1. What is Dual Use NOC?
As per Rule 43 of the Drugs and Cosmetics Rules, 1945, the drugs specified under Schedule D are exempted from the provisions of Chapter III of the Drugs and Cosmetics Act. Accordingly, CDSCO Registration or import licence is generally not required for such products when imported for non-medicinal use under Schedule D of the Drugs and Cosmetics Rules, 1945. However, these products may have dual use, i.e., medicinal as well as non-medicinal use.
If the product is intended for use in the manufacture of drugs or medicines, the applicable CDSCO import registration, licence, and other regulatory requirements under Chapter III of the Drugs and Cosmetics Act and Rules shall apply. On the other hand, where the product is imported for non-medicinal purposes, the importer is required to obtain a No Objection Certificate (NOC) from the concerned CDSCO Zonal Office, which is commonly known as a Dual Use NOC.
2. Who can apply of the Dual Use NOC?
The Dual Use NOC can be applied by an Actual User, Importer, Trader, Manufacturer, or their authorized representative who intends to import drugs in bulk for non-medicinal use and where CDSCO Import Licence or CDSCO Registration is generally not applicable under Schedule D of the Drugs and Cosmetics Rules, 1945.
3. Who will issue the NOC?
The Dual Use NOC is issued by the concerned CDSCO Zonal Office or Sub-Zonal Office after technical review of the application and supporting documents. The applicant is required to submit the online application through the CDSCO SUGAM Portal along with prescribes documents and requisite information
4. What is the process to get Dual Use NOC?
The entire process for obtaining the Dual Use NOC has been divided into the following two steps:
Step I: - The applicant is required to create login credentials on the CDSCO SUGAM Portal and submit the Dual Use NOC application along with prescribed documents, end-use details, and the total quantity proposed to be imported during one year. After review of the submitted documents and details, the concerned CDSCO Zonal Office shall issue the Dual Use NOC specifying the total quantity approved for import.
Step II: - The applicant is required to obtain a separate NOC for each consignment imported during the validity period of the NOC from the approved quantity and submit the same before the Customs Authority for clearance of the consignment.
For example, if the total approved quantity under the NOC is 100 Metric Tons and the current shipment is only 10 Metric Tons, then clearance will be taken only for 10 Metric Tons, while the remaining 90 Metric Tons can be utilized for future consignments.
5. What is the validity of the Dual Use NOC?
The Dual Use NOC is generally issued with validity of one year from the date of issue .
What is the application fee for obtaining the Dual Use NOC?
At present, no government fee is applicable for obtaining a Dual Use NOC for non-medicinal products.
What documents are required for obtaining the Dual Use NOC?
The following documents are generally required for obtaining a Dual Use NOC and below-mentioned list of documents is indicative in nature.
- PAN Card of the firm
- GST Registration Certificate
- Certificate of Incorporation (COI) in case of Company
- Partnership Deed in case of Partnership Firm
- Certificate of Analysis (CoA) of the product
- Product Label and packaging details
- Undertakings, declarations, authorization letters, and other supporting documents as required based on the nature of the entity and end use of the product.
How we can help you?
At BR & Associates, we provide complete end-to-end assistance for obtaining Dual Use NOC from CDSCO. As a leading CDSCO Consultant in India, our services include applicability analysis, documentation preparation, drafting of undertakings and declarations, SUGAM portal registration, filing of Step-1 and Step-2 applications, coordination with CDSCO Zonal/Port Offices, and continuous follow-up until approval and release of consignments. We also assist in handling queries, reconciliation requirements, CDSCO compliance, CDSCO Registration support, and regulatory compliances related to future consignments under the approved NOC.
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