ESI & EPF consultants kerala

Import license in order to import cosmetics and drugs

• Import license either refers to the document in Form 10, meant for importing drugs. The ones mentioned in Schedule X are excluded from this list. It also refers to the form 10-A license needed to import drugs that are detailed in Schedule X.
• The Drugs and Cosmetic Rules (1945) and Drugs and Cosmetics Act (1940) govern the manufacturing, import, distribution and sale of drugs. Presently, the Act also includes finished formulations and bulk drugs, meaning active Pharmaceutical Ingredients.
• In Form 8, you have to submit an application to the licensing authority to get an import license. This excludes the drugs that are mentioned in Schedule X. It also excludes the ones in Form 8-A for the ones mentioned in Schedule X. If you are the manufacturer and hold a valid license for whole selling or distributing drugs, you can apply for the license. Besides, the agent of the manufacturer can apply for the same, provided he has got a valid license to sell or manufacture drug. Besides, Form 9 is also involved in the process, which has to be signed on the manufacturer’s behalf.
• If the license is granted as per Rule 24, the conditions of the same need to be fulfilled. Eventually, the authority will issue a license in Form 10-A or Form 10.
• Unless an import license is cancelled or suspended, is valid for a span of 3 years from the issuing date.

To obtain the import license, you need to furnish the following documents:

• Form 8 or 8A, along with the stamp and sign of the applicant
• Cover letter
• Form 9 (The undertaking has to be given on behalf of the manufacturer, or it should come from the manufacturer himself)
• Labels
• A valid RC (Registration Certificate) copy on Form 41, attested by the importer or Indian agent
• Notarized copy of manufacturing License or wholesale License`
• Permission copy as per rule 122A, which contains the permission application for the importing of new drugs, in case it is in the importer’s name

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