Biologicals- Import License

Biologicals- Import License

Import licence means a licence, Form 10, to import biologicals excluding those specified in Schedule X, or a licence in Form 10-A to import biologicals specified in Schedule X. The applicant fills the Form 8 to obtain the Form 10 and Form 10A.

 

In India import, manufacturing, sale and distribution of biologicals is also regulated under Drugs and Cosmetics Act and Rules.

 

The Drugs and Cosmetics Act and Rules regulate the import license for biologicals in India. An Import License for Biologicals is required in India for the manufacture, import, use, export and storage of dangerous microorganisms/genetically engineered organisms or cells, as notified under the Environment (Protection) Act, 1986.

 

The grant of import licence of an application for import of biologicals in form and manner as prescribed in Rule-24, shall be granted by the licensing authority on being satisfied that the seeker amends all the guidelines as laid by the licensing authority. An Import licence is valid for a period of 3 years from the date of its issue, unless cancelled otherwise.

 

To obtain Import License for Biologicals, Form 10 needs to be submitted to the Biological Division along with the documents as listed by the Central Drug Standard Control Organisation.

 

 

References-

  1. The Drugs and Cosmetics ACT, 1940 and Rules 1945. Available at- http://www.mohfw.nic.in/-WriteReadData/l892s/43503435431421382269.pdf. Accessed on – 13th June 2016.
  2. The Drugs and Cosmetics Rules, 1945. Available at- http://www.rajswasthya.nic.in/Drug%2-0Website%2021.01.11/13%20D%20&%20C%20Rules%20for%20Sales.pdf, Accessed on – 13th June 2016.
  3. Checklist for Import Licence (Form 10). Available at-cdsco.nic.in/writereaddata/bio_div_vacc/check_implic_Form-10.pdf. Accessed on 12th June 2016.

 

 

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