What is a Drug License?
A Drug License is a mandatory legal permit issued by the government under the Drugs and Cosmetics Act, 1940. It authorizes individuals or businesses to manufacture, sell, distribute, import, or export drugs and cosmetics in India.
The primary purpose of this license is to regulate the pharmaceutical industry, ensuring that all medicines sold to the public are safe, effective, and of standard quality. Operating a pharmacy or drug business without a valid license is a punishable offense.
Types of Drug Licenses
Depending on the nature of the business, different types of licenses are issued:
- Retail Drug License: For chemists and pharmacies selling drugs directly to consumers. Issued in Forms 20 and 21.
- Wholesale Drug License: For businesses selling drugs in bulk to retailers or hospitals. Issued in Forms 20B and 21B.
- Manufacturing License: For units manufacturing allopathic, ayurvedic, or homeopathic medicines. Issued in Forms 25 and 28.
- Loan License: For businesses that do not have their own manufacturing unit but use another licensee's facility to manufacture their products.
- Import License: For importing drugs and cosmetics into India.
- Restricted License: For general stores selling household medicines (like paracetamol) without a qualified pharmacist.
Eligibility Criteria
To obtain a drug license, the following conditions must be met:
- Premises Area: Minimum 10 sq. meters for retail or wholesale. Minimum 15 sq. meters for combined retail and wholesale.
- Storage Facilities: Proper storage with refrigerators and air conditioners to maintain the required temperature for drugs (Cold Chain).
- Technical Staff:
- For Retail: A Registered Pharmacist approved by the State Pharmacy Council.
- For Wholesale: A Competent Person (Graduate with 1 year experience or Undergraduate with 4 years experience in drug dealing).
- Clean Record: The applicant should not have been convicted under the Drugs and Cosmetics Act.
Documents Required for Drug License
The documentation varies slightly by state and license type, but generally includes:
- Application Form: Duly filled and signed (e.g., Form 19).
- Fee Receipt: Proof of payment of government fees.
- Constitution of Firm: MOA/AOA for companies, Partnership Deed for firms, or Proprietorship declaration.
- ID & Address Proof: PAN Card, Aadhaar Card of Proprietor/Partners/Directors.
- Premises Proof: Rent Agreement/Sale Deed, Property Tax Receipt, and Layout Plan/Blueprint of the premises.
- Pharmacist/Competent Person Docs: Registration Certificate, Degree/Diploma, Appointment Letter, and Affidavit.
- Storage Proof: Purchase invoice of Refrigerator and Air Conditioner.
- Affidavits: Non-conviction affidavit and other declarations as per state rules.
Registration Process
- Document Collection: Gather all necessary documents and ensure the premises meet the requirements.
- Online Application: Register on the state Drug Control Department's portal and fill out the application form.
- Fee Payment: Pay the requisite government fee online.
- Inspection: A Drug Inspector will visit the premises to verify the facility, storage conditions, and documents.
- Scrutiny & Approval: If the inspection report is positive and documents are in order, the Licensing Authority will grant the license.
- Issuance: The license certificate is issued and can be downloaded from the portal.
Fees & Penalties
Government Fees (Approximate)
- Retail/Wholesale License: ₹3,000
- Restricted License: ₹1,000
- Manufacturing License: ₹7,500 + Inspection Fees
Penalties for Violations
Operating without a license or selling spurious/adulterated drugs can lead to severe penalties:
- Selling without License: Imprisonment of 1-3 years and fine of at least ₹5,000.
- Adulterated Drugs: Imprisonment of 1-3 years and fine of at least ₹1 Lakh.
- Spurious (Fake) Drugs: Imprisonment of 7 years to Life and fine of at least ₹3 Lakhs.
