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Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products

B-1124 RIICO industrial area,phase-III Bhiwadi Tehsil-Tijara, District-Alwar, State- Rajasthan For

M/s Alka Laboratories Pvt. Ltd

Environment Consultant

Vardan Environet

(QCI and NABET/EIA/1619/RA 0037)

D-142, Sushant Lok-III, Sector 57

Gurgaon (Haryana)

Contact no.- 9810355569

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

PRE-FEASIBILITY REPORT

1. INTRODUCTION

Earlier, the assessment of the projects was done on Technical feasibility reports and Cost- Benefit-Ratio which mainly considered financial & technical resources. But no consideration was given to the environment protection in this evaluation and these flaws became apparent with continuous deterioration of environment. Thus in order to have more realistic evaluation, and keeping in view the deteriorating conditions, another dimension was added which is now called as “Environmental Impact Assessment” (E.I.A.). This forms an integral part of the project and is taken into account while appraising the project at different stages. Thus in the new comprehensive approach all considerations like, Technical, Financial & Environmental are given due weightage.

M/s Alka Laboratories Pvt Ltd is proposing a project for manufacturing of following products at Plot no. B-1124 RIICO industrial area, phase-III Bhiwadi, Tehsil-Tijara, District- Alwar, State- Rajasthan. The location of proposed unit is ideal for the point of view of market of the Finished Goods & raw materials for manufacturing of such types of Bulk Drugs & intermediates. Location wise, the site is well connected with Gurgaon through NH-8. There are lots of organized and un-organized manufacturer situated in these area. The availability of raw materials and marketing of finished goods will be no problem for proposed industry.

Table-1 List of Raw Material and Products Product Raw materials Quantity (MT/Annum) Existing

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

6 Aminopenicillin Ammonium Hydroxide, Hydrochloride Acid, Methanol, 150 Pen G Potassium, Sodium Hydroxide, Toulene Trimethoprim Trimethoxybenzaldehyde, Acetic Acid, Acrylonitrile, 75 Activated Carbon, Ammonium Hydroxide, Aniline, Dimethyl Sulfoxide, Dimethylamine, Guanidine Nitrate, Hyflo, Methanol, Potassium Hydroxide, Sodium Hydroxide, Sodium Methoxide, Sulphuric Acid Proposed Nimesulide TrimethoxyBenzaldehyde,Acetic Acid, Acrylonitrile, 600 Activated Carbon, Ammonium Hydroxide, Aniline, Dimethyl Sulfoxide, Dimethylamine, Guanidine Nitrate, Hyflo, Methanol, Potassium Hydroxide, Sodium Hydroxide, Sodium Methoxide, Sulphuric Acid Pentaperazole 2-Chloromethyl 3,4dimethoxypyridine hydrochloride, 120 Sodium 2-mercato-5-difluoromethoxy benzimidazole, Tetra butyl ammonium bromide, Dichloromethane, Sodium hydroxide, Sodium hypochlorite, Acetone Diclofenac 2,6 DichloroPhenol, Toluene, Potassium Carbonate, 420 Sodium Sodium Methoxide Solution, Mono Methyl Chloro Acetate, Analine Oil,Chloro Acethyl Chloride, Ammonium Chloride, Potassium Flakes, Sodium Hydro Sulphate, Activated Carbon, Methanol Diclofenac 2,6 Dichloro Phenol, Toluene, Potassium Carbonate, 180 Potassium Sodium Methoxide Solution, Mono Methyl Chloro Acetate, Analine Oil, Chloro Acethyl Chloride, Ammonium Chloride, Potassium Flakes, Sodium Hydro Sulphate, Activated Carbon, Methanol

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Ornidazole 2-Methyl 5- NitroImidazole, Ethyl Acetate, Ethylne 360 dichloride, Aluminium Chloride, Epichloro Hydrine, Ammonia Liaqur, Sulphuric Acid, Methanol, DM Water Mometasone 8DM, MSC, Lithum Chloride, TEA,2 Furolyl Chloride, 1.2 Furote Acetaone, IPA, MDC, THF, Alumina Oxide, HCL CP,Sodium BI Corbonate, KOH, Carbon, Hyflow Aceclofenac Diclofenac Sodium, T-Butyl Chloro Acetate, Formic 360 Acid, TBAB Mefenamic OCBA, Toluene, DM Water, Soda Ash, Sodium Hydro 420 Acid Sulphite, Cupric Chlorite, 2,3 Xylidine, DMF, HCL Mecobalamin Cynocobalamine, Methyl Iodide, SBH, 1.2 Phenol,Chloroform Acetone, Methanol, DM Water Disulfiram Diethyl Amine, Carbon disulfide, Sodium Hydroxide, 36 Ammonium Par Sulphate, Methanol Ofloxacin Ofloxacin Acid, N-Methyl Piperazine, Dimethyl 180 Sulphoxide,Methanol, Caustic Soda Flakes Deflazacort D-5, Iodine crystal, Calcium oxide, Calcium chloride, 1.2 potassium acetate, Acitic Acid, Acetone,

As per EIA Notification dated 14th Sept., 2006 and amended from time to time, the proposed project falls under Category “A”, Project or Activity 5(f) due to interstate boundary of Haryana and Rajasthan at a distance of 1.6 km in NE direction from the project site. They have to submit Form-I along with Pre-Feasibility Report and other relevant documents for getting Environmental Clearance. This pre-feasibility report has, therefore, been prepared by the consultant to assess the likely impact of the proposed project on various factors which may be affected with the implementation of the program and to suggest remedial/precautionary measures, if any.

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

2. Profile of the Company & Promotors

M/s Alka Laboratories Pvt Ltd was incorporated in 1998 as a Private Limited Company into the business of trading and manufacturing of chemicals, solvents, bulk drugs and APIs. Till FY 2009, the company was manufacturing 6-Aminopenicillin (6-APA) and Nimesulide in small quantities. In 2011, the company converted its plant from single product manufacturing unit into multi product manufacturing unit by installing the additional plant and machineries. The Company has also replaced and installed machineries incl. reactors, Q &

A equipments etc. for better efficiency and quality of the products produced. Directors have vast experiences in this line.

2.1 Need for installation of project  6 Aminopenicillin- 6-APA is the chemical compound (+)-6-aminopenicillanic acid. 6-APA is the core of penicillins. It is obtained from the fermentation brew of the Penicillium mold and used as the main starting block for the preparation of numerous semisynthetic penicillins

 Trimethoprim- Trimethoprim (TMP) is an antibiotic used mainly in the treatment of bladder infections. Other uses include for middle ear infections and travelers' diarrhea. With sulfamethoxazole or dapsone it may be used for Pneumocystis pneumonia in people with HIV/AIDS. It is taken by mouth.

Common side effects include nausea, changes in taste, and rash. Rarely it may result in blood problems such as not enough platelets or white blood cells. May cause sun sensitivity. There is evidence of potential harm during pregnancy in some animals but not humans. It works by blocking folate metabolism via dihydrofolate reductase in some bacteria which results in their death.

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Trimethoprim was first used in 1962. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. It is available as a generic medication and is not very expensive.[6] In the United States 10 days of treatment is about 21 USD. It is primarily used in the treatment of urinary tract infections, although it may be used against any susceptible aerobic bacterial species. It may also be used to treat and prevent Pneumocystis jiroveci pneumonia. It is generally not recommended for the treatment of anaerobic infections such as Clostridium difficile colitis (the leading cause of antibiotic-induced diarrhea). Trimethoprim has been used in trials to treat retinitis.

Resistance to trimethoprim is increasing, but it is still a first line antibiotic in many countries.

 Nimesulide- Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) with pain medication and fever reducing properties. Its approved indications are the treatment of acute pain, the symptomatic treatment of osteoarthritis, and primary dysmenorrhoea in adolescents and adults above 12 years old. It has a multifactorial mode of action and is characterized by a fast onset of action.

It works by blocking the production of prostaglandins (a chemical associated with pain), thereby relieving pain and inflammation.

 Pentaperazole Sodium - Pantoprazole sodium is a proton pump inhibitor indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD). Maintenance of Healing of Erosive Esophagitis.  Diclofenac Sodium - Diclofenac (sold under a number of trade names) is a nonsteroidal anti-inflammatory drug (NSAID) taken or applied to reduce inflammation and as an analgesic reducing pain in certain conditions. Diclofenac is used to treat pain, inflammatory disorders, and dysmenorrhea.  Diclofenac Potassium- Diclofenac (sold under a number of trade names) is a nonsteroidal anti-inflammatory drug (NSAID) taken or applied to reduce inflammation and

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

as an analgesic reducing pain in certain conditions. Diclofenac is used to treat pain, inflammatory disorders, and dysmenorrhea.  Ornidazole - Ornidazole is a drug that cures some protozoan infections. After passive absorption into bacterium cell, the nitro group of ornidazole is reduced to amine group by ferrodoxin type redox system. The formation of redox intermediate intracellular metabolites is believed to be the key component of microorganism killing for Ornidazole.  Mometasone Furote- This medication is used to treat skin conditions such as eczema, psoriasis, allergies, and rash. Mometasone decreases swelling (inflammation), itching, and redness. Mometasone is a medium-strength corticosteroid. This medication is available in

several forms including cream, ointment, and lotion.

 Aceclofenac - Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) analog of Diclofenac. It is used for the relief of pain and inflammation in rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. The drug works by inhibiting the action of cyclooxygenase (COX) that is involved in the production of prostaglandins (PG) which is accountable for pain, swelling, inflammation and fever.

 Mefenamic Acid - Mefenamic acid is a member of the anthranilic acid derivatives (or fenamate) class of NSAID drugs, and is used to treat mild to moderate pain, including menstrual pain, and is sometimes used to prevent migraines associated with menstruation

 Mecobalamin- Mecobalamin is a cobalamin, a form of vitamin B12. Methylcobalamin is

equivalent physiologically to vitamin B12, and can be used to prevent or treat pathology

arising from a lack of vitamin B12 (vitamin B12 deficiency), such as pernicious anemia. Methylcobalamin is also used in the treatment of peripheral neuropathy, diabetic neuropathy, and as a preliminary treatment for amyotrophic lateral sclerosis.

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

 Disulfiram - Disulfiram (sold under the trade names Antabuse and Antabus) is a drug discovered in the 1920s used to support the treatment of chronic alcoholism by producing an acute sensitivity to ethanol (drinking alcohol). Disulfiram works by inhibiting the enzyme acetaldehyde dehydrogenase, which means that many of the effects of a "hangover" are felt immediately after alcohol is consumed.  Ofloxacin- Ofloxacin is an antibiotic useful for the treatment of a number of bacterial infections. When taken by mouth or injection into a vein this includes pneumonia, cellulitis, urinary tract infections, prostatitis, plague and certain types of infectious diarrhea. Other uses, along with other medications, include multidrug resistant tuberculosis. An eye drop may be used for a superficial bacterial infection of the eye and an ear drop may be used for otitis media when there is a hole in the ear drum. Ofloxacin was patented in 1980 and approved for medical use in 1985. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system.  Deflazacort - Deflazacort (trade name Emflaza or Calcort among others) is a glucocorticoid used as an anti-inflammatory and immunosuppressant. 3.0 MANUFACTURING PROCESS:

1. Aceclofenac When diclofenac sodium reacts with t- butyl chloro acetate in presence of phase transfer catalyst TBAB,esterification reaction takes place and as a results of this reaction Aceclofenac t-butyl easter formed .further the Aceclofenac t-butyl easter undergoes to acid hydrolysis in the presence of Formic acid to form Aceclofenac.

Reaction Scheme of Aceclofenac

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

t-butyl Chloro acetate

Formic Acid , TABA

Diclofenac sodium Aceclofenac

Hazardous identification : Emergency overview : toxic, may cause harm to un born child, may impair infertility.

Target organs : cardiovascular system, digestive system reproduction, resproductive system, respiratory system, skin inhalation .

Route of entry : inhalation, eyes, injection, skin

2. Diclofenac Sodium

Step-I°°

2, 6-Dichloro phenol reacts with mono methyl chloro acetate in the presence of potassium carbonate. On the completion of reaction and subsequent work up, reaction mass further reacts with aniline in the presence of sodium methoxide. After workup it gives the intermediate, called AMINE.

Step II

AMINE from stage first reacts with chloro acetyl chloride. After completion the reaction mass saturated with water and centrifuge to get intermediate 2nd known as VOLTA CHLORIDE.

Step III

VOLTA CHLORIDE from step 2nd reacts with anhydrous Aluminum chloride. After completion the reaction, the mass quench into ice and filter to obtain INDOLINONE as STAGE-3RD.

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Step IV

Wet INDOLINONE, from step-3rd, hydrolyzed with caustic by refluxing for 12 hrs. Cool the mass, centrifuge to get diclofenac potassium crude. Crude diclofenac potassium, dissolves in hot water, gives carbon treatment and crystallized by cooling after filtration to obtain crystals of PURE DICLOFENAC POTASSIUM after centrifugation and drying

Reaction Scheme of Diclofenac Sodium

INDOLINONE

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

DICLOFENAC SODIUM

Hazards Identification.: Very hazardous in case of skin contact (irritant), of ingestion. Hazardous in case of eye contact (irritant), of inhalation. Severe over-exposure can result in death.

Target organ: Hypersensitivity, Hematologic, Metabolic, Cardiovascular

Route of entry : inhalation, eyes, injection, skin.

3. Diclofenac Potassium

Step I

Step II

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

AMINE from stage first reacts with chloro acetyl chloride. After completion the reaction mass saturated with water and centrifuge to get intermediate 2nd known as VOLTA CHLORIDE.

Step III

VOLTA CHLORIDE from step 2nd reacts with anhydrous Aluminum chloride. After completion the reaction, the mass quench into ice and filter to obtain INDOLINONE as STAGE-3RD.

Step IV

Wet INDOLINONE, from step-3rd, hydrolyzed with Potassium Hydroxide by refluxing for 12 hrs. Cool the mass, centrifuge to get DICLOFENAC POTASSIUM CRUDE.

CRUDE DICLOFENAC POTASSIUM, dissolves in hot water, gives carbon treatment and crystallized by cooling after filtration to obtain crystals of PURE DICLOFENAC POTASSIUM after centrifugation and drying.

Reaction Scheme of Diclofenac Potassium

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

INDOLINONE

DICLOFENAC POTASIUM

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Hazards Identification: very hazardous in case of skin contact(irritant), hazardous in case of eye contact ,of inhalation,

Target organ: Cardiovascular, GI Bleeding, Ulceration and Perforation, Serious Skin Reactions, Hematologic Toxicity

Route of entry : inhalation, eyes, injection, skin.

4. Ornidazole

Step I

Mixing of Ethylene dichloride, Ethyl Acetate, And 2 M.N.I. After 30 minute addition of Aluminum chloride takes place.

Step II

After maintaining & cooling the Reaction Mass, to the reaction mass addition of Epichloro Hydrine is takes place.

Step III

Filter the reaction Mass and Collect ML in another reactor; dry the wet cake of 2M.N.I. To the ML Aqueous layer add Ethylene dichloride. Separate and collect Organic layer add Sulphuric Acid And collect Aqueous layer set pH 3.5 with Ammonia.

Step IV

The resulting crystalline material is centrifuged and dried, blended, after QC checked passed material is issued for packing.

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Reaction Scheme of Ornidazole

Hazardous identification : Emergency overview : toxic, may cause harm to un born child, may impair infertility.

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Target organs : Eyes ,cardiovascular system, digestive system reproduction, resproductive system, respiratory system, skin inhalation .

Route of entry : inhalation, eyes, injection, skin

5. Ofloxacin

Step I

Mixing of N-methylpiperazine, Q-Acid, with Dimethyl sulfoxide.

Step II

Dilute with methanol After the Reaction is complete

Step III

The resulting crystalline material is centrifuged and dried, blended, after QC checked passed material is issued for packing.

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Hazardous identification : Abdominal or stomach pain, anxiety, black, tarry stools,bleeding gums, blood in the urine or stools, blurred vision, body aches or pain, chest pain, chills, cloudy urine

Target organ : Gastrointestinal, Nervous system

6. Pantoprazole Sodium

Condensation of 2-Chloromethyl-3, 4-dimethoxy pyridine hydrochloride and 2-mercapto-5- difluoromethoxy benzimidazole in presence of dichloromethane and Tetra butyl ammonium bromide were added under stirring to catalyzed the reaction then followed by solution of sodium hydroxide, Aqueous sodium hypochlorite solution was added to the reaction mass, The resulting solid was then filtered and washed with cold acetone and dried under vacuum at 35-40° C. to give Pantoprazole sodium. Reaction Scheme of Pantoprazole Sodium

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

2-(chloromethyl) 3, 4- dimethoxy 5- (Difluromethoxy) -2-mercapto-1-(H)- pyridine hydrochloride Benzimidazole

Pantoprazole Sodium Hazardous identification : Abdominal or stomach pain, blurred vision, dry mouth, flushed, dry skin, fruit-like breath odor, increased hunger, increased thirst increased urination, nausea, sweatin.

Target organ : Gastrointestinam, Respiratory system, Nervous syste

7. Mecobalamine 28

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Step -I

1% Watery solution of Cynocobalamine slowly reacts with SBH at the temperature of 10-15 o

C. On the completion of reaction and subsequent work up.

Step -II

Make solution of Methyl Iodide in Methanol. Reaction mass from 1st stage further reacts with methyl iodide

Step -III

Reaction mass from2nd step further addition with chloroform and phenol at 15-20 o C.

Step -IV

Layer separation, discard aqueous layer.

Step –V

Add acetone and DM Water.P

Step –VI

Layer separation,

Step –VII

Cool and Filter the product aqueous mass in Buchner Funnel to get wet Mecobalamine JP.

Step – VIII

Product wet Cake dry at 50-60 o C.

Reaction Scheme of Mecobalamine

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Hazardous identification : Have blood in your urine, Have an ongoing infection, Have low iron or folate levels, Have a bone disease called polycythemia

Effect on body : Low levels of potassium in the blood, Congestive heart failure, Clots in the arms and legs, Life-threatening allergic reaction called anaphylaxis, in which you may have trouble breathing, your tongue swells and/or throat closes up, and your skin breaks out into hives Fluid building up in the lungs

8. Nimesulide

NS-1- 2Phenoxy Aniline reacts with Methyl sulphonyl Chloride in presence Dimethyl aniline to produce OPMSA.

NS-2- OPMSA reacts with Nitric acid to produce crude Nimesulide and finally crystallized in methanol to give pure Nimesulide. Thereafter dry and packed Reaction Scheme of Nimesulide

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Hazardous identification : Emergency overview : toxic, may cause harm to un born child, may impair infertility.

Target organs : cardiovascular system, digestive system reproduction, resproductive system, respiratory system, skin inhalation .

Route of entry : inhalation, eyes, injection, skin

9. Disulfiram

First of all Diethyl amine undergoes condensation with Carbon di sulphide in presence of inorganic base.Finally quenched with Ammonium par sulphate to form Disulfiram.

Reaction Scheme of Disulfiram

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Hazardous identification: Skin irritation, Eye irritation, Slightly hazardous if inhaled and ingested

Target organs: Skin, Affect Respiratory Tract

Route of entry: Eye Contact, Skin Contact, through inhalation and ingestion.

10. Mometasone Furoate

Step-I

8 DMreacts with Lithum Chloride in the presence of MDC. Along with Potassium hydroxide gives Mometasone Furote Crude.

Step-II

This on further treat with 2Furoyl Chloride and Alumina oxide taken Tri Ethyl Amine and Tetra hydro furon, Pesuets Mometasone Furoate tech, Which was further treat Activated Carbon by taking in Isopropyl Alcohol, to from Mometasone Furoate pure after centrifuge and drying.

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Reaction Scheme of Mometasone Furoate

Hazardous identification : blurred vision, or seeing halos around lights, uneven heartbeats, sleep problems (insomnia), weight gain, puffiness in your face, tired feelin

Route of entry : Only Through skin

11. Mefenamic Acid

Step-I

2,Chloro benzonic acid reacts with 2-3 xyldine in the presence of soda ash. On the completion of reaction and subsequent work up, reaction mass further reacts with cuprihloride n the presence of DMF, after workup it gives the intermediate, called MFN Crude.

Step-II

Crude MFN, dissolves in tolune and DMF,gives carbon treatment and crystallized by cooling after filtration to obtain crystals of Pure MFN after centrifugation and drying.

Reaction Scheme of Mefenamic Acid

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Hazardous identification : Stomach pain , Nausea, Vomiting, Heartburn, Constipation Diarrhea, Rash, Dizziness, Ringing in your ear (tinnitus).

Target organ : Liver, Stomach, Heart, Skin reactions

12. 6- AMINOPENICILLIN

Manufacturing Process of 6APA

Pen G Potassium react with HCL in presence of Sodium Hydroxide and Ammonium Hydroxide Solution in Toluene and Methanol solvent media to get 6APA.

Reaction Scheme of 6APA

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Hazardous identification: Acute oral toxicity, allergic skin reaction, asthma symptoms or breathing difficulties if inhaled.

Taget organs: Skin, Affect Respiratory Tract

Route of entry: Inhalation, Through Skin.

13. TRIMETHOPRIM

Stage:1

Acrylonitrile is added to a precooled 40% DMA Solution and stirred the mass for 10 hours at 20-25 degree . The resultant N,N Dimethylamino propionitrile is separated out from aqueous solution by adding Sodium Hydroxide Solution and separating the layers.

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Stage:2

3,4,5-Trimethoxy Benzaldehyde is condenced with N,N Dimethylamino propionitrile in presence of Methanolic Potassium Hydroxide using Dimethyl Sulfoxide as Solvent. The Condenced product is treated with Aniline in acidic medium diluted with methanol. The 2- 3-anilino propionitrile obtained is centrifuged.

Stage:3

To a solution of 24% Sodium Methox in Methanol Guanidine Nitrate is added and the Gnanidine Base in Meoh is collected by centrifugation of reaction mass.

Stage:4

The 2-3-anilino propionitrile is added to Guanidine Base in Meoh and the contents are the contents are refluxed to yield Trimethoprim crude which is isoed by centrifugation.

Stage:5

The Crude Trimthoprim is dissolved in dilute Acetic Acid and the Trimethoprim Acetate formed in solution is charcolized, filtered and pure Trimethoprim is isolated by neutralizing mass with Ammoum Hydroxide solution followed by centrifuging and drying.

Reaction Scheme of TRIMETHOPRIM

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Hazardous identification: Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation, toxic to blood, bone marrow.

Taget organs:

Route of entry: Inhalation. Ingestion.

14. DEFLAZACORT manufacturing process

D-5, Potassium Acetate, Acetic Acid in presence of Methanol and Calcium Oxide were added Calcium Chloride the reaction then followed by solution of Methanol was added to the reaction mass, The resulting solid was then filtered and washed with cold acetone and dried to give Deflazacort.

Reaction Scheme of Deflazacort

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Hazardous identification: Reproductive toxicity, Suspected of damaging fertility or the unborn child. Causes damage to organs (endocrine system) through prolonged or repeated exposure.

Target organs: Endocrine System

Route of entry: Ingestion, Inhalation, Eye Contact, Skin Contact

3.1Solvent Management System

• All the products will be purified in their respective solvent to remove impurities. •Solvents will be collected and sold off to authorized re-processor for distillation of mixed solvent or will be distilled in the proposed solvent distillation system. •The reactors will be connected to an efficient condenser system with cooling/chilling water/brine circulation. •Reactor and solvent handling pumps will have mechanical seals to prevent leakages. Also provide with breather valve to prevent losses. •Solvent will be taken from storage tank to reactors through closed pipe line. Storage tank will be vented through trap receiver and condenser operated on cooling water. • The condensers will be provided with sufficient HTA and residence time so as to any loss of solvent. • Proper earthing will be provided wherever solvent handling is done. • Entire plant is flame proof. • Solvents will be stored as per statutory requirement. • Solvents will be kept at a separate specified area with all the safety measures.

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Fig:1 Solvent Recovery System

4.0 BASELINE ENVIRONMENTAL SETTING

4.1 The State

Rajasthan is India's largest state by area (342,239 square kilometres (132,139 sq meter) or 10.4% of India's total area). It is located on the western side of the country, where it comprises most of the wide and inhospitable Thar Desert (also known as the "Rajasthan Desert" and "Great Indian Desert") and shares a border with the Pakistani provinces of Punjab to the northwest and Sindh to the west, along the Sutlej-Indus river valley. Elsewhere it is bordered by five[6] other Indian states: Punjab to the north; Haryana and Uttar Pradesh to the northeast; Madhya Pradesh to the southeast; and Gujarat to the southwest. Major features include the ruins of the Indus Valley Civilization at Kalibanga; the Dilwara Temples, a Jain pilgrimage site at Rajasthan's only hill station, Mount Abu, in the ancient Aravalli mountain range; and, in eastern Rajasthan, the Keoladeo National Park near Bharatpur, a World Heritage Site known for its bird life.

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Rajasthan is also home to three national tiger reserves, the Ranthambore National Park in Sawai Madhopur, Sariska Tiger Reserve in Alwar and Mukundra Hill Tiger Reserve in Kota.The state was formed on 30 March 1949 when Rajputana – the name adopted by the British Raj for its dependencies in the region was merged into the Dominion of India. Its capital and largest city is Jaipur, also known as Pink City, located on the state's eastern side. Other important cities are Jodhpur, Udaipur, Bikaner, Kota and Ajmer.

4.2 District Alwar Alwar district is located in the north eastern part of Rajasthan and extends between north latitude 27°03’ and 28°14’ and east longitude 76°07’ and 77°13’. It covers 8720 sq. km of geographical area. Its length from south to north is about 137 km and breadth from east to west is about 110 km. The district occupies about 2.45% of total area of the State. 4.3 Project Site

The Plant site is located at Plot no. B-1124 RIICO industrial area,phase-III Bhiwadi Tehsil-Tijara, District-Alwar, State- Rajasthan It lies near Long: 76 ̊51’16.4 ̎ East and Lat: 28 ̊12’04.9 ̎ North and is at an Altitude of about 263m above mean sea level. The nearest railway station is Inchapuri Railway Station which is at a distance of about 18.30 km from the project site. It is about 5.90 km from NH-8.

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Figure 2 : Google Image 10 Km Buffer Map

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Fig 3: Key Plan of Project Site

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Fig 4: Layout Plan

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

5.0 PROJECT DESCRIPTIONS

5.1 General

The Plant site is located at plot No. B-1124 RIICO industrial area,phase-III Bhiwadi Tehsil- Tijara, District-Alwar, State- Rajasthan. It lies near Long: 76 ̊51’16.4 ̎ East and Lat: 28 ̊12’04.9 ̎ North and is at an Altitude of about 263 m above mean sea level. It is about 18.30 km away from Inchapuri Railway station. It is about 5.90 km from NH-8. M/s Alka Laboratories Pvt Ltd has taken 1.39 ha of land for set up of proposed industry, in which approx 60% of the total area will be covered as Green Belt. The total cost of the project is 1189.19 Lakhs.

Table-2 Plant and Machinery Particulars Existing Proposed D.G. Sets (500KVA) 01 01 Effluent Treatment Plant 25 KLD 63KLD capacity Air Pollution Control System 1 01 Boilers 1 01 D.G. Set 1 1 Sewage treatment plant 08KLD 80KLD

5.2 Raw Materials Requirement Table- 3 Raw material requirement

Sr. Existing Raw Material Name Quantity Product Name/Quantity

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

No. 1 Ammonium Hydroxide 382 6 Aminopenicillin Hydrochloride Acid 186 (150MT/Annum) Methanol 118 Pen G Potassium 272 Sodium Hydroxide 41 Toulene 1000

2 3,4,5- 63 Trimethoprim TrimethoxyBenzaldehyde (75MT/Annum) Acetic Acid 25 Acrylonitrile 17.08 Activated Carbon 4.16 Ammonium Hydroxide 83.33 Aniline 31.25 Dimethyl Sulfoxide 62.5 Dimethylamine 42.5 Guanidine Nitrate 68.75 Hyflo 0.83 Methanol 143.75 Potassium Hydroxide 4.99 Sodium Hydroxide 37.92 Sodium Methoxide 127.09 Sulphuric Acid 37.5 S.no. Proposed Raw Material 1 2-Phenoxy Aniline 426 Nimesulide (600

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Dimethyl Aniline 36 Tonnes/Annum) Methyl Sulphonic Chlorie 270 HCL 144 Mono Chloro Benzene 210 Activated Carbon 12 Nitric Acid 264 Acetic Acid 0 Caustic Flakes 210 Sulphuric Acid 0 Hyflow 0 Acetone 0

2 2-Chloromethyl-3,4- 72 Pentaperazole Sodium dimethoxy pyridine (120Tonnes/Annum) hydrochloride 2-mercato-5-difluoromethoxy 72 benzimidazole Tetra butyl ammonium 0 bromide Dichloromethane 0 Sodium hydroxide 0 Sodium hypochlorite 600 Acetone 84

3 2,6 Dichloro Phenol 294 Diclofenac Sodium (420 Toluene 0 Tonnes/Annum) Potassium Carbonate 138.6

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Sodium Methoxide Solution 617.4 Mono Methyl Chloro Acetate 218.4 Analine Oil 172.2 Chloro Acethyl Chloride 222.6 Ammonium Chloride 373.8 Caustic Soda Flakes 138.6 Sodium Hydro Sulphate 16.8 Activated Carbon 4.2 Methanol 117.6

4 2,6 Dichloro Phenol 126 Diclofenac Potassium Toluene 0 (180Tonnes/Annum ) Potassium Carbonate 59.4 Sodium Methoxide Solution 264.6 Mono Methyl Chloro Acetate 93.6 Analine Oil 73.8 Chloro Acethyl Chloride 95.4 Ammonium Chloride 160.2 Caustic Soda 59.4 Sodium Hydro Sulphate 7.2 Activated Carbon 1.8 Methanol 50.4

5 2-Methyl 5- NitroImidazole 338.4 Ornidazole (360 Ethyl Acetate 169.2 Tonnes/Annum) Ethylne dichloride 450

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Aluminium Chloride 511.2 Epichloro Hydrine 464.4 Ammonia Liaqur 453.6 Sulphuric Acid 237.6 Methanol 453.6 DM Water 4510.8

6 8DM 1.2 Mometasone Furote (1.2 MSC 1.42 Tonnes/Annum) Lithum Chloride 0.6 TEA 4.03 2 Furolyl Chloride 1.2 Acetaone 35.8 IPA 4.27 MDC 22.32 THF 4.32 Alumina Oxide 2.4 HCL CP 25.54 Sodium BI Corbonate 0 KOH 0 Carbon 0.06 Hyflow 0

7 Diclofenac Sodium 381.6 Aceclofenac (360 T-Butyl Chloro Acetate 226.8 Tonnes/Annum)

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Formic Acid 583.2 TBAB 6.48

8 OCBA 399 Mefenamic Acid (420 Toluene 512.4 Tonnes/Annum) DM Water 1680 Soda Ash 285.6 Sodium Hydro Sulphite 16.8 Cupric Chlorite 14.7 2,3 Xylidine 352.8 DMF 142.8 HCL 533.4

9 Cynocobalamine 1.2 Mecobalamin Methyl Iodide 1.08 (1.2Tonnes/Annum) SBH 1.2 Phenol 7.70 Chloroform 10.7 Acetone 11.4 Methanol 0.85 DM Water 72

10 Diethyl Amine 24.12 Disulfiram Carbon di sulfide 24.12 (36Tonnes/Annum) Sodium Hydroxide 11.52 Ammonium Par Sulphate 36

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Methanol 28.8

11 Ofloxacin Acid 154.8 Ofloxacin N-Methyl Piperazine 99 (180Tonnes/Annum) Dimethyl Sulphoxide 39.6 Methanol 90 Caustic Soda Flakes 68.4

12 D-5 1.2 Deflazacort Iodine crystal 1.9 (1.2Tonnes/Annum) Calcium oxide 0.7 Calcium chloride 0.6 Potassium Acetate 1.7

Acitic Acid 1.7 Acetone 4.8 Methanol 7.2

Table-4 Plant Site and Location

S.No Particulars Details 1 Location a Village/ Town/Plot No. B-1124 RIICO industrial area,phase-III Bhiwadi b Tehsil Tijara c District Alwar d State Rajasthan

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

e Latitude 28 ̊12’04.9 ̎ N

d Longitude 76 ̊51’16.4 ̎ E

2 Elevation 263m 3 Land use at the project site Industrial 4 Climatic Conditions Temperature Min: 5oC, Max:47oC Rainfall 631 mm (Normal) 5 Nearest highway National Highway-8 is 5.90 km (approx) in North-West direction.

State Highway -28 is 1.16 km (approx) in North direction.

6 Nearest railway station Inchapuri Railway Station is 18.30 km (approx) in North-West direction.

7 Nearest airport Indira Gandhi International Airport Delhi is 45.90 km (approx) in North-East direction.

8 Nearest major city Bhiwadi city is 0.60 km (approx) in North- West direction.

9 Nearest major settlement Bhiwadi city is 0.60 km (approx) in North- West direction.

10 Features with 10 km : i) Defense installations Nil ii) Archaeological important Nil places

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

iii) Wild life sanctuaries Nil Iv) Reserved/Protected forest PF=Khori khalan, 8.9km in South direction Banvan, 4.5km inSouth direction, Gondhan ,2km in South direction RF= Rangala, 2.1km in North-East direction. v) Industries • Ridhi corporate uniform manufacturing • Keenat glass • Ajanta chemical • Federal mogul • Bansali cables and conductors private Ltd • Western control and automation • Federal mogul india • Hanon climate system India private Ltd • KEI industries limited

vi) Rivers Indori nala at 5.8km in East direction vii) Hill ranges Nil viii) State Boundary Yes, interstate boundary of Haryana is at a distance of 1.6 km in North-East direction.

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

5.3 Power Requirement

Total power requirement for the existing project is 400 KVA and proposed will be 880 KVA.

5.4 Water Supply

Existing fresh water requirement of the project is 21KLD.16 KLD from ground water and 05 KLD from any other agency. Additional 9 KLD of recycled water is being used at the project site. Total water requirement for the proposed project will be 90 KLD.

Table-5 Water Requirement

S. Category Water Wastewater Remark No Consumption Generation (L/Day) L/Day 1. Domestic 12 KLD 12 KLD Domestic water will be treated in STP 2. Industrial Process 40KLD 26 KLD Industrial water will Equipment & 05 KLD 05 KLD be treated in ETP Reactor Cooling Tower 14 KLD Boiler 19 KLD 2 KLD Total Industrial 78 KLD 33 KLD Total Industrial + Domestic 90 KLD 45 KLD

5.5 Man Power Requirment

Existing manpower = 150 Proposed manpower=140 Total manpower =290

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Table-6 Manpower Distribution S.No. Categories Number 1 Manager/Accountant 29 2 Supervisor 19 3 Skilled labour 47 4 Semi Skilled Labour 165 8 Unskilled Helper 30 Total 290

5.6 Land break-up

Table-7 Land break-up

Land Area (m2) S.No Green area 8369 1 Roof top area 3542 2 Paved area 2022 3 Total 13933

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

6.0 SITE ANALYSIS (i) Connectivity The project unit is located at B-1124 RIICO industrial area, phase-III Bhiwadi, Tehsil-Tijara, District-Alwar, State- Rajasthan. The said area is notified by RIICO and it is adjoining with Dharuhera, Kapariwas. Location wise, the site is well connected with Gurgaon through NH-8 and SH-28 and SH-13. There are lots of organized and un-organized manufacturer situated in these area. The availability of raw materials and marketing of finished goods will be no problem for proposed industry. (ii) Climate and Rainfall Climate of the district can be classified as semi-arid. It is characterized by very hot summer and very cold winters with fairly good rainfall during south west monsoon period. In May and June, the maximum temperature may go up to 470C. The potential evapotranspiration rates are quite high especially during May and June. Normal annual rainfall of the district is 631mm. Monthly distribution of normal rainfall, month and season-wise actual rainfall during 2010-2011 are given in Table below (Commissionrate of Agriculture, Govt. of Rajasthan, 2012). Month-Wise Normal Rainfall of Alwar Dist Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total Alwar 9.6 10.2 5.6 5.5 9 15.8 44.2 196 213.3 100.9 20.0 4.1 4.8 630.9 District-wise actual rainfall during 2010-2011 Dist Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Total Alwar 40.4 214. 272. 233. 3.6 21.8 4.5 0.0 44.0 0.0 0.0 21.0 855.0 2 5 0

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

District-wise actual seasonal rainfall during 2010-2011

Dist Annual Normal June 10 - Sep Oct 10 - Dec Jan 11 - Feb March 11 - May Total (Jun 10 to 10 10 11 11 May 11) Alwar 630.9 760.1 29.9 44.0 21.0 855.0

(iii) Geomorphology and Soil Types

The district is quadrilateral in shape. The Aravalli ranges from ridges of rocky hills in most parts and are generally parallel. These make their appearance in the district from north east in Tijara subdivision and run southwards forming boundary of the district in the north east for about 24 km, terminating near Naugaon. Another prominent hill range is at Mandawar, which passes through Jindoli and Alwar towards the extreme south west corner of the district adjacent to Jaipur district. The low hills cover almost entire Thanagaji and Rajgarh tehsils & about one third of the Alwar tehsil 4 and form prominent feature in Bansur, Kishangarh and Tijara tehsils. Mandawar, Behror, eastern part of Alwar, Rajgarh tehsils and western part of Bansur tehsils are gentle plains with scattered peaks of small hills. The highest peak in the district is at Bilahi, which is 775 mamsl.

(iv) Drainage

There is no perennial river in the district. The seasonal rivers, which flow through the district and carry the runoff from the hills are Sabi (Sahibi), Ruparail (Barah), Chuhar Sidh and Landoha. The natural drainage is from south west to north east.

(v) Hydrogeology

Alwar district is mostly underlain by the rocks of Delhi Super Group with minor outcrops belonging to Bhilwara Super Group and Post Delhi Intrusives at places overlain by Quaternary alluvium.The occurrence of ground water in the district is mainly controlled by

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

topographic features, physical characteristics and structural features present in the geological 7 formations. Ground water in the area occurs under confined conditions in phreatic zones, semi-confined conditions in deeper zones and weathered & fractured portions of the hard rocks. About 60% of the district area is covered by Quaternary sediments overlying the hard rock formations. Ground water occurs under phreatic conditions in the shallow aquifers and under semi-confined conditions in the deeper aquifer, which is the principal water bearing zone. Ground water occurs under unconfined conditions in the weathered zones in the joints, fractures and plains of structural weakness available in the hard rocks. In the district the hard rocks are grouped as granite, gneiss, schist of Bhilwara Super group and quartzite, impure limestone, phyllite, granite and pegmatite of the Delhi Super Group. The movement of the ground water in these rocks is controlled by the nature, size openness and continuity of joints & fracture present in them. They do not form important water bearing formation except in the fractured and brecciated quartzite at places. Wells in hard rocks generally yield 50 to 70 m3 /day of all the rock types. Schist, phyllite and their variants form very poor aquifers yielding 10 to 30 m3 /day for heavy drawdown.

7.0 Social Infrastructure available

(1) Education:- Alwar has become a major education hub of Rajasthan these days. Along with numerous government colleges providing Arts, Sciences, and Commerce education, a number of private educational institutes have also opened up. Establishment of Matsya University, Alwar was announced in budget speech of 2012-13 by Hon'ble chief minister of Rajasthan. In the last few years many coaching institutes have become established in the city for the preparation of IAS, RAS, JEE, PMT, AIIMS, and other competitive exams. The coaching class movement started for multiple high quality institutions for IIT JEE and PMT preparation. Those students who follow coaching institutes no longer migrate to other major cities, like Delhi, Jaipur and Kota.

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

(2) Road and Rail:- The nearest airport to Alwar city is Indira Gandhi International Airport Delhi is 45.90 km away . The international and cargo Airport is also sanctioned in Bhiwadi that is 90 km away from Alwar city. Delhi-Jaipur railway line passes through Alwar city. The railway network connects Alwar with Delhi, Mumbai, Jaipur, Agra, Jodhpur, Ajmer, Chandigarh, Amritsar, Katra and other important tourist cities of India. Alwar is well connected by roads from all the major cities of Rajasthan and nearby states. Alwar city is reached from New Delhi Gurgaon-Sohna-Alwar highway that is being widened to six lanes.

(3) Proposed infrastructure Industrial Area (processing area) It is an industrial land and the location is ideal for the marketing point of view of finished goods and raw materials for manufacturing of such types of Bulk Drugs & intermediates. Residential Area (Non processing area) Residential colony is not proposed for proposed project. The local labor will be preferred to provide employment opportunities. Green Belt Greenbelt will be developed in 60% of the total area of the proposed project.

Social Infrastructure Proposed project will result in growth of the surrounding areas by increased direct and indirect employment opportunities in the region including ancillary development and supporting infrastructure. Connectivity The project is well connected with Rail and Road. Industrial Waste management The proposed plant would be based on “ZERO EFFLUENT DISCHARGE”.

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

8.0 REHABILITATION AND RESETTLEMENT (R & R) PLAN

No Rehabilitation and Resettlement plan is applicable because there are no Rehabilitation & Resettlement of the people. 9.0 Project Schedule and Cost Estimates The project will start only after obtaining Environmental Clearance and all other required clearance and will complete after two years of commencement. The Capital Cost of the project is Rs is 1189.19 Lakh 10.0 WASTE MANAGEMENT

10.1 Liquid Effluent According to the nature and quantity of generated effluent, an Effluent Treatment Plant of 25KLD capacity is already existing and of 63KLD capacity is proposed which will be enough to treat the overall generated wastewater quantum due to the proposed manufacturing unit. 10.2 Solid Waste Solid waste estimated to be generated in the proposed industry is in the form of ETP sludge, Boiler Ash and municipal solid waste. The waste generated will be temporarily stored in the form of covered room inside factory premises at cooled and dry place. Boiler Ash will be used for land filling purposes of Low Lying Area whereas ETP sludge will be disposed through authorized TSDF facility Udaipur.

Table-8 Types and Quantity of Solid Waste Existing Proposed ETP sludge 2 Ton/Annum 13 Ton/Annum Ash from boiler 24 Ton/Annum 24 Ton/Annum

10.3 Air Pollution

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Industry has one coal fired boiler with capacity 2 ton and proposed one Coal fired Boiler of the capacity 2 ton, there are two types of Air Pollutants are emitted i.e. Gases and Dust. The

gases emitted from Coal Burning process are Sulphur Dioxide (SO2), Oxide of Nitrogen (NOX)

and CO and CO2. Solid pollutants will be emitted from the Coal Burning is in the form of Particulate Matter (Fly Ash). Removal of fine particles from the gases is a major task, which can be better done by the dust collector and finally emitted in to the Atmosphere 32 meter stack height.

10.4 Noise Pollution Control: There is no danger of noise pollution from plant. The green belt will (plantation of dense trees across the boundary) help in reducing noise levels in proposed plant as a result of attenuation of noise generated due to plant operations, and transportation.  Earmuffs would be used while running the equipments of the plant.  D.G sets are provided with acoustic to control the noise level within the prescribed limit.  A high standard of maintenance will be practiced for plant machinery and equipments, which helps to avert potential noise problems.

11.0 GREEN BELT DEVELOPMENT/ PLANTATION

Green belt development in and around the project site helps in to attenuate the pollution level. About 8369 square meter (60%) land area of project will be developed as green belt and it will be maintained in future also. Green belt will be developed as per Central Pollution Control Board (CPCB) Norms. The Avenue plantation will give priority to native species, and the periphery will be devoted to generation of green belt area. 12.0 CSR Activities

Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd

Proposed project will result in growth of the surrounding areas by increased direct and indirect employment opportunities in the region including ancillary development and supporting infrastructure. Special emphasis on Financial and Social benefits will be given to the local people including tribal population, if any, in the area. Development of social amenities will be in the form of medical facilities, education to underprivileged and creation of self help groups. No adverse effect on environment is envisaged as proper mitigation measures will be taken up for the same.