Biological Import License in India – Form 8 & 10


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    CliniExperts helps you to get the permission to import biologicals in India. We cater end-to-end services from filling an application biological import license in Form 8 and getting approval in Form 10.

    Permission To Import Biologicals (Form 10)– Overview


    As per the Central Drugs Standard Control Organization (CDSCO) new provisions, importers/manufacturers who wish to import r-DNA products/Blood Products/Vaccines/Stem Cells in India are required to obtain Biological Import license in Form 10. The process for obtaining an Biological Import license to import r-DNA products/Blood Products/Vaccines/Stem Cells in India is as follows:

    • The importer must make an application in Form 8 via the Sugam portal.
    • After filling out the details, the importer must attach all the necessary documents.
    • The importer must pay the fees specified in the Drugs and Cosmetics Act and Rules made thereunder.

    What is Form 8 and 10

    Form Names

    8

    The application for Import License for Biological products shall be filed under Form 8

    9

    The undertaking by Indian agent (RC holder) to Authorize the importer to import biological Products in India on its RC.

    10

    The approval or the grant of import License for Biological Products shall be issued under Form 10

    Who Can Apply?


    Any Indian Citizen who have wholesale license/Manufacturing license under Drugs and Cosmetics Act and Rules can apply for Biological Import License.


    How To Apply?

    Creation of SUGAM credentials on the portal, if not have
    Filing of online data on the portal
    Uploading of documents as per the checklist
    Payment of government fee
    Uploading a duly signed copy of the online generated application form
    Submission of application.

    The applicant must pay INR 10,000 for one product and INR 1,000 for each additional product to obtain an Biological Import License to import r-DNA products/Blood Products/Vaccines/Stem Cells in India.

    Validity

    This Biological import license would be valid for three years from the date of approval or till the validity of the Registration Certificate.

    Important Documents

    While making an application for obtaining a registration certificate to import r-DNA products/Blood Products/Vaccines/Stem Cells in India, the importer must submit the following documents:
    Registration Certificate (Form 41) For wholesalers, Wholesale license (Form 20B/21B/21C) or for Manufacturer’s, Manufacturing license in Form 25/28
    Labels Form 9

    Timeline to get Form 10 from

    The timeline for import license is 45 days

    Essential Tips

    To obtain a Biological Import License to import r-DNA products/Blood Products/Vaccines/Stem Cells in India, the importer must ensure that the following points:

    The conditions listed in the Covering Letter of Registration Certificate are fulfilled; otherwise, it may lead to queries/delays in approval.

    The importer’s details (name and address) should be a part of Form 9. These details should match with those on the wholesale license.

    The artwork details must be as per Rule 96 of Drugs and Cosmetics Rule, 1945; otherwise, it may lead to queries/delays in approval.

    The documents submitted should be stamped and signed.

    Expert Advise

    Form 9, which is a requirement to obtain permission, should be signed by an Indian Agent or a Manufacturer.

    Biological Import license is not required in cases where any intermediates or inactive bulks are ordered.

    The shelf life of the imported bulk should be more than 60% from the import date. The importer cannot divert the drugs for sale if imported under Special Economic Zones.

    Frequently Asked Questions

    Which companies or manufacturers can apply for an Biological import license to import the r-DNA products/Blood Products/Vaccines/Stem Cells in India?

    A company with a wholesale license as per Form 20B/21B/21C or a manufacturer with a manufacturing license as Form 25/28 can apply for a Biological import license.

    Does the company or manufacturer require India specific label to obtain an Biological import license?

    Yes

    Does the company or manufacturer need to submit a copy of new drug permission while applying for a Biological import license?

    A copy of new drug permission is required if the drug comes under the definition of a new drug.

    If the importer wants to import multiple drugs from different ports, does the importer require multiple Biological import licenses for drugs registered under one Registration Certificate by a single importer?

    The importer does not require multiple licenses for multiple drugs or classes of drugs manufactured by the same manufacturer. The importer can import such drugs from any ports mentioned under the Drugs and Cosmetics Act and Rules.

    Can the company simultaneously apply for a Registration Certificate (Form 41) and Biological Import license (Form 10)?

    No. First, the company should apply for the Site and Drug Registration in Registration Certificate Form 41. Once the site and product gets approved, the company can apply for a Biological import license.

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