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Import of Drugs and Excipients in India

Customs - Import - Export - SEZ - By: - malay pota - Dated:- 8-2-2017 Last Replied Date:- 13-4-2017 - Import of Drug The import, manufacture, distribution and sale of drugs, cosmetics and medical devices in the country is regulated under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 made there under. The Central Government exercises regulatory control over these articles imported into the country through the Central Drugs Standard Control Organizatio .....

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0.The Central Government has the power to declare any item or medical devices as Drug by Notification in the Official Gazette. By virtue of the said power the Central Government has Notified Disposable Hypodermic Syringe, Disposable Hypodermic Needle, Orthopedic Implant, Catheter; IV Cannula as drugs in 1989. Drugs manufactured outside India can be registered or unregistered. Registered Drugs. Unregistered Drugs. Registered Drug Registered drug means the Drug which is registered in India Unregis .....

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ated Port for entry. The Ports are Mumbai (Sea and Airport), Nava Sheva (Sea Port), Kolkata (Sea and Airport), Chennai (Sea and Airport), Hyderabad (Airport), Delhi (Airport), Kochi (Sea Port) and Ahmadabad (Air Port), Bangaluru (Air Port), Goa (Sea and Air Port). At every Nominated Port CDSCO has Office headed by the Assistant or Deputy Drug Controller of India. Import of the registered Drugs When any drug is registered in India a certificate of Registration in the prescribed Form 41 is issued .....

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import licence will be issued in the prescribed Form 10A. For better understanding, in India the drugs which are specified in Schedule X to the Drugs and Cosmetics Rules cannot be purchased over the counter without the prescription of a qualified doctor. Not only that the retailer also has to preserve the prescription for a period of two years. Labeling on the imported consignment On every import consignment of the registered drugs a label should be affixed showing the name and address of the m .....

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for testing at the Central Drug Testing Laboratory of the Government of India. If the result of the testing comes to the satisfaction of the Drug Controller office the import consignment of drug is allowed to be cleared from the Customs and delivery of the imported consignment is give to the importer. Sometimes it may happen that there is a delay in arrival of the testing result or the consignment of Drug is in a large quantity say 1000 kg or more imported by Air or the import consignment of dru .....

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priate amount stating that they will not use or dispose off the imported drugs until the result of the testing comes. The Drug Controller office at the Nominated port will release the consignment after taking sample. Import of Unregistered drugs Unregistered drug means the drug which is not registered in India hence, no import licence is issued consequently; import of such drug in India is not possible. Considering representation of various Drug Manufacturers Associations for granting exemption .....

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quired to manufacture the final product which has to be exported. The final product which is to be exported should be manufactured from the unregistered drug so imported under the advance authorization. The export has to be made within 12 months from the date of the First import made under the advance authorization. The export of the final products made out of the drug so imported under the authorization to the same buyer against whose export order the advance authorization is issued if due to c .....

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should be destroyed in presence of the Jurisdictional Excise Authority. If the final products manufactured out of the imported material the final product should be destroyed in presence of the Jurisdictional Excise Authority. The advance authorization holder is required to submit documentary evidence regarding such destruction of the imported raw material or the final product manufactured from the imported material. The advance authorization holder has to pay applicable Customs duty on the impor .....

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