
Drugs & Medical Equipment Licence (CDSCO)
CDSCO registration is a mandatory compliance process for all pharmaceuticals, medical devices, cosmetics, and diagnostic products entering the Indian market. Regulated by the Central Drugs Standard Control Organization (CDSCO), operating under the Directorate General of Health Services, Ministry of Health and Family Welfare, it serves as India’s National Regulatory Authority (NRA). The CDSCO oversees approvals and clinical trials and ensures product quality and safety under the Drugs and Cosmetics Act, 1940, and Medical Device Rules, 2017.
Manufacturers and importers must register their products with CDSCO before sale or distribution. This process safeguards public health by setting and enforcing standards, controlling imports, granting licenses, and evaluating new drugs and devices. Induce India supports applicants through each stage of the CDSCO registration lifecycle.
Types of CDSCO Licenses & Registrations
- New Drug Approval (NDA): Required for drugs not previously approved in India.
- Import License: Mandatory for importers of pharmaceuticals, devices, cosmetics, and diagnostics.
- Manufacturing License: Required for Indian companies manufacturing regulated products.
- Medical Device Registration: Based on risk classification (Class A, B, C, D).
- Cosmetic Registration: For skincare, personal care, and cosmetic products.
- Clinical Trial Approval: For sponsors conducting drug/device trials in India.
- Export License: For international shipment of regulated healthcare products.
Eligibility & Documentation
Entities eligible for CDSCO registration include Indian manufacturers, importers, corporate subsidiaries, Indian agents, and foreign companies with Indian representation. Mandatory documents include:
- Technical data sheets
- GMP certificates
- ISO 13485 certification (for medical devices)
- Label and packaging details
- Clinical data, if applicable
Applicants must also ensure compliance with QMS (Quality Management Systems), GCP (Good Clinical Practices), and GMP (Good Manufacturing Practices).
CDSCO Registration Process in Brief
- Create an SUGAM portal account
- Submit application with relevant product and manufacturing details
- Upload documentation and pay applicable fees
- Await scrutiny, queries, or clarifications from CDSCO
- On approval, receive CDSCO Registration Certificate (valid 1–5 years)
Why Choose Induce India?
At Induce India, our regulatory experts simplify CDSCO registration for over 250 clients with 24x7 support, industry expertise, and a 4.5-star Google rating. Our online platform streamlines documentation, submission, and follow-ups, reducing approval delays and ensuring 100% compliance.
FAQs (Short Overview):
- Who needs CDSCO registration? Importers, manufacturers, and agents of regulated products.
- What is the validity? 1 to 5 years, renewable.
- What can cause cancellation? Non-compliance, safety issues, and false information.
- Is labeling important? Yes, detailed, accurate labeling is mandatory.
- Why post-market surveillance? To ensure ongoing safety and effectiveness.
For expert CDSCO consultancy, connect with Induce India to ensure a smooth and compliant path to the Indian healthcare market.