Export of Diagnostic Kits & their components / laboratory reagents

Export of Diagnostic Kits & their components / laboratory reagents

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

Dated: 19th January, 2021

Trade Notice No: 39/2020-21

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 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 IAdenylicAcide 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 [email protected] 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/R T-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