Drug Licence Registration & Renewal Services
- We prepare and file your application (Form 19, 20, 24, 28, or 29 as applicable) with the State Drug Control Authority, including all annexures, affidavits, and fee payment challans, so you can focus on your core business.
- Our experts review your facility against mandatory premises criteria (area, zoning, storage, refrigeration) and coordinate with the drug inspector to expedite the site visit and address any observations promptly.
- We assist in onboarding and credential‑verifying your registered pharmacist or competent person, ensuring their affidavits, educational certificates, experience proofs, and pharmacy council registrations are in perfect order.
- Whether you need separate licences for multiple states or distinct premises within the same state (retail, wholesale, manufacturing, loan license), we manage each application seamlessly under one consolidated engagement.
- Keep your license active and compliant: we track renewal deadlines, file your five‑year renewal applications, process change‑of‑address or addition of partners, and supply periodic status updates so you never face a lapse or penalty.
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Services
Drug License: Mandatory Pharmaceutical Compliance
A Drug License authorizes businesses to legally manufacture, sell, or distribute drugs/cosmetics in India under the Drugs & Cosmetics Act, 1940. Mandatory for pharmacies, wholesalers, manufacturers, and importers, it ensures product safety and quality control. Operating without one risks ₹5 lakh fines, imprisonment, or business closure. We secure your license in 30-45 days.
Choose Your Activity-Specific License
| License Type | Purpose | Governing Authority |
|---|---|---|
| Retail License | Sell directly to consumers (pharmacies) | State Drug Control |
| Wholesale License | Bulk sales to retailers/hospitals | State Drug Control |
| Manufacturing License | Produce drugs/cosmetics | CDSCO (Central) |
| Import License | Bring drugs into India | CDSCO |
| Loan License | Use another's facility for production | State Drug Control |
Note: Separate licenses needed for allopathic, ayurvedic, and homeopathic products.
Mandatory for These Entities
You must obtain a license if involved in:
- 💊 Retail: Pharmacies, medical stores
- 🚚 Wholesale: Distributors supplying retailers
- 🏭 Manufacturing: Drug/cosmetic production units
- 🌍 Import: Bringing pharmaceuticals into India
- 🌿 AYUSH: Ayurvedic, Unani, Siddha sellers
- 🏥 Healthcare: Hospitals with in-house pharmacies
Qualification & Infrastructure Requirements
For Retail License:
- 📜 Pharmacist: B.Pharm/D.Pharm degree + state council registration
- 🏢 Premises: 10 sq.m. area + refrigerator + commercial zoning
For Wholesale License:
- 👨💼 Competent Person: Graduate with 1yr experience OR undergraduate with 4yrs experience
- 🏭 Storage: 10 sq.m. + 18m road access for loading
For Manufacturing:
- 🧪 Technical Staff: Qualified chemist + analyst
- 🏗️ GMP-Compliant Facility: WHO-standard infrastructure
Application Checklist
All Applicants:
- ID Proof: Proprietor/director PAN/Aadhaar
- Address Proof: Electricity bill + municipal tax receipt
- Premises Proof: Lease agreement OR property papers
- Site Plan: Blueprint layout (drawn to scale)
Activity-Specific Additions:
- Retail: Pharmacist registration certificate + degree
- Wholesale: Competent person experience proof
- Manufacturing:
- Machinery list
- Product list with formulations
- GMP compliance certificate
- Import: IE code + overseas supplier details
6-Step Licensing Journey
- Document Compilation: We prepare activity-specific dossier
- Portal Filing: Submit Form 19 (retail/wholesale) or Form 24 (manufacturing) on state portal
- Fee Payment: ₹3,000 via challan
- Inspector Visit: Accompany drug inspector during premises verification
- Committee Review: State drug control committee evaluation
- Issuance: Receive license number in 30 days (retail/wholesale) | 45 days (manufacturing/import)
⚠️ Critical: Premises must be operational before inspection
Maintain Continuous Compliance
- Validity: 5 years from issuance
- Renewal: Apply 30 days before expiry with:
- Updated documents
- Compliance affidavit
- ₹3,000 fee
- Lapse Risks:
- ₹500/day penalty for late renewal
- License cancellation after 6 months
- Business closure orders
Consequences of Non-Compliance
- Unlicensed Operations:
- First offense: ₹5 lakh fine + 1-year imprisonment
- Repeat offense: ₹10 lakh + 2-year imprisonment
- Substandard Drugs: ₹10 lakh fine + 3-year imprisonment
- Adulterated Drugs: Life imprisonment + ₹10 lakh fine
- Misbranding: ₹1 lakh fine per product
Your End-to-End Licensing Partner
We handle complexities: 🔹 Activity Assessment: Match license type to your operations 🔹 Document Drafting: Prepare technical dossiers + affidavits 🔹 GMP Compliance: Guide facility setup for manufacturers 🔹 Inspector Liaison: Resolve queries during verification 🔹 Renewal Management: Auto-alerts + document updates 🔹 Post-License Support:
- Labeling compliance
- Periodic return filings
Your Questions Answered
Q1: Can one license cover multiple locations?
No – each premises requires separate registration.
Q2: Is license transferable if I sell my pharmacy?
No – new owner must apply afresh.
Q3: Do online pharmacies need a license?
Yes! Requires retail license + additional state approvals.
Q4: What if my pharmacist quits?
Hire replacement within 30 days + notify drug control office.
Secure Your Pharmaceutical License in 30 Days!
Stop risking severe penalties or operational shutdowns. CA Vakeel guarantees compliant licensing: 📞 Call: +91 98765 43210 📧 Email: contact@yourlegalfirm.com "From Compliance to Confidence: Legally Dispense Health Solutions!"