POLLUTION CONTROL BOARD ZONAL OFFICE :: D.No.39-33-20/4/1, Vuda Colony, Visakhapatnam - 530018. Ph : 0891-2719380

AMENDMENT FOR CONSENT & AUTHORIZATION ORDER

Order No.7241–VSP/APPCB/ZO-VSP/CFO/2019- Date: 10.07.2019

Sub: APPCB – ZO – VSP – M/s. Gland Pharma Limited(Formulation) , Unit-II, Phase-I, Block-C, VSEZ, Duvvada, Visakhapatnam District – Under Sec.25 of Water (Prevention and Control of Pollution) Act, 1974 and under Sec.21 of Air (Prevention and Control of Pollution) Act, 1981 and Authorization / Renewal of Authorization under Rule 6 of the Hazardous and other Wastes (Management and Transboundary Movement) Rules, 2016 – Amendment – Issued – Reg.

Ref: 1. CFO order No. 7241-VSP/APPCB/ZOVCFO/2016-439, Dt. 23.05.2016. 2. Industry’s representation dt.26.04.2019. 3. RO, Visakhapatnam report dt.15.06.2019. 4. Minutes of the CFO Committee meeting held on 09.07.2019. * * * 1. The Board issued Consent For Operation to M/s. Gland Pharma Limited (Formulation) , Unit-II, Phase-I, Block-C, VSEZ, Duvvada, Visakhapatnam District vide reference 1st cited with a validity period upto 31.07.2021 to produce the following products:

Liquid Vial injections / Lyophilized Injections- 50,000 Nos. /day

2. The hazardous waste authorization issued to the industry in CFO & HWA order vide reference 1st cited for disposal of solid waste are as: Sl. Solid Waste Quantity Hazardous / as Method of Disposal No generated defined under from HW (Management, Handling & Transboundary) Rules, 2008. 1) Used Oil 50 LPA 5.1 of Schedule -I Shall be sent to authorized Re- processors / Re- Cyclers of waste oil 2) ETP Sludge 1.0 34.3 of TSDF Kg/day Schedule – I

3. The industry requested the Board vide reference 2nd cited to issue CFO & HWA amendment for inclusion of the crushed vials – 4000 Kgs/month and used PPE – 2000 Kgs/month.

4. The RO, Visakhapatnam vide reference 3rd cited, submitted a report.

5. The representation of the industry for amendment and verification report of RO, Visakhapatnam dt.15.06.2019 were placed before the CFO Committee meeting held on 09.07.2019. The committee observed that i) the facility requested for an amendment in the CFO & HWA authorization order dt.23.05.2016 for inclusion of crushed vials – 4000 Kgs/month and used PPE – 2000 Kgs/month with mode of disposal ii) the industry disposing the crushed vials and used PPE to TSDF as the wastes are hazardous substances.

6. The Board after careful examination, hereby issues the following amendment to the CFO & HWA order issued vide reference 1st cited, under Section 25 of Water (Prevention & Control of Pollution) Act, 1974 and under Section 21 of Air (Prevention & Control of Pollution) Act, 1981 and amendments thereof and Authorization / Renewal of Authorization under Rule 6 of the Hazardous and other Wastes (Management and Transboundary Movement) Rules, 2016: Hazardous Waste with Disposal Option: Sl. No Solid Waste Quantity Hazardous / as defined Method of Disposal generated under Hazardous and from other Waste (Management & Transboundary Movement) Rules 2016. 1) Used Oil 50 LPA 5.1 of Schedule -I Shall be sent to APPCB authorized re- processors / re-cyclers of waste oil 2) ETP 1.0 Kg/day 35.3 of TSDF, Parawada for Sludge Schedule – I landfill 3) Crushed 4000 28.4 of Schedule –I TSDF, Parawada for Vials Kgs/month landfill 4) Used PPE 2000 33.2 of Schedule - I TSDF, Parawada for Kgs/month incineration.

7. All other conditions stipulated in the Consent for Operation order issued vide reference 1st cited and its amendments remain same.

JOINT CHIEF ENVIRONMENTAL ENGINEER To M/s. Gland Pharma Limited (Formulation), Unit-II, Phase-I, Block-C, VSEZ, Duvvada, Visakhapatnam District