Export of Diagnostic Kits

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Export of Diagnostic Kits

Directorate General of Foreign Trade (DGFT) has invited the application for the export of Diagnostics kits and their components/laboratory reagents vide a Trade Notice No. 45/2020-2021 dated 2nd March 2021. The quota for export of diagnostic kits was fixed for the period from December 2020 to February 2021 vide a Trade Notice 39 dated 19.01.2021. The applications received as per the Trade Notice were issued export licenses and the quota has not been exhausted.  Hence, the exporters are requested to apply for the license by filling the application online through the DGFT’s ECOM system for Export Authorization (Non-SCOMET Restricted Items).

Important Announcement for Exporter

  • 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
  • As per the trade notice, the DGFT also announced that the export quota for Diagnostic Kits has been fixed and shipment will be allowed only based on the export quota. Export quota for the period of December 2020 to February 2021 for Diagnostics kits and their components/laboratory reagents is still available.
  • 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 these diagnostic kits after 01.02.2020 need not apply again. Even though, they need to submit the required documents through [email protected] mentioning the file number in the subject of the mail.

 Export Quota for Diagnostic Kits

The details of the quantity remaining for the allocation are as follows:

Sl.No Type of Diagnostic Kits Quantity (Nos)
1 VTM Kits or its component element (15 ml Falcom Tube or Cryovials, Swabs sterile synthetic fibre swabs (Nylon polyester, Rayon or Dacron) exported as part a kit or individually 30405596
2 RNA Extraction kits or their component elements (Silicone Columns, Poly Adenylic Acid or Carrier RNA, Proteinase K, Magnetic Stands, Beads) exported as part of a kit or individually 22362999
3 RT-PCR Kits (COVID/Non-COVID) or it’s a component element (Probe specific for COVID 19, Primers specific for covid 19 Reverse Transcriptase Enzyme and Deoxy Nucleotide Triphosphate) exported as part of a kit or individually 10461487

Revised Date for Application Submission

The application filed for the export of Diagnostic Kits (VTM/RNA Extraction kits/RT-PCR Kits) from 4th March – 9th March 2021 will be 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 6 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 that 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 to 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 Export of Diagnostic Kits is attached below for reference.

TN 45

 

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Post by Renu Suresh

Renu is experience content writer specialised in compliances and company rules.