Final Findings issued recommending imposition of anti-dumping duty on imports of Ursodeoxycholic Acid (UDCA) from China PR and Korea RP (19.01.2023).

Product description – Ursodeoxycholic Acid also known as Ursodiol or UDCA. It is an active pharmaceutical ingredient. It is produced using cholic Acid which upon oxidation gets converted into chenodeoxycholic acid. The chenodeoxycholic acid so formed undergoes enzymatic oxidation to form Lithocholic acid. Lithocholic acid further undergoes the process of bio-catalytic reduction to form Ursodeoxycholic acid (Crude) and is further treated to form Ursodeoxycholic acid.

HS Codes – UDCA falls under Chapter and 30 of the Customs Tariff Act, 1975. UDCA comes under HS code 2915, 2916, 2918, 2922, 2924, 2931, 2933, 2934, 2939, 2941 and 2942. However, the PUC is majorly imported various 29181690 and 29181990.

Uses – UDCA used for medical therapy in gallstone disease (cholelithiasis), therapy in primary biliary cholangitis and for biliary sludge.

Countries involved – China PR and Korea RP

Applicant – M/s Arch Pharmalabs Limited

Date of Initiation – 24th January 2022

Period of Investigation – 1st October 2020- 30th September 2021 (12 months)

Injury Period – 2018-19, 2019-20, 2020-21 and the POI.

Margin and proposed duty –

Producers Dumping Margin Injury Margin Proposed duty
China PR  
Zhongshan Belling Biotechnology Co., Ltd. 130-140% 150-160% 435.10 $/KG
Sichuan Xieli Pharmaceutical Co., Ltd. 120-130% 130-140% 438.75 $/KG
Suzhou Tianlu Bio-pharmaceutical Co. Ltd. 150-160% 150-160% 450.40$/KG
Others 210-220% 170-180% 465.94$/KG
Korea RP  
Daewoong Bio Incorporated 50-60% 90-100% 378.38$/KG
Others 70-80% 110-120% 381.93$/KG

Key Finding –

  1. The other interested parties alleged that Shilpa Medicare Limited and Raichem Medicare Private Limited are also producers of the subject goods. The Authority had sent communications to both the parties, but they did not respond. Therefore, the Authority proceeded on facts available with it to determine the total Indian production.
  2. The sales price of the responding Korea RP to its related party were found to be at a price significantly lower than the average selling price to other entities. Therefore, sales to the related entity were not considered by the Authority in determining the normal value.
  3. The entire volume of exports made by the Korean producer to a particular importer in India were not reflected in the DG Systems data. The Authority has considered the volume of imports from Korea based on the exports reported by the Korean producer in the response.
  4. Prior to the commencement of production by the applicant, imports from the subject countries were priced in the range of 330-340 USD/KG. However, post the commencement of production, import price have started declining and are in the range 210-220 USD/KG.
  5. The price undercutting was found to be significantly negative. However, the Authority examined the transaction wise imports and found that the low-priced imports have forced the domestic industry to reduce their selling prices in competition to the landed price of the imports.
  6. There are significant imports from other countries at prices materially higher as compared to the imports of from the subject countries. These imports are meant for export for formulation and not consumption in the domestic market and such subject goods do not compete with the imports from the subject countries.
  7. The financial challenges faced by the domestic industry cannot be linked to adverse performance of the product under consideration as all the loss was incurred before the commencement of production of the subject goods.
  8. The prices of UDCA API have declined from Rs 24,136/KG in 2018-19 to Rs 15,518/KG whereas the prices of UDCA formulation have increased sharply.
  9. Whereas cost of UDCA (considering benchmark price) is only Rs 28,000/KG, the price set up by the formulation manufacturer is Rs 1,85,000/KG. Therefore, the impact of anti-dumping duty will be insignificant for the end user.