Drug- Import License

Drug- Import License

Import licence means either a licence in Form 10 to import drugs excluding those specified in Schedule X, or a licence in Form 10-A to import drugs specified in Schedule X.

In India import, manufacturing, sale and distribution of drug is regulated under Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945 and New Drugs and Clinical Trials Rules 2019. At present, bulk drug (Active Pharmaceutical Ingredients) and finished formulations are regulated under the said Act.

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, or by the manufacturer’s agent (Importer) in India either having a valid License under the Rules to manufacture for sale of a drug or having a valid wholesale License for sale or distribution of drugs under these Rules and an undertaking in Form 9 duly signed by or on behalf of the manufacturer.

The grant of import licence of an application for an import licence in the form and manner prescribed in Rule 24, the licensing authority shall, on being satisfied that, if granted, the conditions of the licence will be observed, issue an import licence in Form 10 or Form 10-A.
An Import licence unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue.

Below mentioned documents are required for obtaining import licence-

  • Cover Letter
  • Form-8/8A duly Signed & Stamped by applicant
  • Form 9 (Undertaking given by Manufacturer or on behalf of manufacturer by the Indian agent))
  • Copy of Wholesale Licence or Manufacturing Licence
  • Labels
  • Copy of valid Registration Certificate (RC) on Form 41 duly attested by the Indian Agent
  • Copy of new drug permission in Form CT-19/CT-20 in case of New Drug in the name of Indian Agent.

Reference

    1. The Drugs and Cosmetics ACT, 1940 and Rules 1945. Available at- https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf. Accessed on – 11th April 2016.

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