Overview of CDSCO
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It operates under the Directorate General of Health Services, Ministry of Health & Family Welfare.
DCGI vs. CDSCO: The Drug Controller General of India (DCGI) is the head of the CDSCO. While CDSCO is the organization, DCGI is the authority responsible for approving licenses for drugs and medical devices.
Why is CDSCO Registration Important?
- Legal Compliance: Mandatory for manufacturing, importing, and selling drugs and medical devices in India.
- Product Safety: Ensures that products meet quality and safety standards.
- Market Access: Required to enter the vast Indian healthcare market.
- Public Trust: Builds credibility with doctors, hospitals, and consumers.
Types of CDSCO Registration
- Medical Device Registration: For all classes of medical devices (A, B, C, D).
- Drug Import License: For importing drugs and pharmaceuticals into India.
- Cosmetics Registration: For importing and selling cosmetic products.
- Clinical Trial Approval: For conducting clinical research on new drugs.
- Test License: For importing small quantities for testing and analysis.
Registration Process
- Portal Registration: Create an account on the CDSCO SUGAM portal.
- Application Submission: Submit the relevant form (e.g., MD-14 for medical device import) with details.
- Document Upload: Upload technical documents like Device Master File (DMF) and Plant Master File (PMF).
- Fee Payment: Pay the government fees via the Bharat Kosh portal.
- Review & Query: CDSCO reviews the application. If there are queries, you must respond promptly.
- Approval: Upon successful review, the license or registration certificate is issued.
Documents Required
For Medical Devices:
- Device Master File (DMF)
- Plant Master File (PMF)
- ISO 13485 Certificate
- Free Sale Certificate (FSC) from country of origin
- CE Design Certificate / Declaration of Conformity
- Power of Attorney (for foreign manufacturers)
For Cosmetics:
- Form COS-1
- Manufacturing License from country of origin
- List of Ingredients & Percentage
- Product Labels
- Non-Animal Testing Declaration
Fees & Costs
Fees vary significantly based on the product category and risk class:
- Medical Devices (Import): Ranges from $1,000 to $3,000+ per site and product, depending on Class (A, B, C, D).
- Cosmetics: Approx. $1,000 per category and additional fees per variant.
- Drugs: Fees apply per manufacturing site and per drug formulation.
Note: These are government fees. Professional service fees are additional.
Timeline for Approval
- Medical Devices: 6 to 9 months (can be faster for Class A).
- Cosmetics: 3 to 6 months.
- Clinical Trials: 3 to 6 months.
Timelines can extend if the CDSCO raises queries regarding technical data or documentation.
