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ANNEXURE IA

Point (i): Proponent has proposed for drug formulation on 40 acres of land for 14 therapeutic classes but has not provided quantity of production of tablets, capsules and injectables as well as not provided quantity of material (API and Excipient) to be used and stored. For the purpose of EIA assessment and appraisal PP was asked for providing API Chemicals and other material with quantities that will be handed and stored. Detailed impact assessment, along with the mitigation measures in respect of proposed drug formulation units in the proposed SEZ area needs to be carried out.

Reply: Summary of Impact Assessment is given below:

GMR has planned to develop an Aviation SEZ within the Rajiv Gandhi International Airport in

Shamshabad (RGIA) near Hyderabad for which GMR has received environmental clearance

vide letter number 11-1/2010-IA.III dated 18th June, 2010 from MoEF&CC. The proposed

project is for amendment of Environmental Clearance for changing from Aviation SEZ to Multi-

sector SEZ. The SEZ covers an area of 253.85 acre (102.70 ha) out of which about 25% of

the area is already developed and in operation. Out of 253.85 acres, formulation units have

been proposed in 40 acres area. The industries of formulation units proposed will produce

tablets, capsules and Injectables in the tune of:

Tablets: 3 billion per annum

Capsules: 450 million per annum

Injectable: 18 million units per annum

The therapeutic classes of tablets, capsules, Injectables and excipients are shown in Table 1,

2 & 3 respectively.

Table 1: Therapeutic Classes-Tables & Capsules

Sl. No. Therapeutic Segment Name of Molecule Quantity in kg

per annum

1 Antiarrhythmics Amiodarone Hydrochloride 20

2 Antibiotic Azithromycin Monohydrate 25

Moxifloxacin Hydrochloride 10

3 Anticoagulant Enoxaparin sodium 50

4 Antiemetic; Ondansetron Hydrochloride Dihydrate 100

5 Anti-epileptic/anticonvulsant Levetiracetam 15

6 Antipsychotic Olanzapine 75

7 Antiviral Ganciclovir 20

8 Beta-blocker agent Timolol maleate 15

9 Bisphosphonate- used to treat or prevent osteoporosis

Ibandronate Sodium 50

10 Proton pump inhibitors- used to treat symptoms of gastroesophageal reflux disease

Omeprazole Sodium 75

11 Thiazide diuretic Chlorothiazide 15

12 Used for the acute treatment of migraine

Sumatriptan Succinate 100

13 Used to treat or prevent overactive parathyroid gland (hyperparathyroidism)

Paricalcitol 15

14 Vasodilating agent Sildenafil citrate 15

Total 600

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Table 2: Therapeutic Classes-Injectables

Sl. No Therapeutic Segment Name of Molecule Quantity in kg

per annum

1 Antiarrhythmics Adenosine 5

Procainamide Hydrochloride 10

Antibacterial Linezolid 25

Tobramycin 20

2 Anticoagulant Bivalirudin 8

Anti-inflammatory Dexamethasone Sodium Phosphate 5

3 Beta-Adrenergic Blocking Agents Esmolol Hydrochloride 15

4 Haematinic Agents Iron Sucrose 75

5 Ocular Hypotensive Agent Latanoprost 10

6 Antibiotic Vancomycin Hydrochloride 100

Total 273

Table 3: List of Common Excipients to be used

Sl. No. Name of Excipients Quantity in kg per annum

1 Lactose monohydrate 150

2 Microcrystalline cellulose 100

3 Talc 200

4 Citric acid Anhydrous 200

5 Pre-gelatinised starch 100

6 Icing sugar with starch 100

7 Colloidal silicon dioxide 50

8 StarCap 1500® 100

9 Sesame oil 100

10 Glycerol formal 100

11 Heavy magnesium oxide 150

12 Succinic acid, USP-NF 15

13 Microcrystalline wax 20

14 Povidone K 30 50

15 Magnesium sterate 15

16 Heavy magnesium oxide, USP 30

17 L-Arginine Base, USP 10

1,100

Environment Impact Assessment:

For the purpose of impact assessment, environmental factors going to be affected by the

proposed formulation units were identified and suitable mitigation measures were suggested

to reduce the impact.

For impact on air environment, as there are no process emission sources, the major sources

of air emission from the proposed formulation units has been considered to be emergency DG

sets, boilers and hot water generator running on Low sulphur HSD and FO.

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It has been observed that the maximum GLC from the operation of formulation units have

occurred in within the airport area which reduces considerably on reaching the nearby

settlements.

Similarly noise generated from pumps and compressors are reduced to around 40dB(A) near

the boundary of the project.

The units will have a complete zero liquid discharge scheme with the treated water from STP

and ETP being reused majorly in flushing and cooling purposes.

The hazardous wastes to be generated from the units have been identified as well as

quantified for treatment and disposal as per prescribed norms.

For the recyclable portion of the municipal solid waste, GHIAL has established a compost

plant within the airport premises where all the food waste generated from various sources from

the airport is processed and converted into compost which is used as natural manure to the

plants of the vast airport landscape within the airport. The same will be followed for similar

waste generated from the formulation units.

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ANNEXURE IB

Point – (ii) Risk assessment is also required to be done for storing of API chemicals, other raw material and chemicals, if any. PP is required to submit Risk Assessment Report for chemicals/raw materials to be used and stored.

Reply: Summary of Risk Assessment is given below:

Risk assessment is the determination/estimate of risk related to a well-defined situation and a

recognized threat, which may become a hazard if situations worsen. Risk Assessment shall

involve process understanding, hazard identification and consequence analysis, and

implementing regulation intended to minimize chemical plant incidents, protect workers and

the public, and shine light on industry practices, that regulation is called the Risk Management

Program (RMP).

The proposed facility will be used for formulation of drug and not for manufacturing APIs,

Intermediates or raw chemicals. These will be manufactured elsewhere, and this site will

procure only APIs as starting materials for dilution, proportioning and mixing with excipients

for preparation of pharmaceutical products. Hence, preparation and formulation industry is

non-polluting and non-hazardous. The medications will be used for treating different kind of

disease such as pain, blood pressure controlling, heart disease, prevention of osteoporosis,

some kind of skin and urinary tract infections etc. The raw chemicals, i.e. APIs, and stabilizing

excipients will be simply mixed, blended and compressed or filled into capsule or dissolved in

water, converting into right dosage form that means converting raw material to human

consumable format with right dose. The chemicals that will be procured for formulation are

very stable, safe and non-reactive. The list of drugs substance and raw materials that will be

procured, stored and processed in a safe way are given in Table1, 2 & 3 of Annexure-1A.

None of the above listed materials are self-reactive nor explosive, these are very well studied

and are extremely safe materials used by humans from past several decades. According to

the established guidelines of 29 CFR 191 0.1200(b)(6)(vii), any drug, as that term is defined

in the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), when it is in solid, or

liquid final form for direct administration to the patient (e.g., tablets or pills, injections); and

drugs which are packaged by the Formulation manufacture for sale to consumers in a retail

establishment (e.g., Rx Prescription/over-the-counter drugs).

The drugs substance and raw materials will be stored in safe places and the formulation will

take place in designated formulation unit. The materials which will not be used for the purpose

will be rejected and sent back to manufacturer.

The overall risk of above operations is found low to medium because of following factors:

Quantity of flammable materials used Manufacturing process involves only physical operations (milling, blending,

compression / filling) without involvement of any reactions. The consequences are localized and low The impact of risk and consequences are limited to on-site only

Disaster Management: Hyderabad Airport has a robust Aerodrome Emergency Plan including

Hazardous Material Response & Dangerous Goods Emergency Plan, However the entire

airport eco system including SEZ is covered under the Aerodrome Emergency Plans. To have

a high focus a Disaster Control Room (DCR) will be set up having links with all control rooms.

An officer will be manning the DCR. On getting information about any accident, the officer will

verify from the control room and inform the Disaster Controller (DC) and/or other co-ordinators

immediately.

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ANNEXURE IIA

Point – (iii) Civil Aviation and Disaster Management Authorities are required to look in to safety of airport in light of storage of raw and processed material that is needed for pharma products in the proposed SEZ.

Civil Aviation and Disaster Management Authorities have been contacted by us to provide

their inputs on the safety of airport in light of storage of raw and processed material that is

needed for pharma products in the proposed SEZ.

It may be noted that:

Emergency & Disaster Management Programs are well established considering all

types of business units at SEZ & RGIA. The aerodrome emergency plan is given in

subsequent section

Regular Hazard Identification and Risk Assessment will be carried out at all SEZ

facilities with mitigation measures.

Occupational Health and Safety Management System (OSHAS – 18001) and

Environment Management Systems (ISO -14001) will be implemented within 6

month.

Fire fighting equipment, Hydrants, Powder / Foam type extinguishers on

vehicles and mounted on walls will be kept readily available at all SEZ facilities

Air Emission monitoring of HSD Boiler and Formulation units will be carried out.

Compliance to all regulatory & the inspector of factories requirements will be

ensured while handling and storing of fuel, drug ingredients, dangerous goods and

waste materials.

Regular Training will be conducted all the facility units staffs on Safety,

Environment, Fire and Emergency preparedness.

Disposal of hazardous waste will be done at authorized TSDFs

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ANNEXURE IIB

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ANNEXURE III AERODOME EMERGENCY PLAN

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ANNEXURE IV

Point-(iv) Proponent is required to furnish details about manufacturing/assembly of

defense parts, electrical and mechanical components along with quantities and

processes

Reply:

Defense Parts, Electrical and Mechanical Engineering Components

The units supporting light engineering works that are proposed to be set up in this sector. Works which will be implemented under this category are as given below: A. Defense Parts The defense parts envisaged at the SEZ site include items such as camera and imaging systems exclusively used in the defense applications. Imaging solution companies provide specialized camera system products such as short wave infrared (SWIR) imaging cameras, MWIR imaging cameras, thermal imaging cameras, low noise CCD/CMOS cameras are designed for ultra-low noise readout. The quantity is given in the table below:

TABLE PROPOSED PRODUCT

Proposed product Total Quantity

Camera and Imaging Systems 33,000 nos/annum

Products and professional services offered in this industry enable electronic and semi-conductor companies to deliver next-generation devices, systems and services competitively to customers in aerospace, defense, medical, industrial, automotive and security industries.

TYPICAL PROCESS FLOW CHART – THERMAL IMAGING CAMERAS

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B. Electrical And Mechanical Components Light engineering works (mechanical and electrical) uses medium to low end technology. Entry barrier is low on account of the comparatively lower requirement of capital and technology. This segment is characterized by the dominance of small players having smaller capacities of production. Light engineering goods are essentially used as inputs by the heavy engineering industry. Components which are generally manufactured under this segment are given below:

Sr.No Description UOM Quantities/annum

1 Electrical distribution and control equipment

Nos 10,000 to 12,000

2 Switch gears Nos 10,000 to 12,000

3 Auto components Metric

tonnes 1,000

4 Process control instruments Nos 5,000 to 6,000

Electrical Distribution and Control Equipment High-performance power distribution & control devices include contactors, overload relays, molded case circuit breakers, earth leakage circuit breakers, push buttons & pilot lights for applications including factory automation, manufacturing applications and building automation. Switchgears

Depending on the specific method used, switchgear / control gear manufacturing is roughly comprised of the following processes: cutting and bending, welding, pre-treatment, undercoating, finish coating, and assembly. Typical process is shown in the figure below: Auto Components

Basic manufacturing process for auto components involve casting, forging, metal cutting, milling & grinding, and numerical control. Process Control Instruments

Manufacturing process controls include all systems and software that exert control over production processes. Control systems include process sensors, data processing equipment, actuators, networks to connect equipment, and algorithms to relate process variables to product attributes. Advanced control methodologies (such as adaptive control and intelligent control), as well as improvements in computer and information technologies (such as digital signal processors, workstations, and real-time operating systems), can be used to make manufacturing processes more flexible and adaptive, while maintaining optimum process performance.

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TYPICAL PROCESS FLOW CHART-SWITCH GEARS

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ANNEXURE V

Point (v): Proponent is also required to submit the coordinates of the project site

Reply: