Application Procedure for Diagnostic Kits Exports

·      Only Manufacturer Exporters Allowed to Apply Online for Export Authorisation through DGFT’s ECOM System

·      Already Filed Online application Need not Apply again

·      Three Day window will Open from 5 Aug to 8 Aug only

[DGFT Trade Notice No. 20/2020-21 dated 30 July 2020]

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

Reference is invited to the DGFT Notification No. 09 dated 10.06.2020 restricting the export of Diagnostic Kits/Laboratory Reagents/Diagnostic Apparatus.

2. Export quota has been fixed for the following diagnostic kits:

S.No.

Diagnostic Kit

Export Quota (Units/Nos)

I

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

2. The application procedure and criteria for export of above mentioned Diagnostic kits 1s outlined below:

I.     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 Trade Notice No. 50 dated 18.03.2019. There is no need to send any hard copy of the application via mail or post.

Ill.   Exporters who have already filed an online application for 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 August, 2020 will only be considered.

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

VI.   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 "VTMIRNA Extraction kits/RT-PCR Kits".

ii.    Only 1 application per IEC may be considered during the month

iii.    The documents to be submitted may include the following:

a.    Copy of Purchase order/ Invoice

b.    Copy of IEC

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

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

VII. 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.

3. This issues with the approval of Competent Authority.

(Issued from File No. 01/91/180/21/AM20/EC/E-21933)