Anti-dumping investigation concerning imports of “Dialyzers” originating in or exported from China PR and Malaysia.

To be published in Part-I Section I of the Gazette of India Extraordinary

F. No. 6/19/2026-DGTR Government of India Ministry of Commerce & Industry Directorate General of Trade Remedies (DGTR) 4th Floor, Jeevan Tara Building, 5, Parliament Street, New Delhi- 110001

Dated: June, 2026 INITIATION NOTIFICATION

Case No. : AD (OI) (17/2026)

SETU Case ID: AD/OI/019/2026

Subject: Initiation of an anti-dumping investigation concerning imports of

“Dialyzers” originating in or exported from China PR and Malaysia.

1. F. No. 6/19/2026-DGTR: Having regard to the Customs Tariff Act, 1975 as amended from time to time (hereinafter referred to as the “Act”) and the Customs Tariff (Identification, Assessment and Collection of Anti-dumping duty on Dumped Articles for Determination of Injury) Rules, 1995 as amended from time to time (hereinafter referred to as the “AD Rules” or the “Anti-dumping Rules”), Poly Medicure Limited (hereinafter also referred to as the “applicant” ) has filed an application before the Designated Authority (hereinafter referred to as the “Authority”), for initiation of an anti-dumping investigation concerning imports of “Dialyzers” (hereinafter referred to as “subject goods” or “product under consideration” or “PUC”), originating in or exported from China PR and Malaysia (hereinafter referred to as “subject countries”)
2. The applicant has alleged that dumped imports of the subject goods from the subject countries are causing material injury and has requested the imposition of anti-dumping duty on the imports of the subject goods from the subject countries. A. PRODUCT UNDER CONSIDERATION
3. The product under consideration in the present application is “Dialyzers”. Dialyzer is a disposable medical device used in haemodialysis treatment. A dialyzer acts as an artificial kidney and performs the critical function of removing waste substances such as urea and creatinine, excess fluid, and toxins from a patient’s blood.

alysis treatment. A dialyzer acts as an artificial kidney and performs the critical function of removing waste substances such as urea and creatinine, excess fluid, and toxins from a patient’s blood. It is a life-saving medical consumable and forms an indispensable part of the haemodialysis system. 4. It is an essential component of a dialysis machine and facilitates the process of blood purification during dialysis treatment. The dialyzer works on the principle of diffusion and filtration through a semi-permeable hollow fibre membrane, whereby impurities in the blood pass into the dialysate are retained while blood cells and essential components are passed through the membrane. Dialyzers are available in different membrane surface areas and are also classified on the basis of membrane flux. 5. Dialyzers manufactured and exported by Fresenius bearing brand names as, F6 HPS, F7 HPS, FX5, FX8, FX10, FX60, FX80, HF60, HF80, are excluded from the 6/19/2026-DGTR I/131876/2026

membrane flux. 5. Dialyzers manufactured and exported by Fresenius bearing brand names as, F6 HPS, F7 HPS, FX5, FX8, FX10, FX60, FX80, HF60, HF80, are excluded from the 6/19/2026-DGTR I/131876/2026

scope of the investigation.

Unit of measurement 6. The prescribed unit of measurement for the product under consideration is Number or Pieces.

Tariff classification 7. The product under consideration is classified under Chapter 90 of the Customs Tariff Act under the sub-headings 90189031. The customs classification is indicative only and not binding on the scope of the product under consideration.

PCN Methodology

8. The product under consideration is produced and sold in various membrane surface areas and flux categories. Each type of Dialyzer is used by the consumer depending on the dialysis requirements. Further, due to different types of characteristics (i.e., flux type, surface area etc.,), there is difference in the cost and price of the product. The cost and price of each type of product may differ significantly. In view of the same, the applicant proposed the following PCN methodology:

Parameter Specification Code Surface Area of Dialyzer 1.3 M2 and below X Above 1.3 M2 and below 1.8 M2 Y 1.8 M2 and above Z Flux High H Other (Mid and Low) M

9. The parties to the present investigation may provide their comments on the scope of the product under consideration and propose product control numbers (PCN) methodology with justification and evidence, if any, within 15 days of circulation of the receipt of intimation of initiation of the investigation. B.

ration and propose product control numbers (PCN) methodology with justification and evidence, if any, within 15 days of circulation of the receipt of intimation of initiation of the investigation. B. LIKE ARTICLE 10. The applicant has stated that there are no significant differences in the article produced by the applicant and exported from the subject countries. The article produced by the applicant and that imported from the subject countries is comparable in terms of physical and chemical characteristics, manufacturing process and technology, functions and uses, product specifications, pricing, distribution and marketing, and tariff classification of the subject goods. The subject goods and the article manufactured by the applicant are technically and commercially substitutable. 11. The applicant has claimed that the consumers of the product under consideration are using the subject goods and the article manufactured by the applicant 6/19/2026-DGTR I/131876/2026

stitutable. 11. The applicant has claimed that the consumers of the product under consideration are using the subject goods and the article manufactured by the applicant 6/19/2026-DGTR I/131876/2026

interchangeably. Thus, for the purposes of initiation of the present investigation, the article produced by the applicant has been prima facie considered as like article to the product under consideration being imported from the subject countries. C. SUBJECT COUNTRIES 12. The subject countries in the present investigation are China PR and Malaysia. D. PERIOD OF INVESTIGATION (POI) 13. The Authority has considered the period from 1st January 2025 to 31st December 2025 (12 months) as the period of investigation (POI) for the present investigation (hereinafter referred to as “POI”). The injury investigation period shall cover the period 1st April 2022 to 31st March 2023, 1st April 2023 to 31st March 2024, 1st April 2024 to 31st March 2025 and the period of investigation. E. DOMESTIC INDUSTRY AND STANDING 14. The application has been filed by Poly Medicure Limited. The applicant has submitted that they have not imported the subject goods from the subject countries and are not related to producers and exporters from the subject countries. The applicant has submitted that they are the major domestic producer of the subject goods in India. 15. Besides the applicant, there is only one other producer producing the subject goods in India namely, NIPRO Medical India Pvt. Ltd. (“Nipro”). Nipro operates as a100% Export Oriented Unit (EOU).

. 15. Besides the applicant, there is only one other producer producing the subject goods in India namely, NIPRO Medical India Pvt. Ltd. (“Nipro”). Nipro operates as a100% Export Oriented Unit (EOU). The company manufactures the subject goods almost entirely for export. The Authority has considered domestic sales of Nipro as domestic production for the purpose of determination of standing. 16. Based on the information available on record, it is seen that production by the applicant constitutes a major proportion of domestic production. Thus, the applicant satisfies the criteria of standing and constitutes domestic industry within the meaning of Rule 2(b) of the AD Rules and the application satisfies the requirements of Rule 5(3) of the AD Rules. F. BASIS OF ALLEGED DUMPING a. Normal Value for China 17. The applicant has claimed that China PR should be treated as a non-market economy and the normal value should be determined in terms of Rule- 7 of Annexure I of the AD Rules. The applicant has cited Para 8(2) of Annexure I of the AD Rules and has stated that the Chinese producers should be directed to demonstrate that market economy conditions prevail in the industry producing the subject goods in terms of Para 8(3) of Annexure I of the AD Rules. The applicant has claimed that for China PR, normal value should be determined in accordance with Para 7 and 8 of Annexure I of the AD Rules. 18.

in terms of Para 8(3) of Annexure I of the AD Rules. The applicant has claimed that for China PR, normal value should be determined in accordance with Para 7 and 8 of Annexure I of the AD Rules. 18. The applicant has submitted that efforts were made to determine normal value on the basis of price or constructed value in a market economy third country. However, the applicant could not get reliable information regarding the information on price or cost in market economy in a third country. Therefore, the normal value has been constructed based on cost of production of the applicant, duly adjusted for selling, general and administrative expenses, with reasonable profit. The same 6/19/2026-DGTR I/131876/2026

has been considered for the purpose of initiation of the investigation. There is sufficient evidence claimed by the applicant with regard to Normal value of subject goods in China PR. b. Normal Value for Malaysia 19. The applicant has claimed that comparable domestic prices in Malaysia were not available due to the confidential nature of such information; therefore, the normal value was determined on an alternative basis by constructing the cost of production based on the cost of production of the applicant with appropriate additions for selling, general and administrative expenses and reasonable profits. 20.

e basis by constructing the cost of production based on the cost of production of the applicant with appropriate additions for selling, general and administrative expenses and reasonable profits. 20. However, the Authority for the purpose of initiation has considered the normal value which has been constructed on the basis of the cost of production in India, with reasonable addition for selling, general & administrative expenses, and profits for both the subject countries. c. Export Price 21. The export price of the product under consideration has been determined by considering the CIF price of the product under consideration as reported in DG System data. Adjustments have been made for ocean freight, inland freight, marine insurance, handling charges, port expenses and dealers commission, bank charges. d. Dumping Margin 22. The normal value and the export price have been compared at ex-factory level, which prima facie shows that the dumping margin is above the de-minimis level and is significant with respect to the product under consideration exported from the subject countries. Thus, there is prima facie evidence that the product under consideration from the subject countries is being dumped in the Indian market by the exporters from the subject countries. G. INJURY AND CAUSAL LINK 23. The applicant has provided prima facie evidence with respect to the injury suffered by the domestic industry due to the dumped imports.

rters from the subject countries. G. INJURY AND CAUSAL LINK 23. The applicant has provided prima facie evidence with respect to the injury suffered by the domestic industry due to the dumped imports. The volume of the subject imports from the subject countries has increased significantly in absolute terms. There is evidence of price undercutting and price depression due to imports of subject goods from subject countries. On account of volume and price effect, the subject imports have had an adverse impact on the profitability parameters of the domestic industry. The domestic industry has incurred financial losses, cash losses and negative return on capital employed during the period of investigation. There is sufficient prima facie evidence of injury being caused to the domestic industry by the dumped imports from the subject countries to justify initiation of an anti-dumping investigation. H. INITIATION OF ANTI-DUMPING INVESTIGATION 24. On the basis of the duly substantiated written application submitted by the applicant and having reached satisfaction based on the prima facie evidence submitted by the applicant concerning the dumping of the product under consideration originating in or exported from the subject countries, the 6/19/2026-DGTR I/131876/2026

the prima facie evidence submitted by the applicant concerning the dumping of the product under consideration originating in or exported from the subject countries, the 6/19/2026-DGTR I/131876/2026

consequential injury to the domestic industry as a result of the alleged dumping of the product under consideration and the causal link between such injury and the dumped imports, and in accordance with Section 9A of the Act read with Rule 5 of the AD Rules, the Authority, hereby, initiates an anti-dumping investigation to determine the existence, degree, and effect of the dumping with respect to the product under consideration originating in or exported from the subject countries and to recommend the appropriate amount of anti-dumping duty, which if levied, would be adequate to remove the injury to the domestic industry. I. PROCEDURE 25. The provisions stipulated in Rule 6 of the AD Rules shall be followed in this investigation. J. SUBMISSION OF INFORMATION 26. All the interested parties are required to register themselves on SETU Portal (https://setu.dgtr.gov.in). All communications and submissions from the interested parties shall be uploaded on the SETU portal under their registered name and corresponding SETU case ID (AD/OI/019/2026). It should be ensured that the narrative part of the submission is in searchable PDF/MS-Word format and data files are in MS-Excel format. 27.

red name and corresponding SETU case ID (AD/OI/019/2026). It should be ensured that the narrative part of the submission is in searchable PDF/MS-Word format and data files are in MS-Excel format. 27. The known producers/exporters in subject countries, the government of subject countries through its Embassy in India, and the importers and users in India who are known to be associated with the product under consideration are being informed separately to enable them to file all the relevant information within the time limits mentioned in this initiation notification. All such information must be filed in the form and manner as prescribed by this initiation notification, the AD Rules, and the applicable trade notices issued by the Authority. 28. Any other interested party may also make a submission relevant to the present investigation in the form and manner as prescribed by this initiation notification, the AD Rules, and the applicable trade notices issued by the Authority within the time limits set out below. 29. Any party making any confidential submission before the Authority is required to make a non-confidential version of the same available to the other interested parties. 30. The interested parties are further advised to keep a regular watch on the official website of the Directorate General of Trade Remedies at www.dgtr.gov.in and SETU portal (https://setu.dgtr.gov.in) for any updated information with respect to this investigation.

atch on the official website of the Directorate General of Trade Remedies at www.dgtr.gov.in and SETU portal (https://setu.dgtr.gov.in) for any updated information with respect to this investigation. Interested parties are directed to regularly visit the website of DGTR (https://www.dgtr.gov.in/) to stay apprised with the further developments in the subject investigation and remain informed regarding notices that may be issued from time to time regarding questionnaire formats, PCN methodology, PCN discussion/meeting schedule, notice of oral hearing, corrigendum, amendment notifications, and other such information. K. TIME LIMIT 31. Any information relating to the present investigation should be uploaded on the SETU portal (https://setu.dgtr.gov.in) under their registered name and corresponding case ID AD/OI/019/2026. 32. Both versions of each submission, the confidential version (CV) and the non- confidential version (NCV) must be uploaded in the respective designated columns 6/19/2026-DGTR I/131876/2026

9/2026. 32. Both versions of each submission, the confidential version (CV) and the non- confidential version (NCV) must be uploaded in the respective designated columns 6/19/2026-DGTR I/131876/2026

within 37 days from the date on which the nonconfidential version of the application filed by the domestic industry would be circulated by the Authority or transmitted to the appropriate diplomatic representative of the exporting country as per Rule 6(4) of the AD Rules, 1995. If no information is received within the stipulated time limit or the information received is incomplete, the Authority may record its findings based on the facts available on record and in accordance with the AD Rules. 33. All the interested parties are hereby advised to intimate their interest (including the nature of interest) in the instant matter and file their questionnaire responses within the above time limit as stipulated in this notification through SETU portal only. 34. The 15-day period to file comments on the scope of the PUC/ PCN Methodology shall run concurrently with the time limit mentioned in this Initiation Notification. 35. Extension due to Modification of PUC/PCN: An extension of time by 15 days shall be granted if the Authority, through a subsequent notice, modifies the PUC, and PCN that was not previously proposed or is different from the initiation notification. This extension of 15 days shall be granted from date of such notification of modified PUC and PCN.

the PUC, and PCN that was not previously proposed or is different from the initiation notification. This extension of 15 days shall be granted from date of such notification of modified PUC and PCN. Extension of time by 15 days stated in this paragraph is not applicable in instances where there is no change in the PUC, and PCN methodology after initiation of investigation. Requests for a further extension of time, beyond the 15-day extension (if granted), will ordinarily not be considered except in case of exceptional circumstances, in line with the Rule 6(4) of the AD Rules. 36. Any request for an extension must be submitted by the concerned parties through the SETU portal at least one day before the original deadline specified above. Requests submitted after this time will not be considered. L. SUBMISSION OF INFORMATION ON CONFIDENTIAL BASIS 37. Where any party to the present investigation makes confidential submissions or provides information on a confidential basis before the Authority, such party is required to simultaneously submit a non-confidential version of such information in terms of Rule 7(2) of the AD Rules and in accordance with the relevant trade notices issued by the Authority in this regard. Failure to adhere to the above may lead to rejection of the response/submissions. 38. The parties making any submission (including Appendices/ Annexures attached thereto), before the Authority including questionnaire responses, are required to file confidential and non-confidential versions separately. 39.

submission (including Appendices/ Annexures attached thereto), before the Authority including questionnaire responses, are required to file confidential and non-confidential versions separately. 39. Such submissions must be clearly marked as ‘confidential’ or ‘non-confidential’ at the top of each page. Any submission that has been made to the Authority without such markings shall be treated as ‘non-confidential’ information by the Authority, and the Authority shall be at liberty to allow other interested parties to inspect such submissions. 40. The confidential version shall contain all information which is, by nature, confidential, and/or other information, which the supplier of such information claims as confidential. For the information which is claimed to be confidential by nature, or the information on which confidentiality is claimed because of other reasons, the supplier of the information is required to provide a good cause statement along with the supplied information as to why such information cannot be disclosed. 41. The non-confidential version of the information filed by the interested parties is required to be a replica of the confidential version with the confidential information preferably indexed or blanked out (where indexation is not possible) and such information must be appropriately and adequately summarized depending upon 6/19/2026-DGTR I/131876/2026

tial information preferably indexed or blanked out (where indexation is not possible) and such information must be appropriately and adequately summarized depending upon 6/19/2026-DGTR I/131876/2026

the information on which confidentiality is claimed. The non-confidential summary must be in sufficient detail to permit a reasonable understanding of the substance of the information furnished on a confidential basis. However, in exceptional circumstances, the party submitting the confidential information may indicate that such information is not susceptible to summary, and a statement of reasons containing a sufficient and adequate explanation as to why such summarization is not possible, must be provided to the satisfaction of the Authority. 42. The interested parties can offer their comments on the issues of confidentiality within 7 days from the date of circulation of the non-confidential version of the documents. 43. The Authority may accept or reject the request for confidentiality on examination of the nature of the information submitted. If the Authority is satisfied that the request for confidentiality is not warranted or if the supplier of the information is either unwilling to make the information public or to authorize its disclosure in generalized or summary form, it may disregard such information. 44.

arranted or if the supplier of the information is either unwilling to make the information public or to authorize its disclosure in generalized or summary form, it may disregard such information. 44. Any submission made without a meaningful non-confidential version thereof or a sufficient and adequate cause statement in terms of Rule 7 of the AD Rules, and appropriate trade notices issued by the Authority, on the confidentiality claim shall not be taken on record by the Authority. M. INSPECTION OF PUBLIC FILE 45. All non-confidential versions of submissions made by any interested party will be accessible to other interested parties through their respective login on the SETU portal. N. NON-COOPERATION 46. In case any interested party refuses access to and otherwise does not provide necessary information within a reasonable period or within the time stipulated by the Authority in this initiation notification, or significantly impedes the investigation, the Authority may declare such interested party as non-cooperative and record its findings based on the facts available and make such recommendations to the Central Government as it deems fit.

(Amitabh Kumar) Designated Authority

6/19/2026-DGTR I/131876/2026