Agenda for Approval Committee meeting for EOU and SEZ under Pune Cluster scheduled on 01st July, 2026. — 09-sez-biotech

SEEPZ SPECIAL ECONOMIC ZONE ANDHERI (EAST), MUMBAI.

AGENDA FOR

MEETING OF THE APPROVAL COMMITTEE FOR SECTOR SPECIFIC SPECIAL ECONOMIC ZONE FOR BIOTECHNOLOGY AT PUNE OF M/S. SEZ BIO TECHNOLOGY SERVICES PVT. LTD. – SEZ.

DATE : 01.07.2026

TIME : 11.00 AM.

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MEETING OF THE APPROVAL COMMITTEE FOR SECTOR SPECIFIC SPECIAL ECONOMIC ZONE FOR BIOTECHNOLOGY AT PUNE, UNDER THE CHAIRMANSHIP OF DEVELOPMENT COMMISSIONER, SEEPZ-SEZ ON 01.07.2026

INDEX

Agenda Item No.

Subject

Agenda Item No. 01 :- Confirmation of the Minutes of the Meeting held on 30.06.2025 Agenda Item No. 02 :- Action taken report for the Minutes of the meeting held on 30.06.2025 Agenda Item No. 03 :- M/s Serum Institute of India Pvt. Ltd., (Unit – PBPI) under SEZ Bio Tech Services Pvt. Ltd.,- SEZ for approval of updating the ITC HS Code in the LOA

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मेसस एसईजेड बायोटेक सवसेज ा. लिमटेड - एसईजेड, पुणे के बायो-फामा के लए सेटर िवश िवशेष आ थक "े# के लए "े#ीय िवकास आयु% एसईईपीजेड-एसईजेड, मुंबई क' अ)य"ता म+ 30.06.2025 को आयो,जत अनुमोदन सिम/त क' 32 व0 बैठक के कायवृ4। 1 एसईजेड का नाम मेसस एसईजेड बायोटेक सवसेज ा. लिमटेड - एसईजेड 2 सेटर बायो-फामा 3 मी6टग नं. 32nd 4 तारीख 30.06.2025 उप:;थत सद;य <. नाम और पदनाम (एस/>ी.)
िवभाग 1

ीमती िमतल िहरेमठ संयु% िवकास आयु% पुणे A;टर एसईजेड, पुणे 2 ी अभनव राठी उप आयु%, आयकर िवभाग आयकर िवभाग से नािमत 3 ी संजीव पािटल, उBोग अ/धकारी महाराD सरकार से नािमत 4 ी.

नाम (एस/>ी.)
िवभाग 1

ीमती िमतल िहरेमठ संयु% िवकास आयु% पुणे A;टर एसईजेड, पुणे 2 ी अभनव राठी उप आयु%, आयकर िवभाग आयकर िवभाग से नािमत 3 ी संजीव पािटल, उBोग अ/धकारी महाराD सरकार से नािमत 4 ी. मंचक जाधव, उप-"े#ीय अ/धकारी महाराD दूषण िनयं#ण बोड से नािमत 5 ीमती पुGपा गंगावणे, एफटीडीओ पुणे डीजीएफटी िवभाग से नािमत 6 ी शांत रोहणेकर, अधी"क सीमा शुIक िवभाग पुणे नािमत िवशेष आमंि#त <. नाम एवं पदनाम (>ी/ >ीमती) िवभाग 1 ी. शJभू दयाल मीना, िविनद अ/धकारी सीKज़-एसईज़ेड, पुणे A;टर एज+डा िवषय < 01 : िद 17.01.2025 को आयो,जत 31 व0 बैठक के कायवृ4 क' पुि िवचार-िवमश के बाद, सिम/त ने 17.01.2025 को आयो,जत 31व0 अनुमोदन सिम/त क' बैठक के कायवृ4 क' पुि क'। एज+डा िवषय <. 02:- 17.01.2025 को आयो,जत बैठक के कायवृ4 क' कारवाई Mरपोट िवचार-िवमश के बाद, सिम/त ने 17.01.2025 को आयो,जत बैठक के लए क' गई कारवाई Mरपोट नोट क' है। एज+डा आइटम नंबर 03: मेसस SEZ बायोटेक सवसेज ाइवेट लिमटेड (डेवलपर)Oारा अ/धकृत कायP के लए अ/तMर% सामQी सूची क' िवचार-िवमश के पRात, सिम/त ने मेसस SEZ बायोटेक सवसेज ाइवेट लिमटेड (डेवलपर) Oारा ;तुत अ/तMर% सामQी सूची (600 के Minutes of the 32nd Meeting of the Approval Committee meeting held under the Chairmanship of Development Commissioner SEEPZ-SEZ for Sector Specific Special Economic Zone for Bio- Pharma sector of M/s. SEZ Biotech Services Pvt. Ltd. - SEZ, held on 30.06.2025. 1 Name of the SEZ M/s. SEZ Biotech Services Pvt. Ltd. - SEZ 2 Sector Bio-Pharma 3 Meeting No. 32nd
4 Date 30.06.2025 Members present Sr No. Name and Designation(S/Shri.) Department 1 Smt. Mital Hiremath Jt. Development Commissioner Pune Cluster SEZ, Pune 2 Shri.

tor Bio-Pharma 3 Meeting No. 32nd
4 Date 30.06.2025 Members present Sr No. Name and Designation(S/Shri.) Department 1 Smt. Mital Hiremath Jt. Development Commissioner Pune Cluster SEZ, Pune 2 Shri. Abhinav Rathi Dy. Commissioner, IT Nominee of Income Tax, Pune 3 Shri. Sanjiv Patil, Industries Officer Nominee of Govt. of Maharashtra

4 Shri. Manchak Jadhav Sub-Regional Officer Nominee of Maharashtra Pollution Control Board 5 Smt. Pushpa Gangawane. FTDO Nominee of DGFT, Pune 6 Shri. Prashant Rohnekar Superintendent Nominee of Customs, Pune Special Invitee Sr Name and Designation Department 1 Shri Shambhu Dayal Meena Specified Officer SEEPZ-SEZ, PUNE CLUSTER Agenda Item No.01: Confirmation of the Minutes of the 31st meeting held on 17.01.2025 After deliberation, the committee approved the minutes of the 31st UAC Meeting held on 17.01.2025 Agenda Item No.02: Action taken report for the minutes of the meeting held on 17.01.2025 After deliberation, the Committee has noted the Action taken report for the meeting held on 17.01.2025 Agenda Item No.03: Application of M/s. SEZ Biotech Services Pvt. Ltd. (Developer) for approval of additional List of Material for authorized operations. After deliberation, the Committee approved the additional list of material ( 600 KLP ETP UF Plant (Effluent Treatment Plant) with spares and accessories) submitted by M/s SEZ Bio-tech Services Pvt Ltd. (Developer) totally valued at Rs. 0.80 Crores duly certified by the Chartered Engineer & Registered Valuer Shri Sadanand Purohit, (Registered No.

ries) submitted by M/s SEZ Bio-tech Services Pvt Ltd. (Developer) totally valued at Rs. 0.80 Crores duly certified by the Chartered Engineer & Registered Valuer Shri Sadanand Purohit, (Registered No. M-038153) for authorised operations and development of their SEZ in terms of Rule 12(2) of SEZ Rules, 2006. अ)य" को धUयवाद Vापन के साथ बैठक समाW हुई। Meeting ended with a vote of thanks to the Chair.

(VानेXर बी. पाटील, आईएएस) (Dnyaneshwar B. Patil, IAS) अ)य" एवं िवकास आयु% Chairman-cum- Development Commissioner signaturerectangle-1-186 Digitally signed by Dnyaneshwar Bhalchandra Patil Date: 2025.07.04 14:04:16 IST % DSUnknown q 1 G 1 g 0.1 0 0 0.1 9 0 cm 0 J 0 j 4 M []0 d 1 i 0 g 313 292 m 313 404 325 453 432 529 c 478 561 504 597 504 645 c 504 736 440 760 391 760 c 286 760 271 681 265 626 c 265 625 l 100 625 l 100 828 253 898 381 898 c 451 898 679 878 679 650 c 679 555 628 499 538 435 c 488 399 467 376 467 292 c 313 292 l h 308 214 170 -164 re f 0.44 G 1.2 w 1 1 0.4 rg 287 318 m 287 430 299 479 406 555 c 451 587 478 623 478 671 c 478 762 414 786 365 786 c 260 786 245 707 239 652 c 239 651 l 74 651 l 74 854 227 924 355 924 c 425 924 653 904 653 676 c 653 581 602 525 512 461 c 462 425 441 402 441 318 c 287 318 l h 282 240 170 -164 re B Q

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Action Taken for Approval Committee held on 30-06-2025 Agenda Item No. Subject Remarks Agenda Item No. 01 Confirmation of the Minutes of the 1st Meeting held on 17-01-2025 Committee confirmed the minutes of meeting held on 17.01.2025 Agenda Item No. 02 Application for List of Goods(M/s. SEZ Bio- Tech Services Pvt. Ltd (Developer) ) Approval letter issued on 04.07.2025

GOVERNMENT OF INDIA, OFFICE OF THE DEVELOPMENT COMMISSIONER, SEEPZ SPECIAL ECONOMIC ZONE, GOVT. OF INDIA, ANDHERI (EAST), MUMBAI

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AGENDA NOTE FOR CONSIDERATION OF APPROVAL COMMITTEE

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a. Proposal : Application dated 21.05.2026 of M/s. Serum Institute of India Pvt. Ltd. (Unit – PBP-I) located in SEZ Bio Tech Services Pvt. Ltd.-SEZ for approval of updating the ITC HS Code in the LOA. b.

oposal : Application dated 21.05.2026 of M/s. Serum Institute of India Pvt. Ltd. (Unit – PBP-I) located in SEZ Bio Tech Services Pvt. Ltd.-SEZ for approval of updating the ITC HS Code in the LOA. b. Specific Issue on which decision of AC is required: -
Approval of Approval Committee for updating the ITC HS Code in the LOA of the Unit in terms of Rule 19(2) of SEZ Rules, 2006, as detailed below. Sr. No. Approved items as per LOA with Old ITC HS Codes/Description Proposed Modified ITC HS Code/Description Old ITC HS Code Item Description New ITC HS Code Item Description Remarks 1 300220 Viral & Bacterial Vaccines in Single and Multi doses or in Bulk Form-657 Lacs Vials Amp. 300241 Vaccines for human medicine Change in ITC HS Code and Item Description as the earlier item description effectively falls under the umbrella of “Vaccines for human medicine” 2 30022019 Meningococcal A, C, Y, W, X Polysaccharide Conjugate Vaccine in Single and Multi doses or in bulk form 50 million doses. 30024119 Meningococcal A, C, Y, W, X Polysaccharide Conjugate Vaccine in Single and Multi doses or in bulk form 50 million doses. Change in ITC HS Code only. 3 30045010 Erythropoietin EPO Injection Multi Strength 20 lakh vials 30045010 Erythropoietin EPO Injection Multi Strength 20 lakh vials No Change 4 30021099 Dengue Monoclonal Antibody in Single and Multi doses or in Bulk form – 3.5 Million Doses. 30024119 Dengue Monoclonal Antibody in Single and Multi doses or in Bulk form – 3.5 Million Doses. Change in ITC HS Code only. 5 30021290 Biosimilar Monoclonal

es or in Bulk form – 3.5 Million Doses. 30024119 Dengue Monoclonal Antibody in Single and Multi doses or in Bulk form – 3.5 Million Doses. Change in ITC HS Code only. 5 30021290 Biosimilar Monoclonal Antibodies in single or multi dose or in bulk form doses litres grams 30021290 Biosimilar Monoclonal Antibodies in single or multi dose or in bulk form doses litres grams No Change 6 30022019 Human Papilloma Virus HPV Vaccine in Single or multi dose or in bulk form 75 million doses litres grams 30024119 Human Papilloma Virus HPV Vaccine in Single or multi dose or in bulk form 75 million doses litres grams Change in ITC HS Code only.

7 30045010 Erythropoietin EPO Injection Multi strength 20 lakh PFS 30045010 Erythropoietin EPO Injection Multi strength 20 lakh PFS No Change 8 30045010 Polysialylated Erythropoietin PSA EPO Multi strength 17.5 lakh PFS 30045010 Polysialylated Erythropoietin PSA EPO Multi strength 17.5 lakh PFS No Change 9 30063000 C - T b 100 Million doses 30063000 C - T b 100 Million doses No Change c. Relevant provisions of SEZ Act, 2005 & Rules, 2006/Instruction/
Notification :- As per 1st proviso to Rule 19(2) of SEZ Rules, 2006, “the Approval Committee may also approve proposals for broadbanding, diversification, enhancement of capacity of production, change in Items of manufacturing or service capacity, if it meets the requirements of Rule 18”. d. Other Information: - M/s. Serum Institute of India Pvt. Ltd. (Unit – PBP-I) have been issued LOA No.

hange in Items of manufacturing or service capacity, if it meets the requirements of Rule 18”. d. Other Information: - M/s. Serum Institute of India Pvt. Ltd. (Unit – PBP-I) have been issued LOA No. SEEPZ/NEWSEZ/SIIPL- SBSPL/03/2015-16 dated 10.03.2016 located at Poonawalla Bio-technology Park SEZ (Developed by SEZ Bio tech Services Pvt. Ltd.), Manjari Budrukh, Taluka Haveli, Pune 412307. DCP: 18.10.2019 LOA Valid up to: 17.10.2029 Reasons for Updating the ITC HS Code in LOA The Unit has stated that the Indian Customs Tariff was comprehensively rationalized and realigned on 01 January, 2022 adopting the 7th edition of the Global Harmonized System (HS-2022). Resultantly, many of the items of manufacture approved in the subject LOA have undergone modification in their ITC/HS Code as per the above table. The unit has confirmed that the changes in ITC/HS Codes/description of the items of manufacture have been requested with a view to comply with the updated Indian Customs Tariff and that the same will not alter the production capacity and approved projections/conditions of the LOA. Specified Officer’s Verification Report The Specified Officer vide letter dated 17.06.2026 has submitted that, “For item Sl.No. 1, 2, 4 and 6 of the above table there is change in ITC HS Code w.e.f. 01.01.2022 due to adoption of the 7th edition of Global Harmonised System (HS-2022) in the Indian Customs Tariff. Similarly, for S.No. 1, the item description is changed to "Vaccines for human medicine" under Chapter 300241 of the Customs Tariff w.e.f. 01.01.2022.

d System (HS-2022) in the Indian Customs Tariff. Similarly, for S.No. 1, the item description is changed to "Vaccines for human medicine" under Chapter 300241 of the Customs Tariff w.e.f. 01.01.2022. Products which were earlier classified under Ch 300220 of the Customs Tariff are now classified under Ch 300241 of the Customs Tariff w.e.f. 01.01.2022. Further, product earlier classified under Chapter 30021099 is now classified under Chapter 30024119 of the Customs Tariff w.e.f. 01.01.2022. In fact, the old HS Codes of 300220 & 300210 are omitted from the Customs Tariff w.e.f. 01.01.2022 as seen in the Chapter 30 Tariff Codes obtained from the CBIC website (Copy enclosed for reference), as these are now classified under Ch 300241. The change in HS codes/description, will not alter the production capacity or any other projections/conditions of the LOA.” e. Recommendation: Approval Committee may like to consider the request of the Unit for updating the ITC HS Code in the LOA in terms of Rule 19(2) of SEZ Rules, 2006.

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