What is a CDSCO Non-Conviction Certificate (NCC) in India?
A CDSCO Non-Conviction Certificate (NCC) is an officially issued document by India’s central drug regulatory authority that confirms the following:
- The applicant (whether an individual, company, or firm) has not been convicted under the Drugs & Cosmetics Act, 1940 or its associated rules, and
- No regulatory convictions have been formally recorded against them by the central authority
It is commonly required for:
- Export registration of pharmaceutical products or medical devices
- Obtaining marketing authorization in international markets
- Submissions to foreign regulatory bodies
- Participation in government tenders in select countries
The certificate is officially issued by the Central Drugs Standard Control Organization (CDSCO), which operates under the Directorate General of Health Services, Ministry of Health & Family Welfare.
Who Requires a CDSCO NCC?
This certificate is typically needed by:
- Licensed drug manufacturers
- Medical device manufacturers
- Pharmaceutical exporters
- Companies seeking product registration in overseas markets
Note: This is strictly a regulatory compliance certificate and should not be confused with a criminal background check for individuals.
Procedure to Obtain a CDSCO Non-Conviction Certificate
While the process may differ slightly based on the product category involved, the general steps are outlined below:
Step 1: Confirm Valid Licensing
The applicant must hold:
- A current and valid manufacturing license
- A valid wholesale or export license (wherever applicable)
- No active prosecution proceedings under the Drugs & Cosmetics Act
Step 2: Compile Required Documents
The standard documentation typically includes:
- A formal application letter addressed to the concerned CDSCO Office
- A copy of the valid manufacturing license
- A complete list of the products involved
- A self-declaration affirming no conviction under the Drugs & Cosmetics Act
- Details of all directors or partners of the firm
- A copy of the export order (required in certain cases)
- Proof of fee payment (where applicable)
Step 3: Submit the Application
The application may be submitted to:
- The CDSCO Zonal Office with territorial jurisdiction over the applicant’s manufacturing site, OR
- Through the CDSCO SUGAM online portal
Step 4: Regulatory Verification
Upon receiving the application, CDSCO will proceed to:
- Verify the current status of the applicant’s license
- Review prosecution and conviction records
- If necessary, seek a compliance report from the State Drug Control Authority
Step 5: Issuance of the NCC
If no adverse records are identified during verification:
- The NCC is formally issued on official CDSCO letterhead
- Processing time generally ranges from 10 to 30 working days
Key Considerations
- A CDSCO Non-Conviction Certificate is typically valid for one year from the date of issuance, or until the expiry of the applicant’s manufacturing or import license — whichever occurs first. Timely renewal is essential to maintain uninterrupted compliance for export activities or tender participation.
- Certain destination countries may require legalization or apostille of the certificate before it is accepted.
- If any prosecution is currently pending against the applicant — even in the absence of a formal conviction — CDSCO reserves the right to either decline the application or include an appropriate clarificatory note within the certificate.