Executive Summary:
This trade notice concerns the procedure and criteria for submitting and approving export applications for diagnostic kits and their components/laboratory reagents, referencing DGFT Notification No. 09. It announces the availability of leftover export quota for specific diagnostic kits from December 2020 to February 2021. Online applications are accepted from March 4th to March 9th, 2021.
Key Points / Main Content:
* **Export Quota Availability:**
* Leftover export quota for diagnostic kits (IRTPCR, RNA Extraction, and VTM Kits) and their components is available.
* **Application Procedure:**
* Exporters must apply online through the DGFT ECOM system for Export authorizations Non-SCOMET Restricted items.
* Hard copies of applications are not required.
* Exporters who applied after 01.02.2020, should email their application file number and documents.
* **Application Timeline:**
* Online applications are accepted from March 4th to March 9th, 2021.
* **Application Examination:**
* Applications will be examined as per Para 2.72 of the Handbook of Procedures.
* **Export License Validity:**
* Export licenses are valid for 6 months.
* **Eligibility Criteria:**
* Documentary proof of manufacturing VTMRNA Extraction kits/RTPCR Kits.
* Only one application per IEC will be considered.
* **Required Documents:**
* Copy of Purchase order/Invoice
* Copy of IEC
* Undertaking on company letterhead certifying fulfillment of domestic commitments/orders.
* All documents must be self-attested.
* **Application Submission:**
* All relevant documents must be submitted with the application.
* Incomplete or late applications will not be considered.
Impact Analysis:
* **Exporters:**
* Impact: Opportunity to apply for export licenses for diagnostic kits within the specified quota and timeframe.
* Action Required: File online applications with required documents between March 4th and March 9th, 2021, and comply with eligibility criteria.
* **DGFT RAs (Regional Authorities):**
* Impact: Responsible for processing and approving export license applications.
* Action Required: Examine applications according to Para 2.72 of the Handbook of Procedures and issue export licenses with 6 months validity.
* **Customs Authorities:**
* Impact: Responsible for monitoring and facilitating the export of diagnostic kits based on approved licenses.
* Action Required: Verify export licenses and ensure compliance with the specified quota and regulations.
* **Manufacturers of Diagnostic Kits:**
* Impact: Opportunity to export surplus diagnostic kits if domestic commitments are met.
* Action Required: Provide necessary documentation and undertaking to prove manufacturing capability and fulfillment of domestic orders.
Key Entities Referenced
Directorate General of Foreign Trade: An organization under the Ministry of Commerce and Industry responsible for implementing foreign trade policy.
Diagnostic Kits: Refers to the diagnostic test kits whose export is being regulated by this trade notice.
COVID-19: Refers to the Coronavirus disease that the diagnostic kits are used to detect.
RTPCR Kits: A type of diagnostic kit whose export is being regulated.
Trade Notice No.45 202021: The unique identifier for this trade notice.
Trade Notice 39: A previous trade notice related to export quotas, dated 19.01.2021.
DGFT Notification No. 09: A notification dated 10.06.2020 restricting the export of Diagnostic KitsLaboratory ReagentsDiagnostic Apparatus.
Handbook of procedures: A document containing guidelines for examining applications, as mentioned in Para 2.72.
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Ministry of Commerce & Industry
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Directorate General of Foreign Trade
Export Cell/faata warse
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feet: 2n¢ March, 2021
Trade Notice No.45 /2020-21
To
1. All Members of the Trade
2. All DGFT RAs
3. All Custom Authorities
Subject: Procedure and Criteria for submission and approval of applications
for export of Diagnostic Kits and their components/laboratory
reagents.
Reference is invited to DGFT Notification No. 09 dated 10.06.2020
restricting the export of Diagnostic Kits/Laboratory Reagents/Diagnostic
Apparatus.
2. The quota for export of the following types of diagnostic kits was fixed for
the period from December, 2020 to February, 2021 vide 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. The details of quantity remaining
for allocation are as under:
S.No. Item Description Quantity (Nos)
IRT-PCR Kits( COVID/Non-COVID)or its
component elements (Probe Specific for
1 Covid-19, Primers specific for Covid-19
10461487
"Reverse Transcriptase Enzyme and Deoxy
Nucleotide Triphosphate) exported as part of
la kit or individually
RNA Extraction Kits or its component
lelements (Silicone Columns, Poly
2. {AdenylicAcide or Carrier RNA, Proteinase K, 22362999
IMagnatic Stands, Beads) exported as part of
la kit or individually
VIM Kits or its component elements (15 ml
Falcom Tube or Cryovials, Swabs sterile
3. |synthetic fibre swabs (Nylon, polyster, Rayon 30405596
lor Dacron) exported as part of a kit or
individually
w2/-Djs
3. Export of Diagnostic kits and their components/laboratory reagents as per
above mentioned leftover export quota is available and Exporters are requested to
apply for export license by filing applications 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.
4. Exporters who have already filed an online application for export of these
diagnostic kits after 01.02.2020 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.
Di 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 4t» March to 9t March, 2021.
6. All the applications will be examined as per the Para 2.72 of Handbook of
procedures.
T. Validity of the export license will be for 6 months only.
8. The following eligibility criteria will be applicable for consideration of
applications:
¢ Documentary proof of manufacturing “VTM/RNA Extraction
kits/RT-PCR Kits
e Only 1 application per IEC may be considered during this period.
9. The documents to be submitted may include the following:
e Copy of Purchase order/Invoice
e Copy of IEC
e Undertaking duly signed by the authorized signatory in the
company letter head to _ be submitted by the
manufacturer certifying thatas on date, all domestic
commitments/orders have been fulfilled.
10. All the documents must be duly self-attested by the authorized person of the
firm.
11. 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.
12. This issues with the approval of Competent Authority.
(Nitish Suri
Deputy Director General of Foreign Trade
E-mail: nitish.suri@nic.in
(Issued from File No. 01/91/180/21/AM20/EC/E-21933)