Procedure and Criteria for submission and approval of applications for export of Diagnostic Kits

Circular No.: ES/340/2020-21                                                   14th October, 2020

To: Members of the Council

Sub: Procedure and Criteria for submission and approval of applications for export of Diagnostic Kits

Dear Member,

DGFT issues Procedure and Criteria for submission and approval of applications for export of Diagnostic Kits vide Trade Notice No.29/2020-21 dated 13th October, 2020, .

In this connection, DGFT vide Notification No. 9/2015-20 dated 10th June, 2020 had restricted export of Diagnostic Kits/ Laboratory Reagents/ Diagnostic Apparatus.  

Export quota has been fixed for the following diagnostic kits for the period from September, 2020 to November, 2020:

Sr. No.

Diagnostic Kit

Export Quota (Unit/ Nos.)

1

VTM Kits

150 Lakh

2

RNA Extraction Kits

400 Lakh

3

RT- PCR Kits

100 Lakh

Given here-below is the application procedure and criteria for export of above Diagnostic Kits  

I.      Export of Diagnostic Kits as per the export quota fixed above will be allowed for the period from September,

       2020 to November, 2020.

II.    Only Manufacturer exporters may apply online through DGFT’s ECOM system for Export authorizations (Non- SCOMET Restricted items) – Please refer to Trade Notice No. 50 dated 18th March, 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 export of these diagnostic kits need not apply again. However, they need to write a mail with the application file number and also 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/ RT-PCR Kits)” filed from
      19th to 21st October, 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:

       i)   Documentary proof of manufacturing “VTM/ RNA Extraction Kits/ RT-PCR Kits)”
       ii)  Only 1 application per IEC to be considered during the period.

       iii) Documents to be submitted may include the following:

    a) Copy of Purchase order/Invoice

    b) Copy of IEC

    c) Undertaking duly signed by the authorised signatory in the company letterhead to be submitted by the
        manufacturer certifying that as on date, all domestic commitments/ orders have been fulfilled.

     iv) All the documents must be duly self-attested by the authorized person of the firm. 

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.

Members may kindly make a note of the above procedures and criteria.

Thanking you,

Yours faithfully,

S.BALARAJU
EXECUTIVE DIRECTOR 

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