Drug License in India
Obtaining a drug license is essential to legally operate a pharmacy, wholesale distribution, or manufacturing business in India. Tax Pal Solutions simplifies the process with fast approvals, compliance support, and expert guidance.
Key Benefits of a Drug License
- Legal Authorization: Operate pharmacies, wholesale, or manufacturing units.
- Fast Approvals: Streamlined online submission and verification.
- Compliance Management: Ensure adherence to the Drugs & Cosmetics Act.
- State-Specific Expertise: Guidance according to state regulations.
- Trusted by Businesses: Supporting 20,000+ businesses across India.
What is a Drug License?
A drug license is an official permit issued under the Drugs and Cosmetics Act, 1940 that allows a business to manufacture, sell, distribute, or import drugs and cosmetics.
- Purpose: Ensures safety, quality, and accountability of pharmaceuticals.
- Validity: Typically 5 years, after which renewal is mandatory.
Types of Drug Licenses
| License Type | Purpose |
|---|---|
| Drug Manufacturing License | For companies producing medicines (allopathic, ayurvedic, homeopathic) with GMP compliance. |
| Wholesale Drug License | Supply drugs in bulk to retailers, hospitals, and institutions. |
| Retail Drug License | Pharmacies selling directly to consumers. Requires a registered pharmacist. |
| Loan License | Market your brand using another manufacturer’s facility. |
| Drug Import License | Import drugs or raw materials in compliance with regulations. |
| Drug Export License | Export drugs that meet Indian and foreign regulatory standards. |
| Multi-Drug License | Combined license for multiple drug types, simplifying compliance. |
Purpose of a Drug License
- Protect Public Health: Ensure safe medicines in controlled environments.
- Prevent Fake Drugs: Legal framework reduces counterfeit distribution.
- Accountability: Identifies responsible individuals/businesses.
- Standardized Operations: Uniform standards for storage, staffing, and record-keeping.
Governing Laws & Authorities
Legal Framework:
- Drugs and Cosmetics Act, 1940 – Core regulation of drugs & cosmetics.
- Drugs and Cosmetics Rules, 1945 – Detailed procedures and forms.
- Pharmacy Act, 1948 – Standards for pharmacists and pharmacy operations.
- Medical Device Rules, 2017 – Regulations for medical devices.
- New Drugs & Clinical Trials Rules, 2019 – Procedures for clinical trials and new drug approval.
- Cosmetic Rules, 2020 – Safety regulations for cosmetics.
Authorities:
- CDSCO (Central Drugs Standard Control Organisation): National approvals, imports, specialized products.
- State Drug Control Organizations: Local license issuance and inspections for retail and wholesale.
Eligibility Criteria
| Requirement | Details |
|---|---|
| Age | Applicant must be ≥ 21 years old. |
| Business Entity | Proprietorship, Partnership, LLP, Private Ltd Company. |
| Legal Record | No prior convictions under Drugs & Cosmetics Act. |
| GST Registration | Mandatory for selling products. |
| Premises | Permanent structure, minimum area: 10–15 sq.m, proper storage with refrigeration. |
| Staff | Registered pharmacist (retail) or competent person (wholesale/manufacturing). |
Documents Required
| License Type | Essential Documents |
|---|---|
| All Licenses | Application form, fee receipt, PAN, GST, site plan, affidavit of non-conviction. |
| Retail | Pharmacist degree & registration, appointment letter, premises documents, purchase invoices for refrigerator/AC. |
| Wholesale | Competent person documents, technical staff qualifications, premises proof, invoices. |
| Manufacturing | Technical staff biodata, SMF, SOPs, machinery list, environmental & fire NOCs, lab details, plant layout. |
| Import/Export | CDSCO license, shipment details, product compliance certificates. |
Application Process
- Research & Preparation: Identify license type, check regulations, ensure premises compliance, gather documents.
- Online Application Submission: Create account on state portal → Fill form → Upload documents → Pay fees.
- Verification & Inspection: Authorities review documents and inspect premises.
- License Issuance: Approval granted → License available for download → Display license at premises.
Fees & Penalties
| License Type | Government Fee (INR) |
|---|---|
| Retail/Wholesale | ₹3,000 |
| Restricted | ₹1,000 |
| Schedule X Drugs | ₹500 extra |
| Manufacturing | ₹7,500 + inspection fees |
| Renewal | Same as original license fee |
Penalties for Non-Compliance:
- Selling drugs without license: 1–3 years jail + ₹5,000 fine.
- Spurious/adulterated drugs: 7–10+ years jail + fines up to ₹10 lakh.
- License can be cancelled, and stock seized.
Validity & Renewal
- Validity: 5 years for retail/wholesale licenses.
- Renewal Process: Apply 60 days before expiry → Pay fee → Submit documents → Inspection (if required) → Receive renewed license.
- Late Renewal: Within 6 months → Regular fee + 2% per month. Beyond 6 months → Apply for a new license.
Compliance Requirements
- Maintain proper sales and purchase records.
- Follow storage regulations, especially for temperature-sensitive drugs.
- Employ qualified personnel during operational hours.
- Display license prominently in premises.
- Adhere to Good Manufacturing/Distribution Practices (GMP/GDP).
- Avoid unauthorized changes in premises or business structure.
Certification
