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A SURVEY BASED STUDY OF GENERIC AND BRANDED
MEDICINES MARKET
Dissertation work submitted to JNTUK
In the partial fulfilment for the award of degree of
BACHELOR OF PHARMACY
BY
CHITRAM AKHILA(17AB1R0020)
ILLA DINESH(17AB1R0027)
MADALA SURESH (17AB1R0038)
POPURI PRAVALLIKA (17AB1R0063)
S PAVAN KALYAN ADITYA (17AB1R0066)
Under the esteemed guidance of
Dr. CH. V. PRASADA RAO M.S(Pharma),(Ph.D)
Professor & HOD Pharmacy Practice
VIGNAN PHARMACY COLLEGE
(Affiliated to JNTUK, KAKINADA, Approved by AICTE& PCI, New Delhi)
VADLAMUDI, GUNTUR DIST., ANDHRA PRADESH, INDIA, PIN:522213
2021
Department of Pharmacy Practice, Vignan Pharmacy College
1
VIGNAN PHARMACY COLLEGE
Approved by AICTE, PCI & Affiliated to JNTU KAKINADA)
VADLAMUDI, GUNTUR DIST., ANDHRA PRADESH, INDIA, PIN:522 213
URL:www.vignanpharmacycollege.in
Contact: 0863-2347768, 69, 34
DECLARATION BY THE CANDIDATES
We, Chitram Akhila (17AB1R0020),Illa Dinesh (17AB1R0027), Madala Suresh (17AB1R0038), Popuri
Pravallika (17AB1R0063), S Pavan Kalyan Aditya (17AB1R0066)students of B. Pharmacy, Vignan
Pharmacy College, Jawaharlal Nehru Technological University, Kakinada, do here by declare that the
evaluation embodied in the dissertation entitled“A SURVEY BASED STUDY OF GENERIC DRUGS AND
BRANDED MEDICINES MARKET”is the genuinework carried out by us under the guidance of Dr.Ch. V.
Prasada Rao,Professor& HOD Department of Pharmacy Practice, Vignan Pharmacy College. We declare that
the work embodied in this thesis has not been submitted for the award of degree or diploma of this or any other
University.
Date:
Place: Vadlamudi
Chitram Akhila (17AB1R0020)
Illa Dinesh (17AB1R0027)
Madala Suresh (17AB1R0038)
Popuri Pravallika (17AB1R0063)
S Pavan Kalyan Aditya (17AB1R0066 )
Department of Pharmacy Practice, Vignan Pharmacy College
2
VIGNAN PHARMACY COLLEGE
Approved by AICTE, PCI & Affiliated to JNTU KAKINADA)
VADLAMUDI, GUNTUR DIST., ANDHRA PRADESH, INDIA, PIN:522 213
URL:www.vignanpharmacycollege.in
Contact: 0863-2347768, 69, 34
CERTIFICATE
This is to certify that Chitram Akhila (17AB1R0020),Illa Dinesh (17AB1R0027), Madala Suresh
(17AB1R0038), Popuri Pravallika (17AB1R0063), S Pavan Kalyan Aditya (17AB1R0066)are bonafide
students of this institution and have submitted the main project entitled“A SURVEY BASED STUDY OF
GENERIC DRUGS AND BRANDED MEDICINES MARKET ”in the partial fulfilment for the award of the degree
of “BACHELOR OF PHARMACY”prescribed by the Jawaharlal Nehru Technological
University,
Kakinada.
Project guide
External Examiner
Dr.Ch. V. Prasada Rao,MS(pharm), Ph.D
Principal
Dr. P. SrinivasaBabuM.Pharm, Ph.D
Department of Pharmacy Practice, Vignan Pharmacy College
3
In Dedication to Our Parents, Guide, Teachers and
Our Beloved Principal Sir.
Department of Pharmacy Practice, Vignan Pharmacy College
4
ACKNOWLEDGEMENT
On the occasion of presenting this dissertation, we would like to thank the Almighty for providing strength and
power by his enormous blessings to overcome all the hurdles and hindrances during this project work.
We are thankful to my parents, who have struggled their present days for the wealth of my tomorrow, who
showed their blessings, love and encouragement in every activity of mine.
We also thank chairman Dr.L. RATHAIAH, Vignan Pharmacy College for providing necessary facilities to
carry out this research work.
We are grateful to my guide Dr. Ch.V. Prasada Rao, MS(Pharma), Ph.D., Professor& HOD of Pharmacy
Practice, Vignan Pharmacy College for providing necessary facilities to carry out this research work.
We owe our deep sense of gratitude, great pleasure and sincere whole hearted thanks to Dr. P. SRINIVASA
BABU Principal, Vignan Pharmacy College for his guidance support, encouragement and valuable suggestions.
We also thank to all Staff Members of Vignan Pharmacy College for their help during our project work.
We thank our friends for their cheerful support and cooperation during my course of work and extremely
thankful to Lab Technicians for their help during the course of work.
Department of Pharmacy Practice, Vignan Pharmacy College
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Table of Contents
CHAPTER
TITLE
PAGE NO
LIST OF ABBREVATIONS
LIST OF TABLES
LIST OF FIGURES
ABSTRACT
1
INTRODUCTION
1.1 Introduction to pharmaceutical industry
1.2 Introduction to project
1.3 Generic drugs
1.4 Global generic drug industry
1.5 Indian generic drug industry
1.6 Indian generic drugs
2
LITERATURE REVIEW
3
AIM AND OBJECTIVES
4
PLAN OF THE WORK
5
MATERIALS & METHODS
5.1 Online feedback forms
5.2Cross sectional survey method among three target groups.
6
RESEARCH ANALYSIS
6.1Analysis of professionally qualified (science background)
individuals
6.2 Analysis of professionally qualified (non-science
background) individuals
6.3Analysis of pharmacist working in medical store
(pharmacy
7
RESULTS AND DISCUSSION
8
CONCLUSION
9
BIBLIOGRAPHY
Department of Pharmacy Practice, Vignan Pharmacy College
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LIST OF ABBREVATIONS
SYMBOL
ABBREVATIONS
CAGR
Compound annual growth rate
FY
Fiscal year
API`S
Active pharmaceutical ingredient
R&D
Research and development
M&A
Merger and Acquisitions
GDP
Gross Domestic Price
DGCIS
Directorate general of commercial intelligence and statistics
HS codes
Harmonized System codes
ODS
Ozone depleting substance
IMS
Institute for management studies
USFDA
United states food and drug administration
ANDA
Abbreviated New Drug Administration
CL
Compulsory License
PwC
Price water house cooper report.
Department of Pharmacy Practice, Vignan Pharmacy College
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LIST OF TABLES
TABLE
NO
LIST OF TABLES
1
Top 10 Global players
2
Leading Indian players by sales (INR Billion)
3
list of Indian generic drugs
4
Awareness among individuals about generic medicine law passed by Indian
government.
5
Comparative analysis on the effect of generic medicines vs branded medicines.
6
Count of responses regarding FDA guidelines of generic medicines.
7
Total count of responses regarding current use of generic medicines.
8
Total count of responses regarding cost variation among branded and generic
medicines.
9
Total count of responses regarding knowledge about generic medicine availability.
10
Total count of responses regarding knowledge about generic medical stores.
11
Total number of responses regarding questioning medical stores for generic
medicines.
12
Total no of responses regarding seeking patient opinion on cost of medicine before
prescribing.
13
Total no of responses regarding substitution of branded with generic alternative.
14
Total number of responses regarding the reason behind high cost of branded drugs.
15
Total number of responses regarding the reason behind low cost of generic drugs
16
Total number of responses regarding the savings per month using generic medicines.
17
Total no of responses regarding public opinion for generic drug laws.
18
Total number of responses regarding knowledge about generic medicines.
Department of Pharmacy Practice, Vignan Pharmacy College
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19
20
Total number of responses regarding knowledge about cost of generic medicines.
Total number of responses regarding doctor preference to medicine.
21
Total number of responses regarding patient concern related to cost of medicine.
22
Total number of responses regarding effect of medicines with different costs.
23
Total number of responses regarding safety of generic drugs.
24
Total number of responses regarding patient’s preference.
25
Total number of responses regarding knowledge about cheap alternative of
medicine.
26
Total no of responses regarding substitution of branded with generic alternative.
27
Total number of responses regarding any new /advertisements encouraging generic
drugs.
28
Total number of responses regarding generic medicines advertisement.
29
Total number of responses regarding choice of medication.
30
Total number of responses regarding storage of generic medicines.
31
Total number of responses regarding reasons for not storing generic medicines.
32
Total number of responses regarding patient’s choice of cheaper alternative medicine.
33
Total number of responses regarding generic medicine suggestions.
34
Total number of responses regarding availability issue of generic medicines.
35
Total number of responses regarding usage of generic medicine.
36
Total number of responses regarding quality variation.
37
Total number of responses regarding affect of business due to low cost of generic
medicine.
Department of Pharmacy Practice, Vignan Pharmacy College
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LIST OF FIGURES
FIGURE NO
LIST OF FIGURES
1
Import of medicinal and pharmaceutical products.
2
Export of medicinal and pharmaceutical products.
3
Growth in Indian pharmaceutical industry.
4
Guntur district map.
5
Leading Companies in the Generic Industry.
6
Savings by year ($ in billions)
7
Graphical view of responses regarding generic medicines law passed by
Indian government.
8
Graphical view of responses regarding the effect of generic medicines..
9
Graphical view of responses regarding FDA guidelines of generic
medicines..
10
Graphical view of responses regarding current usage of generic medicine.
11
Graphical representation of responses regarding cost variation among
branded and generics
12
Graphical view of responses regarding knowledge about generic medicine
availability.
13
Graphical view of responses regarding knowledge about generic medical
stores
14
Graphical view of responses regarding questioning medical stores for
generic medicines.
15
Graphical responses regarding seeking patient opinion on cost of
medicine before prescribing
16
Graphical responses regarding substitution of branded with generic
alternative
17
Graphical responses regarding the reason behind high cost of branded
Department of Pharmacy Practice, Vignan Pharmacy College
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drugs.
18
Graphical responses regarding the reason behind low cost of generic
drugs.
19
Graphical responses regarding the savings per month using generic
medicines.
20
21
22
23
24
25
Graphical view of responses regarding public opinion for generic drug
laws.
Graphical view of responses regarding knowledge about generic
medicines.
Graphical view of responses regarding knowledge about cost of generic
medicines.
Graphical view of responses regarding doctor preference to medicine.
Graphical view of responses regarding patient concern related to cost of
medicine.
Graphical view of responses regarding effect of medicines with different
costs.
26
Graphical view of responses regarding safety of generic drugs.
27
Graphical view of responses regarding patient’s preference.
28
Graphical view of responses regarding knowledge about cheap alternative
of medicine.
Graphical responses regarding substitution of branded with generic
alternative.
Graphical view of responses regarding any new/advertisements
encouraging generic drugs.
29
30
31
Graphical responses regarding generic medicines advertisement.
32
Graphical view of responses regarding choice of medication.
33
Graphical view of response regarding storage of generic medicines.
34
Graphical view of responses regarding reasons for not storing generic
medicines.
Graphical view of responses regarding patient’s choice of cheaper
alternative medicine.
Graphical view of responses regarding generic medicine suggestions.
35
36
37
38
Graphical view of responses regarding availability issue of generic
medicines.
Graphical view of responses regarding usage of generic medicine.
Department of Pharmacy Practice, Vignan Pharmacy College
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39
Graphical view of responses regarding quality variation.
40
Graphical view of response regarding affect of business due to low cost of
generic medicine.
Department of Pharmacy Practice, Vignan Pharmacy College
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ABSTRACT
ABSTRACT
The concept of generic prescription is widely accepted in various parts of the world. Nevertheless, it has failed
to gain popularity in India due to factors such as non-availability and distrust on the product quality. Cost of the
medicines is a concern for the patients. Within India cost of medicines varies, the basic reason behind this is the
brand price quoted by the pharmaceutical industries. Survey was undertaken to review and analyze various facts
about branded and generic medicines of the same drugs.
Method:
The survey was conducted for following target groups and individuals. The groups are Literate population
(science background), Common public (educated but non science background) and Practicing Pharmacists. The
different sets of questionnaires were prepared for each group and survey was conducted (online feedback form).
The questions were designed as to check awareness, knowledge and preference of medication.
Results:
The highlighting results of this survey-based project are that a greater number of consumers want economic
alternative to the brand medicines which includes persons with or without science background, a remarkable
number of consumers does not have knowledge about generic medicines, most of the physicians do not prefer
generic medicines and most of the practicing pharmacists have very less business through generic medicines.
Conclusion:
Even if generic medicines are going to be made available free of cost at the government hospitals the war of
prices between branded and generic may not stop. More stringent rules and regulation are required for making
the drugs available at reasonable cost for the masses. For the benefit of the patients, if pharmacist needs to
change a brand for generic medicine, should be permitted by law.
Keywords:
Survey, Questionnaire, Branded medicine, Generics, Regulations.
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Department of Pharmacy Practice, Vignan Pharmacy College
INTRODUCTION TO PHARMACEUTICAL INDUSTRY
1.1 INTRODUCTION TO PHARMACEUTICAL INDUSTRY
Global Pharmaceutical Industry: The Global Pharmaceutical Industry is one of the multinational industries which gained
a high cycle of growth especially in 1960s and the industry is in high risk, regulated and driven
by lengthy R&D expenditures. The industry can be different in medicinal chemical, biological,
ethical, proprietary product and private formula manufactures by their backgrounds and
operation sectors and does not cover consumer or animal healthcare. In 2008 total revenue of
global pharmaceutical industry was $615.1 billion and expected to reach $734 billion at the
end of 2013. United States, Europe and Japan are the largest pharmaceutical market.
[1]
The
report critically analyse the Global Pharmaceutical Industry, importance and growth with the
expect of internal and external environment analysis, plausible views of industry in the future
and moral values.
Table No.1:- Top 10 Global players
Sr. No. Company
2013 ($m)
2012 ($m)
Growth ($m)
Growth (%)
1
Pfizer
47878
51214
-3336
-7
2
Novartis
47468
46732
736
2
3
Roche
39163
38006
1156
3
4
Merck & Co.
37437
40601
-3164
-8
5
Sanofi
37124
39511
-2387
-6
6
GlaxoSmithKline
33330
33335
-5
0
7
Johnson & Johnson
28125
25351
2774
10
8
AstraZeneca
25711
27925
-2214
-9
9
Lilly
20962
20567
395
2
10
AbbVie
18790
18380
410
2
2
Department of Pharmacy Practice, Vignan Pharmacy College
INTRODUCTION TO PHARMACEUTICAL INDUSTRY
Indian pharmaceutical industry
The Indian pharmaceutical industry currently tops the chart amongst India's sciencebased industries with wide ranging capabilities in the complex field of drug manufacture and
technology. A highly organized sector, the Indian pharmaceutical industry is estimated to be
worth $ 4.5 billion, growing at about 8 to 9 percent annually. It ranks very high amongst all
the third world countries, in terms of technology, quality and the vast range of medicines that
are manufactured. It ranges from simple headache pills to sophisticated antibiotics and
complex cardiac compounds; almost every type of medicine is now made in the Indian
pharmaceutical industry. Indian pharmaceutical industry has been witnessing significant
growth over past few years. The size of the Indian pharmaceutical market increased from USD
6 Billion in 2005 to USD 18 Billion in 2012 by 2020, India ‘s pharmaceuticals market is
expected to reach US$45 billion and become the sixth largest pharmaceutical market in the
world [2]
The Indian pharmaceutical sector is highly fragmented with more than the 20,000
registered units. It has expanded drastically in the last two decades. The Pharmaceutical and
Chemical industry in India is an extremely fragmented market with severe price competition
and government price control. The Pharmaceutical industry in India meets around 70% of the
country's demand for bulk drugs, drug intermediates, pharmaceutical formulations, chemicals,
tablets, capsules, orals, and injectibles.[3] There are approximately 250 large units and about
8000 Small Scale Units, which form the core of the pharmaceutical industry in India
(including 5 Central Public Sector Units).
―They (sales) are expected to rise to $23.6 billion in 2013 and reach $27.0 billion in
2016. As a percentage of health care expenditures, pharmaceutical sales were 22.6 per cent in
2012; they are expected to reach 23.6 per cent in 2013 and 27 per cent by 2016[4].
India is among the top five emerging Pharma markets and has grown at an estimated
compound annual growth rate (CAGR) of 13 per cent during the period FY 2009–2013. The
Indian pharmaceutical market is poised to grow to US$ 55 billion by 2020 from the 2009
levels of US$12.6 billion,[5] according to the report titled India Pharma2020‘byMcKinsey&Co.
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Department of Pharmacy Practice, Vignan Pharmacy College
INTRODUCTION TO PHARMACEUTICAL INDUSTRY
India is among the top five emerging Pharma markets and has grown at an estimated
compound annual growth rate (CAGR) of 13 per cent during the period FY 2009–2013. The
Indian pharmaceutical market is poised to grow to US$ 55 billion by 2020 from the 2009
levels ofUS$12.6billion,[5] according to the report titled India Pharma2020‘byMcKinsey&Co.
The country ‘s Pharma industry accounts for about 1.4 per cent of the global Pharma
industry in value terms and 10 per cent in volume terms. Both domestic and export-led
demand contributed towards the robust performance of the sector. An increase in insurance
coverage, an ageing population, rising income, greater awareness of personal health and
hygiene, easy access to high-quality healthcare facilities and favorable government initiatives
are some of the important factors expected to drive the Pharma industry in India. The
Government of India has unveiled Pharma Vision 2020‘aimed at making India a global leader
in end-to-end drug manufacturing [6].
Current Scenario
Indian pharmaceutical industry is expected to grow at 19% in 2013. India is now among
the top five pharmaceutical emerging markets. There will be new drug launches, new drug
filings, and Phase II clinic trials throughout the year. On back of increasing sales of generic
medicines, continued growth in chronic therapies and a greater penetration in rural markets,
the domestic pharmaceutical market is expected to register a strong double-digit growth of 1314 per cent in2013.
Moreover, the increasing population of the higher-income group in the country will
open a potential US$ 8 billion market for multinational companies selling costly drugs by
2015. Besides, the domestic Pharma market is estimated to touch US$ 20 billion by 2015,
making India a lucrative destination for clinical trials for global giants [7].
The Indian pharmaceutical industry accounts for over 8 percent of global
pharmaceutical production
[8]
. The industry has over 60,000 generic brands across 60
therapeutic categories and manufactures more than 400 different active pharmaceutical
ingredients (APIs). The Indian Pharma industry has been growing at compounded annual
growth rate (CAGR) of more than 15 % over the last five years and has significant growth
opportunities
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Department of Pharmacy Practice, Vignan Pharmacy College
INTRODUCTION TO PHARMACEUTICAL INDUSTRY
Market Size
On improved utilization of manufacturing facilities, the domestic pharmaceutical
market is likely to see high revenue growth and profit margins. Pharmaceutical sales in India
are expected to grow by 14.4 % to US$ 27 billion in 2016 from US$ 22.6 billion in 2012,
according to a report 2014 Global Life Sciences Outlook‘. India‘s pharmaceutical exports
stood at US$[9]
14.84 billion in FY 2013–14. The United States (US) is the country‘s biggest market for
Pharma exports accounting for about 25 %, followed by the United Kingdom (UK). ―India has
been able to make its name as a quality supplier of affordable medicines across the globe
[10]
.
Pharma exports from India will be more than the size of the domestic sales by FY
2015, according to a report by India Ratings & Research. The country provides generic
medicines to almost 200 countries. It is responsible for about 40 per cent of the generic and
over the-counter drugs consumed in the US. Indian generics market is expected to grow to
US$ 26.1 billion by 2016 from US$ 11.3 billion in 2011 [11].
Table No. 2 Leading Indian players by sales (INR Billion)
Company name
Sales in INR billion
Ranbaxy Lab
76.86
Cipla
69.77
Dr Reddy's Labs
66.86
Lupin Ltd.
53.64
Aurobindo Pharma
42.84
Sun Pharma
40.15
Cadila Health
31.52
Wockhardt
26.50
Jubilant Life
26.41
Ipca Labs
23.52
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Department of Pharmacy Practice, Vignan Pharmacy College
INTRODUCTION TO PHARMACEUTICAL INDUSTRY
Challenges: Over the past decade, pharmaceutical companies have entered a difficult period where
shareholders, the market, and regulators have created significant pressures for change within
the industry [12]. The core issues for most of drug companies are declining productivity of inhouse R & D, patent expiration of number of block buster drugs, increasing legal and
regulatory concern, and pricing issue. As a result larger pharmaceutical companies are shifting
to new business model with greater outsourcing of discovery services, clinical research and
manufacturing.
Future Growth: India will see the largest number of merger and acquisitions (M&A) in the
pharmaceutical and healthcare sector. A survey conducted across 100 companies has revealed
that one- fourth of the respondents were optimistic about acquisitions in the pharmaceutical
sector [13].
Government policies: The Indian government has been making efforts to improve nationwide provision of
healthcare. It has launched policies that are aimed at:
• building more hospitals,
• boosting local access to health care,
• improving the quality of medical training,
• increasing public expenditure on healthcare to 2-3% of GDP, up from a current low of 1%
[14]
. Some of the significant government allocations on healthcare spend include a five-year tax
break for opening hospitals anywhere in India, with an added focus on tier II and tier III
markets, both in the 2008-09 Union Budget
[15]
. Some of the significant government
allocations on healthcare spend include a five-year tax break for opening hospitals anywhere
in India, with an added focus on tier II and tier III markets, both in the 2008-09 Union Budget.
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Department of Pharmacy Practice, Vignan Pharmacy College
INTRODUCTION TO PHARMACEUTICAL INDUSTRY
Growth of Import-Export
a) IMPORTS: As per the Directorate General of Commercial Intelligence and Statistics (D.G.C.I.S.)
Kolkata, the value of imports of ―Medicinal and Pharmaceuticals Products for the latest period
2007-08 to 2010-11 is as under: In the year 2010-11 the import as shown declined in growth
compared to previous year
[16]
. The country is almost self-sufficient in production of most of
formulations / pharmaceuticals products.
FIGURE: 1: Import of medicinal and pharmaceutical products.
It may be observed that the imports have shown a growth of 29.43% in the year
2011-12 compared to previous year. The country is almost self-sufficient in production of most
of formulations/ pharmaceuticals products. As such imports are being resorted to on quality &
economic considerations and not necessarily due to non-availability from domestic sources.
Manufacturers of Drugs & Pharmaceuticals are free to produce any drugs approved by the
Drug control authorities [17].
Import of Drugs & Pharmaceuticals is regulated as per the Foreign Trade
Policy of Government of India. Import of some drugs and drug intermediates are restricted
under current Foreign Trade Policy. These restrictions are basically due to common HS codes
assigned to some narcotic substances or similarity to some Ozone Depleting Substances (ODS)
with pharmaceutical products.
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Department of Pharmacy Practice, Vignan Pharmacy College
INTRODUCTION TO PHARMACEUTICAL INDUSTRY
b) EXPORTS:As Per DGCIS, Kolkata Exports of―Drugs and pharmaceuticals and Fine Chemicals for
the period 2007-08 to 2010-11 are below: -
FIGURE: 2: Export of medicinal and pharmaceutical products.
Growth in Indian Pharmaceutical Industry: The domestic Pharma Industry has recently achieved some historic milestones through
a leadership position and global presence as a world class cost effective generic drugs
‘manufacturer of AIDS medicines. Many Indian companies are part of an agreement where
major AIDS drugs based on Lamivudine, Stavudine, Zidovudine, Nevirapine [17]
FIGURE: 3: Growth in Indian pharmaceutical industry.
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Department of Pharmacy Practice, Vignan Pharmacy College
INTRODUCTION OF THE PROJECT
1.2 INTRODUCTION OF THE PROJECT
Project location: GUNTUR, it is one of the districts in coastal Andhra region.it is bounded on the south by
prakasam district and on the west by the state of Telangana. Andhra Pradesh bounded by west
Godavari on the east, Bay of Bengal on the south, Guntur and suryapet districts in the west
and a portion of it also borders with the state of Telangana.
Demographics: Guntur district is one of the nine districts in the Andhra region of the Indentation
Andhra Pradesh. The administrative seat of the district is located at Guntur, the largest city of
the district in terms of area and with a population of 670,073. [3]It has a coastline of
approximately 100 km (62 mi) on the right bank of Krishna River, that separates it from
Krishna district and extends till it empties into the Bay of Bengal. It is bounded on the south by
Prakasam district and on the west by the state of Telangana.[4]It has an area of 11,391
km2(4,398 sq mi) and is the 2nd most populous district in the state, with a population of
4,889,230 as per 2011census of India.
Guntur District Map:-
FIGURE: 4: Guntur district map.
Health Service: -
[18]
. The following major national and state health programs are
implemented by health dept.
 General Health Services
 Epidemic Control Measures & Reproductive and Child health programs - This includes
family welfare programs, health services for children, health for 40 plus, Aids control.
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Department of Pharmacy Practice, Vignan Pharmacy College
INTRODUCTION OF THE PROJECT
1.3 GENERIC DRUGS
A generic drug is identical - or bioequivalent to a brand name drug in dosage form,
safety, strength, route of administration, quality, performance characteristics and intended use.
Although generic drugs are chemically identical to their branded counterparts, they are
typically sold at substantial discounts from the branded price. The determination of drug
approval is made according to whether it is pharmaceutically equivalent, bio-available, and
bioequivalent. World Health Organization (WHO) provided a definition for counterfeit drugs.
After the patent is over, the same drug can be copied by anybody and the costs reduce
drastically. Many of the anti-diabetic, antihypertensive and antibiotic drugs are available now
as Generic formulations.
After the expiry of patent of the patented drug, generic drugs are marketed. Generic
drugs are available at affordable prices with maintaining quality
[19]
. These Generic
formulations balance public interest as critical disease like cancer, AIDS etc. Brand name and
generic versions of medicines like high blood pressure, diabetes, etc. Today about 50% of all
prescriptions are filled with generic drugs. The FDA has established standards for generic
drugs that might seem complicated but are really simple.
The most important advantage with generic drugs is less expensive than the branded
versions. They are cheaper as no R & D investments are involved as in the case of branded or
new drug. Generic manufacturers are able to sell their products for lower prices because they
are not required to repeat the costly clinical trials of new drugs and generally do not pay for
costly advertising, marketing, and promotion. In addition, multiple generic companies are
often approved to market a single product; this creates competition in the market place, often
resulting in lower prices. So, generics can cost between 20 and 80 percent less.[20]
According to the FDA, to substitute a generic for brand name drug must follow
following criteria - It must contain the same active ingredients (the chemical substance that
makes the drug work), the same dosage strength (the amount of active ingredients, for
example 20 mg or 40 mg), the same dosage form (that it, it needs to be available in the same
form as the original – for example as liquid, pill, etc.), have same route of administration (the
way the medication is introduced into the body)
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Department of Pharmacy Practice, Vignan Pharmacy College
INTRODUCTION OF THE PROJECT
The generic market reached 100 billion dollars in 2010. The generic growth is three times
higher than the overall growth of drugs. According to expectation of pharmaceutical industry,
percentage of generic drugs in the US market will rise from 14 to 21.[21] This growth will enhance
the export of pharmaceutical products from India will double every year. In future contribution
from the Indian pharmaceutical companies will increase due to low cost of worker, innovation,
recent success in track record in design operation of high-tech manufacturing, testing, quality
control, research, clinical testing and biotechnology.
Availability of Generic drugs in the Indian Market is very low. It is only supplied to the
Government and other hospitals or to the physician ‘s dispensary. For more profit, generally
branded drugs are promoted to doctors while branded generics are sold at the Maximum Retail
Price (MRP). But distributor ‘s buys branded generic from companies at the discount of 1015% of the MRP. In present situation, consumer patients are not benefited and retail chemists
earn huge profit [22].
Generic Drugs are available all over the world at affordable prices with maintaining
quality. These Generic formulations balance public interest like critical disease like cancer,
AIDS etc. Most nations require generic drug manufacturers to prove their formulation exhibits
bioequivalence to the innovator product. A number of developing countries have made use of
compulsory licensing or government use orders to enable the supply of more affordable
generic drugs in recent years. India today has the distinction of producing high quality generic
medicines that are sold around the world. India tops in the world in exporting generic
medicines and currently, the Indian pharmaceutical industry is one of the world's largest and
most developed industry.
Scope of generic drugs
In today ‘s era, the scope of generic drugs is increasing day by day specially in several
ill health conditions such as diabetes, cardiovascular and in microbial diseases etc. When any
patent expires, new generics are introduced into the market
[23]
. The scope is also increased
due to Para IV filings and Bolar provisions. Recently, Para IV filing strategy has been adopted
by leading Indian pharmaceutical companies to introduce generic drug of its own taking
advantage of shortcoming in patent application of patent holders.
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INTRODUCTION OF THE PROJECT
According to this, a generic manufacturer challenges the original patented drug and
claims that the generic version proposed to be launched by the manufacturer does not infringe
the patent holder ‘s version. In case a patent challenge is won, it entitles the first to file Para IV
generic manufacturer a 180 days exclusivity, if company come up with an equivalent of the
innovator ‘s branded formulation [24]. Bolar provision ‘allows generic manufacturers to prepare
and develop regulatory procedures before patent expires, so that, products are ready for market
as soon as the patent ends. With these provisions, in India, the scope of generic drug
manufacturing has also increased.
Basic Generic Drugs Requirement: 
Same active ingredient(s)

Same route of administration

Same dosage form

Same strength

Same condition of use

Inactive ingredient already approved in similar NDA
GENERIC INDUSTRY
The generic drug industry covers the marketing and sale of medication containing the same
active ingredients (API's) and dosages as brand-name drugs manufactured by the
pharmaceutical industry. Generic drugs are under the same governance as brand-name drugs
and must adhere to the same standards. When brand-name drugs come off patent, the market is
opened up to generic versions. Patent protection generally protects a drug's intellectual
property rights for about 20 years, but because the patent is effective from the clinical trial
stage [25].
Since the late 1970‘s the substitution of generic drugs for brand name drugs has become a
relatively common physician practice. At the same time, several studies reported a connection
between physicians ‘sources of drug information, their attitudes toward generics and their
prescribing.
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INTRODUCTION OF THE PROJECT
By 2003 generic drug prescriptions represented 43 percent of all prescriptions written and 47 percent of
new (non-refill) prescriptions Generic drugs were also one of the fastest growing sectors of the
pharmaceutical industry to Given the rise in direct-to-consumer advertising, the use of formularies to
control costs, and continued concern about drug safety, it is time to revisit physicians ‘opinions and
practices regarding generic drug substitution.
FIGURE NO: 5: Leading Companies in the Generic Industry.
1.4 GLOBAL GENERIC INDUSTRY: The availability of generic drugs will drive demand in developing countries. Growing
middle classes in Asia, the Middle East, and Latin America will seek affordable versions of
the best-selling drugs. Central and South American governments are stepping up healthcare
efforts and with a growing 65-and-older population, the use of generic drugs in the region is
growing exponentially. Chinese and Indian drug manufacturers already produce more than
80% of API's used in medication worldwide. With patent expirations, the production and
demand for generic drugs and APIs in China, India, Latin America, and Central & Eastern
Europe is expected to climb.
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INTRODUCTION OF THE PROJECT
Teva is the world's biggest generic company and is continuing to climb. During the
course of 2010, Teva launched 18 generics that targeted drugs with 12.2 billion in U.S. Sales.
Teva reported that it accounts for 21.8% of total U.S. Generic prescriptions.
[26]
Teva
manufactures 71 billion tablets a year in 77 pharmaceutical and API facilities around the
world.
Sandoz is the number two generic company worldwide. It is Novartis' generic unit, located
in Germany with a 7.8 % market share. The company has strong results from the U.S.,
Canada, Russia, Italy, Japan, and biosimilars. Sandoz has three strategic priorities: 1. To be first-to-market as originators' substance patents expire of become unenforceable
2. To be cost competitive by leveraging economics of sale in development and production
3. To differentiate Sandoz based on its extensive global reach and advanced technical expertise
in the development
An Economic Analysis of Generic Drug Usage: -This independent analysis,
conducted by the IMS Institute.

The use of generic prescription drugs in place of their brand name Counterparts saved the
health care system more than $931 billion over the past decade [27].

In 2010 alone, generic use generated more than $157 billion in savings.

Savings from newer generic medicines—those that have entered the marketsince2001—
continue to increase exponentially and account for more than one-third of the total savings.
FIGURE NO: 6: - Savings by year ($ in billions)
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Department of Pharmacy Practice, Vignan Pharmacy College
INTRODUCTION OF THE PROJECT
1.5 INDIAN GENERIC DRUGS INDUSTRY: India supplies 20% of generic drugs worldwide Posted 01/03/2013. Every fifth tablet,
capsule and injectables generic drug being used in the world is manufactured in India,
according to India ‘s Health Minister Ghulam Nabi Azad [29].
―Being a world leader in generics, India already has a huge presence in the highly
regulated markets in terms of Pharma exports. Almost two thirds of Indian generic exports are
to the highly regulated markets (e.g., the US and Europe), which speaks volumes about the
quality of Indian medicines.
Already this year, India ‘s Dr. Reddy ‘s, Lupin Labs, Sun Pharma, Ranbaxy and Cipla
have invested over $ 500 million in R&D, which is allowing increased innovation in
manufacturing processes and will ultimately help to lower the cost of medicines production.[29]
Growth of Generic Drug Industry: In future contribution from the Indian pharmaceutical companies will increase due to
low cost of worker, innovation, recent success in track record in design operation of high-tech
manufacturing, testing, quality control, research, clinical testing and biotechnology. Most of
the Indian companies have United States Food and Drug Administration (USFDA) approved
plants, about 20% of all Abbreviated New Drug Applications (ANDA) to the USFDA are field
by Indian companies. Now India ‘s share of the generic market is about to 35% [30]. Hence the
contribution of the Indian pharmaceutical industry for the growth of generic drugs in the world
is very high.
Over the next few years, an abnormally large number of blockbuster drugs are
scheduled to lose their patent protection, opening the doors to cheaper generic drugs. These
drugs are Blockbuster-brand products and offer tremendous scope to generic manufactures.
Growth in the use of generics in India is being encouraged by instructions being issued
to governmental hospitals and doctors to prescribe and to pharmacies to dispense generics to
the maximum extent possible ‘.
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LITERATURE SURVEY
Availability of Generic drugs in the Indian Market: Availability of Generic drugs in the Indian Market is very low. It is only supplied to
the Government and other hospitals or to the physician ‘s dispensary. For more profit,
generally branded drugs are promoted to doctors while branded generics are sold at the
Maximum Retail Price (MRP). But distributor ‘s buys branded generic from companies at the
discount of 10-15% of the MRP
[31]
. In present situation, consumer patients are not benefited
and retail chemists earn huge profit.
Exports of generic drugs by Indian Pharma companies: India's pharmaceutical industry is gaining its position as a global leader. The Pharma
market in India is expected to touch US$ 74 billion in sales by 2020 from the current US$ 11
billion, according to a Price water house Cooper (PwC) report [32].
India has world renowned capacity in producing low cost, high quality bulk and
generic drugs. The share of Indian Pharma companies in the total pie of approvals for generic
drugs (called abbreviated new drug applications (ANDA) approvals in the US) has risen
steadily. In 2011 itself, more than a third of the ANDA approvals were by Indian firms. As a
consequence, formulation exports from India, essentially generic drugs, have grown at 21 per
cent compounded annual growth rate (CAGR) between 2005-06 and 2010-11. With patents of
about US$ 150 billion worth of drugs set to expire between 2010 and 2015, it is expected that
the growth momentum in exports would continue over the next five years, with exports
growing at 14-16 percent CAGR [34].
Department of Pharmacy Practice, Vignan Pharmacy College
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INTRODUCTION OF THE PROJECT
1.6 INDIAN GENERIC DRUGS
Table No. –3 list of Indian generic drugs
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Department of Pharmacy Practice, Vignan Pharmacy College
INTRODUCTION OF THE PROJECT
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Department of Pharmacy Practice, Vignan Pharmacy College
LITERATURE SURVEY
2.LITERATURE SURVEY
1. Philip mathewet.al 2015 reported in the article Generic drugs: Review and experiences from
South India: The cost of pharmaceuticals, as a percentage of total health care spending, has
been rising worldwide. This has resulted in strained national budgets and a high proportion of
people without access to essential medications. Though India has become a global hub of
generic drug manufacturing, the expected benefits of cheaper drugs are not translating into
savings for ordinary people. This is in part due to the rise of branded generics, which are
marketed at a price point close to the innovator brands. The drug availability at the community
pharmacy was 73.3% when analyzed using WHO-HAI tool and the savings for the final
consumers were up to 93.1%, when compared with most-selling brand of the same formulation.
2. Anita Kotwani et.al 2010 reported in the article Will generic drug stores improve access to
essential medicines for the poor in India? Start with awareness and advocacy for generic
equivalents of medicines for the public. Publicize evidence-based results about the quality of
generic medicines available at generic drug stores. Stock the generic drug stores with all the
essential medicines. Open stores in the private sector, not only in urban areas but also in
villages and small towns. If quality medicines at affordable prices are accessible to the general
public in the private sector, then access to essential medicines will improve.
3. Anil C Anand et.al 2017 reported in the article Using generic drugs in India: Some
Thoughts: The price of pharmaceuticals has become an issue of great concern for people and
governments around the world. Thus, governments across the globe must make efforts to
correct the present distortions around the concept of generic drugs. Effective price competition
remains the rule in generic markets for large-selling drugs. Smaller markets and those for
injectable products often have less price competition and are more susceptible to supply
disruptions.
4. Puneeta Gupta, Mehvish Khan et.al 2019 reported in the articleGenerics and Biosimilars; A
Step Towards Sustainable and Low-Cost Health Care: Millions of people across the globe
go without essential medicines resulting in many avoidable deaths each year. It's no secret that
the cost of prescription drugs, including the life-saving ones has been rising far faster than
inflation over the last few years. If we take the example of diabetes and as India has the largest
number of patients with the condition in the world; it has been shown that patients belonging to
the low-income group in urban India were spending. 27% of their annual income and those in
rural India 34% of their annual income on diabetes care; most of which was spent on purchase
of medicines.
5. Richard G Frank, Thomas G McGuire, Ian Nasonet.al 2021 reported in the articleThe
Evolution of Supply and Demand in Markets for Generic Drugs: Competition in generic
drug markets varies widely by market size and product form. Recent changes in demand-side
market structure imply more downward pressure on prices stemming from buy-side
concentration. The FDA's greater regulatory oversight puts upward pressure on costs, and the
lengthening of the supply chain increases production uncertainty for producers. Demand and
supply-side changes point to further market instabilities across all generic markets due to
producers' changing economic position.
6. Pola B Gupta et.al 2008 reported in the articleSurvey of Pharmacists: Impact of the Generic
Department of Pharmacy Practice, Vignan Pharmacy College
19
LITERATURE SURVEY
Drug Scandal and Implications for Marketing Generic Drugs: The generic drug scandal
that made headlines in 1989 shocked consumers, prescribers, pharmacists, insurers, the
pharmaceutical industry, the FDA and Congress. Using data collected after the scandal was
reported, this study investigates the impact of scandal on pharmacists' confidence in generics,
and their attitudes, opinions and behavior toward generics. Based upon the findings, the author
provides a set of recommendations for marketing generic drugs.
7. Proteesh Rana, Vandana Roy et.al 2015 reported in the articleGeneric medicines: issues and
relevance for global health: Generic medicine is a pharmaceutical product which is
bioequivalent to the innovator product in sterms of dosage form, strength, route of
administration, quality, safety, performance characteristics, and intended use. Generic
medicines are a cornerstone for providing affordable medicines to patients. The major generic
markets in the world include United States of America followed by European Union, Canada,
Japan, and Australia. The major suppliers of generic medicines China and India are showing
tremendous growth in the generic medicine sector. There are many legal and regulatory issues
along with quality concerns associated with the use of the generic products. Lately, bilateral
international agreements called free trade agreements, delaying tactics by originator companies
like strategic patenting and litigations on generic manufacturers, have been a major setback for
the generic medicine industry.
8. Pieter Dylst, Arnold Vulto and Steven Simoenset.al 2015 reported in the article Societal
value of generic medicines beyond cost-saving through reduced prices: Generic medicines
have an additional societal value beyond their cost-saving potential through reduced prices.
Generic medicines increase access to pharmacotherapy, provide a stimulus for innovation by
both originator companies and generic companies and, under the right circumstances, have a
positive impact on medication adherence. Conclusion: Generic medicines offer more to society
than just their cost-saving potential through reduced prices. As such, governments must not
focus only on the prices of generic medicines as this will threaten their long-term sustainability.
Governments must therefore act appropriately and implement a coherent set of policies to
increase the use of generic medicines.
9. Kate MacKrill, Maria Kleinstäuber & Keith J. Petrieet.al 2019 reported in the article The
effect of rebranding generic medicines on drug efficacy and side effects: Branded medicines
have a greater placebo effect, resulting in a heightened therapeutic response, whereas generics
are associated with greater side effect reporting. These two studies investigated whether
enhancing the appearance of a generic medicine could increase placebo and decrease nocebo
responding. While the sample characteristics and familiarity of the medicines may have
influenced the findings, we found no evidence that enhancing the branding of generic
medicines improved response to the medication or reduced side effects.
10. Kevin A Schulman et.al 2020 reported in the article Challenges in Ensuring the Quality of
Generic Medicines: A refill of a generic attention deficit hyperactivity disorder prescription
leads to new side effects and raises questions about the quality of generic drugs. The studies
have mixed results; some interventions in some settings were useful, while others were not. Not
all interventions consistently improved the uptake of generic medicines. There was limited
literature available and further work is required to develop a range of interventions.
Department of Pharmacy Practice, Vignan Pharmacy College
20
AIM AND OBJECTIVES
3.AIM AND OBJECTIVES
Aim:
 The aim is to make study and understand about generic drug market and branded drug market, role
of sales representatives and chemists in this regard.
 To understand the promotional strategies used by the pharmaceutical companies to sell their products.
Objectives:
 To study the awareness of generic drugs amongst doctors, chemists & distributors.
 To understand the perception of Chemists & Distributors towards Generic drugs.
 To know what promotional strategies are used by pharmaceutical companies to sell their products in the
market.
 To carry out comparative analysis of generic drugs and branded drugs.
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Department of Pharmacy Practice, Vignan Pharmacy College
SAMPLE DESIGN
4.PLAN OF WORK
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Department of Pharmacy Practice, Vignan Pharmacy College
LITERATURE SURVEY
5. MATERIALS & METHODS

Research Method: Survey Method

Research Tool: Questionnaire containing open as well as close ended questions.

Data Collection Method: Personal Interviews method (a structured questionnaire with
open and closed ended questions)

Research region: Guntur district

Duration of research: 2months

Duration of Data collection:6Weeks

Respondents: Educated (science students)
Educated(non-science)
Pharmacists
Chemists
Distributors

Sampling technique: Random sampling
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH METHODOLOGY
RESEARCH METHODOLOGY
WHAT IS RESEARCH?
Research is a logical and systematic search for new and useful information on a particular topic.
Research is done with the help of study, experiment, observation, analysis, comparison and
reasoning. Research is in fact ubiquitous. For example, we know that cigarette smoking is
injurious to health; heroine is addictive; cow dung is a useful source of biogas; malaria is due to
the virus protozoan plasmodium; AIDS (Acquired Immuno Deficiency Syndrome) is due to the
virus HIV (Human Immuno Deficiency Virus). How did we know all these? We became aware
of all these information only through research. More precisely, it seeks predictions of events,
explanations, relationships and theories forthem.
As stated by Gerald Milburn Scientific research is a chaotic business, stumbling along amidst
red herrings, errors and truly, creative insights. Great scientific breakthroughs are rarely the
work of a single researchers plodding slowly by inexorably towards some final goal. The crucial
idea behind the breakthrough may surface a number of times, in different places, only to sink
again beneath the babble of an endless scientific discourse.
WHAT ARE THE OBJECTIVES OF RESEARCH?
The prime objectives of research are
(1) To discover new facts
(2) To verify and test important facts
(3) To analyze an event or process or phenomenon to identify the cause
(4) To develop new scientific tools, concepts and theories to solve and understand scientific and
nonscientific problems
(5) To find solutions to scientific, nonscientific and social problems.
(6) To overcome or solve the problems occurring in our everyday life.
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Department of Pharmacy Practice, Vignan Pharmacy College
RESEARCH METHODOLOGY
SOME IMPORTANT AVENUES OF RESEARCH ARE: (1) A research problem refers to a difficulty which a researcher or a scientific community or an
industry or a government organization or a society experience. It may be a theoretical or a
practical situation. It calls for a thorough understanding and possible solution.
(2) Research on existing theories and concepts help us identify the range and applications of them.
(3) It is the fountain of knowledge and provides guidelines for solving problems.
(4) Research provides basis for many government policies. For example, research on the needs
and desires of the people and on the availability of revenues to meet the needs helps a
government to prepare a budget.
IMPORTANCE OF RESEARCH METHODOLOGY IN RESEARCH STUDY: -
It is necessary for a researcher to design a methodology for the problem chosen. One
should note that even if the methods considered in two problems are same the methodology
may be different. It is important for the researcher to know not only the research methods
necessary for the research under taken but also the methodology. For example, a researcher not
only needs to know how to calculate mean, variance and distribution function for a set of data,
how to find a solution of a physical system described by mathematical model, how to
determine the roots of algebraic equations and how to apply a particular method but also need
to know
(i) Which is a suitable method for the chosen problem?
(ii) What is the order of accuracy of the result of a method?
(iii) What is the efficiency of the method? And soon.
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Department of Pharmacy Practice, Vignan Pharmacy College
RESEARCH METHODOLOGY
STEPS IN RESEARCH PROCESS:1. Formulating the Research Problem
2. Extensive Literature Review
3. Developing the objectives
4. Preparing the Research Design including Sample Design
5. Collecting the Data
6. Analysis of Data
7. Generalization and Interpretation
8. Preparation of the Report or Presentation of Results-Formal write ups of
conclusion reached.
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RESEARCH ANALYSIS
6. RESEARCH ANALYSIS
For professionally qualified (science background) individuals:
FIGURE NO: 7: Graphical view of responses regarding generic medicines law passed by Indian government.
ROW LABELS
Yes
No
Grand Total
COUNT
45
15
60
TABLE NO :4: Awareness among individuals about generic medicine law passed by Indian government.
INFERENCE:

75% of individuals replied, they do know that Government of India has passed a law about generic
medicines.

Whereas, 25% of individuals replied, they don’t know that Government of India has passed a law
about generic medicines.
27
Department of Pharmacy Practice, Vignan Pharmacy College
RESEARCH ANALYSIS
FIGURE NO: 8: Graphical view of responses regarding the effect of generic medicines.
ROW LABELS
Yes
No
May be
GRAND TOTAL
COUNT
36
05
18
60
TABLE NO: 5: Comparative analysis on the effect of generic medicines vs branded medicines.
INFERENCE:

Above than 60% of individuals say that generic drugs are having same effect as that of the branded
drugs.

10% of individuals feel that generic drugs are not having same effect as like that of the branded
drugs.

Whereas 30% of individuals feel may be generic drugs have same effect as like that of the branded
drugs.
28
Department of Pharmacy Practice, Vignan Pharmacy College
RESEARCH ANALYSIS
FIGURE NO: 9: Graphical view of responses regarding FDA guidelines of generic medicines.
ROW LABELS
Yes, follow exactly
Yes, certain parameters
Can`t say
No
Grand Total
COUNT
22
31
06
01
60
TABLE NO: 6: count of responses regarding FDA guidelines of generic medicines.
INFERENCE:

According to 36.7% of individuals, generic drugs follow the FDA guidelines as branded drugs.

According to 51.7% of individuals, generic drugs follow certain parameters of FDA guidelines as
branded drugs.

According to 10% of individuals, generic drugs may or may not follow the FDA guidelines as
branded drugs.

1.7% of individuals believe that, generic drugs do not follow the FDA guidelines as branded drugs.
29
Department of Pharmacy Practice, Vignan Pharmacy College
RESEARCH ANALYSIS
FIGURE NO: 10: Graphical view of responses regarding current usage of generic medicine.
ROW LABELS
Yes
No
Grand Total
COUNT
13
47
60
TABLE NO: 7: Total count of responses regarding current use of generic medicines.
INFERENCE:

21.7% of individuals said that, they are currently using generic medicine.

Whereas, 78.3% of individuals said that, they are currently not using generic medicine.
30
Department of Pharmacy Practice, Vignan Pharmacy College
RESEARCH ANALYSIS
FIGURE NO: 11: Graphical representation of responses regarding cost variation among branded and generics.
ROW LABELS
Yes A huge difference
Yes but little bit
Don’t know
COUNT
38
14
09
TABLE NO: 8: Total count of responses regarding cost variation among branded and generic medicines.
INFERENCE



63.3% of individuals say that they found a huge cost difference between generic and branded
medicines.
23.3% of individuals say that they found a little cost difference between generic and branded
medicines.
15% of individuals say that they don’t know cost difference between generic and branded
medicines.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 12: Graphical view of responses regarding knowledge about generic medicine availability.
ROW LABELS
Yes
No
Grand Total
COUNT
41
19
60
TABLE NO: 9: Total count of responses regarding knowledge about generic medicine availability.
INFERENCE:

More than 68.3% of individuals know medical shops where generic medicines are available.

19% of individuals don’t know medical shops where generic medicines are available.
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RESEARCH ANALYSIS
FIGURE NO: 13: Graphical view of responses regarding knowledge about generic medical stores.
ROW LABELS
Yes
No
Grand Total
COUNT
41
19
60
TABLE NO: 10: Total count of responses regarding knowledge about generic medical stores.
INFERENCE:

73.3% of individuals would like to know the medical stores where generic medicine is available.

26.7% of individuals don’t want to know such medical stores which sell generic medicine.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 14: Graphical view of responses regarding questioning medical stores for generic medicines.
ROW LABELS
Always
Never
Often
Grand Total
COUNT
09
18
33
60
TABLE NO: 11: Total number of responses regarding questioning medical stores for generic medicines.
INFERENCE:

15% of individuals always ask for generic medicine in medical store.

30% of individuals never ask for generic medicine in medical store.

55% of individuals often ask for generic medicine in medical store.
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RESEARCH ANALYSIS
FIGURE NO: 15: Graphical responses regarding seeking patient opinion on cost of medicine before prescribing
ROW LABELS
Always
Never
Often
Grand Total
COUNT
02
37
21
60
TABLE NO: 12: Total no of responses regarding seeking patient opinion on cost of medicine before prescribing
INFERENCE:

According to 3.3% of individuals, their doctors always ask whether the cost of medicine is concern
before prescribing the medicine.

61.7% of individuals say that their doctor never ask them about cost concern before prescribing.

35% of individuals say that their doctor often ask them about cost preference before prescribing.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 16: Graphical responses regarding substitution of branded with generic alternative
ROW LABELS
Yes
No
Grand Total
COUNT
08
52
60
TABLE NO: 13: Total no of responses regarding substitution of branded with generic alternative.
INFERENCE:
 According to 86.7% of individuals say that their doctor or pharmacist never asked them to switch
from generic to branded alternative.
 According to 13.3% of individuals say that their doctor or pharmacist asked them to switch from
generic to branded alternative.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 17: Graphical responses regarding the reason behind high cost of branded drugs.
ROW LABELS
High quality
Better therapeutic effect
Company`s reputation
Can`t say
Any other
COUNT
17
22
31
04
04
TABLE NO: 14: Total number of responses regarding the reason behind high cost of branded drugs.
INFERENCE:

51.7% of individuals believe that company reputation is the reason for high cost of branded drugs.

36.7% of individuals believe that best therapeutic effect is the reason for high cost.

28.3% of individuals believe that high quality is the reason for high cost.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 18: Graphical responses regarding the reason behind low cost of generic drugs.
ROW LABELS
low quality
less therapeutic effect
Company`s reputation
Can`t say
Any other
COUNT
06
14
19
07
23
TABLE NO: 15: Total number of responses regarding the reason behind low cost of generic drugs.
INFERENCE:

More than 31.7% of individuals say that company`s reputation is reason for generic drug low cost.

23.3% of individuals say that less therapeutic effect is reason generic drug low cost.

10% of individuals say that low quality may be the reason.

38.3% of individuals say that there may be any other reasons for low cost.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 19: Graphical responses regarding the savings per month using generic medicines.
ROW LABELS
Up to 25%
Up to 50%
Up to 75%
Can`t say
Grand Total
COUNT
13
22
10
15
60
TABLE NO: 16: Total number of responses regarding the savings per month using generic medicines.
INFERENCE

Almost 36.7% of individuals think that they save 50% per month by using generic medicines.

21.7% of individuals think that they save 25% per month by using generic medicines.

10% of individuals think that they save 75% per month by using generic medicines.

31.7% of individuals can’t say what their savings per month using generic medicines.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 20: Graphical view of responses regarding public opinion for generic drug laws.
ROW LABELS
Yes
No
Grand Total
COUNT
53
07
60
TABLE NO: 17: Total no of responses regarding public opinion for generic drug laws.
INFERENCE:

Almost 88.3% of individuals think that government should come up with stringent laws regarding
generic medicines.

11.7% of individuals think that there is no need of such laws for stringent laws.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
15. What are the disadvantages of generic medicines according to you?
Majority of the population said generics are less effective compared to its brand name medicine, many of
them perceive generics to be of poor quality and few don’t know about disadvantages.
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RESEARCH ANALYSIS
FOR EDUCATED INDIVIDUALS (NON SCIENCE BACKGROUND):
FIGURE NO: 21: Graphical view of responses regarding knowledge about generic medicines.
ROW LABELS
Yes
No
Grand Total
COUNT
41
20
61
TABLE NO: 18: Total number of responses regarding knowledge about generic medicines.
INFERENCE:

More than 68.3% of individuals know about the generic drugs.

33.3% of individuals don’t know about the generic drugs.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 22: Graphical view of responses regarding knowledge about cost of generic medicines.
ROW LABELS
Yes
No
Grand Total
COUNT
33
28
61
TABLE NO: 19: Total number of responses regarding knowledge about cost of generic medicines.
INFERENCE:

More than 55% of individuals know that generic drugs are available at cheap price.

45% of individuals don’t know that generic drugs are available at cheap price.
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RESEARCH ANALYSIS
FIGURE NO: 23: Graphical view of responses regarding doctor preference to medicine.
ROW LABELS
Always
Never
Often
Grand Total
COUNT
11
22
30
63
TABLE NO: 20: Total number of responses regarding doctor preference to medicine.
INFERENCE:



50% of individuals say that their doctor often gives preference to low cost medicine.
36.7% of individuals say that their doctor never gives preference to low cost medicine.
18.3% of individuals say that their doctor always gives preference to low cost medicine.
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RESEARCH ANALYSIS
FIGURE NO: 24: Graphical view of responses regarding patient concern related to cost of medicine.
ROW LABELS
Yes
No
Grand Total
COUNT
25
35
60
TABLE NO: 21: Total number of responses regarding patient concern related to cost of medicine.
INFERENCE:

41.7% of individuals replied that, they ask their doctor for medicine having low price.

58.3% of individuals replied that, they don’t ask their doctor for medicine having low price.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 25: Graphical view of responses regarding effect of medicines with different costs.
ROW LABELS
Yes same effect
Yes even better effect
No give less effect
Can`t say
Grand total
COUNT
23
05
04
28
60
TABLE NO: 22: Total number of responses regarding effect of medicines with different costs.
INFERENCE:

46.7% of individuals can`t say whether generic drugs have same effect as branded drugs.

38.3%% of individuals believe that generic drugs have same effect as branded drugs.

8.3% of individuals believe that they are more effective than branded drugs.

6.7% of individuals believe that generic drugs are not effective as branded drugs.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 26: Graphical view of responses regarding safety of generic drugs.
ROW LABELS
Yes
No
Grand Total
COUNT
44
17
61
TABLE NO: 23: Total number of responses regarding safety of generic drugs.
INFERENCE:

More than 73.3% of individuals replied that, generic drugs are as safe as branded drugs.

26.7% of individuals replied that, generic drugs are not as safe as branded drugs.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 27: Graphical view of responses regarding patient’s preference.
ROW LABELS
Yes in emergency
Yes always
No
Grand Total
COUNT
41
12
09
62
TABLE NO: 24: Total number of responses regarding patient’s preference.
INFERENCE:

68.3% of individuals said that even they know that generic drugs are of low cost they still pay for
branded drugs in emergency conditions.

20% of individuals said that even they know that generic drugs are of low cost they still pay for
branded drugs always.

15% of individuals said that they wouldn’t pay more for branded drugs.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 28: Graphical view of responses regarding knowledge about cheap alternative of medicine.
ROW LABELS
Yes
No
Grand Total
COUNT
42
19
61
TABLE NO: 25: Total number of responses regarding knowledge about cheap alternative of medicine.
INFERENCE:

More than 70% of individuals replied that, they would like to know whether there is any cheap
alternative for their medicines.

30% of individuals replied that, they wouldn’t like to know any alternative for their medicine.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 29: Graphical responses regarding substitution of branded with generic alternative.
ROW LABELS
Yes if physician permits
Yes if it reduces my bill
No
Can`t say
COUNT
31
22
03
07
TABLE NO: 26 Total no of responses regarding substitution of branded with generic alternative.
INFERENCE:

51.7% of individuals say that they would switch to generic medicine if physician permits.

36.7% of individuals say that they would switch to generic medicine if their bill reduces to half.

11.7% of individuals say that they couldn’t decide whether they switch to generic medicine or not.

5% of individuals say that they wouldn’t switch to generic medicine on any cost.
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RESEARCH ANALYSIS
FIGURE NO: 30: Graphical view of responses regarding any new/advertisements encouraging generic drugs.
ROW LABELS
Yes
No
Grand Total
COUNT
22
38
60
TABLE NO: 27: Total number of responses regarding any new /advertisements encouraging generic drugs.
INFERENCE

63.3% of individuals said that during the last three months they have not seen or heard
advertisement, news or information encouraging people to use generic medicines.

36.7% of individuals said that during the last three months they have seen or heard advertisement,
news or information encouraging people to use generic medicines.
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RESEARCH ANALYSIS
FIGURE NO: 31: Graphical responses regarding generic medicines advertisement.
ROW LABELS
News papers
TV channels
Online
Medical stores
COUNT
06
09
35
26
TABLE NO: 28: Total number of responses regarding generic medicines advertisement.
INFERENCE




58.3% of individuals have seen or heard information regarding generic medicines through online.
43.3% of individuals have seen or heard information regarding generic medicines through pharmacy.
15% of individuals have seen or heard information regarding generic medicines through TV channels.
10% of individuals have seen or heard information regarding generic medicines through news papers.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 32: Graphical view of responses regarding choice of medication.
ROW LABELS
Yes
No
Grand Total
COUNT
10
50
60
TABLE NO: 29: Total number of responses regarding choice of medication.
INFERENCE


More than 83.3% of individuals don’t follow TV advertisements for selecting their medication.
16.7% of individuals follow TV advertisements for selecting their medication.
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RESEARCH ANALYSIS
FOR PHARMACISTS WORKING IN MEDICAL STORES, CHEMISTS, and
DISTRIBUTORS.
FIGURE NO: 33: Graphical view of response regarding storage of generic medicines.
ROW LABELS
Few
All
No
Grand Total
COUNT
16
10
5
31
TABLE NO: 30: Total number of responses regarding storage of generic medicines.
INFERENCE:
 53.3% of pharmacists replied that, they do keep few generic medicines in their pharmacy.
 33.3% of pharmacists replied that, they do keep all generic medicines in their pharmacy.
 16.7% of pharmacists replied that, they don`t keep generic medicines in their pharmacy.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 34: Graphical view of responses regarding reasons for not storing generic medicines.
ROW LABELS
Less demand
Less or no prescription
Don’t know
Grand Total
COUNT
08
09
13
30
TABLE NO: 31: Total number of responses regarding reasons for not storing generic medicines.
INFERENCE
 43.3% of pharmacists can`t say why they don’t store generic medicine.
 30% of pharmacists say that, they don’t store them because of less or no prescription.
 26.7% of pharmacists say that, they don’t store them because of less demand.
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RESEARCH ANALYSIS
FIGURE NO: 35: Graphical view of responses regarding patient’s choice of cheaper alternative medicine.
ROW LABELS
5%
10%
15%
20%
Grand total
COUNT
06
08
09
07
30
TABLE NO: 32: Total number of responses regarding patient’s choice of cheaper alternative medicine.
INFERENCE

According to 30% of pharmacists, 15% patients ask them for generic medicine/cheaper
alternative to brand.

According to 26.7% of pharmacists, 10%patients ask them for generic medicine/cheaper
alternative to brand.

According to 23.3% of pharmacists, 20% patients ask them for generic medicine/cheaper
alternative to brand.

According to 20% of pharmacists, 5% patients ask them for generic
medicine/cheaper
alternative to brand.
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RESEARCH ANALYSIS
FIGURE NO: 36: Graphical view of responses regarding generic medicine suggestions.
ROW LABELS
Always
Never
often
Grand Total
COUNT
10
07
14
31
TABLE NO: 33: Total number of responses regarding generic medicine suggestions.
INFERENCE
 46.7% of pharmacists often suggest generic medicines to patients.
 33.3% of pharmacists always suggest generic medicines to patients.
 23.3% of pharmacists never suggest generic medicines to patients.
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RESEARCH ANALYSIS
FIGURE NO: 37: Graphical view of responses regarding availability issue of generic medicines.
ROW LABELS
Yes
No
Grand Total
COUNT
09
21
60
TABLE NO: 34: Total number of responses regarding availability issue of generic medicines.
INFERENCE:

70% of pharmacists replied that there is no availability issue of generic medicine.

30% of pharmacists replied that there is availability issue of generic medicine.
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RESEARCH ANALYSIS
6. What kind of difficulties do you face about generic medicine availability or sale?
According to pharmacists most of the patients strictly follow prescription which mostly has branded
medicines and few of them said there is very less demand of generics. Some percentage said that there is no
difficulty in keeping generic medicines.
7. Which pharmaceutical industries make generic medicines?
Majority of the pharmacists were aware that large no. of companies deal in generics, they named a few
prominent ones which included GSK, Cipla, Ranbaxy, Lupin, FDC,Alkem, Intas, Emcure etc.
Department of Pharmacy Practice, Vignan Pharmacy College
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RESEARCH ANALYSIS
FIGURE NO: 38: Graphical view of responses regarding usage of generic medicine.
ROW LABELS
Yes
No
Grand Total
COUNT
17
13
30
TABLE NO: 35: Total number of responses regarding usage of generic medicine.
INFERENCE:

56.7% of pharmacists said that they personally use generic medicine instead of branded
medicines.

43.4% of pharmacists said that they don’t use generic medicine.
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RESEARCH ANALYSIS
FIGURE NO: 39: Graphical view of responses regarding quality variation.
ROW LABELS
Yes
No
Grand Total
COUNT
13
18
31
TABLE NO: 36: Total number of responses regarding quality variation.
INFERENCE:

60% of pharmacists believe that there is no quality difference between generic and branded
medicines.

43.3% of pharmacists believe that there is quality difference between the generic and branded
drugs.
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RESEARCH ANALYSIS
10. Why generic medicines have lesser price than branded?
Pharmacists said that less price of generics could be because of low investment in marketing, company
policies and reputation, quality difference and very few were aware about the patent expiration of parent
molecule.
11. What are the disadvantages of generic medicines?
More than 90 % of pharmacists responded saying none and few find poor quality is major disadvantage.
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RESEARCH ANALYSIS
FIGURE NO: 40: Graphical view of response regarding affect of business due to low cost of generic medicine.
ROW LABELS
COUNT
Yes
No
Grand Total
09
21
30
TABLE NO: 37: Total number of responses regarding affect of business due to low cost of generic medicine.
INFERENCE:

70% of pharmacists believe Government with new law, making generic medicines available free
of cost at government hospitals, do not affect their business.

30% of pharmacists believeGovernment with new law, making generic medicines available free
of
cost
at
government
hospitals,
do
affect
their
business.
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RESULT AND DISCUSSION
7.RESULT AND DISCUSSION
Survey conducted among different groups of population showed various opinions about generic drugs. The
survey result of professionally qualified science background individuals showed that people were quite aware
about various government policies about generic drugs. Nearly 60% of individuals said that the generics are as
effective as branded medicines. More than 63.3% individuals found a huge cost difference between generic and
branded medicines.
More than 31.7% people didn’t know such stores where generic medicines are available but when they were
asked if they would like to know such store near about 73.3% responded positively.
Though professionally qualified 30% science background individuals never asked about generic medicines in
medical stores and about 33% asked often, more than 37% said their doctor never asked about the cheaper
alternatives or about generic version of branded medicines. More than 51.7% of people thought reason of high
cost of the branded medicines is due to company’s reputation and 28.3% said it could be the high quality of
branded medicines that make them costly. The survey results of pharmacist shows that many of them do not
keep all kind of generic medicines. 53.3% of pharmacists said that they keep few regular generic medicines.
The main reason behind not keeping generic medicines was less demand from the patients. As per the
pharmacist in the survey 10-15% of patients asked about generic or cheaper alternatives to brand, more than
40% pharmacists never suggest generic medicines to patients, though they were well aware about all major
generic manufacturing companies. Besides all above when they were asked about their business regarding new
government policy of free drug distribution more than 70% pharmacist said that it may not affect their business.
The survey result of educated but non-science background shows that a good number nearly 68.3% of
population knew about the generic medicine, but more than 58.3 % of them never asked their physician about
generic medicine or cheaper alternative to branded medicine. In a few instances when patient asked doctor
about generic medicine physicians replied that branded medicines will act quickly and effectively compared to
generic medicine. This shows the attitude of physicians about generic medicines. More than 46.7% of
individuals were not aware about effects of generic medicines while nearly 6.7% said that generics are less
effective than branded. Near about 49% individual thought generics are not as safe as branded, but 70% were
ready to know the cheaper alternative to branded. The war of generics versus branded getting popular in country
like India and electronic and print media is approaching to this issue significantly. More than 58.3% people in
the survey got aware about OTC and generic medicines via these media and consulted with the physician about
these generic medicines rather than blindly following the TV or other advertisements.
Department of Pharmacy Practice, Vignan Pharmacy College
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CONCLUSION
8.CONCLUSION
Survey of 60 science background individuals, 60 educated but non-science background individual and 30
Pharmacist was carried out to throw light on generics versus branded medicine scenario in Andhra Pradesh state
particularly in districts of Krishna and Guntur. It isobvious from survey that educated and non educated would
like to have access to generic medicine and want to have more knowledge and information about generics from
the doctors as most of them do not like to violet prescription. Thus it could be suggested that doctors can write
generic alternative to branded medicines for the benefit of the patients as most of the individuals in survey have
conclusively said that they would like to have cheaper alternative to branded medicines. There is strong belief
amongst the educated individuals that if doctor has prescribed the branded medicines it cannot be changed and
generic alternative may have less effect. This myth was revealed in survey of pharmacists as most of them know
generic medicines are not compromised medicines and could be as efficacious as branded medicines. The main
reason of less sell of generic medicines is due to lack of such prescriptions received from physicians. There is
also willingness from pharmacist side to help the people by supplying generic alternative to branded medicines
which the author belief should be supported by law.
Food and drug administration has stringent rules and regulations in bringing out generic medicines in public use
thus there is no reason to believe that generics are substandard than branded (though does not reflect from
survey of educated people and therefore people need to be informed in this regard). India is a leading country in
Pharma manufacturing sector and is serving humanity by producing cost effective but quality medicines in the
entire world and also supplying these medicines to most of the countries, at the same time the poor population
in India is still unable to get access to modern medicines. Thus, the new regulation of generic medicine and
implementation steps should be taken by the government.
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BIBLIOGRAPHY
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