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

 Notice Date : 19 January 2021

Ministry of Commerce & Industry
Directorate General of Foreign Trade
Udyog Bhawan, New Delhi

Dated: 19th January, 2021

Trade Notice No: 39/2020-21-DGFT


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 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

3. The application procedure and criteria for export of above Diagnostic kits is outlined below:

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

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(enclosed). 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 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 Handbook of procedures.

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

VII. The following eligibility criteria will be applicable for consideration of applications:

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

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

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.

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

4. 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.

5. This issues with the approval of Competent Authority

(Nitish Suri)
Deputy Director General of Foreign Trade

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


F.No 01/91/110/01/AM19/EC/Vol. II
Government of India
Ministry of Commerce & Industry
Department of Commerce
Directorate General of Foreign Trade
Udyog Bhawan, New Delhi

Date: 18th March 2019

Trade Notice No. 50/2018-19


All IEC Holders

All EPC’s

All RAs of DGFT

Subject: Online tiling and processing of applications for export of Restricted items (Non-SCOMET) at DGFT HQ.

DGFT in its endeavour to simplify the filing of application and expediting the processing and issuance of export authorisation has undertaken following measures:

A. Online Filing and processing of applications for export authorisation of restricted items (Non-SCOM ET)

2. Under Para 2.51 of Handbook of Procedure of FTP 2015-20 , Exim Facilitation Committee (EFC) in DGFT (Hqrs.) considers applications for export of Restricted items (Non-SCOMET ) as specified in Appendix-1,2 4 of Schedule 2 of the ITC (HS) Classifications of export items. Presently, the applications for export of Restricted items (Non-SCOMET) are filed in hard copy and thereafter, the consultation with the concerned agencies is also done manually.

3. It has been decided that w.e.f. 19.3.2019 the applications by the exporters will be filed online on E-COM module for Export Authorisations (Non-SCOMET Restricted items). Further, the consultation process with administrative departments will also be online.

4. The process for filing online Application is as under:-

i. Link for filing online application: Home Page of DGFT website ( ⇒ Services ⇒  Online ECOM applications              Restricted export item (Non-SCOMET).

ii. User manual for filing online application for Restricted items (Non-SCOMET) is available on the DGFT website at ( Services Online ECOM applications Help Restricted export item(Non-SCOMET).

5. Following documents are required to be uploaded on the portal :

i. Copy of Purchase Order(s) of firm(s) involved in the export of the item/product.

ii. Aayat Niryat Form (ANF)-1 (Applicants Profile).

iii. Relevant documents as per the Trade Notice No. 35 dated 25.10.2018.

6. No hard copy of the application and documents is required to be submitted to DGFT (HQ).

7. As a transition arrangement, applications shall be accepted off-line also till 31.03.2019. From 01.04.2019, it is mandatory to apply online only.

B. Issue of export authorisation / license by DGFT (Hqrs) for export of Non-SCOMET Restricted items

1. To avoid any delay in grant of export authorizations, it has been decided that w.e.f. 01.04.2019, export authorizations for Restricted items (Non-SCOMET ) shall be issued by the Export Cell, DGFT (Hqrs). The authorizations shall be issued under the signature of FTDO (Non-SCOMET) or any other official designated for the purpose.

2. However, issues relating to revalidation and penal action in terms of FTDR Act, if any related to the export authorization, shall continue to be handled by the concerned jurisdictional Regional Authority as usual, in terms of the existing provision in FTP/HBP.

3. Further, jurisdictional Regional Authorities will continue to issue export authorizations in those Restricted items (Non-SCOMET) cases, against which permissions have been issued by DGFT(Hqrs) before 31.03.2019.

(Soumya  Chatopadhyay)
Joint Director General of Foreign Trade
DGFT (Hqrs)
Tel — 011-23063419

Copy to:

1. PS to Hon’ble C1M

2. PS to Hon’ble MOS

3. PSO to Commerce Secretary

4. PPS to DGFT

5. All EFC Members


on 20 January 2021
Notification No : Trade Notice No: 39/2020-21-DGFT
Published in Miscellaneous
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