Central Drugs Standards Control Organization
Lockene is a trusted partner for industry leaders when it comes to comprehensive CDSCO compliance. We specialize in ensuring that all essential licensing requirements are fulfilled with the highest level of professionalism and efficiency. Leveraging our expertise and advanced online CDSCO services, we streamline the compliance process for businesses across India, helping them navigate regulatory complexities smoothly and effectively.
The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for drugs and medical devices. Operating under the Ministry of Health and Family Welfare, Government of India, CDSCO is responsible for ensuring the safety, quality, and effectiveness of pharmaceuticals. It establishes and enforces regulations, oversees clinical trial approvals, and conducts inspections. CDSCO’s role is to protect public health by managing the drug approval process and ongoing supervision. This authority allows CDSCO significant control over risk management while also enabling it to promote innovation by maintaining rigorous standards.
Benefits
Protects Public Health
Ensures only safe, effective drugs and devices reach users.
Clear Regulations
Guides manufacturers for smooth compliance and operations.
Supports Innovation
Encourages R&D while maintaining product safety and efficacy.
Aligns Global Standards
Elevates India’s regulatory system and boosts trade.
Service Checklist
Documents
Applicants must submit detailed product and quality documents for CDSCO approval.
- Application Submission
- Technical Documentation
- Payment of Fees
- Authorized Agent Appointment
Eligibility
Manufacturers and importers can register with CDSCO by meeting its standards and guidelines..
- Authorized Entities
- GMP Compliance
- Product Approval
- Certification Testing
Who Needs
Anyone in India dealing with drugs, medical devices, or cosmetics must obtain CDSCO licensing for registration.
- Pharmaceutical Companies
- Medical Device Manufacturers
- Cosmetic Product Importers
- Clinical Trial Organizations