An application for an import License is made to the licensing authority in Form 8 for drugs excluding those specified in Schedule X, and in Form 8-A for drugs specified in Schedule X, either by the manufacturer himself having a valid wholesale License for sale or distribution of drugs under these Rules.
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Grant CDSCO Import License.
Import of Drugs having Dual-use and drugs, which are used as Raw Material for the manufacturing of other drugs, requires permission from area offices of CDSCO.Dual Use means drugs that can use in both pharmaceuticals and other industries. These are substances covered under the definition of drugs but are not used for medicinal objectives and are used in other industries such as the textile industry, chemical industry, food industries, etc.
(1) Before applying, one should check that the application is error-free.
(2) The Master formula has to be attested duly by the Licensing authority.
(3) Documents such as bills, and invoices must clear the main objective of the application.
(4) The time period for Dual NOC is 1 year.
(1) Before submission of the application, the applicant needs to make sure that the application is complete with no errors.
(2) The clearance needed for dual-use is advisable to be made by the manufacturer or the agent authorized before the technical review stage for the consideration process before the beginning of the import process to avoid penalisation, preferably before two months of applying.
(3) The required documents, such as bills, invoices, etc., should clearly state the purpose of the intention of usage.
(4) The permission for importing drugs by the Actual User is limited to one year.
(5) The Zonal Officer maintains all required information in such cases.
(1) Covering Letter.
(2) Legal Undertaking
(3) If the imported drugs are already registered with CDSCO, then shall also enclose information regarding the details.
(4) declaration is required regarding the drugs that will not use for pharmaceutical or any other medical objective.
(5) Detailed information on the previously permitted quantity of drugs.
(1) What is Dual Use Noc?
(2) Where is Dual use Noc applicable?
(3) What is the permision time period for dual use noc by actual user?
(4) Is due diligence for the required dual use noc mandatory
