Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-26092025-266462
EXTRAORDINARY
PART I-Section 1
PUBLISHED BY AUTHORITY
No. 255]
NEW DELHI, TUESDAY, SEPTEMBER 23, 2025/ASVINA 1, 1947
6363 GI/2025
(1)
MINISTRY OF COMMERCE AND INDUSTRY
(Directorate General of Trade Remedies)
INITIATION NOTIFICATION
New Delhi, the 23rd September, 2025
Case No. AD(OI)- 22/2025
Subject: Initiation of anti-dumping investigation concerning imports of "Ethambutol Hydrochloride"
originating in or exported from China PR and the Kingdom of Thailand.
1. F. No.6/25/2025.— M/s Lupin Limited (hereinafter also referred to as the "Applicant") has filed an application
before the Designated Authority (hereinafter also referred to as the “Authority") in accordance with the
Customs Tariff Act, 1975 as amended from time to time (hereinafter also referred to as the "Act") and the
Customs Tariff (Identification, Assessment and Collection of Anti-Dumping Duty on Dumped Articles and for
Determination of injury) Rules, 1995 as amended from time to time (hereinafter also referred to as the "Rules")
for imposition of Anti-dumping duty on imports of “Ethambutol Hydrochloride” (hereinafter also referred to as
the "subject goods or PUC”) from the People's Republic of China (“China”) and the Kingdom of Thailand
("Thailand").
A. PRODUCT UNDER CONSIDERATION
2. The Product under Consideration in the present investigation is "Ethambutol Hydrochloride” is a bacteriostatic
drug with molecular formula C10H24N2O22HCl. It is a white crystalline powder manufactured from Ethambutol,
which is a pure compound (free base). Ethambutol exists as an oily liquid with poor water solubility and
limited stability. To make it suitable for use in tablets and other dosage forms, it is converted into its salt form
called Ethambutol Hydrochloride (HCL). The present investigation seeks to cover the Product under
Consideration when they are imported into India in both the forms.
3. The product finds major uses in in the treatment of pulmonary tuberculosis (TB). It is typically administered as
part of a combination therapy with other anti-TB medications to prevent drug resistance.
4. The subject goods are classified under Chapter 29, heading 2905 “Ethambutol, ethambutol HCL". The subject
goods are being imported under sub-heading 29051490 of the Customs Tariff Act, 1975. In any case, the
customs classification is for indicative purposes only and the description of goods shall prevail for the
imposition and collection of duties.
5. The applicant has not proposed adoption of Product Control Numbers (PCN) for the subject good.
B. LIKE ARTICLE
6. Rule 2(d) with regard to like article provides as under: -
"like article" means an article which is identical or alike in all respects to the article under investigation
for being dumped in India or in the absence of such article, another article which although not alike in all
respects, has characteristics closely resembling those of the articles under investigation;
7. The applicant has submitted that subject goods which, are being dumped into India, are identical to the goods
produced by the domestic industry. The applicant has further claimed that there are no differences either in the
technical specifications, functions or end-uses of the dumped imports and the domestically produced subject
goods. In addition, applicant also claimed that the two are technically and commercially substitutable and
hence should be treated as 'like articles' under the Anti-Dumping Rules. Therefore, for the purpose of the
present investigation, the subject goods produced by the applicant in India are being treated as 'like article' to
the subject goods being imported from the subject country.
C. DOMESTIC INDUSTRY & STANDING
8. Rule 2(b) defines domestic industry as follows:
"'domestic industry' means the domestic producers as a whole of the Like Article or domestic producers
whose collective output of the said article constitutes a major proportion of the total domestic production of
that article, except when such producers are related to the exporters or importers of the alleged dumped
article, or are themselves importers thereof, in which case such producers shall be deemed not to form part
of domestic industry"
9. The application has been filed by M/s Lupin Limited. The applicant has stated that apart from the applicant,
there are two other producers of the subject goods in India, viz. M/s Cadila Pharmaceuticals Limited and
Themis Medicare Ltd. The applicant has submitted that M/s Cadila Pharmaceuticals Limited is an importer of
subject goods from the subject countries. The same has been verified from the DG Systems data and it is found
that Cadila Pharmaceuticals Limited has imported small quantity of PUC in the POI. Further, as claimed by the
applicant, Themis Medicare Ltd. has stopped the production of product under consideration. Therefore, Lupin
Ltd. constitutes 100% of the total eligible domestic production in India.
10. This Directorate vide email dated 22nd August 2025 asked M/s Cadila Pharmaceuticals Limited and Themis
Medicare Ltd. to clarify and provide information related to manufacturing of subject goods, like manufacturing
capacity, production quantity, domestic sales, import quantity of PUC, if any. However, no reply has been
received till date from both the companies.
11. The Authority notes that the applicant holds major share in total domestic production in the country. The
applicant has claimed that they have neither imported the subject goods from the subject country nor are they
related to any exporter or importer of the subject goods from the subject country. Therefore, the Authority has
considered the petitioner as Domestic Industry within the meaning of the Rule 2(b) of the Rules and the
application satisfies the criteria of standing in terms of Rule 5(3) of the Rules supra.
D. SUBJECT COUNTRY
12. The subject countries for the present investigation are People's Republic of China and the Kingdom of
Thailand.
E. PERIOD OF INVESTIGATION (POI)
13. The period of investigation for the purpose of the present investigations is 1st April 2024 to 31st March 2025
(12 months). The injury investigation period shall cover the periods 2021-22, 2022-23, 2023 -24 and the period
of investigation.
F. DUMPING MARGIN COMPUTATION
i. Normal Value
a) Normal Value for China
14. The applicant has cited and relied upon Article 15(a) (i) of China's Accession Protocol. The domestic industry
has claimed that the producers in China PR must be asked 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 Rules with regard
to the manufacture, production and sale of the product under consideration. It has been stated by the domestic
industry that in case the responding Chinese producers are not able to demonstrate that their costs and price
information are market driven, the normal value should be calculated in terms of provisions of para 7 and 8 of
Annexure I to the Rules.
15. The applicant has claimed that the data relating to cost or price in market economy third country or recourse to
alternative methods are not available. The applicant has determined normal value for China PR based on the
best estimates of cost of production in India with reasonable addition for selling, general & administrative
expenses, and profits. Normal value for China PR, for the purpose of initiation of the investigation, has been
constructed based on the best estimates of the cost of the production of the domestic industry after duly
adjusting the selling, general and administrative expenses and profits.
b) Normal Value for Thailand
16. The applicant has claimed that it did not have access to any evidence of domestic selling price or information
regarding actual cost of production of the producers in Thailand. Therefore, the domestic industry has
constructed the normal value based on the best estimates of cost of production in India, duly adjusted with
selling, general and administrative expenses, along with a reasonable profit margin. The Authority, for the
purpose of initiation of the investigation constructed the normal value in Thailand for the subject goods on the
basis of cost of production in India, duly adjusted for selling, general and administrative expenses and
reasonable profit margin.
ii. Export Price
17. The export price for subject goods from subject countries has been computed based on the DG Systems
transaction wise import data. Price adjustments for subject countries have been claimed on account of ocean
freight, inland freight, marine insurance, bank charges, port expenses and commission.
iii. Dumping Margin
18. The normal value and the export price have been compared at the ex-factory level, which prima facie establishes
that the dumping margin is above the de minimis level and is significant with respect to the product under
consideration from the subject countries. Thus, there is sufficient prima facie evidence that the product under
consideration from the subject countries is being dumped in the domestic market of India by the exporters from
the subject countries.
G. ALLEGATION OF INJURY AND CASUAL LINK
19. Information furnished by the applicant has been considered for assessment of injury to the domestic industry.
The applicant has furnished prima facie evidence establishing that the imports have caused material injury to the
domestic industry. The imports are undercutting the prices of the domestic industry. The imports have prevented
price increases, which otherwise would have occurred. The domestic industry has been forced to sell at non-
remunerative prices in order to compete with the low import prices and to maintain its market share. This has
adversely impacted the profitability of the domestic industry which has deteriorated in the injury period. There is
sufficient prima facie evidence of material injury being caused to the domestic industry due to the dumped
imports from the subject country to justify initiation of anti-dumping investigation.
H. INITIATION OF THE INVESTIGATION
20. On the basis of the duly substantiated application by or on behalf of the domestic industry, and having
satisfied itself, on the basis of the prima facie evidence submitted by the domestic industry, substantiating the
dumping of product under consideration and subsequent injury to the domestic industry, the Authority hereby
initiates an anti-dumping investigation into the alleged dumping and consequent material injury to the domestic
industry in accordance with Section 9A of the Act read with Rule 5 of the Rules, to determine the existence,
degree, and effect of alleged dumping and to recommend the amount of dumping duty, which if levied would
be adequate to remove the injury to the Domestic Industry.
I. PROCEDURE
21. The provisions stipulated in Rule 6 of the Rule shall be followed in the present investigation.
J. SUBMISSION OF INFORMATION
22. All communication should be sent to the Designated Authority via email at the email address jd11-
dgtr@gov.in, adv13-dgtr@gov.in, dir16-dgtr@gov.in and consultant-dgtr@govcontractor.in. 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.
23. The known producers/exporters in the subject countries, the government of the subject countries through its
embassy in India, and the importers and users in India who are known to be associated with the subject goods
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 Rules, and the applicable trade notices issued by the Authority.
24. 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 Rules, and the applicable trade notices issued by the
Authority within the time limits mentioned in this initiation notification.
25. 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.
26. Interested parties are further directed to regularly visit the official website of the Directorate General of Trade
Remedies (https://www.dgtr.gov.in/) to stay updated and apprised with the information as well as further
processes related to the investigation.
K. TIME LIMIT
27. Any information relating to the present investigation should be sent to the Designated Authority via email at
the email addresses jd11-dgtr@gov.in, adv13-dgtr@gov.in, dir16-dgtr@gov.in and consultant-
dgtr@govcontractor.in within 30 days from the date of the receipt of the notice as per the Rule 6(4) of the
Rules. If no information is received within the prescribed time-limit or the information received is incomplete,
the Authority may record its findings on the basis of the facts available on record in accordance with the Rules.
28. All the interested parties are here by advised to intimate their interest (including the nature of interest) in the
instant matter and file their questionnaire responses within the above time limit. Where an interested party
seeks additional time for filing of submissions, it must demonstrate sufficient cause for such extension in terms
of Rule 6(4) of the ADD Rules, 1995 and such request must come within the time stipulated in this notification.
L. SUBMISSION OF INFORMATION ON CONFIDENTIAL BASIS
29. 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 Rules and in accordance with the relevant trade notices
issued by the Authority in this regard. Failure to adhere to the same may lead to rejection of the response /
submissions
30. 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.
31. 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.
32. The non-confidential version of the information filed by the interested parties should 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 the
information on which confidentiality is claimed.
33. The non-confidential summary must be 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 as to why such summarization is not possible, must be provided to the satisfaction of the
Authority.
34. The interested parties can offer their comments on the issues of confidentiality claimed by the interested
parties within 7 days from the date of circulation of the non-confidential version of the submissions.
35. Any submission made without a meaningful non-confidential version there of or a sufficient and adequate
cause statement in terms of Rule 7 of the Rules, and appropriate trade notices issued by the Authority, on the
confidentiality claim shall not be taken on record by the Authority.
36. 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 warranted or if the
37. 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.
The Authority, on being satisfied and accepting the need for confidentiality of the information provided, shall
not disclose it to any party without specific authorization of the party providing such information.
M. INSPECTION OF PUBLIC FILE
38. A list of registered interested parties will be uploaded on the DGTR's website along with the request therein to
all of them to email the non-confidential version of their submissions/response/information to all other
interested parties.
N. NON-COOPERATION
39. 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 subsequently
time period provided through separate communication, 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.
SIDDHARTH MAHAJAN, Designated Authority
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