Omeprazole and Lansoprazole are Two Separate Bulk Drugs – FPS Benefits Allowed to Each of the Two under Sl No. 503 of Table I

[DGFT Trade Notice No. 19 dated 17^th February 2016]

Subject: Clarification on availability of benefit under Focus Product Scheme on the export of item 'OMEPRAZOLE AND LANSOPRAZOLE'.

The product description appearing under ITC HS 30049034 mentioned at SI No.472 of Appendix 37-D, Table-1 of Foreign Trade Policy 2009-14 which was placed at serial no. 503 in Table 1 of Appendix 37 D as notified vide public notice no. 52 dated 25.02.2014, is as under:

'OMEPRAZOLE AND LANSOPRAZOLE'

2. DGFT has received representations stating that the bulk drugs Omeprazole and Lansoprazole are two different export products but have the same ITC HS code for availing FPS benefit under Foreign Trade Policy 2009-14. These products should be given different serial numbers in Table 1, Appendix. 37D of HBP 2009-14. It is also stated that Omeprazole and Lansoprazole are two different molecules with their different identifications belong to group "Proton Pump Inhabitor". There is no combination of these two bulk drugs under any brand name in the market.

3. Department of Pharmaceuticals have been consulted who have clarified that this entry be interpreted as two specific entries containing finished dosage forms based upon either Omeprazole or Lansoprazole used as the Active Pharmaceuticals Ingredients rather than treating this entry as a formulated product containing both of these bulk drugs.

4. Accordingly all RAs are advised that while considering grant of Focus Product Scheme benefit of Foreign Trade Policy 2009-14 under ITCHS 30049034 mentioned at SI No.472 of Appendix 37-D, Table-1 which was placed at serial no. 503 in Table 1 of Appendix 37D notified vide public notice no. 52 dated 25.02.2014, the product whether omeprazole is exported or lansoprazole is exported, it will be incentivised under FPS.