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 application for Import License for Biological products shall be filed under Form 8
The undertaking by Indian agent (RC holder) to Authorize the importer to import biological Products in India on its RC.
The approval or the grant of import License for Biological Products shall be issued under Form 10
Any Indian Citizen who have wholesale license/Manufacturing license under Drugs and Cosmetics Act and Rules can apply for Biological Import License.
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Creation of SUGAM credentials on the portal, if not have |
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Filing of online data on the portal |
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Uploading of documents as per the checklist |
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Payment of government fee |
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Uploading a duly signed copy of the online generated application form |
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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.
This Biological import license would be valid for three years from the date of approval or till the validity of the Registration Certificate.
The timeline for import license is 45 days
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.
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.
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.
Yes
A copy of new drug permission is required if the drug comes under the definition of a new drug.
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.
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.