Drug License
Legally Manufacture, Distribute, or Retail Pharmaceutical Products
Drug License is a mandatory authorization required under the Drugs and Cosmetics Act, 1940 for manufacturing, distributing, or selling pharmaceutical products and medical devices. Aggarwal H K & Co. provides comprehensive drug license application services, ensuring your pharmaceutical business operates with complete legal compliance.
What is Drug License?
Drug License is issued by the State Drug Control Department or Central Drugs Standard Control Organization (CDSCO) permitting businesses to engage in manufacturing, wholesale, retail, or distribution of drugs, pharmaceuticals, and cosmetics.
Types of Drug Licenses
Manufacturing License
Required for manufacturing pharmaceutical products, allopathic drugs, ayurvedic medicines, or cosmetics at production facilities.
Wholesale License
For businesses involved in wholesale distribution and supply of drugs to retailers, hospitals, and medical institutions.
Retail License
Mandatory for pharmacies and medical stores selling pharmaceutical products directly to consumers.
Loan License
Arrangement where a license holder allows another party to manufacture products using their license.
Why Drug License is Essential?
Legal Compliance
Operating without a drug license can result in heavy penalties, imprisonment, and closure of business under the Drugs Act.
Quality Assurance
Ensures that your business meets quality standards and safety protocols required for handling pharmaceutical products.
Business Credibility
License builds trust with suppliers, customers, and regulatory authorities, essential for establishing pharmaceutical business.
Market Access
Required for supplying to hospitals, government institutions, and participating in pharmaceutical tenders.
Key Requirements
Qualified Person
A registered pharmacist with valid qualification (B.Pharm/M.Pharm/D.Pharm) must be employed as the responsible person.
Adequate Infrastructure
Proper storage facilities, temperature control, and hygiene standards as per regulatory requirements.
Quality Standards
Compliance with Good Manufacturing Practices (GMP) for manufacturing or Good Storage Practices (GSP) for distribution.
Registration Process
We handle complete license application including site inspection preparation, documentation, qualification verification, application filing with drug control authorities, and obtaining license certificate.
Documents Required
- Qualification certificates of pharmacist
- Premises ownership or rental agreement
- Layout plan of premises
- List of drugs to be dealt with
- Form of application as prescribed
- Challan for license fee payment
- NOC from local authority
License Validity
Drug licenses are typically valid for 5 years and must be renewed before expiry with updated documentation and compliance verification.
Start Your Pharmaceutical Business Legally! Trust Aggarwal H K & Co. for expert drug license application services with complete documentation and regulatory compliance support.