail/Wholesale) or 15 sq. mtrs (Combined).
  • Storage: Refrigerator & Air Conditioning for temperature control.
  • Premises: Commercial or Mixed Land Use area.

Registration Process

Comprehensive steps to open your medical store.

Documents Required

  • Pharmacist Registration Certificate & Affidavit
  • Blueprint/Key Plan of Premises
  • Ownership Proof / Rent Agreement
  • Refrigerator Purchase Bill
  • ID & Address Proof of Proprietor/Directors
  • Experience Certificate (for Wholesale)

Application Steps

  • Document Collection & Verification
  • Creating Online ID on Drug Dept Portal
  • Uploading Documents & Fee Payment
  • Inspection by Drug Inspector (DI)
  • Grant of Drug License

Timeline & Validity

  • Processing Time: 30-45 Working Days.
  • Validity: 5 Years (Renewable).
  • Retention Fee: Payable every 5 years.
  • Changes: Modifications allowed post-issuance.

Start Your Medical Business

Open your Chemist Shop or Distribution Agency with complete legal compliance. Expert guidance at every step.

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Frequently Asked Questions

Common queries about Drug License Registration.

What is the difference between Retail and Wholesale Drug License?
A Retail Drug License (Form 20/21) is for chemists/pharmacies selling drugs to end consumers. A Wholesale Drug License (Form 20B/21B) is for distributors or stockists who sell drugs to retailers or other bulk buyers.
Is a registered pharmacist mandatory for a Drug License?
Yes, for a Retail License, employing a registered pharmacist is mandatory. For a Wholesale License, you need either a registered pharmacist or a "Competent Person" (a graduate with 1 year of experience or a matriculate with 4 years of experience in drug dealing).
What are the minimum area requirements for a pharmacy?
For a retail or wholesale shop individually, the minimum carpet area required is 10 square meters. If you are applying for both retail and wholesale licenses in the same premises, the minimum area required is 15 square meters.
How long is a Drug License valid?
A Drug License is typically valid for 5 years from the date of issue. It must be renewed before expiry by paying the retention fee to continue business operations without interruption.
Can I operate a pharmacy from a residential premise?
Generally, the premises should be commercial or mixed-use. If it is a residential property, you may need a conversion certificate or specific approval from the local municipality, along with a separate entry for the shop.
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