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Get your drug license registration in India done by India's leading experts. We offer fast, affordable, and 100% compliant drug license services for retail, wholesale, manufacturing, import/export, and online pharmacies.
15+ years of experience | PAN India Service | Trusted by 2,000+ businesses
A drug license is a legal permit issued by the government to businesses involved in the manufacture, sale, distribution, or import of drugs and medicines. It ensures that only qualified and compliant entities can operate in the pharmaceutical sector, protecting public health and safety.
For pharmacies, chemists, and medical stores selling drugs directly to consumers.
For distributors and suppliers selling drugs to retailers, hospitals, or other businesses.
For companies manufacturing drugs, cosmetics, or medical devices. Includes GMP and Schedule M compliance.
For businesses importing or exporting drugs and medicines, including FDA and CDSCO approvals.
Renew your license online with our hassle-free process and compliance reminders.
Check the status and authenticity of your drug license online. We help with verification and compliance audits.
Legal Requirement: No person or business can sell, stock, exhibit, or distribute drugs without a valid license.
Quality Assurance: Ensures medicines are safe, effective, and stored under proper conditions.
Business Growth: Enables you to expand into new markets, supply to hospitals, and participate in government tenders.
We are India's most trusted drug license consultants, helping businesses of all sizes get licensed quickly and hassle-free.
We ensure your application meets all CDSCO, FDA, and state requirements. Zero rejection record for compliant clients.
Get your drug license in as little as 15-30 days. Priority handling for urgent cases and renewals.
We serve every state and city in India. Local expertise, national reach.
Thousands of successful drug license registrations for pharmacies, wholesalers, manufacturers, and importers.
No hidden charges. All-inclusive packages for new registration, renewal, and verification.
Personal consultant for every client. WhatsApp, phone, and email support throughout the process.
Apply online for new drug license, renewal, verification, and status check. We handle all types of drug licenses:
For medical stores, pharmacies, and chemists. Fastest approval for drug license for medical store and drug license online apply.
For distributors and B2B suppliers. Wholesale drug licence with easy documentation and expert guidance.
For pharma manufacturers. CDSCO registration, FDA license, and drug license registration process in India made simple.
For importers/exporters. Drug license apply online for global trade, including FDA registered and food and drug administration registration.
Everything you need to know about drug license registration in India.
Government fees vary by state and license type. For example:
We provide a transparent quote including all charges.
Typical processing time is 15–30 working days for retail/wholesale, and 30–60 days for manufacturing/import/export licenses. Timelines may vary by state and application completeness.
Yes! We offer drug license renewal and drug license verification services online for all states. Get reminders, status updates, and compliance support.
The Drugs and Cosmetics Act, 1940 governs the manufacture, sale, and distribution of drugs in India. Obtaining a proper drug license is mandatory for any business dealing with pharmaceuticals or cosmetics.
A drug license ensures that medicines and drugs are manufactured, stored and sold under proper conditions to maintain their quality and efficacy. It helps regulate and monitor the pharmaceutical industry to prevent misuse of drugs and protect public health.
In India, drug licenses are categorized based on the nature of the pharmaceutical business:
Required for pharmacies and chemist shops selling drugs directly to consumers.
Required for distributors supplying drugs to retailers and institutions.
Required for companies manufacturing drugs and cosmetics.
Required for businesses importing drugs and cosmetics into India.
| License Type | Minimum Area Required | Additional Requirements |
|---|---|---|
| Retail Pharmacy | 10 square meters | Proper storage facilities, display area |
| Wholesale | 15 square meters | Separate storage for different drug categories |
| Manufacturing Unit | As per Schedule M | Separate areas for production, testing, storage |
We simplify the complex drug license application process with our systematic approach
We conduct a detailed consultation to understand your business model and determine the exact type of drug license(s) required. Our experts analyze your premises, staff qualifications, and business operations to ensure all prerequisites are met before application.
Our team prepares the complete documentation package including all required forms, affidavits, and supporting documents. We verify all technical details including premises specifications, pharmacist qualifications, and compliance with storage requirements.
We submit your application to the relevant authority (State Drugs Control Department, CDSCO, or Ayush Department) based on license type. Our team ensures proper filing with all attachments and follows up for acknowledgment.
We coordinate the drug inspector's visit and ensure your premises meets all requirements during inspection. Our experts accompany the inspector and address any queries regarding your application or facility setup.
We follow up with the authorities until your drug license is issued. The original license is collected from the office and delivered to you along with guidance on compliance requirements during the license validity period.
Typically takes 25-30 working days from application submission to license issuance, depending on the state and type of license. Manufacturing licenses may take longer due to additional inspections.
The drug licensing system in India involves multiple regulatory bodies depending on the type of license and products involved:
While retail and wholesale licenses are issued by state authorities, manufacturing licenses for certain categories like vaccines, sera, and blood products require approval from both state and central authorities. Import licenses are exclusively granted by CDSCO.
The Drugs and Cosmetics Rules, 1945 prescribe specific forms for different types of drug license applications:
| Form No. | Purpose | Applicable For |
|---|---|---|
| Form 8 | Application to import drugs (excluding Schedule X) | Importers |
| Form 8A | Application to import Schedule X drugs | Importers of controlled substances |
| Form 19 | Application for retail/wholesale license (excluding Schedule X) | Retailers, Wholesalers |
| Form 19C | Application for retail/wholesale license for Schedule X drugs | Pharmacies dealing in controlled drugs |
| Form 24 | Application for manufacturing license (excluding Schedules C, C(1), X) | Manufacturers of general drugs |
| Form 24F | Application for manufacturing Schedule X drugs | Manufacturers of controlled drugs |
| Form 27 | Application for manufacturing biological products | Vaccine manufacturers, Blood banks |
| Form 40 | Application for registration of imported drugs | Importers of foreign drugs |
The exact form requirements may vary slightly between states. Our experts will guide you on the specific forms needed for your application based on your business location and activities.
Obtaining a drug license comes with ongoing compliance obligations that businesses must fulfill:
The Drugs and Cosmetics Act prescribes strict penalties for violations including imprisonment (1-3 years) and fines (up to Rs. 5000 or more). Serious violations may lead to cancellation of license. Regular compliance audits are recommended to avoid such situations.
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