, CIN No. : U24230TG1989PTC010584 Ref.: HDPLlMoEFCC/EC/JAN-2018 Date: 16-01-2018 To The Member Secretary (Industry-2), Impact Assessment Division Ministry of Environment, Forests & Climate Change, Govt. of India, Indira Paryavaran Bhawan, Aliganj, Jor Bagh Road, New Delhi-11 0 003. Dear Sir, Sub: Mis. Harika Drugs Pvt. Ltd., Sy. Nos. 165/A, 165/AA & 165/E, Gummadidala Village & Mandai, Sangareddy District, Telangana State - Reply to EDS. Ref.: Essential Details Sought (EDS) dated 14-01-2018 Greetings from Harika Drugs Pvt. Ltd., We are pleased to apprise you that, Hon'ble EAC committee has exempted Public Hearing based on the presentation and documents submitted during ToR presentation and issued ToR. We are attaching the signed ToR copy for your ready reference, where point NO.8 (i) covers the above. This is for your consideration. Thanking you, Yours faithfully, For Harika Drugs Pvt. Ltd. U. Amarnath Managing Director Encl.: As above HARIKA DRUGS PRIVATE LIMITED Office: 5-5-35/145/NR, Plot No. 110, Prasanth Nagar, Kukatpally, Hyderabad - 500 072. Telangana, INDIA. ({) : +91-40-2381 4863, +91-40-23700915, Fax: +91-40-23700731,121: [email protected],in, [email protected] Factory: Gummadidala - 502313. Sangareddy District, Telangana, INDIA. Tel: +91-08458-275369,121: [email protected] ; J-11 011/398/2017 -IA-11(1) Government of India Ministry of Environment, Forest and Climate Change (lA Division) Indira Paryavaran Bhawan Jor Bagh Road, New Delhi- 3 Dated: 25th September, 2017 To, M/s Harika Drugs Pvt Ltd H.No.S-5-35/145/NR, Plot No. 10 Prasanth Nagar, Kukatpally Hvderabad - 72 (Telangana) Sub: Expansion of Active Pharmaceuticals Ingredients (APis) with R&D in District Sangareddy (Telangana) by M/s Harika Drugs Pvt Ltd - Terms of Reference - reg. 1 Ref: Online proposal no. IAITG/IND2/66988/2017 dated 26 h July, 2017 Sir, This refers to your proposal no. IAITG/IND2/66988/2017 dated dated 26th July, 2017 along with project documents including Form-1, Pre-feasibility Report and draft 'Terms of Reference' as per the EIA Notification, 2006. 2. It is noted that the project involves expansion of 'Active Pharmaceutical Ingredients (APis) with R&D Facility' from the present capacity of 1.93 TPM (3 products) to 50.02 TPM (19 products with R&D facility, maximum 6 products at a time) by M/s Harika Drugs Pvt Ltd in an area of 2.227 ha (existing area 1.104 ha, additional required 1.123 ha) at Sy.Nos.165/A, 165/AA & 165/E, Gummadidala (V & M), Sangareddy District (Telangana). 3. The project/activity is covered under category A of item 5(f) 'Synthetic organic chemicals' of the schedule to Environmental Impact Assessment Notification, 2006 and requires appraisal at Central Level by the Sectoral Expert Appraisal Committee (EAC) in the Ministry. 4. The details of the products presently manufactured and after the proposed expansion are reported to be as under:- (a.) Existing Products S. No. Name of the roduct Quanti TPM Quanti TPA 1 Pheniramine Maleate 1 12 2 Promethazine Hydrochloride 0.67 8.04 3 0.26 3.12. 23.16 (b.) Details of proposed products s. List of Products Quantity Quantity CAS No. Therapeutic No. ka/day ITPAl Category 1. Benzydamine HCI 13.33 4.8 132-69-4 Anti- Inflammatory ~ 2. Buclizine 25 9 129-74-8 Antihistamine Dihvdrochloride 3. Carisoprodol 333.33 120 I 78-44-4 Muscle Relaxant 4. Chlorpheniramine 16.67 6 113-92-8 Antihistamine Maleate 5. Chromium Picolinate 83.33 30 14639- Nutritional I 25-9 supplement 6 Doxylamine 25 9 562-10-7 Antihistamine Succinate 7. Gliclazide 200 172 I 21187- Oral antidiabetic I 98-4 8 Hydroxyzine 66.67 24 2192-20- Antihistamine Dihvdrochloride 3 9 Imipramine 20 7.2 113-52-0 Antidepressant Hvdrochloride 10 Meclizine 25 9 1104-22- Antihistamine Dihydrochloride 9 Monohydrate 11 Meloxicam 33.33 12 71125- Anti-inflammatory 38-7 12 Orphenadrine Citrate 333.33 120 4682-36- Anticholinergic 4 --- 13 Oxomemazine 13.33 14.8 4784-40- antihistamine Hydrochloride 1 14 Oxomemazine 20 7.2 I ~689-50- antihistamine 15 Pheniramine 233.33 84 132-20-7 antihistamine Maleate Prochlorperazine 26.67 9.6 84-02-6 Neuroleptic 16 Maleate 17 Promethazine 333.33 120 58-33-3 Antihistamine Hvdrochloride 18 Promethazine 16.67 6 17693- Antihistamine Theoclate 51-5 19 Sertraline 233.33 84 113-92-8 Antidepressant Hydrochloride I Total 6 products at time 1666.65 600 out of total19products R & D Activity 1 I R&D 0.5 0.2 I Total 6 products at time 1667.2 600.2 out of total 19 products and R&D products 5. Total land area of the existing unit is 2.23 h~ and no additional land will be required for the proposed expansion. Industry has already fdeveloped greenbelt area of 35.4% i.e., 0.7886 Ha out of total area of the project i.e. 2.23 Ha. The estimated project cost is Rs. 36.97 Crores which includes existing investment/ of Rs. 15.97 Crores. Total capital cost earmarked towards environmental pollution control measures is Rs. 6.04 Crores including existing investment of Rs. 2.44 Crores and the rec;urring cost (operations and maintenance) J i :;.;--- after expansion will be about Rs. 4.5 Crores per annum. Total employment generation will be 239 persons, out of which direct 85 and indirect 154 persons after expansion. 6. There are no National Parks, Wildlife Sanctuaries, Biosphere Reserves, Tiger/Elephant Reserves, Wildlife Corridors etc. within 10 km distance. However, the eco­ sensitive areas lying within the 10km distance from the project are as under:- s. Description Distance and Direction wrt site No. 1. Water bodies (i) Pond Near Nawabpet at 3.3 km (NE) ii) Pond Near Kanukunta at 2 km (E) ii) Pond near Anantaram at 2 km (ESE) v) Pond Near Gummadidala at 1 km (SSE) v) Pond Near Bonthapally at 3.4 km (SSW) i) Erra Cheruvu Gummadidala at 0.7 km (SW) ii) Pond near Mambapur at 1. 7 km (SW) ii) Pond Near Nallavalli at 2.2 km (NW) 2. Reserve Forests (i) Narsapur Reserved Forest Block (Gottimukkula RF, Nallagutta RF, Naguvaram RF, Royyapalli RF, Mangapet RF, Bonthapalli RF, Jinnaram RF, Mambapur RF, Nalavalli RF) at 3 km (W) ii) Nawabpet RF at 2 km (N) ii) Kanukunta RF at 5.3 km (NE) v) Bijilipur RF at 8.9 km (NE) v) Dabilpur RF at 8.3 km (SE) 7. The Expert Appraisal Committee (lndustry-2) noted that project/activity was earlier accorded EC vide letter dated 15th July, 2005 for the capacity of 1.93 TPM. The monitoring report on compliance status of EC conditions has been forwarded by the RO, Chennai vide letter dated 5th September, 2017. The same was found to be satisfactory and in order. 8. Draft Terms of Reference were discussed and finalised during 28th Expert Appraisal Committee (lndustry-2) meeting held during 18-20 September, 2017. The committee has recommended the standard ToR applicable for such projects (refer Ministry's Website) for preparation of EIA/ EMP report, along with the additional terms and conditions as under:- (i) Public consultation is exempted in terms of the provisions of para 7(ii) of the EIA Notification, 2006. (ii) For total ground water abstraction of 206.9 KLPD, permission from the concerned regulatory authority/CGWA shall be obtained. (iii) ESR plan for 5 years @5% of the project cost in consultation with nearby villagers to be submitted. (iv) Layout plan earmarking space for development of green belt of 5 m width along the plant periphery, and also ensuring 33% of the project area to be developed as green area with native species plantation. (v) Compliance report for the existing environmental clearance, if any, duly certified by the concerned Regional Office of the Ministry to be submitted. 9. Based on the recommendations of the EAC, the Ministry of Environment, Forest and Climate Change, hereby accords terms of reference for preparation of EIA/ EMP reports for the above said project, subject to the compliance of the standard ToRs applicable for such project/ activities and the additional terms and conditions as mentioned above. ~ !. 10. You are required to submit the final EINEMP rF!n,C'lrto:: prepared by the consultants accredited with the Quality Council of India/National Board of Education and 1 Training (QCI/NABET), to the Ministry for grant of i clearance, within 3 years as per this Ministry's OM No. J-11 013/41/2006-IA.II (I) 8th October, 2014. "J ~q(z.ol7 (5. K. Srivastava) Scientist E Copy to: 1. The APCCF(C), MoEF&CC, Regional Office (SEZ), 1st and lind Floor, Hand loom Export Promotion Council, 34, Cathedral Garden Road, ngambakkam, Chennai- 34 2. The Member Secretary, Telangana Pollution Co Board, A-3, Paryavaran Bhavan, Sanath Nagar Industrial Estate, Hyderabad - 8 (Telangana) 3. Guard File/ Monitoring File/ Website/ Record File .