• CCI AD FROM 5th April 2021

Procedure and Criteria for submission and approval of applications for export of Diagnostic Kits and their components/ laboratory reagents

Circular No. ES/409/2020-21                                                                                       20th January, 2021

To: Members of the Council

Sub: Procedure and Criteria for submission and approval of applications for export of Diagnostic Kits and their components/ laboratory reagents

Dear Member,

O/o DGFT has issued Trade Notice No. 39/2020-21 dated 19th January, 2021 prescribing Procedure and Criteria for submission and approval of applications for export of Diagnostic Kits and their components/laboratory reagents.

In this regard, reference is invited to DGFT Notification No. 09 dated 10th June, 2020 restricting the export of Diagnostic Kits/Laboratory Reagents/Diagnostic Apparatus.

The quota for export of the following types of diagnostic kits has been fixed for the period from December, 2020 to February, 2021 as follows:

S. No.

Types of Diagnostic Kits

Export Quota (Units/Nos)

1

VTM Kits or its component elements (15 ml Falcom Tube or Cryovials, Swabs  sterile   synthetic   fibre   swabs (Nylon,
polyster, Rayon or Dacron) exported as part of a kit or  individually.

660 Lakh

2

RNA Extraction Kits or its component elements  (Silicone   Columns,   Poly AdenylicAcide or  Carrier RNA, Proteinase K, Magnatic Stands, Beads) exported as part of a kit or individually.

400 Lakh

3

RT-PCR Kits (COVID/Non-COVID) or    its    component    elements    (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

280 Lakh

Given below is the application procedure and criteria for export of above Diagnostic kits:

i. Export of Diagnostic kits and their components/laboratory reagents as per above mentioned export quota is for the period till February, 2021.

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 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 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) or their components/ laboratory reagents” for the above quantities may be applied from 21st to 31st January, 2021.

v. All the applications will be examined as per the Para 2.72 of HBP.

vi. Validity of the export license will be for 3 months only.

vii. Following eligibility criteria will be applicable for consideration of applications:

1) Documentary proof of manufacturing “VTM/ RNA Extraction kits/ RT-PCR Kits.

2) Only 1 application per IEC may be considered during this period.

3) 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.

4) 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 make a note of the above procedures and critera.

Thanking you,

Yours faithfully,

S.BALARAJU
EXECUTIVE DIRECTOR