To Trade Drugs, Cosmetics And Medical Devices In India, Businesses Require a CDSCO Certificate.
In India, the Central Drugs Standard Control Organization (CDSCO) is Responsible For Regulating The Safety And Quality Of Products Related To Drugs, Cosmetics, and Medical Devices. Currently, it Operates Under the Ministry of Health & Family Welfare.
Average Time Required for CDSCO Certification
Indicative Timeline by Product Category
| Product Type | Estimated Time |
|---|---|
| Cosmetics Registration | 2–4 months |
| Medical Device Registration | 3–6 months |
| Drug Manufacturing License | 3–6 months |
| Drug Import Registration | 4–6 months |
| Medical Device Import License | 3–5 months |
Factors That Affect CDSCO Registration Timeline
The factors that affect the timeline for issuing a CDSCO registration certificate are as follows:
1. Product Classification
Different CDSCO regulations cover different types of products; Drugs or higher-risk medical Devices require a great deal of regulation, therefore longer periods of review by the authority.
2. Accuracy of Documentation
Properly completed dossiers, test reports, and authorizations are critical; missing, inaccurate, or incomplete documents cause the majority of delays.
3. CDSCO Online Application Process
Applications must be completed using the SUGAM online application system. Technical issues, application errors(such as selecting the wrong form), and missing document uploads will delay the application process.
4. Regulatory Queries
If CDSCO raises queries or asks for clarification, the approval timeline extends depending on how quickly the applicant responds.
5. Inspection & Testing Requirements
Some Categories require inspections of both Places (Sites) of Products, which increases overall time.
Step-by-Step CDSCO Registration Process Timeline
Here’s a simplified breakdown of the CDSCO registration process and expected duration at each stage:
Document Preparation – 1 to 2 weeks
CDSCO Online Application Filing – 2 to 5 days
Government Scrutiny & Query Resolution – 1 to 3 months
Inspection / Testing (if applicable) – 1 to 2 months
Issuance of CDSCO Registration Certificate – Final approval
Can CDSCO Certification Be Obtained Faster?
Yes, the timeline can be reduced by:
Ensuring error-free documentation
Correct product classification
Timely response to CDSCO queries
Professional handling of CDSCO online registration
Engaging regulatory experts significantly improves approval speed and reduces the risk of rejection.
Importance of Timely CDSCO Certification
CDSCO certification delays can result in:
Postponing product introduction to the market.
Increased risk of non-compliance with the regulations.
Penalties or restrictions on importation.
Obtaining the CDSCO registration certificate on time ensures legal compliance, market access, and consumer trust.
