DGFT has laid down the Procedure & Criteria for Submission & Approval of applications for export of Diagnostic Kits

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DGFT vide Trade Notice No. 20/2020-21 dated July 30, 2020, has laid down the Procedure and Criteria for submission and approval of applications for export Diagnostic Kits/Laboratory Reagents/Diagnostic Apparatus. The Export quota has been fixed for the following diagnostic kits:

S.No.

Diagnostic Kit

Export Quota (Units/Nos)

1

VTM Kits 238 Lakh

2

RNA Extraction Kits 149 Lakh

3

RT-PCR Kits- single tube

34 Lakh

4 RT-PCR Kits – double tube

40 Lakh

5 RT-PCR Kits – triple tube

40 Lakh

The application procedure and criteria for export of above mentioned Diagnostic kits are outlined below:

I. The export of Diagnostic kits as per the export quota fixed above will be allowed for the month of August.

II. Exporters (Only Manufacturers) may apply online through DGFT’s ECOM system for Export authorizations (Non-SCOMET Restricted items) – Please refer to Trade Notice No. 50 dated 18.03.2019. There is no need to send any hard copy of the application via mail or post.

III. Exporters who have already filed an online application for the export of these diagnostic kits need not apply again. However, they need to submit the documents as described in this trade notice through email at export-dgft@nic.in mentioning the specific file number in the subject of the mail.

IV. Online applications for export of “Diagnostic Kits (VTM/RNA Extraction kits/RTPCR Kits)” filed from 5th to 8th 2020 will only be considered.

V. All the applications will be examined as per the Para 2.72 of Handbook of Procedures.

VI. The validity of the export license will be for 3 months only.

VII. The following eligibility criteria will be applicable for issuance of Export licenses:

  • Documentary proof of manufacturing “VTM/RNA Extraction kits/RT-PCR Kits”.
  • Only 1 application per IEC may be considered during the month
  • The documents to be submitted may include the following:
    • Copy of Purchase order/invoice
    • Copy of IEC
    • Undertaking duly signed by the authorized signatory in the company letterhead to be submitted by the manufacturer certifying that as on date, all domestic commitments/orders have been fulfilled.
    • All the documents must be duly self-attested by the authorized person of the firm.

VIII. All the relevant documents as specified above must be submitted along with the application to verify the eligibility criteria. Incomplete applications will not be considered for any allocation. Any application received through email or submitted outside the timeline specified will not be considered.

The Trade Notice can be accessed at: https://content.dgft.gov.in/Website/dgftprod/ca561293-04d9-426e-91cc-1234a86b5d03/TN20.pdf

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