Procedure and Criteria for submission and approval of applications for export of Diagnostic Kits and their components/laboratory reagents - DGFT - Trade Notice No. 15/2021-22

Ministry of Commerce Industry Directorate General of Foreign Trade Export Cell Date: 09 August 2021 Trade Notice No. 15/2021-22 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 and their components/laboratory reagents has been fixed for the month of July, August and September, 2021 as below: S.No Item Description Quantity 1. 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 2504 Lakh Kits 2. RNA Extraction Kits or its component elements (Silicone Columns, Poly Adenylic Acid or Carrier RNA, Proteinase K, Magnetic Stands, Beads) exported as part of a kit or individually 886 Lakh Kits 3. VTM Kits or its component elements (15 ml Falcon Tube or Cryovials, Sterile synthetic fibre swabs (Nylon, polyster, Rayon or Dacron) exported as part of a kit or individually 1700 Lakh Kits 3. 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 and Trade Notice No.03/2021-22 dated 10.05.2021 . There is no need to send any hard copy of the application via mail or post. 4. 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 10th August to 17th August, 2021. 5. All the applications will be examined as per the Para 2.72 of Handbook of procedures. 6. Validity of the export license will be for 6 months only. 7. The following eligibility criteria will be applicable for consideration of applications: Documentary proof of manufacturing VTM/RNA Extraction kits/RT-PCR Kits. The documents to be submitted may include the following: Copy of Purchase order/Invoice Copy of IEC 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. 8. All the documents must be duly self-attested by the authorized person of the firm. 9. 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. 10. This issues with the approval of Competent Authority (Nitish Suri) Deputy Director General of Foreign Trade E-mail: [email protected] (Issued from File No. 01/91/180/21/AM20/EC/E-21933)