DRUG REGISTRATION SERVICES
Dual Use NOC
Import of Drugs having Dual use and drugs, which are used as Raw Material for the manufacturing of other drugs requires permission from Zonal Offices of CDSCO.
Dual use means drugs which can be used in both pharmaceutical as well as other industries.
These are substances which are covered under the definition of the drugs but are not used for medicinal purposes and are used in other industries like textile industries, chemical industries and food industries etc. or are used as a starting material / intermediate for synthesis of other drugs.
In cases of imports of such drugs, an application for NOC i.e. No Objection Certificate needs to be procured from the Zonal Office of CDSCO.
download actChecklist of Documents
- Covering letter
- Bill of Entry/Invoice/Indent/Purchase order/Sales Contract & Certificate of Analysis of all the batches imported & In case of High Seas sales : Copy of High Seas sales agreement
- Legal Undertaking on Rs.100 stamp paper(Notarized) as per proforma:
3.1 Annexure-I, if the drug is imported by the Actual user
3.2 Annexure-II, if the drug is imported by the Trader - In case of the drug registered for import with CDSCO, details shall be enclosed
- End use declaration for Not for medicinal use.
- In case of use as Animal Feed supplement/Food supplement/Conversion from one drug to another drug(brief manufacturing process or manufacturing flowchart)/Cosmetic use/use in any other industry.
6.1 Submit required permissions from the concerned departments and justifications of Dual use. - Reconciliation data of previously permitted quantity
Why NKG for Drug Regulatory Services
NKG experts have a competent understanding of how to obtain Dual NOC from Zonal offices.
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NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
