Agenda for Approval Committee meeting for SEZ Pune Cluster to be held on 29 February 2024. — 04-5-wockhardt-infrastructre-development-ltd-sez

SEEPZ SPECIAL ECONOMIC ZONE ANDHERI (EAST), MUMBAI.

AGENDA FOR

MEETING OF THE APPROVAL COMMITTEE FOR SECTOR SPECIFIC SPECIAL ECONOMIC ZONE FOR MANUFACTURING OF PHARMACEUTICAL PRODUCTS AT AURANGABAD OF M/S. WOCKHARDT INFRASTRUCTURE DEVELOPMENT LTD.-SEZ

DATE : 29.02.2024

TIME : 12.00 P.M.

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MEETING OF THE APPROVAL COMMITTEE FOR SECTOR SPECIFIC SPECIAL ECONOMIC ZONE FOR MANUFACTURING OF PHARMACEUTICAL PRODUCTS AT AURANGAD, UNDER THE CHAIRMANSHIP OF DEVELOPMENT COMMISSIONER, SEEPZ- SEZ ON 29.02.2024

INDEX

Agenda Item No.

Subject

Agenda Item No. 01 :- Confirmation of the Minutes of the meeting held on 26.08.2022 Agenda Item No. 02 :- Request for approval for broad banding of products submitted by M/s. Wockhardt Ltd. Unit 2

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1 Minutes of the 29th Meeting of the Approval Committee held under the Chairmanship of Zonal Development Commissioner SEEPZ-SEZ, Mumbai for Sector Specific Special Economic Zone for Pharmaceutical in Wockhardt Infrastructure Development Ltd.-SEZ, Aurangabad, held on 26.08.2022 via video conferencing. 1 Name of the SEZ Wockhardt Infrastructure Development Ltd.-SEZ 2 Sector Pharmaceutical 3 Meeting No. 29th 4 Date 26.08.2022 Members present S r Name and Designation (S/Shri.) Department 1 Smt. Mital S. Hiremath Joint Development Commissioner Pune Cluster-SEZ, Pune 2 Smt. Pradnya R. Gholap DCIT (TDS) Pune Nominee of Income Tax, Pune 3 Dr. Dileeraj Dabhole Dy. DGFT Nominee of DGFT, Pune 4 Smt. Sunita Jagtap Superintendent Nominee of Customs, Pune Special Invitee S r Name and Designation Department 1 Shri V. U Golhait Specified Officer Wockhardt Infrastructure Development Ltd-SEZ, Aurangabad, SEZ-Pune Cluster Agenda Item No.01: Confirmation of Minutes of the 28th meeting held on 26.07.2022 After deliberation, the Committee confirmed the minutes of the 28th Approval Committee meeting held on 26.07.2022. Agenda Item No.02: Application submitted by M/s. Wockhardt Ltd. Unit 1 for broad branding of products After deliberation, Committee approved the proposal of the Unit for broad banding of products, as detailed below, required for authorized operations, in terms of Rule 19(2) of SEZ Rules, 2006. (i) Approved authorized operation/activity: Pharmaceutical product for Human Consumption (Tablets / Capsule) in Vials / Ampules / Bottles etc. File No.S-SEZ-MINS0WCK/1/2022-JDCP

2 (ii) Proposed (additional) authorized operation/manufacturing activity for Broad Banding: Sr. No. Product HSN Code SKU Brands Qty /volume projected in 5 years (2024- 2027) 1 Human Insulin 3004311 0 Vial, Cartridge, Re- usable Pen, Disposable Pen (assembled with drug filled cartridges Wosulin, Wozulim, Newsulin, Consegna, Glysolin, Winsulin or other trademarks as per availability in different countries 7000 2 Insulin Glargine 3004311 0 Vial, Cartridge, Re- usable Pen, Disposable Pen (assembled with drug filled cartridges Glaritus, Valvey, Glarzen or other trademarks as per availability in different countries 9700 3 Insulin Aspart - Regular 3004311 0 Vial, Cartridge, Re- usable Pen, Disposable Pen (assembled with drug filled cartridges As per availability in different countries 1700 4 Insulin Aspart - 30/70 3004311 0 Vial, Cartridge, Re- usable Pen, Disposable Pen (assembled with drug filled cartridges As per availability in different countries 350 (in last 3 yrs) File No.S-SEZ-MINS0WCK/1/2022-JDCP

3 5 Insulin Lispro

Regular 3004311 0 Vial, Cartridge, Re- usable Pen, Disposable Pen (assembled with drug filled cartridges As per availability in different countries 250 (in last 1 yrs) 6 Insulin Lispro

25/75 3004311 0 Vial, Cartridge, Re- usable Pen, Disposable Pen (assembled with drug filled cartridges As per availability in different countries 50 (in last 1 yrs) The unit had submitted application for renewal of their LOA on 18.05.2022 and the projection for the additional products, as detailed below, were considered by the unit in their renewal application. The projections were monitoring during the LOA renewal and approved in the 28th UAC meeting held on 26.07.2022 Revised projections: (Rs. in lakhs) 2022-23 2023-24 2024-25 2025-26 2026-27 Total FOB value of export 5280 15030 20050 25040 35040 100440 FE Outgo 3283 9561 13695 18519 24957 70015 NFE 1997 5469 6355 6521 10083 30425 (iii) Investment / Capital Goods / Raw Material ( Rs. In lakhs) Projections for the next block period of 5 yrs. Capital Goods Indigenous 4,200.90 Imported 16,803.60 Total 21,004.50 Raw Material Indigenous 122,52.62 Imported 36,757.87 File No.S-SEZ-MINS0WCK/1/2022-JDCP

4 TOTAL 49,010.50 Input Services Indigenous 700.33 Imported 15.00 TOTAL 715.33 Employment Male 450 Female 50 TOTAL 500 Meeting ended with a vote of thanks to the Chair. (Shyam Jagannathan, IAS) Chairman-cum- Development Commissioner File No.S-SEZ-MINS0WCK/1/2022-JDCP

GOVT. OF INDIA, OFFICE OF THE ZONAL DEVELOPMENT COMMISSIONER, SEEPZ – SEZ (PUNE CLUSTER), ANDHERI (EAST), MUMBAI

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AGENDA NOTE FOR CONSIDERATION OF THE APPROVAL COMMITTEE

a. Proposal: - Proposal of M/s. Wockhardt Ltd Unit-2. located at, MIDC Aurangabad -SEZ, for approval of broad banding of Additional new product for manufacturing without any revision in projection.

b. Specific Issue on which decision of Approval Committee is required:

Approval of the Committee for broad banding of Additional new product for manufacturing without any revision in projection, in terms of Rule 19(2) of SEZ Rules, 2006.

Broad banding of additional items of product in existing LOA as authorized operations as detailed below:

Current Approved Operations Proposed additional authorized Operations Manufacturing pharmaceuticals product i.e., Nasal and Inhaler dosage Form for Human Usage. • Human Insulin • Insulin Glargine

ITC-HS Code 30043110 For both the above Products

Reason for Broad Banding: The unit has submitted that they are not in a position to commence their operation, as the products and the manufacturing facility needs to be registered in foreign countries before it can export any product. Such registration, which involves the Inspection of the plant too by the Food and Drug Administration officials of the Importing countries (USFDA) and it takes normally 18 to 24 months. The unit has been regularly applying for inspection to USFDA Authority and paying fee for the same and due to pandemic situation in the past, the Inspection was delayed and hence the unit is yet to commence its operations and has been seeking extension of LOA since the expiry of LOA w.e.f 24.02.2014 due to above reasons.

Further, the Unit has now submitted their application for approval of 11th Extension for the validity of LOA vide their letter dated 22.01.2024 and it is in process.

M/s Wockhardt Ltd. is committed to make the unit operational therefore they have submitted the application for broad banding for adding new product i.e. Human Insulin in their existing LOA to make the unit operational in due course in terms of File No.S-SEZ-PRO0WCK/1/2022-JDCP

Rule 19(2) of SEZ Rules, 2006. The applicant has Unit-1 for Human Insulin product. The approval of BOA for extension and UAC approval for broad banding will facilitate the utilization of existing facility for manufacturing of Human Insulin for export.

List of products is as below:

Sr. No Product SKU Brands 1 Human Insulin Vial, Cartridge-usable pen, Disposable Pen (assembled with

drug

filled

with cartridges Wosulin,

Wozulim,

Newsulin, Consegna, Glysolin, Winsulin, or other trademarks as per availability in different countries. 2 Insulin Glargine Vial, Cartridge, Re-usable pen,

Disposable

Pen (assembled with drug filled with cartridges Glaritus, Valvey, Glarzen or other trademarks asper availability in different countries.

Unit has submitted the Quantity/ volume forecast over the period of 5 years.

Quantity is in ‘000’s Product SKU FY 25FY 26FY 27FY 28FY 29 Human Insulin Vial, Cartridge-usable pen, Disposable Pen (assembled with drug filled with cartridges 1000 1500 2000 2500 3000 Insulin Glargine Vial,

Cartridge,

Re-usable

pen, Disposable Pen (assembled with drug filled with cartridges 1100 1950 2800 3850 4800

c. Relevant Provision: • As per 1st proviso to Rule No.19(2) of SEZ Rules, 2006 “the Approval Committee may also approve proposals for broad banding, diversification, enhancement of capacity of production, change in the items of manufacturing or service capacity, if it meets the requirements of rule 18”.

d. Other Information: -

• M/s. Wockhardt Ltd, Unit-2. is an existing SEZ Unit with, LOA No. SEEPZ- SEZ/NEWSEZ/WOCKHARDT-AURBD/02/LOA-02/2012-13/2402 Dated 25.02.2013.

• Unit has also submitted that the aforesaid product shall be covered in their existing approved projections in their LOA.

e) ADC’s Observation: -

Approval Committee may kindly consider the proposal of the unit for Broad Banding of Additional new product without any revision in projection, in terms of Rule19(2) of SEZ Rules, 2006. File No.S-SEZ-PRO0WCK/1/2022-JDCP

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File No.S-SEZ-PRO0WCK/1/2022-JDCP