capacity expansion of drug manufacturing unit from 2...
TRANSCRIPT
Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd
11
Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products
At
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
12
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
13
6 Aminopenicillin Ammonium Hydroxide, Hydrochloride Acid, Methanol,
Pen G Potassium, Sodium Hydroxide, Toulene
150
Trimethoprim Trimethoxybenzaldehyde, Acetic Acid, Acrylonitrile,
Activated Carbon, Ammonium Hydroxide, Aniline,
Dimethyl Sulfoxide, Dimethylamine, Guanidine
Nitrate, Hyflo, Methanol, Potassium Hydroxide,
Sodium Hydroxide, Sodium Methoxide, Sulphuric Acid
75
Proposed
Nimesulide TrimethoxyBenzaldehyde,Acetic Acid, Acrylonitrile,
Activated Carbon, Ammonium Hydroxide, Aniline,
Dimethyl Sulfoxide, Dimethylamine, Guanidine
Nitrate, Hyflo, Methanol, Potassium Hydroxide,
Sodium Hydroxide, Sodium Methoxide, Sulphuric Acid
600
Pentaperazole
Sodium
2-Chloromethyl 3,4dimethoxypyridine hydrochloride,
2-mercato-5-difluoromethoxy benzimidazole, Tetra
butyl ammonium bromide, Dichloromethane, Sodium
hydroxide, Sodium hypochlorite, Acetone
120
Diclofenac
Sodium
2,6 DichloroPhenol, Toluene, Potassium Carbonate,
Sodium Methoxide Solution, Mono Methyl Chloro
Acetate, Analine Oil,Chloro Acethyl Chloride,
Ammonium Chloride, Potassium Flakes, Sodium Hydro
Sulphate, Activated Carbon, Methanol
420
Diclofenac
Potassium
2,6 Dichloro Phenol, Toluene, Potassium Carbonate,
Sodium Methoxide Solution, Mono Methyl Chloro
Acetate, Analine Oil, Chloro Acethyl Chloride,
Ammonium Chloride, Potassium Flakes, Sodium Hydro
Sulphate, Activated Carbon, Methanol
180
Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd
14
Ornidazole 2-Methyl 5- NitroImidazole, Ethyl Acetate, Ethylne
dichloride, Aluminium Chloride, Epichloro Hydrine,
Ammonia Liaqur, Sulphuric Acid, Methanol, DM Water
360
Mometasone
Furote
8DM, MSC, Lithum Chloride, TEA,2 Furolyl Chloride,
Acetaone, IPA, MDC, THF, Alumina Oxide, HCL
CP,Sodium BI Corbonate, KOH, Carbon, Hyflow
1.2
Aceclofenac Diclofenac Sodium, T-Butyl Chloro Acetate, Formic
Acid, TBAB
360
Mefenamic
Acid
OCBA, Toluene, DM Water, Soda Ash, Sodium Hydro
Sulphite, Cupric Chlorite, 2,3 Xylidine, DMF, HCL
420
Mecobalamin Cynocobalamine, Methyl Iodide, SBH,
Phenol,Chloroform Acetone, Methanol, DM Water
1.2
Disulfiram Diethyl Amine, Carbon disulfide, Sodium Hydroxide,
Ammonium Par Sulphate, Methanol
36
Ofloxacin Ofloxacin Acid, N-Methyl Piperazine, Dimethyl
Sulphoxide,Methanol, Caustic Soda Flakes
180
Deflazacort D-5, Iodine crystal, Calcium oxide, Calcium chloride,
potassium acetate, Acitic Acid, Acetone,
1.2
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
15
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
16
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
17
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
18
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
19
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.
t-butyl Chloro acetate
Formic Acid, TABA
Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd
20
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
21
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
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
DICLOFENAC SODIUM
Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd
22
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
23
DICLOFENAC POTASIUM
INDOLINONE
Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd
24
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
25
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
26
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
27
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
28
+
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
Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd
29
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
30
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
31
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
32
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
33
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
34
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
35
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
36
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
37
Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd
38
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
39
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
40
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
41
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
42
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
43
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
44
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
45
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
capacity
25 KLD 63KLD
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
46
No.
1 Ammonium Hydroxide 382 6 Aminopenicillin
(150MT/Annum) Hydrochloride Acid 186
Methanol 118
Pen G Potassium 272
Sodium Hydroxide 41
Toulene 1000
2 3,4,5-
TrimethoxyBenzaldehyde
63 Trimethoprim
(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
47
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-
dimethoxy pyridine
hydrochloride
72 Pentaperazole Sodium
(120Tonnes/Annum)
2-mercato-5-difluoromethoxy
benzimidazole
72
Tetra butyl ammonium
bromide
0
Dichloromethane 0
Sodium hydroxide 0
Sodium hypochlorite 600
Acetone 84
3 2,6 Dichloro Phenol 294 Diclofenac Sodium (420
Tonnes/Annum) Toluene 0
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
48
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
(180Tonnes/Annum ) Toluene 0
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
Tonnes/Annum) Ethyl Acetate 169.2
Ethylne dichloride 450
Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd
49
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
Tonnes/Annum) MSC 1.42
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
Tonnes/Annum) T-Butyl Chloro Acetate 226.8
Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd
50
Formic Acid 583.2
TBAB 6.48
8 OCBA 399 Mefenamic Acid (420
Tonnes/Annum) Toluene 512.4
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
(1.2Tonnes/Annum) Methyl Iodide 1.08
SBH 1.2
Phenol 7.70
Chloroform 10.7
Acetone 11.4
Methanol 0.85
DM Water 72
10 Diethyl Amine 24.12 Disulfiram
(36Tonnes/Annum) Carbon di sulfide 24.12
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
51
Methanol 28.8
11 Ofloxacin Acid 154.8 Ofloxacin
(180Tonnes/Annum) N-Methyl Piperazine 99
Dimethyl Sulphoxide 39.6
Methanol 90
Caustic Soda Flakes 68.4
12 D-5 1.2 Deflazacort
(1.2Tonnes/Annum) Iodine crystal 1.9
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
52
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
Rainfall
Min: 5oC, Max:47oC
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
places
Nil
Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd
53
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
54
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.
No
Category Water
Consumption
(L/Day)
Wastewater
Generation
L/Day
Remark
1. Domestic 12 KLD 12 KLD Domestic water will
be treated in STP
2. Industrial Process 40KLD 26 KLD Industrial water will
be treated in ETP Equipment &
Reactor
05 KLD 05 KLD
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
55
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
S.No Land Area (m2)
1 Green area 8369
2 Roof top area 3542
3 Paved area 2022
Total 13933
Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd
56
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.
2
272.
5
233.
0
3.6 21.8 4.5 0.0 44.0 0.0 0.0 21.0 855.0
Capacity expansion of Drug manufacturing unit from 2 existing products to 12 proposed products by M/s Alka Laboratories Pvt Ltd
57
District-wise actual seasonal rainfall during 2010-2011
Dist Annual Normal June 10 - Sep
10
Oct 10 - Dec
10
Jan 11 - Feb
11
March 11 - May
11
Total (Jun 10 to
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
58
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
59
(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
60
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
61
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
62
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.