Project 115
Project 115
BACHELOR OF PHARMACY
Submitted by,
Shri.P.S. KORE
2022-23
0
DECLERATION
We, the under designed, hereby declare that the A practice school report
on entitled
Shri.P.S. KORE
is our original work the empirical result in this the A practice school report is based
on data collected by us. We understand that any such copying label to be punished as
the authorities.
SUBMITTED BY,
Date: - / / 2022
Place: - Kasegaon
1
ACKNOWLEDGEMENT
We would like to express our deep gratitude to our guide Mr.P.S. KORE whose
valuable guidance and suggestions provided an experienced indulgence in making
this product more than acceptable to management at Rajarambapu College of
Pharmacy, Kasegaon.
We are also thankful to her for constant, valuable guidance & suggestions from Dr.
Vaibhav Raje (M.D.in orthopedic), which helped us a lot while preparing the project.
We are also thankful to the lab assistant’s and all office staff and library staff for their
valuable suggestion and support during project work.
It’s our duty to be thankful to all of them who had helped directly or indirectly for
completion of project work successfully. We are also thankful to our parents who had
supported each and every time during the project period. We are indeed very
appreciative of the timely assistance extended to us our group members.
2
Kasegaon Education Society’s
CERTIFICATE
This is to certify that; A practice school report the entitled
submitted by
during the academic year 2022-2023 in practical fulfillment for the award of the
B.Pharm.- I prescribed by the Shivaji University Kolhapur. The A practice school
report is submitted through the principal college of Rajarambapu college of
pharmacy, kasegaon.
Date: - / /2022
Place: - Kasegaon
3
Kasegaon Education Society’s
CERTIFICATE
This is to certify that, A practice school report entitled
Submitted
during the academic year 2021-2022 in practical fulfillment of or the award of the
B.pharm.- I prescribed by the Shivaji University Kolhapur. The project is submitted
through the principal college of Rajarambapu college of pharmacy, kasegaon.
Date: - / /2022
Place: - Kasegaon
4
INDEX
Sr. No Title Page
No.
1 Student Declaration 1
2 Acknowledgement 2
3 Certificate 3
4 Introduction 6
5 Government Policies 8
6 Objectives and Scope 10
7 Literature Review 11
8 Research Methodology 19
9 Research Design 19
10 Data Sources 20
11 Data Analysis 22
12 Conclusion 28
13 References 30
5
INTRODUCTION
Drug & pharmaceutical industry plays a vital role in the health care of the any
country. Rapid growth of this industry requires further attention because even after
accounts for less than 2 percent of the drug production in the world. Annual per
care expense in India is a dismal 0.8 percent of GDP compared with 12.4 percent in
U.S.A. 6.5% in Japan and 6.2 percent in the U.K, despite higher incidence of disease
and malnutrition. The poverty and disease in India on one hand call for higher
the growth of industry due to poor affordability of an average Indian. Drug &
The Indian Pharmaceutical industry, valued at $46.2 billion has been witnessing
attractive growth rate of 15% to 20% consistently over the past decade. This growth
spending and exports. Exports which currently accounts for 20% of the production
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value has grown by a compound annual growth rate of 34% in the past few years
due to competitive price advantages from India's low labor and other input cost
The Indian market for pharmaceutical products stands at an enormous $58.8 billion.
The big 10 companies account for over 30% of that, take away 45 marketer and
average sales don't even come anywhere near the $2.5 million marks, that's how
fragmented it is some 50,000 brands from over 20,00 companies growing fast
enough to embarrass rainy day mushrooms and enough diseases to savage Indian
population all several times over and turn Dr. Dolittle into Dr. Don't care
aspects:
Patents
Price
Product quality
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Government Policies
In a country lacking the assurance of free health care for all (not to talk of an
effective e justification for the policy. But it killed any incentive to invest in R&D
(Research and Development), which makes global drug manufacturers what they are:
leader of mankind's war on disease. India's per capital consumption of drugs is said
to be just $3. In the US its over $100 and in Japan, over $400. India has about 20%
of the world's disease burden (with just 16% of its population). Western spending is
high because in a system where the government pays the bills, the patients get
themselves prescribed all sorts of pills for ailments that aren't terribly serious. But
why is Indian spending so low? Only 35% of the population has access to modern
(read allopathic) medicines. India has alternative system of medicines, Ayurveda, e.g.,
are not quacks, neither are homeopaths who make their own medicines.
India also exports sizable quantities of drugs & pharmaceuticals. More companies are
now venturing into traditional health care systems beside modern medicine. With the
launching of new drugs policy, all bulk drug formulation and intermediaries except
five bulk drugs have been de-licensed. Many drugs that were hither to underprice
control have been taken out of such control. Actually, the list of controlled drugs has
been halved and is limited to 73 items.
Higher rate of return has been allowed for those drugs that are still under price
control. Companies with 51 percent foreign equity have been brought on par with
wholly Indian companies, automatic clearance would be given for 51 percent foreign
equity automatic approval would be given for foreign technology agreement as well.
Earlier such companies had restriction on the product they could manufacture or
import. A National Drug Authority is to be set up to monitor quality control and
rational use of medicine. A national pharmaceutical pricing authority is also to be set
up to fix prices in respect of drug, which would continue to be under price control
(Ramaswamy & Meera Kumari, 1988).
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The various legislations that govern the Indian
Pharmaceutical Industry are:
9
OBJECTIVE AND SCOPE
The present study of the pharmaceutical industry of India revolves
around the following basic objectives:
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LITERATURE REVIEW
Historical Prospective
The production of bulk drug was virtually nonexistent in India at the time of
independence in 1947. It increased from a meager $715 million in 1962 to $2.4
billion in 1980 and further about $8.4 billion in 1990. Production of formulation is
increased from $90 million in 1947 to $14.4 billion in 1980 to $36.3 billion in 1990.
The demand for pharmaceuticals increased due to increase in population, increase in
affordability of a section of population and government emphasis on health program.
The industry grew despite claims of price & production control. By the year 2000 the
demand for pharmaceuticals is expected to reach up to $6.72 billion per annum.
There has been 1000% growth in the number of drug manufacturers in India
since 1970. That was the year when the Indian Patent Acts and Drug Price Control
Order (DPCO) came into force (The Eastern pharmacist 1988). While the first
accorded intellectual property protection to manufacturing processes (not product
formulas), the second began regulating prices to ensure that drug manufacturer who
were being allowed to copy foreign drugs would make them cheaply available to the
common man.
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industries most of which have run into losses or very nominal profits leading to a
slowing down of the growth.
The pharmaceutical industry in India is going through a major shift in its business
model in the last few years in order to get ready for a product patent regime from
2009 onwards. This shift in the model has become necessary due to the earlier
process patent regime put in place since 1972 by the Government of India. This was
done deliberately to promote and encourage the domestic health care industry in
producing cheap and affordable drugs. As prior to this the Indian pharmaceutical
sector was completely dominated by multinational companies (MNCs). These firms
imported most of the bulk drugs (the active pharmaceutical ingredients) from their
parent companies abroad and sold the formulations (the end products in the form
of tablets and capsules, syrups etc.) at prices unaffordable for a majority of the
Indian population. This led to a revision of Government of India’s (GOI) policy
towards this industry in 1972 allowing Indian firms to reverse engineer the patented
drugs and produce them using a different process that was not under patent. The
entry of MNC’s was also discouraged by restricting foreign equity to 40%. The
licensing policy was also biased towards indigenous firms and firms with lesser
foreign equity. All these measures by GOI laid foundations to a strong manufacturing
base for bulk drugs and formulations and accelerated the growth in the Indian
Pharmaceutical Industry (IPI), which today consists of more than 20,000 players. As a
result, the Indian pharmaceutical industry today not only meets the domestic
requirement but has started exporting bulk drugs as well as formulations to the
international market.
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LARGE MARKET SHARE FOR GENERIC DRUGS
As there was no efficient patent protection between 1970 and 2005, many Indian
drug producers copied expensive original preparations by foreign firms and produced
these generics by means of alternative production procedures. This proved more
cost- efficient than the expensive development of original preparations as no funds
were required for research, which contained the financial risks. This spending block
may come to as much as EUR 600 m for only one drug. This kind of money could
previously only be raised by large corporations in the industrial countries. The
competitiveness of generics producers is based on cost-efficient production. In this
field, Indian companies are currently in top position. At one-fifth, India’s share in the
global market for generic drugs is considerably higher than its share in the overall
pharmaceuticals market (approx. 2%). At the same time, India’s pharmaceutical
companies gained know-how in the manufacture of generic drugs. Hence the name
“pharmacy of the poor” which is frequently applied to India. This is of significance
not least for the domestic market as disposable income is as little as EUR 1,900 per
year for roughly 140 million of the total of 192 million Indian households1, which
means the majority of Indians cannot afford expensive western preparations.
13
Globalization has not caused traditional medicine to be abandoned but with higher
education, rising income and a change in lifestyle, western medical treatment is
gaining in importance. At present the population especially in rural areas still sees
western medicine as a stop-gap cure which is unlikely, though, to provide a lasting
solution to health problems. Today, about 70% of the population on the Indian
subcontinent depends entirely or at least in part on traditional Indian medicine
which is cheaper and more easily available than western drugs.
Indian companies have recognized the opportunity presented by western
pharma in search of lower costs and higher profits, and are exploiting the
low- c o s t base and pool of highly skilled labour in their market to develop a
thriving outsourcing industry, positioning India as a key provider of contract
research and manufacturing services.
India is increasing its R&D and biotechnology focus and taking advantage of the
low R&D productivity of developed markets to gain partnerships with western
players. These alliances enable the companies to gain expertise in discovery
and development as well as maximizing revenues if and when products reach
the market.
Pharma’s and biotech’s in the US, Europe and Japan have realized the
increasing role of India at a global level. Many players are outsourcing non-
core activities of the research and manufacturing process. Outsourcing is a
popular option, while off-shoring via direct investment, joint venture or
acquisition is also proving successful.
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DRUG PROMOTION METHOD
“The commercial needs of countless, fiercely competing pharmaceutical companies
has led them to depend on the tried and tested 3Cs: convince, if possible, confuse if
necessary, and corrupt if nothing else works.”
Health professionals in developing countries work in overstretched and under
resourced sectors on low pay and in difficult conditions. In such conditions the
promotions from the drug companies are inviting. Disparities in health spending
between the world’s richest countries and the world’s poorest countries are such
that a relatively cheap promotion in a developing country will generate much more
interest there than it would in a developed country.
The aim of drug promotion is to persuade people to buy more drugs and/or to pay
higher prices. This is done by increasing the perceived value of the drug via one or
more of several approaches including:
drugs.” The main aim of promotion is not to inform but to persuade. Consumer
goods.
15
Each move requires motivation and decision making so drug companies study how to
bypass people’s defenses by giving the impression that the message is coming from a
trustworthy source.
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STRENGTHS AND WEAKNESSES OF INDIA’S
PHARMACEUTICAL INDUSTRY
India’s comparative advantages lie in its cost competitiveness, its reverse engineering
experience, its large pool of less expensive English-speaking scientific and
engineering workers, and its well-developed chemical industry infrastructure. India’s
pharmaceutical companies can also operate at much lower profit margins that their
Western counterparts. Today, India produces some of the cheapest drugs in the
world, especially because labor costs are 50 to 55 percent cheaper than in the West.
Industry experts indicate that infrastructure costs are 40 percent lower and fixed cost
are estimated to be 12 percent to 20 percent less that in the United States and
Western Europe. Consequently, India can produce bulk drugs that cost 60 percent
less that in the West and can open a production plant in India 40 percent cheaper
than in developed countries. Because of this, India has become a hub for
pharmaceutical research and development and clinical trials for many leading foreign
pharmaceutical companies.
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METHODOLOGY & PROCEDURE OF WORK
A Research Methodology defines the purpose of the research, how it proceeds, how
to measure progress and what constitute success with respect to the objectives
determined for carrying out the research study. The appropriate research design
formulated is detailed below. Exploratory research: this kind of research has the
primary objective of development of insights into the problem. It studies the main
area where the problem lies and also tries to evaluate some appropriate courses of
action. The research methodology for the present study has been adopted to reflect
these realties and help reach the logical conclusion in an objective and scientific
Research Design
The research design is the basic framework, which provides guidelines for the rest of
the research process. The present research can be said to be exploratory. The
research design determines the direction of the study throughout and the
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Nature of Data
Primary Data:
Primary data is basically fresh data collected directly from the target respondents;
Discussions Etc.
Secondary Data:
Secondary data that is already available and published. It could be internal and
external source of data. Internal source: which originates from the specific field or
area where research is carried out e.g. publish broachers official reports etc.
External Source:
This originates outside the field of study like books, periodicals, journals,
Data Collection
Primary data
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Primary data was selected from the sample by a self-administrated questionnaire
https://forms.gle/R2pDuSK8C9hPGmXe8
SAMPLE SIZE:
Secondary Data:
Analytical Tools:
Simple statistical tools have been used in the present study to analyze and
interpret the data collected from the field. The study has used percentiles method
and the data are presented in the form of tables and diagrams.
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Data Analysis
21
Table no. 03 Age group of patients
AGE GROUP OF PATIENTS NO. OF PATIENTS
1 To 30 YEARS 35
31 To 60 YEARS 65
61 To 90 YEARS 15
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Table no. 04 Response about pre-medication
RESPONSE ABOUT PRE-MEDICATION NO. OF PATIENT
YES 44
NO 63
NO 68
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Fig no. 07 Types of treatment
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Fig no. 09 Bill amount of medicine
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Fig no .11 Supportive taken by patient
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Conclusion
Indian Drug and Pharmaceutical (D & P) industry presents a picture of fast
development. Today, India manufactures most of its requirement of bulk drugs and
formulation. In fact, more than 30,000 different pharmaceutical formulation worth
210$ million are manufactured and sold in India. The Indian orthopedic industry has
tremendous potential for growth. Demographic and lifestyle factors have made this
one of the highest growth markets globally, attracting several multinational
companies to sell and in some cases, establish local knowledge and research centers
in India.
India is increasing its R&D and biotechnology focus and taking advantage of the low
R&D productivity of developed markets to gain partnerships with western players.
These alliances enable the companies to gain expertise in discovery and development
as well as maximizing revenues if and when products reach the market. India can
produce bulk drugs that cost 60 percent less that in the West and can open a
production plant in India 40 percent cheaper than in developed countries. Because of
this, India has become a hub for pharmaceutical research and development and
clinical trials for many leading foreign pharmaceutical companies.
27
In this survey we found majorly patients in 30-to-60-year age group mostly male
candidate suffering from diabetics and accidental case. There were some patients in
the treatment mostly try pre-medication, found not effective or slightly effective
therefore they shift treatment towards orthopedic specialist.
Mostly orthopedic physician preferred traditional medicine system for the better
result physician should be shift on novel drug delivery system in this section there
was presence of generic drug can be modified into novel drug to reduce dosing
frequency and produce greater pharmacological effect specially targeted diabetic
patient in future.
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