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Revised Procedure and Criteria for Export of Diagnostic Kits

Renu Suresh

Expert

Published on: Jul 24, 2025

Revised Procedure and Criteria for Export of Diagnostic Kits

The Directorate General of Foreign Trade (DGFT) has revised the procedure and criteria for the export of Diagnostic Kits vide Trade Notice No.29/2020-21. With this notification, DGFT has fixed the export quota for Diagnostic Kits for the period from September 2020 to November 2020. As per the revised procedure, the firm applies for the export authorization should be the manufacture of VTM/RNA Extraction kits/RT-PCR Kits. The present article briefs the Revised Procedure and Criteria for Export of Diagnostic Kits

Important Announcement for Exporter

  • The Trade Notice on 13th October 2020 has outlined the revised Procedure and Criteria for submission and approval of online applications for the export of Diagnostic Kits.
  • The DGFT has announced that the Diagnostic Kits is put it in the restricted category, making it mandatory for exporters to get a license from DGFT for export of the product.
  • As per the revised procedure, the DGFT also announced that the export quota for Diagnostic Kits has been fixed and shipment will be allowed for the period from September 2020 to November 2020.
  • The exporter (only manufactures) can apply for export authorization as Non-SCOMET Restricted items and exports are not required to forward any hard copy of the application via email or post to DGFT.
  • Exporters who have already filed an online application for the export of diagnostic kits need not apply again. Even though, they need to submit the required documents mentioning the file number in the subject of the mail.

Amendment in Export Policy of Diagnostic Kits - Trade notice dated June 10th,2020

As per the Trade Notice No.08 dated 10.06.2020, DGFT has amended the Export Policy of Diagnostic Kits, Laboratory Reagents and Diagnostic Apparatus and placed their exports in the Restricted Export Item (Non-SCOMET) category from free earlier. With this notification, the DGFT has placed Diagnostic Kits exports in the Restricted Export Item category from free earlier. Hence the exporter needs to obtain an export authorization from the Government for shipments of Diagnostic Kits.

Procedure and Criteria for Export of Diagnostic Kits – Trade notice dated July 30th, 2020

As per the trade notice dated July 30, DGFT also announced that the export quota for Diagnostic Kits has been fixed and the application filed for the export of Diagnostic Kits (VTM/RNA Extraction kits/RT-PCR Kits) from 5th – 8th August 2020 will only is considered for the issue of export authorization All applications for the export of Diagnostic Kits will be processed as per the Handbook Procedure. Only one application per Import Export Code (IEC) will be considered during a Month. Know more about trade notice dated July 30 – Procedure and Criteria for Export of Diagnostic Kits

Revised Date for Application Submission

The application filed for the export of Diagnostic Kits (VTM/RNA Extraction kits/RT-PCR Kits) from 19th – 31st October 2020 will only is considered for the issue of export authorization. All applications for the export of Diagnostic Kits will be processed as per the Handbook Procedure. Note: Only one application per Import Export Code will be considered during the month.

The validity of Export Authorization/License

The validity of Export Authorization for the export of Diagnostic Kits (VTM/RNA Extraction kits/RT-PCR Kits) is 3 months from the date of the issue.

Revised Criteria for Issuance of Export License

As per the revised guidelines, the below-mentioned eligibility criteria are applicable for the issuance of Export licenses:
  • The firm applies for the export license should be the manufacture of VTM/RNA Extraction kits/RT-PCR Kits.
  • The applicant needs to submit the following documents to DGFT for obtaining the Export License
    • Documentary proof of manufacturing of VTM/RNA Extraction kits/RT-PCR Kits.
    • Copy of Purchase order or Invoice
    • Copy of the Import Export Code of the Firm
  • Undertaking duly signed by the authorized signatory in company letterhead to be submitted by the manufacturer certifying that as on date, all domestic commitments have been fulfilled.
Note: All documents must be duly self–attested by the authorized person of the firm.

Procedure to get the License for Export of Diagnostic Kits

The exporter can obtain the Export Authorization of Non-SCOMET Restricted items by applying DGFT‘s ECOM application module. After a successful login using the ECOM application module through Digital Certificate on the new DGFT website, the ECOM Reference number will be displayed. After providing the following details, the exporter needs to upload all supporting documents (refer above).
  • Shipment Details
  • Details of Products to be exported
  • Details of foreign Buyer or Consignee
Once the DGFT accepted the license request, the export authorization for the shipment of Diagnostic Kits will be issued. Click here to know more about Procedure to Obtain Export Authorization of Non-SCOMET Restricted items

Other Conditions to Get Export License

  • All the relevant documents as specified above must be submitted along with the application to verify the eligibility criteria and to issue an export license.
  • Incomplete applications will not be considered for any allocation.
  • Any application received through email or submitted outside the timeline specified will not be considered for the monthly quota.
The DGFT’s notification pertaining to the Revised Procedure and Criteria for Export of Diagnostic Kits is attached below for reference.
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