Procedure and Criteria for Export of Diagnostic Kits

The Directorate General of Foreign Trade (DGFT) has specified the procedure and criteria for the export of Diagnostic Kits vide Trade Notice No. 20/2020-2021. With this notification, the DGFT has amended the Export Policy of Diagnostic Kits, Laboratory Reagents and Diagnostic Apparatus and placed their exports in the Restricted Export Item (Non-SCOMET) category from free earlier. Hence the exporter needs to obtain an export authorization from the Government for shipments of Diagnostic Kits.

DGFT also announced that export quota for Diagnostic Kits has been fixed and shipment will be allowed only based on the export quota. The exporter can apply for export authorization/license online through the New DGFT Platform under Non-SCOMET Restricted items sections. The present article briefs the Procedure to obtain an export license for the export of Diagnostic Kits.

Important Announcement for Exporter

The Trade Notice on 30th July 2020 has outlined the detailed Procedure and Criteria for submission and approval of applications for the export of Diagnostic Kits.

• The DGFT has announced that the Diagnostic Kits is put it in the restricted category, making it mandatory for exporters to get a license from DGFT for export of the product.
• As per the trade notice, the DGFT also announced that export quota for Diagnostic Kits has been fixed and shipment will be allowed only based on the export quota.
• The exporter can apply for export authorization as Non-SCOMET Restricted items and exports are not required to forward any hard copy of the application via email or post to DGFT.
• Exporters who have already filed an online application for the export of diagnostic kits need not apply again. However, they need to submit the required documents through [email protected] mentioning the file number in the subject of the mail.

Export of Diagnostic Kits

DGFT with a Notification on 4th April 2020 had revised the Export Policy of Diagnostic Kits from Free to Restricted and Further with Notifications on 10th June 2020 export on the following was revised under the Export Policy 2018.

The export policy of Diagnostics kits, laboratory reagents is revised by amending the DGFT Notification No.59 dated 04.04.2020 is as follows:

Sl.No	ITC HS Code	Description
207 G	Ex322	VTM Kits and reagents RNA extraction kits and reagent  RT-PCR kits and reagents

The export policy of following diagnostics instruments, apparatus, and reagents is amended to Restricted.

• 15 ml falcon tube or cryovials
• Swab sterile synthetic fibre swabs (Nylon, polyester, Rayon or Dacron)
• Silicon columns
• Poly adenylic Acid or Carrier RNA
• Proteinase K
• Magnetic stand
• Beads
• Probes (specific for COVID 19 testing)
• Primers (specific for COVID 19 testing)
• Taq Polymerase enzyme
• Reverse transcriptase enzyme
• Deoxy nucleotide triphosphates

Note All other diagnostics kits, reagents, instruments, and apparatus falling under the HS codes above freely exportable subject to the submission of an undertaking to the prescribed custom authorities duly signed by the authorized signatory on the company letterhead.

Export Quota for Diagnostic Kits

The DGFT is fixed exported export quota for following Diagnostic Kits:

Sl.No	Diagnostic Kits	Export Quota
1	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

Prescribed Date for Application Submission

The application filed for the export of Diagnostic Kits (VTM/RNA Extraction kits/RT-PCR Kits) from 5th – 8th August 2020 will only is considered for the issue of export authorization. All applications for the export of Diagnostic Kits will be examined as per the Handbook Procedure.

The validity of Export Authorization/License

The validity of Export Authorization/License for the export of Diagnostic Kits is 3 months from the date of the issue.

Eligibility Criteria to Obtain Export License

The firm applies for the export license should be the manufacture of VTM/RNA Extraction kits/RT-PCR Kits.

Documents Required for Export License

The exporter needs to furnish the following documents to obtain export authorization for the shipment of Diagnostic Kits

• Copy of Purchase order
• Copy of the Import Export Code of the Firm
• Undertaking duly signed by the authorized signatory in company letterhead to be submitted by the manufacturer certifying that as on date, all domestic commitments have been fulfilled.

Note: All documents must be duly self – attested by the authorized person of the firm.

Procedure to get the license for Export of Diagnostic Kits

The exporter can obtain the Export Authorization of Non-SCOMET Restricted items by applying DGFT‘s ECOM application module. After a successful login using the ECOM application module through Digital Certificate on the DGFT website, the ECOM Reference number will be displayed.

After furnishing the following details, the exporter needs to upload all supporting documents.

• Shipment Details
• Details of Products to be exported
• Details of foreign Buyer or Consignee

Once the DGFT accepted the license request, the export authorization for the shipment of Diagnostic Kits will be issued.

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