A pharmaceutical drug (medicine or medication and officially medicinal product) is a drug used in health care. Such drugs aid the diagnosis, cure, treatment, or prevention of disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. Pharmaceutical or drug or medicines are classified in various other groups besides their origin on the basis of pharmacological properties like mode of action and their pharmacological action or activity, such as by chemical properties, mode or route of administration, biological system affected, or therapeutic effects. An elaborate and widely used classification system is the Anatomical Therapeutic Chemical Classification System (ATC system). The Pharmaceutical industry in India is the world's third-largest in terms of volume. The total turnover of India's pharmaceuticals industry between 2008 and September 2009 was US$21.04 billion. While the domestic market was worth US$12.26 billion. The industry holds a market share of $14 billion in the United States.
The pharmaceutical industry has been one of the fastest growing segments of the Indian manufacturing sector with an average annual growth rate of about 14%. It is projected to grow at an average annual rate exceeding 15% during 2007-2010 and is likely to reach the level of about USD 23 to 28 bn. This growth would be fuelled mainly by (i) access to low cost and high volume of generic drugs, (ii) mergers and acquisitions, (iv) industry consolidation, and (v) high growth of contract manufacturing. According to the Federation of Indian Chambers of Commerce and Industry (FICCI), another apex industry association, there are some 6,000 firms engaged in the sector. In terms of revenue generation, there are 100 big companies (including subsidiaries of MNCs) each with sales of at least USD 650,000, 200 medium size companies with sales ranging between USD 210,400 and USD 650,000; and 5700 small companies with sales of less than USD 210,400. India is the world's leading producer of generic drugs; its annual per capita consumption of pharmaceuticals has been among the lowest placed approximately at USD 4.50 per person as compared to USD 820 in the United States and USD 13 in China. Indian pharmaceutical companies now supply nearly all the country's demand for formulations and nearly 70% of its demand for bulk drugs. The Indian firms produce nearly 60,000 generic brands in 60 therapeutic categories and between 350 and 400 bulk drugs. India's drug market consists mainly of second and third generation drugs no longer subject to patent protection in the developed world.
The content of the book includes information about drugs and pharmaceuticals. The major contents of this book are project profiles of projects like Drugs and Pharmaceutical Industries in India, L-Ascorbic Acid, Pharmaceutical Unit, Liquid Glucose, Glucose Saline, IV Fluids, Paracetamol, Sorbitol, Aspirin and Ibuprofen.
Project profile contains information like properties, market survey, manufacturing, process flow diagram, raw material suppliers, suppliers of plant and machinery, plant economics, land and building, plant and machinery, fixed capital, working capital requirement/month, total working capital/month, total capital investment, turn over/annum, profit sales ratio, rate of return, breakeven point (B.E.P)
This book is very useful for new entrepreneurs, technical institutions, existing units and technocrats.
fluids are fluids which are intended to be administered to a patient
intravenously, directly through the circulatory system. These fluids
sterile to protect patients from injury, and there are a number of
types available for use. Many companies manufacture packaged
fluids, as well as products which can be mixed with sterile water to
solution for intravenous administration.
are given when someone’s body fluid volume falls. There are a number of
which can cause a drop in fluid volume. Vomiting and diarrhea are a
example, which is why people are encouraged to drink fluids when they
to keep their fluid volume stable. Another cause is blood loss, which
problems both because people lose blood products, and because they
loss in fluid volume. Electrolyte levels in the blood can also become
as a result of rapid changes in fluid volume, in which case intravenous
can be used to restore the balance.
fluids can be broken into two broad groups. Crystalloids such as saline
solutions contain a solution of molecules which can dissolve in water.
crystalloids are administered, they tend to create low osmotic
allowing fluid to move across the blood vessels, and this can be linked
edema. Colloids contain particles which are not soluble in water, and
create high osmotic pressure, attracting fluid into the blood vessels.
an example of a commonly administered intravenous colloid.
nursing homes and hospital where patients are suffering from acute
or considerable debilitating conditions, the intra venous fluids are
used as IV
drips. The basic function of IV fluids is to replenish the body fluids.
Although there are a number of IV fluids but generally three types of
are used in hospitals as IV drips. They are as follows:
and sodium chloride injection fluid
chloride injection solution (Saline solution).
saline is injected intravenously, it compensate the deficiency of
when dextrose is injected it gives energy due to glucose content of it
dextro-saline is given in combination, it replenishes the dehydration
as gives energy thereby recouping debility syndrome and also in general
care of malaise.
(D-glucose, Corn Sugar, Starch Sugar, Blood Sugar, Grape Sugar) is by
most abundant Sugar in nature and occurs either in the free state
(mono saccharine form) or
chemically linked with other sugar varieties. In the free state,
it occurs in substantial
quantities in honey, fruits, and berries. As a polymer of a hydro
units, it occurs in starch, cellulose, and glycogen. Sucrose is a
of dextrose and fructose. Commercial production of dextrose by
starch yields white crystalline sugars that are either anhydrous (C6H12O6)
or hydrated (C6H12O6H2O).
Solution (5%) is an isotonic solution and supplies calories to human
instantaneously without disturbing the electrolytic balance.
substance Dextrose, known under the synonym anhydrous dextrose, is used
preparation of Dextrose injection.
name ‘Dextrose’ is used to preserve a distinction from Glucose syrup, a
preparation made by heating starch with water in presence of a small
of acid until the hydrolysis has reached a suitable stage. Glucose
very viscous syrup of approximately the following composition: -
is an important commercial product, and is used (e.g. in the
sweets) chiefly because of the sticky, gum-like dextrin it contains.
Chloride (sodium chloride (sodium chloride injection) injection)
is a sterile, nonpyrogenic solution for fluid and electrolyte
single dose containers for intravenous administration. It contains no
nominal pH is 5.5 (4.5 to 7.0). Composition, osmolarity, and ionic
concentration are shown below:
Sodium Chloride Injection, USP contains 4.5 g/L Sodium Chloride (sodium
chloride (sodium chloride injection) injection), USP (NaCl) with an
of 154 mOsmol/L (calc). It contains 77 mEq/L sodium and 77 mEq/L
Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride (sodium
(sodium chloride injection) injection), USP (NaCl) with an osmolarity
mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride.
are many options while choosing IV fluids:
3 mEq/L Ca2+ as
are four main ranges of application of highly specialized intravenous
of discarded water and electrolyte metabolism, especially in severe
of acid base in balances.
volume substitution and volume replacement in surgery of accident
suffering blood loss.
nutrition for severally ill and post-operative patients
of Iv Fluids
fluids or Intravenous fluids are life saving drugs, which are widely
surgery, pediatrics, urology, obstetrics and gynecology.
fluids are given mostly to patients suffering from dehydration,
vomiting, gastroenteritis and excessive perspiration.
are various intravenous transfusion solutions manufactured for use in
such as dextrose solutions, sodium chloride solutions, dextrose-sodium
combination solutions, multiple electrolyte solutions, diuretic
peritoneal dialysis and haemodialysis solutions, amino acid solutions,
volume expanders and anticoagulation solutions for collecting blood etc.
of various grades that can be produced include the following :-
normal saline IP 540 ml. in glass bottle USP II.
dextrose 5% IP 540 ml. in glass bottle USP II.
20% BP 250 ml.
solution A LP 75 ml. in 540 ml. glass bottle.
solution B 75 ml. in 375 ml. glass bottle.
dextrose 10% IP 540 ml.
dextrose 20% IP 540 ml.
with 100 ml/500 mg.
with 0.5% 100 ml.
5% and sodium chloride 0.9% 540 ml.
Elyte-M and Elyte-G.
I.V. 100 ml.
for injection in 10 ml. glass ampoules.
basic raw materials for the production of IV solutions are water,
specific pharmaceutical drugs.
process of manufacture of Dextrose, sodium chloride and Dextrose sodium
chloride fluids consist mainly 3 steps.
making by adding proper quality of ingredients.
Aseptic PVC (Medicinal Grade) Bottle Filling & Sealing.
DISTILLED WATER PREPARATION
water distillation unit is fed with fully dematerialized water, the
generally prepared by multiple evaporation and subsequent condensation.
for injection is prepared by a simple process called multiple stage
evaporation. The raw water is first treated with KMnO4 solution (Wt.% 0.5 - 1.90)
in order to remove
the odour and microorganism present in the water. Next comes the main
the process distillation in 3 repeated times.
in a method of separation of substances which differ appreciably their
press is a method of separation. There are various types of
methods using different equipments in the pharmaceutical industry.
distillation is highly effective in the point of view of unity of the
liquid. The raw water heated in the reboiler to get vaporized. This
changed in condenser and transferred to the reboiler of distillation
repeated distillation makes highly pure water.
for injection is to be minimum required quantity of pure NaCl is added
filling and sealing vessels. Sodium chloride injection water contains
weight per volume of Sodium chloride.
method used in the preparation of I.V. fluids is the same except little
modification in certain basis. In most of the cases the method involves
of various ingredients in proper concentration followed by dissolution
pyrogen free distilled water under controlled conditions of
particulate matter, pyrogenicity and aseptic environment.
5 % injection contains 540 ml. of I.V. solution with Dextrose 27 gr. in
chloride injection contains 540 ml. of fluid with Dextrose 27 gr. and
chloride 4.86 gr. in a glass bottle.
chloride injection contains 540 ml. of fluid with sodium chloride 4.86
gr. in a
solution may be of different types as per requirements. The major
(a) Common solutions
dextrose with 0.9% Nacl
(b) High Caloric
dextrose with normal salinic (DNS)
(d) Renal solution
manmtol 10 and 20%
FILTRATION AND FILLING
of various ingredients for dissolution.
free distilled water is collected in a reactor and weighed ingredients
in appropriate manner. The mixer is set as per the finished product
solution from this reactor pumped through serial filtration to retain
particulate matter and other carbonaceous matter.
solution is then filled in plastic polyethylene bottles and sealed.
of Plant and Machinery
M/s. YOGESHWAR MACHINERY MFG CO.
Address: Shed 2, Bajrang Estate, Nr. Nagarvel Hanuman, Amraiwadi,
Ahmedabad-380026, Gujarat (India).
Phone: +91- 79 - 65440260
Mobile No.: +91-9376124131
Email: [email protected]
Mr. Dharampal Singh
M/s. Parth Engineers & Consultant
Address: Plot No. C-1/4519, Phase - IV, B/h. Indo German Tool Room,
Vatva, Ahmedabad – 382445, Gujarat, INDIA.
Phone : +91-79-25841154, +91-79-25841155
+91-9825015826 , +91-9825015825
E-mail : [email protected] , [email protected]
Address: CF-255, Salt Lake City,
Kolkata - 700 064, India
Address: 24, Whispering Palms Shopping Centre Akruli Road Lokhandwala
Kandivli (East), Mumbai - 400 101, India
Address: No. 2, 4th Floor, Third Cross Street,
V. P Colony,
Ayanavaram, Chennai, Tamil Nadu - 600 023, India
Mobile / Cell Phone: +(91)-9940477548
Address: Firertech House, 211, 38th Main, 2nd Cross, BTM Layout, 2nd Stage,
Bangalore- 560 068, India
Systems Private Limited
Address: 1/9 B, Jindal House, Asaf Ali Road, New Delhi
- 110 002, India
OF RAW MATERIALS
Address: No. C - 44, Industrial Area, Phase - 3, S. A. S. Nagar, Mohali
Address: C - 4, Indraloc, Old Nagardas Road,
Andheri East, Mumbai - 400 069, India
Address: No. 1 - F, Vallabh Avenue, Chandravali Char Rasta, Water Tank
Karelibaug, Vadodara - 390 018, India
Mobile / Cell Phone: +(91)-9825107848
Address: Gr. 24, T V Industrial Estate, 248 Worli Road, S.k Ahire Marg,
400 030, India
Address: 215, IInd Floor, DLF Galleria, DLF Phase IV, Gurgaon - 122
FLUID (FFS TECHNOLOGY)
SALINE, DEXTROSE 5% AND
C 0.225%), DEXTROSE 10% INJ.
DA), DEXTROSE 5% INJ. (5%
DEXTROSE 5% & SC 0.9% INJ
COST OF LAND & BUILDING
1. Land Area
Required 5 Acres
COST OF PLANT & MACHINERY
2. PLANT &
3. OTHER FIXED
OF RAW MATERIALS
1. NaCl Salt 750
2. Dextrose 37800
3. PP Resin 45000
& ETP Chemicals
5. Printed Packing
label, Sticker etc. for 750000 Nos.
6. Carton Boxes for
24 bottles each 31500 Nos.
7. Consumables Store
1. RAW MATERIAL
2. SALARY &
WORKING CAPITAL FOR 3 MONTHS
1. By Sale of
1800000 Bottles 1000 ml
each Normal Saline
2. By Sale
of 1800000 Bottles 1000 ml
each Dextrose 5% & Sodium Chloride 0.225%.
3. By Sale of
1800000 Bottles 1000 ml
each Dextrose 10% injection 10% DA
4. By Sale
of 1800000 Bottles 1000 ml
each Dextrose 5% Injection 5% DA
5. By Sale
of 1800000 Bottles 1000 ml
each Dextrose 5% & Sodium Chloride 0.9% Inj. DNS
PROFIT = RECEIPTS
- COST OF PRODUCTION
SALES RATIO = Profit / Sales x
OF RETURN = Operating profit / T.C.I x
EVEN POINT (B.E.P)
B.E.P. = ——————————————— X 100
COSTS + PROFIT