A Study of generic drugs

A PROJECT REPORT ON
"A STUDY TO UNDERSTAND THE PRESCRIPTION PATTERN OF GENERIC DRUGS"
At
HINDUSTAN ANTIBIOICS LTD.
PIMPRI, PUNE.
Submitted by:-
Mr. SANTOSH PANCHAKSHARI SALGARE
Roll No. 13037
MBA – BT - II
Submitted to:-
DEPARTMENT OF MANAGEMENT OF SCIENCES
Savitribai Phule Pune University
For Partial fulfillment of MBA degree.
2013 – 2015

CERTIFICATE
This is to certify that the project on
"A STUDY TO UNDERSTAND THE PRESCRIPTION PATTERN OF GENERIC DRUGS"
Under taken at ―Hindustan Antibiotics Ltd‖ Pimpri, Pune.
has been submitted by
Mr. SANTOSH PANCHAKSHARI SALGARE
Roll No - 13037
MBA BT II (2013-15)
In partial fulfilment of the requirement for the Degree of
Master in Business Administration –Biotechnology (MBA-BT) from the
DEPARTMENT OF MANAGEMENT
SCIENCES,
SAVITRIBAI PHULE PUNE UNIVERSITY.
Dr. Manish Varma
(Faculty Of PUMBA)
Project Guide
External Examiner Dr. B.V. Sangvikar
Professor & Head
PUMBA

ACKNOWLEDGEMENT
I would like to express my sincere gratitude to Dr. B. V. Sangvikar, Head of The Department, Department Of Management Sciences, University Of Pune for allowing me to carry out this project work.
I also acknowledge my deep sense of gratitude to Mr. B.G. Mupade (Dy. GENERAL MARKETING MANAGER) who gave me a chance to be a part such a Prestigious Organization.
Moreover, I am also grateful to Mrs. A Mandre (Head Training Dept.) &Mr. R. Ganesh, Marketing Department of HAL, Who made available time to time & given a constant encouragement for the completion of this project report.
I wish to owe my sincere thanks to my Project Guide Dr. Manish Varma (Faculty PUMBA), Dr. (Mrs) Supriya Patil, (Course Co-ordinator, MBA- Biotechnology, PUMBA), and Dr. Atish Chintamani, (Faculty, PUMBA) for their able guidance and useful suggestions which helped me in completing the project work.
I would also like to express my heartfelt thanks to my parents and my friends Mr. Nakul Gavhane, Rohit Aher, Amar Panche & Prathamesh Sonawane for their help and wishes for the successful completion of the project.
Finally I owe my regards to all those who supported & helped me in any respect directly or indirectly during the tenure of this project.
SANTOSH PANCHAKSHARI SALGARE

Table of Contents
SR. NO.
TOPIC
PAGE NO.
1.
Executive Summary
7
2.
Introduction to Pharmaceutical Industry
8
3.
Introduction to the project
15
4.
Company Profile
25
5.
Objectives
33
6.
Sample Design
33
7.
Research Methodology
34
8.
Research Analysis
38
9.
Finding
66
10.
Observation
67
11.
Suggestions
68
12.
Recommendations
69
13.
SWOT Analysis
70
14.
Annexure (Questionnaire)
71
15.
Bibliography
81

1. EXECUTIVE SUMMARY
The project "A STUDY TO UNDERSTAND THE PRESCRIPTION PATTERN OF GENERIC DRUGS" was undertaken as part of academic requirement of two years MBA-Biotechnology course and was conducted for Hindustan Antibiotics Ltd, Pharma Company in India. Hindustan Antibiotics Limited (HAL) is the first drug manufacturing company to be set up in the public sector by Government of India with active co-operation of WHO and UNICEF, HAL is the first drug manufacturing unit in India to undertake commercial production of antibiotics like Penicillin, Streptomycin, Gentamicin, Ampicillin &Amoxicillin etc.
The project objectives are as follows:
A. To study the awareness of Generic Drugs amongst Doctors, Chemists & Distributors.
B. To understand the perception of Doctors, Chemists & Distributors towards Generic
drugs & Prescription Pattern of Generic Drugs.
C. To carry out Comparative analysis of Generic drugs & Branded Drugs.
The Sample size of 166 doctors including BAMS, MBBS & MD - Who are practicing in Solapur Districts, 129 chemists & 16 Distributor‘s are constituted the for the study.
The Major findings of the study were:
 82% doctors believe that generic drugs are safe as branded drugs.
 73 % doctors allow generic drugs to be substitute for branded drugs
 71% doctors feel that generic drugs are not differ from FDA standards.
 More than 91% chemist store generic drugs & 86% chemist receive Prescription for generic drugs weakly.
 According to doctors patients can save more than 50% money by taking generic drugs.
 69% doctors feel that Prescription will not affect by free samples which are given by MR.
 According to 53% distributors, average demand for generic drugs is 25 – 50%.
 More than 77% chemist & 53% distributors‘ feels that due to low cost of generic drugs it will not affect sell of branded drugs.

2. INTRODUCTION TO PHARMACEUTICAL INDUSTRY
2.1 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 $734 billion at the end of 2013. United States, Europe and Japan are the largest pharmaceutical market. [1] The report critically analyse the Global Pharmaceutical Industry, importance and growth with the expect of internal and external environment analysis, plausible views of industry in the future and moral values.
Table No. 2.1:- Top 10 Global players
Sr. No.
Company
2013 ($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
Source - http://www.pmlive.com/top_pharma_list/global_revenue
[1]- http://www.ukessays.com/essays/international-business/global-pharmaceutical-industry.php

2.2 Indian pharmaceutical industry
The Indian pharmaceutical industry currently tops the chart amongst India's science- based 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 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]
[2] & [3] - The Indian Pharmaceutical Industry Business, Legal & Tax Issues, April 2014. [4] - http://www.vccircle.com/news/pharmaceuticals/2014/02/17/india%E2%80%99s-pharma-sales- reach-27b-2016-deloitte-report

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 Pharma 2020‘ by McKinsey & 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 favourable 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.
2.2.1 Current Scenario [6]
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 13-14 per cent in 2013.
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.
The Indian pharmaceutical industry accounts for over 8 percent of global pharmaceutical production. 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.
[5] - http://www.ibef.org/industry/pharmaceutical-india.aspx
[6] - http://www.pharmabiz.com/ArticleDetails.aspx?aid=79940&sid=9

2.2.2. Market Size [7] 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$ 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. 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.
Table No. 2.2 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 Source-http://www.pharmaceutical-drug-manufacturers.com/articles/top10-pharmaceuticals-companies-in-india [7] - http://www.ibef.org/industry/pharmaceutical-india.aspx

2.2.3. Challenges: - [8]:- 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. The core issues for most of drug companies are declining productivity of in-house 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.
2.2.4. Future Growth:-[9]
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.
The Indian pharmaceutical market is expected to grow at a CAGR of 15.3 % during 2011- 12 to 2013-14. The growth of Indian Pharma companies will also be driven by the fastest growing molecules in the diabetes, skincare, and eye care segment.
2.2.4. Government policies:-[10]
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 healthcare,
• improving the quality of medical training,
• increasing public expenditure on healthcare to 2-3% of GDP, up from a current low of 1%.
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. 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.
[8] & [9] - http://www.pharmabiz.com/ArticleDetails.aspx?aid=79940&sid=9
[10] - www.pwc.com/india

2.2.5. Growth of Import-Export [11]
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. The country is almost self-sufficient in production of most of formulations / pharmaceuticals products.
Source - Department of Pharmaceuticals, Annual Report 2012-13
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.
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.
[11] - Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceuticals, Annual Report 2012-13

b) EXPORTS:-[12]
As Per DGCIS, Kolkata Exports of ―Drugs and Pharmaceuticals and Fine Chemicals‖ for the period 2007-08 to 2010-11 are below:-
Source - Department of Pharmaceuticals, Annual Report 2012-13
2.2.6. Growth in Indian Pharmaceutical Industry:-[13]
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
2.2.7. Projected Growth:-[14]
[12] - Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceuticals, Annual Report 2012-13
[13] & [14] - Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceuticals, Annual Report 2012-13

3. INTRODUCTION OF THE PROJECT
3.1 Project location: - Solapur district [15]:- Solapur District is a district in Maharashtra state of India. The city of Solapur is the district headquarters. It is located on the south east edge of the state and lies entirely in the Bhima and Seena basins. The entire district is drained by the Bhima River. The Solapur district comprises of three revenue Sub-divisions, eleven revenue Talukas and 1144 revenue villages. 3.2 Demographics:-[16] :- According to the 2011 census Solapur District has a population of 4,315,527 roughly equal to the nation of Moldova or the US state of Kentucky. This gives it a ranking of 43rd in India (out of a total of 640). The district has a population density of 290 inhabitants per square kilometer (750 /sq mi). Its population growth rate over the decade 2001- 2011 was 12.1%. Solapur has a sex ratio of 932 females for every 1000 males, and a literacy rate of 77.72%. 3.3 Solapur District Map:-[17]
Source http://en.wikipedia.org/wiki/Solapur_district
3.4 Health Service: - [18]. The following major national and state health programmes are implemented by health dept.
 General Health Services
 Epidemic Control Measures & Reproductive and Child health programmes - This includes family welfare programmes, health services for children, health for 40 plus, Aids control.
[15]- [16]-[17]-[18] - http://en.wikipedia.org/wiki/Solapur_district

3.5. 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. [19]
After the expiry of patent of the patented drug, generic drugs are marketed. Generic drugs are available at affordable prices with maintaining quality. 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)
[19] - http://www.who.int/trade/glossary/story034/en/
[20] - http://en.wikipedia.org/wiki/Generic_drug

The generic market reached 100 billion dollar 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 10-15% of the MRP. In present situation, consumer patients are not benefited and retail chemists earn huge profit.
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. 3.1.1. Scope of generic drugs [22] 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. 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. [21] - shopper‘s guide to prescription generic drugs. [22] - http://blog.oureducation.in/generic-drugs/

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. ‗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.
3.1.2. Basic Generic Drugs Requirement:-[23]
 Same active ingredient(s)
 Same route of administration
 Same dosage form
 Same strength
 Same condition of use
 Inactive ingredient already approved in similar NDA
3.2. 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'sintellectual property rights for about 20 years, butbecause the patent is effective from the clinical trialstage.
Since the late 1970‘s the substitution of generic drugs for brand name drugs has become a relatively common physician practice. By the late 1980‘s more than three in five (62.5%)family physicians ―said they had enough confidence in generic drugs to prescribe them intheir practices, but that only 26.9 percent said they actually prescribed mostly generics‖ (Bower and Burkett, 1987). At the same time, several studies reported a connection between physicians‘ sources of drug information, their attitudes toward generics and their prescribing patterns.
[23] - http://www.fda.gov/downloads/Drug/SmallBusinessAssistance/ucm127615.pdf

By 2003 generic drug prescriptions represented 43 percent of all prescriptions written and47 percent of new (non-refill) prescriptions Generic drugs were also one of the fastest growing sectors of the pharmaceutical industry.2 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. [24]
Graph no: - 3.2.1- Leading Companies in the Generic Industry:-
Source: - new Pharma thinkers - The Generic Market Industry
3.3. 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. [25]
[24] - (IMS Health, 2004).
[25] - New Pharma thinkers - The Generic Market Industry

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 [27]
3.3.1. An Economic Analysis of Generic Drug Usage:-This independent analysis, conducted by the IMS Institute.[28]
 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.
 In 2010 alone, generic use generated more than $157 billion in savings.
 Savings from newer generic medicines—those that have entered the market since2001—continue to increase exponentially and account for more than one-third of the total savings.
Graph no. 3.3.2
Source - www.tevagenerics.com/assets/base/pdf/Savings,AnEconomicAnalysis.pdf
[26] & [27] - new Pharma thinkers - The Generic Market Industry
[28] - http://www.tevagenerics.com/assets/base/pdf/Savings,AnEconomicAnalysis.pdf

3.4. INDIAN GENERIC DRUGS INDUSTRY:- India supplies 20% of generic drugs worldwide Posted 01/03/2013. Every fifth tablet, capsule and injectibles generic drug being used in the world is manufactured in India, according to India‘s Health Minister Ghulam Nabi Azad.
―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]
3.4.1. Growth of Generic Drug Industry:-[30]
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%. 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.
In December‘ 2011, Ranbaxy receives approval for the generic ‗Atorvastatin‘ tablets Of the original brand name drug ‗Lipitor‘ owned by Pfizer, Inc. [29] - http://www.cci.gov.in/images/media/presentations/ComIssGenPharmIndusIndia_20100401142346.pdf [30] - international journal of pharmaceutical, chemical and biological sciences.

In March 2012, Natco Pharma got compulsory License (CL) for ‗Sorafenib to sylate‘ of the original brand name drug ‗Nexavar‘ owned by Bayer Corp. under the provisions of the section 84 of the Indian Patent Act 1970. It is used for the treatment of Liver and Kidney cancer. Its price now Rs 8,800 for 120 tablets (one month‘s therapy) as against Rs. 2,84,428 being the cost of ‗Nexavar‘ sold by Bayer Corp. 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‘.
3.4.2. Availability of Generic drugs in the Indian Market:- [31]
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. In present situation, consumer patients are not benefited and retail chemists earn huge profit. 3.4.3. Exports of generic drugs by Indian Pharma companies:-[32] 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. 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 per cent CAGR, [31] & [32] - www.ijpcbs.com/ THE IMPORTANCE OF GENERIC DRUGS IN INDIA

3.5 INDIAN GENERIC DRUGS [33] Table No. - 3.5.1. [33] - INDIAN DRUGS & PHARMACEUTICALS LIMITED w.e.f- 10.01.2013 Table Continues...

4. COMPANY PROFILE
HINDUSTAN ANTIBIOTICS LIMITED (HAL)
Hindustan Antibiotics Limited (HAL) is the first drug manufacturing company to be set up in the public sector by Government of India with active co-operation of WHO and UNICEF. Set up on 10th March, 1954, HAL is the first drug manufacturing unit in India to undertake commercial production of antibiotics like Penicillin, Streptomycin, Gentamicin, Ampicillin &Amoxycillin etc. HAL has diversified in formulation activity and has facility to manufacture various dosage forms - injectibles, capsules, tablets, large volume parental, liquid orals, etc. conforming to pharmacopoeia standards. HAL has also diversified into Agriculture and Veterinary products. HAL had also entered into a biotech product InjHemax (Recombinant Erythropoietin).

HAL R&D has the distinction of being the only laboratory in the public sector in India which has come out with its own discoveries Viz. Hamycin as an Antifungal and Aureofungin for Plant Fungal Control.
HAL manufacturing unit is situated at Pimpri, an industrial suburb in the city of Pune, which is 160 K.M. South west of Mumbai in India. HAL with its social objective of providing affordable drugs throughout India.
―HAL CURE FOR MILLIONS CARE FOR ALL‖
4.1. VISION:-
The thrust of all training activities is to improve the quality of the product, quality of men, quality of leadership in Managerial category; thereby giving the organization a competitive edge.
4.2. OBJECTIVES: -
1. To update the knowledge of employees
2. To develop necessary skills of the employees to cope up with the modern changing technology.
3. To change the attitude of the employees so as to dedicate them for organizational commitments.
4.3. MANUFACTURING FACILITY:-
Apart from manufacturing bulk drugs, H.A.L. diversified into Formulation manufacturing. The Company has the facility to manufacture various dosage forms like Injectibles, Capsules, Tablets, large volume parenteral. The Company also diversified into Veterinary and Agriculture segments manufacturing number of products. H.A.L. has dry powder injectibles with manufacturing capacity of 480 lakhs vials /annum

4.4. QUALITY ASSURANCE: -
Product manufactured by H.A.L. is at par with International standard. Quality is built into the system with emphasis on stability and bioavailability studies, in process Control and Quality Assurance. Highly skilled and trained staff monitors the function with care to the minute details.
Fig. 4.4.1.
4.5. RESEARCH & DEVELOPMENT: -
Holding a pioneering position, research and development wing of H.A.L. draws its strength from the well-coordinated contributions from microbiology, biochemistry, organic chemistry pharmacology, toxicology, parasitological, immunodiagnostics and formulation.
4.6. INDUSTRIAL MICROBIOLOGY:-
 Maintenance of high yielding strains for large scale fermentation.
 Strain improvement by mutation (using physical and chemical agents)
 Natural selection and cell infusion technique (protoplast fusion)
 Development of media composition for establishing basic fermentation parameters & subsequently screening the productivity for the strain.
 Developing or improving newer bioassay method for novel microbial metabolites and antibiotics
4.7. BIOCHEMISTRY:-
 Isolation and purification of Enzymes.

 Immobilization of Enzymes.
 Development of bio-conversion processes for industrially important products of intermediates using immobilizes enzyme system.
4.8. PHARMACOLOGY AND TOXICOLOGY:-
 Broad evaluation of pharmacological activities of microbial, synthetic and plant products in laboratory animals.
 Chemical-pharmacological and structural activity relationships.
 Pre-clinical toxicological studies in various laboratory species on commercial basis.
 Bioavailability, biological assay, in-vivo potency, cellular and molecular mechanism of action of drugs.
4.9. BACTERIOLOGY AND IMMUNODIAGNOSTICS:-
 Development of Immunodiagnostic kits in collaboration with various laboratories.
 Maintenance of various parasitic strains for screening microbial metabolites for anti-parasitic activity.
4.9.1PRODUCT DEVELOPMENT UNIT:-
 Developing newer dosage forms (human, veterinary & agricultural use) with necessary stability data and analytical method.
 Research in the area of pharmaceutical technology especially on drug delivery system.
 Improvement of existing formulations for cost effectiveness.
 Investigation on product complaints.
 Innovative studies on packaging and presentation of drug dosage forms.
4.9.2 ORGANIC AND ANALYTICAL CHEMISTRY:-
 Process development for bulk drugs or their key intermediate production.
 Improvement of existing down-stream process for cost effectiveness.
 Technology absorption, adaptation and its subsequent improvisation.
 Isolation and characterization of new chemical entities (NCE) from fungal metabolites for basic research.
 Chemical Analysis of various microbial metabolites.

4.9.3 PILOT PLANT:-
 Up-scaling work on fermentation, chemical and bio-chemical processes development at bench scale.
 Transfer of technology obtained from either in-house R&D or from outside source.
 Manufacturing of drugs or their intermediate at semi-plant scale for our captive requirement and small scale clinical or field trials.
Fig 4.9.3.1
4.9.4 RECOGNITIONS:-
During its span of 5 decades the Company has been recognized by having received numerous awards both National and International for manufacturing quality products.
4 Presidential Awards for best all round performance, Export Merit Certificate from Export Promotion Council of India, Excellent Marketing Management Performance Award and recently in 2007 H.A.L. has been awarded the Udyog Ratna Award.
4.9.5 MARKET:-
Product manufactured by H.A.L. is available throughout the country and in international market. They export pharmaceutical product to various countries like , Netherlands , U.A.E. ,

Uganda , Tanzania , Kenya , Yemen , Sri Lanka etc. which on-going activities as mentioned above H.A.L. are geared up and on the thresh – hold of achieving greater heights in the world of pharmaceuticals
4.9.6. FUTURE:-
The pharmaceutical industry is expected to increase to US$ 30 Bn by 2012.Going forward, the Indian pharmaceutical industry is taking leaping strides in innovative drug discovery with clinical trials underway in 34 molecules consequently; the Indian drug discovery market has grown from USD 470 million in 2005 to USD 800 million in 2007.
The market is growing at about 30% annually spurred by the high cost advantage of up to 50% for clinical trials as compared to those in western countries. The industry growth is being driven by six important factors, namely:
1. Doubling of disposable incomes and the number of middle class households;
2. Large future potential due to low penetration level (30%) coupled with a large population base and rising prevalence of chronic diseases;
3. Increasing public health expenditure and rise of private hospital care facilities including corporate hospital chains and rising Health Insurance sector;
4. Adoption of product patent regime in 2005 at the right time with a l large number of projected expiry of globally patented drugs in 2010; and
5. Growth of emerging markets and its aggressive penetration by relatively smaller companies.
6. With these drivers, the industry has a bright future growth promise and potential. The right mix of policies and programs of the Department of Pharmaceuticals will be an enabling, empowering and ensuring factor in its realization.

4.9.7 COMPANY PRODUCT PROFILE:-
I. Branded Product List:-

II. Generic Product List:-

OBJECTIVES
The project objectives are as follows:
 To study the awareness of Generic Drugs amongst Doctors, Chemists & Distributors.
 To understand the perception of Doctors, Chemists & Distributors towards Generic Drugs & Prescription Pattern of Generic Drugs.
 To carry out Comparative analysis of Generic drugs & Branded Drugs.
SAMPLING DESIGN
 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: Solapur District
 Duration of research: 2 months
 Duration of Data collection: 6 Weeks
 Respondents: Doctors-166
Chemists-129
Distributors-16
 Sampling technique: Random sampling
 Data Analysis: MS Excel, SPSS V 22

5. RESEARCH METODOLOGY
5. 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 for them. 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.
5.1 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 analyse an event or process or phenomenon to identify the cause and
(4) To develop new scientific tools, concepts and theories to solve and understand scientific
And non scientific problems
(5) To find solutions to scientific, non scientific and social problems and
(6) To overcome or solve the problems occurring in our everyday life.
5.2 IMPORTANCE OF RESEARCH:-
Research is important both in scientific and non scientific fields. In our life new problems, events, phenomena and processes occur every day. Practically, implementable solutions and suggestions are required for tackling new problems that arise. Scientists have to

undertake research on them and find their causes, solutions, explanations and applications. Precisely, research assists us to understand nature and natural phenomena.
5.3 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 experiences. 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.
5.4 RESEARCH METHODS AND RESEARCH METHODOLOGY:-
Is there any difference between research methods and research methodology?
(a) Research methods are the various procedures, schemes and algorithms used in research. All the methods used by a researcher during a research study are termed as research methods. They are essentially planned, scientific and value-neutral. They include theoretical procedures, experimental studies, numerical schemes, statistical approaches, etc. Research methods help us collect samples, data and find a solution to a problem. Particularly, scientific research methods call for explanations based on collected facts, measurements and observations and not on reasoning alone. They accept only those explanations which can be verified by experiments.
(b) Research methodology is a systematic way to solve a problem. It is a science of studying how research is to be carried out. Essentially, the procedures by which researchers go about their work of describing, explaining and predicting phenomena are called research methodology. It is also defined as the study of methods by which knowledge is gained. Its aim is to give the work plan of research.

5.5 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 so on.
5.6 TYPES OF RESEARCH:-
Research is broadly classified into two main classes:
1. Fundamental or basic research
2. Applied research
A. Basic Research
Basic research is an investigation on basic principles and reasons for occurrence of a particular event or process or phenomenon. It is also called theoretical research. Study or investigations of some natural phenomenon or relating to pure science are termed as basic research. Basic researches sometimes may not lead to immediate use or application. It is not concerned with solving any practical problems of immediate interest. But it is original or basic in character. It provides a systematic and deep insight into a problem and facilitates extraction of scientific and logical explanation and conclusion on it. It helps build new frontiers of knowledge. The outcomes of basic research form the basis for many applied research. Researchers working on applied research have to make use of the outcomes of basic research and explore the utility of them. Research on improving a theory or a method is also referred as fundamental research. For example, suppose a theory is applicable to a system provided the system satisfies certain specific conditions. Modifying the theory to apply it to a general situation is a basic research.

B. Applied Research
In an applied research one solves certain problems employing well known and accepted theories and principles. Most of the experimental research, case studies and inter-disciplinary research are essentially applied research. Applied research is helpful for basic research. A research, the outcome of which has immediate application is also termed as applied research. Such a research is of practical use to current activity. For example, researches on social problems have immediate use. Applied research is concerned with actual life research such as research on increasing efficiency of a machine, increasing gain factor of production of a material, pollution control, preparing vaccination for a disease, etc. Obviously, they have immediate potential applications.
5.7 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. Generalisation and Interpretation
8. Preparation of the Report or Presentation of Results-Formal write ups of conclusion reached.

6. RESEARCH ANALYSIS
6.1 DOCTOR ANALYSIS
Q.1 QUALIFICATION:-
Table no. 1
Fig.1
Row Labels Count of BAMS
BAMS
95
MBBS
47
MD
23 Grand Total 165

Q.2. Do you believe that Generic drugs differ from FDA standards?
Table No.2
Fig. 2
Inferences:
 71% doctors Believe that generic drugs are not differ from FDA standards.
 Although the Food and Drug Administration states that generic drugs must be therapeutically equivalent with brand name drugs, only 29 % doctors believe that Generic drugs are differ from FDA standards.
 Although most brand name drugs cost more than their generic substitutes, the mark-up on generic drugs is generally more than that on brand name drugs
Row Labels Count of YES
NO
116
YES
48 Grand Total 164

Q.3 Do you allow Generic drugs to be substitute by Branded drugs?
Table no. 3
Fig.3
Inferences:
 73 % doctors allow generic drugs to be substitute for branded drugs
 Only 27 % doctors are not allow generic drugs to be substitute for branded drugs
 Approximately one in five doctors believe that some drugs with narrow therapeutic indices that should not be substituted even when required by third parties, and that most doctors support the use of generics today.
Row Labels Count of NO
NO
44
YES
120 Grand Total 164

Q.4 Do Patients need influence choice to prescribe Brand over Generic drugs?
Table no. 4 Row Labels Count of NO
NO
79
YES
85 Grand Total 164
Fig no. 4
Inferences:
 51 % doctors says that Patients need influence choice to prescribe Brand over Generic drugs
 48 % doctors says that Patients need don‘t influence choice to prescribe Brand over Generic drugs

Q.5 - Do you agree that Branded Companies are benefitted by giving patients with Rx, Branded drugs than Generic drugs?
Table no.5 Row Labels Count of YES
NO
35
YES
129 Grand Total 164
Fig. no.5
Inferences:
 78.66% Doctors agree that Branded Companies are benefitted by giving patients with Rx, Branded drugs than Generic drugs.
 21.34 % Doctors don‘t agree that Branded Companies are benefitted by giving patients with Rx, Branded drugs than Generic drugs.

Q. 6 Do you feel patients are pressured with health care plan, Insurance companies to Rx Generic drugs?
Table no. 6 Row Labels Count of YES
NO
110
YES
54 Grand Total 164
Fig. no. 6
Inferences:
 67.07 % doctors feel patients are pressured with health care plan, Insurance companies to Rx Generic drugs
 32.93 % doctors come up with this sentence that patients are not pressured with health care plan, Insurance companies to Rx Generic drugs.

Q.7 Brand name drugs MR visit regularly and give free samples but Generic drugs representative do not give, so is it affects to Rx?
Table no.7 Row Labels Count of NO
NO
113
YES
51 Grand Total 164
Fig. no.7
Inferences:
 Above 68 % doctor‘s prescription is not affect by free samples given by branded drugs MR
 31 % doctor‘s prescription is not affect by free samples given by branded drugs MR

Q. 8 According to you, are Generic drugs as safe and effective as Brand drugs?
Table no.8
Fig.no.8
Inferences:
 Above than 82 % doctors say that Generic drugs are safe and effective as Brand drugs.
 17 % doctors feel that Generic drugs are not safe and effective as Brand drugs.
Row Labels Count of NO
NO
29
YES
135 Grand Total 164
0
20
40
60
80
100
120
140
160
NO
YES
Total
Total

Q.9 How much it will help to the patients to save money, by taking Generic drugs?
Table no.9 Row Labels Count
30 - 50 %
35
20 - 30 %
12
> 50 %
117 Grand Total 164
Fig.no.9
Inferences:
 72 % doctors agree that patients can save more than 50 % money by taking generic drugs.
 21 % doctors agree that patients can save more than 30 - 50 % money by taking generic drugs.
 Only 7 % doctors agree that patients can save more than 20 - 30 % money by taking generic drugs.

Q. 10 Do you purchase or Rx Generic drugs?
Table no.10 Row Labels Count of PURCHASE
PRESCRIBE
80
PURCHASE
84 Grand Total 164
Fig no. 10
Inferences:
 51.22 % doctors purchases generic drugs.
 48.78 % doctors Rx generic drugs.

Q. 11 If you Purchase Generic drugs, then how frequently you purchase?
Table no.11 Row Labels Count of REGULARILY
> 3 MONTHS
41
> 6 MONTHS
4
NA
79
REGULARILY
40 Grand Total 164
Fig. no. 11
Inferences:
 Above 24 % doctors regularly purchases generic drugs.
 25 % doctors purchase generic drugs after every 3 months
 Only 2 % doctors purchases generic drugs after every 6 months.

Q.12 Do you feel Internet Marketing is beneficial to you?
Table no. 12 Row Labels Count of NO
NO
122
YES
42 Grand Total 164
Inferences:
 74 % doctors feel Internet Marketing is not beneficial to you.
 Only 25 % doctors feel Internet Marketing is beneficial to you.

Q.13 If yes, then how much it will beneficial to you in terms of Percentage?
Table no.13 Row Labels Count of NA
0 -25%
2
25 - 50%
19
50 -75%
15
75 -100%
5
NA
123 Grand Total 164
Fig No

6.2 CHEMIST ANALYSIS
Q. 14 How many patients do visit your stores, Daily?
Table no. 14 Row Labels Count of 25 - 50
0 - 25
12
25 - 50
52
50 - 75
36
75 & ABOVE
28 Grand Total 128
Fig no. 14
9%
41%
28%
22%
Total
0 - 25
25 - 50
50 - 75
75 & ABOVE

Q.15 Do you store Generic drugs?
NO
11
YES
117 Grand Total 128
Fig no. 15
Inferences:
 More than 91 % chemist store generic drugs.
 Only 9 % chemist does not store generic drugs.

Q. 16 - Do you receive Prescriptions for Generic drugs?
NO
18
YES
110 Grand Total 128
Fig no.16
Inferences:
 Above 85 % chemist receive Prescriptions for Generic drugs.
 14 % chemist does not receive Prescriptions for Generic drugs.

Q. 17 - If yes, then how many prescriptions of Generic drugs you receive, weakly?
Table no. 17 Row Labels Count of 40 - 60%
0 - 20%
12
20 - 40%
44
40 - 60%
32
60 & ABOVE
24
NA
16 Grand Total 128
Fig no.17
Inferences:
 34 % chemist receives 20 – 40 % prescriptions of generic drugs.

Q. 18 Do you get discount on purchasing Generic drugs from distributors?
NO
24
YES
104 Grand Total 128
Fig no. 19
Inferences:
 More than 81 % chemist get discount on purchasing generic drugs, from distributors.

Q. 20 - If yes, how much of discount you get from distributors on purchasing Generic drugs?
Table no. 20 Row Labels Count of 10 - 15%
0 - 5%
7
10 - 15%
34
15 - 20%
32
5 - 10%
31
NA
24 Grand Total 128
Fig no. 20

Q. 21 Is there any effect of taxation on purchasing & selling Generic drugs?
NO
18
YES
110 Grand Total 128
Fig no. 21
Inferences:
 More than 85 % chemist believes that there is effect of taxation on purchasing % selling of generic drugs.

Q. 22 Does Generic drugs due to their lower prices, affects the Sell of branded drugs?
Table no.22 Row Labels Count of NO
NO
99
YES
29 Grand Total 128
Fig no. 22
Inferences:
 77 % chemist believes that low cost of generic drugs affects selling & purchasing of branded drugs.

6.3 DISTRIBUTORS ANALYSIS
Q. 23 How many chemists does visit your stores, Daily?
Table no. 23 Row Labels Count of 50 -75
25 - 50
6
50 -75
6
75 - ABOVE
3 Grand Total 15
Fig no 23

Q. 24 Do you store Generic drugs?
YES
15 Grand Total 15
Fig no. 24
Inferences:
 All distributors stores generic drugs.

Q. 25 Do you receive orders for Generic drugs?
YES
15 Grand Total 15
Fig no. 25
Inferences:
 All distributors receive orders for generic drugs.

Q. 26 What is the average demand for Generic drugs?
Table no. 26 Row Labels Count of 50 -75%
0 -25%
1
25 - 50%
8
50 -75%
5
75 - 100%
1 Grand Total 15
Fig no. 26
Inferences:
 25 - 50% average demand for generic drugs.

Q.27 Do certain doctors purchase Generic drugs?
NO
2
YES
13 Grand Total 15
Fig no. 27
Inferences:
 86% doctors purchases generic drugs.

Q. 28 Do you suggest to doctors or chemist for purchasing Generic drugs?
NO
4
YES
11 Grand Total 15
Fig no. 28
Inferences:
 73% distributors suggest to chemist & doctors for purchasing generic drugs.

Q. 29 Does Generic drugs due to their lower prices, affects the Sell of branded drugs?
Table no. 29
Fig no. 29
Inferences:
 More than 50% distributors believe that low cost of generic drugs affects sell of purchasing drugs.
Row Labels Count of YES
NO
7
YES
8 Grand Total 15

7. FINDINGS
 82% doctors believe that generic drugs are safe as branded drugs.
 73 % doctors allow generic drugs to be substitute for branded drugs
 71% doctors feel that generic drugs are not differ from FDA standards.
 More than 91% chemist store generic drugs & 86% chemist receive Prescription for generic drugs weakly.
 According to doctors patients can save more than 50% money by taking generic drugs.
 69% doctors feel that Prescription will not affect by free samples which are given by MR.
 According to 53% distributors, average demand for generic drugs is 25 – 50%.
 More than 77% chemist & 53% distributors‘ feels that due to low cost of generic drugs it will not affect sell of branded drugs.

8. OBSERVATION
 Physicians support generic substitution in most cases and consider them knowledgeable about generic bioequivalence. In fact, three in four physicians say they allow generic substitutes for brand name drugs. However, they also say that a patient‘s needs influence their choice to prescribe brand over generic.
 Physicians say brand name drug representatives visit weekly and give free samples but generic drug representatives don‘t & it doesn't affect to generic drugs sale.
 Physicians say that almost all patients want to talk about the appropriate use of their medications and cost at least some of the time. Most physicians say they know some (thing) about the price differences between brand name drugs and generic drugs. Primary care physicians are twice as likely as medical specialists to say they know a lot about price differences between brand name drugs and generic substitutes. Primary care physicians are more likely than medical specialists to say their patients want them to prescribe generic drugs and that the price difference is often so great they feel they must prescribe generics.
 Primary care physicians are more likely to have an office or clinic based practice, to see more than 100 patients in a typical week, to see patients of all ages, and to write more prescriptions in a week than are medical specialists.
 Primary care physicians are more likely than medical specialists to say they support generic substitution for brand name drugs in most cases, but there are some situations where it is not appropriate.

9. Suggestions
 An initiative should be taken to increase awareness about Generic drugs among Doctors, chemist & Distributors to increase the Sales of the antibiotic product.
 Company should target and promote the Generic Drugs in Government Hospitals as well as Private hospitals.
 Efficacy Safety, Quality, and Availability of product are the important attributes which should be considered for launching Generic Drugs.
 New strategies of reminder aids should be used by company, to increase sale.
 Company should have Strong Distribution network in market so Generic Drugs will available throughout market.
 As per the survey, Availability and Affordability are the most important parameters; hence company can focus on these parameter.

10. RECOMMENDATIONS
 The company have to be concentrate on the targeting General physicians & Government hospitals, these Doctors and Patients should be followed in General & Multispecialty hospitals as target customers as mostly they are the source of Patients having Different Bacterial Infections.
 Price of the Generic Drugs should be main factor in launching the generic drugs, so company should consider this factor while launching.
 Company should Increase awareness of generic drugs by taking initiative in advertisement.
 Company should invest valuable time in Improvement of efficacy & quality of Generic drug to increase market share.

10. SWOT ANALYSIS
10.1 SWOT ANALYSIS Strengths Weaknesses
 The support from the Indian Government is a major strength for HAL India.
 The product portfolio of HAL is unique.
 Most advance Machineries, Equipment‘s and good infrastructure make an advantage as well.
 Its prime location at middle of the city helps in good logistical services.
 Large area is available for expansion and starting a new production segment.
 The company has its all segments in antibiotics hence performances have been disappointing.
 There is no alternative segment which can boost the company‘s market share.
 A major part of HAL sales is lagging in sales force.
 No promotional activities making HAL to fill the heat from the competitors.
 A poor management system and marketing network
 No brand image of the company in the market as compared to competitors Opportunities Threats
 The generic markets in the foreign countries are a major opportunity for the company.
 Launching of new product can help to come up in market again.
 The competition in the domestic markets will intensify in the coming years after the product patents regime come into effect.
 Improper funding from government will effect on companies expansion plans.

11. ANNEXURE
QUESTIONNIARAE FOR DOCTOR
Q.1 - Do you believe that Generic drugs differ from FDA standards?
a) YES b) NO
Q.2 - Do you allow Generic drugs to be substitute by Branded drugs?
a) YES b) NO
Q.3 - Do Patients need influence choice to prescribe Brand over Generic drugs?
a) YES b) NO
Q.4 - Do you agree that Branded Companies are benefitted by giving patients with Rx, Branded drugs than Generic drugs?
a) YES b) NO
Q.5 - Do you feel patients are pressured with health care plan, Insurance companies to Rx Generic drugs?
a) YES b) NO
Q.6 - Brand name drugs MR visit regularly and give free samples but Generic drugs representative do not give, so is it affects to Rx?
a) YES b) NO
Q.7 - According to you, are Generic drugs as safe and effective as Brand drugs?
a) YES b) NO Name of Doctor : ____________________________ Specialisation : ____________________________ Name of Hospital: ____________________________ Qualification : ____________________________

Q.8 - If the Generic drugs are the same as the Branded drugs, why do they look different? Comment please!
Q.9 - Why do Generic drugs cost-low?
Q.10 - How much it will help to the patients to save money, by taking Generic drugs?
a) 10-20% b) 20-30%
a) 30-50% b) above 50 %
Q.11 - Do you purchase or Rx Generic drugs?
a) Prescribe b) Purchase
Q.12 - If you Purchase Generic drugs, then how frequently you purchase?
a) Regularly b) ˃ 3 months
c) ˃ 6 months d) ˃ 9 months
e) ˃ 1year
Q.13 - Enlist some of the newest Generic drugs, which you regularly Purchases in day-to-day practice?
a)
b)
c)
d)
e)

Q. 14 - Do you feel Internet Marketing is beneficial to you?
a) YES b) No
Q.15 - If yes, then how much it will beneficial to you in terms of Percentage?
a) 0 - 25% b) 25 - 50%
c) 50 – 75% d) 75 - 100%
Q.16 - Any suggestion?
Date: Sign:

QUESTIONNAIRAE FOR CHEMIST
Q.1 - How many patients does visit your stores, Daily?
a) 0-25 b) 25-50
c) 50-75 d) 75 and above
Q.2 - Do you store Generic drugs?
a) YES b) NO
Q.3 - Do you receive Prescriptions for Generic drugs?
a) YES b) NO
Q.4 - If yes, then how many prescriptions of Generic drugs you receive, weakly?
a) 0-20% b) 20-40%
c) 40-60% d) 60 and above
Q.5 - Enlist some of the Newest Generic drugs, you have in your stores?
a)
b)
c)
d)
e)
f)
g) Name of Chemist : ____________________________ Qualification : ____________________________ Name of Hospital : ____________________________

Q.6 - which Generic drug has high demand, from above list?
a)
Q.7 - Do you get discount on purchasing Generic drugs from distributors?
a) YES b) NO
Q.8 - If yes, how much of discount you get from distributors on purchasing Generic drugs?
a) 0-5% b) 5-10%
c) 10-15% d) 15-20%
Q.9 - Is there any effect of taxation on purchasing & selling Generic drugs?
a) YES b) NO
Q.10 - If yes, how much does it affect?
a) 0-5% b) 5-10%
Q.11 - Does Generic drugs due to their lower prices, affects the Sell of branded drugs?
a) YES b) NO
Q.12 - If yes, how much does it affects?
a) 5-10% b) 10-15%
c) 15-20% d) 20-25%
Q.13 - Does distributors provide schemes on Purchasing Generic drugs?
a) YES b) NO
Q.13 - If purchased in bulk does distributors or company provides special offer?
a) YES b) NO

a) YES b) No
a) 0 - 25% b) 25 - 50%
c) 50 – 75% d) 75 - 100%
Date: Sign:

QUESTIONNAIRAE FOR DISTRIBUTOR
Q.1 - How many chemists does visit your stores, Daily?
a) 0-25 b) 25-50
Q.2 - Do you store Generic drugs?
a) YES b) NO
Q.3 - Do you receive orders for Generic drugs?
a) YES b) NO
Q.4 - If yes, then how many chemist place orders daily?
a) 0-25 b) 25-50
Q.5 - Enlist some of the Newest Generic drugs, you have in your stores?
a)
b)
c)
d)
e)
f)
g) Name of Distributors : ____________________________ Qualification : ___________________________

Q.6 - What is the average demand for Generic drugs?
a) 0 - 25% b) 25 - 50%
c) 50 – 75% d) 75 - 100%
Q.7 - which Generic drug has high demand, from above list?
a)
Q.8 - Is Generic drugs demand is seasonal?
a) YES b) NO
Q.9 - If yes, what type?
Q.10 - Does certain doctors purchases Generic drugs?
a) YES b) NO
Q.11 - If yes, what is the NO.?
a)
Q.12 - Do you get discount on purchasing Generic drugs from manufactures?
a) YES b) NO
Q.13 - If yes, how much of discount you get from manufacture on purchasing Generic drugs?
a) 0-5% b) 5-10%
c) 10-15% d) 15-20%

Q.13 - Do provide discount to your costumers for purchasing Generic drugs?
a) YES b) NO
Q.14 - If yes, how much of discount you provide?
a) 0-5% b) 5-10%
c) 10-15% d) 15-20%
Q.15 - Do you suggest to doctors or chemist for purchasing Generic drugs?
a) YES b) NO
Q.16 - Is there any effect of taxation on purchasing & selling Generic drugs?
a) YES b) NO
Q.17 - If yes, how much does it affect?
a) 0-5% b) 5-10%
Q.18 - Does Generic drugs due to their lower prices, affects the Sell of branded drugs?
a) YES b) NO
Q.19 - If yes, how much does it affects?
a) 5-10% b) 10-15%
c) 15-20% d) 20-25%
a) YES b) No
a) 0 - 25% b) 25 - 50%
c) 50 – 75% d) 75 - 100%

Date: Sign:

12. BIBLIOGRAPHY
1. BOOKS :-
 Research Methodology by C. R. Kothari.
 Marketing Management by Phillip Kotler.
2. ANNUAL REPORT :-
 Government of India Ministry of Chemicals & Fertilizers Department of
Pharmaceuticals, Annual Report 2012-13
3. JOURNAL:-
 international journal of pharmaceutical, chemical and biological sciences
3. WEB LINKS:-
 http://www.ukessays.com/essays/international-business/global-pharmaceutical- industry.php
 http://www.pmlive.com/top_pharma_list/global_revenue  http://www.vccircle.com/news/pharmaceuticals/2014/02/17/india%E2%80%99s- pharma-sales-reach-27b-2016-deloitte-report
 http://www.ibef.org/industry/pharmaceutical-india.aspx
 http://www.pharmabiz.com/ArticleDetails.aspx?aid=79940&sid=9
 http://www.pharmaceutical-drug-manufacturers.com/articles/top10-pharmaceuticals- companies-in-india
 http://www.ibef.org/industry/pharmaceutical-india.aspx
 http://www.pharmabiz.com/ArticleDetails.aspx?aid=79940&sid=9
 www.pwc.com/india
 http://en.wikipedia.org/wiki/Solapur_district
 http://www.who.int/trade/glossary/story034/en/
 http://www.fda.gov/downloads/Drug/SmallBusinessAssistance/ucm127615.pdf

 (IMS Health, 2004
 http://www.tevagenerics.com/assets/base/pdf/Savings,AnEconomicAnalysis.pdf
 http://www.cci.gov.in/images/media/presentations/ComIssGenPharmIndusIndia_20100401142346.pdf
 www.ijpcbs.com/ THE IMPORTANCE OF GENERIC DRUGS IN INDIA
 INDIAN DRUGS & PHARMACEUTICALS LIMITED w.e.f- 10.01.2013
4. ENCYCLOPEDIA
 Wikipedia

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