Overview of Drug Licence Registration
A drug licence is mandatory for any business manufacturing, distributing, retailing or importing drugs, cosmetics and medical devices in India. The application requires compliant premises, qualified staff, storage systems and documentation under the Drugs and Cosmetics Act.
Key Benefits for Your Business
- Legal authority to manufacture or sell drugs and cosmetics
- Premises, storage and cold chain compliance
- Schedule M and GMP readiness for manufacturing units
- Qualified technical staff verification support
- Clean inspection results with documented systems
Industries We Support
pharma manufacturers, Ayurveda and herbal units, cosmetic makers, medical device makers, distributors, wholesalers and pharmacy retail chains and more. Our team will tailor the documentation to your operations.
Documents You Will Need
- Premises ownership or rent agreement and layout
- Qualification certificates of technical staff
- Equipment, storage and refrigeration details
- Company registration and PAN documents
- Water test report and pollution clearances where applicable
How the Certification Works with SR Certifications
- 🔍 Free Gap AnalysisOur auditors review your current processes and identify what is needed to meet the standard.
- 📄 Documentation & ImplementationPolicies, manuals, SOPs and formats are prepared and implemented with your team.
- 🎓 Awareness TrainingManagement and staff training builds understanding of the new system and their roles.
- ✅ Internal Audit & Corrective ActionA practice audit is conducted and findings are closed before the certification audit.
- 🏆 Certification Audit & CertificateThe accredited registrar audits your site and the certificate is issued and validated.
Frequently Asked Questions
Which drug licence do I need?
The category depends on the activity — manufacturing, wholesale, retail or import — and each has its own application route and premises requirements.
Do manufacturing units need GMP compliance with a drug licence?
Yes. Manufacturing licences require GMP implementation as per Schedule M, along with documented quality control systems.
How long does drug licence approval take?
After joint inspection with correct premises and staff documents, approvals are generally granted within a few weeks.
