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

Page 2

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

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COMPANY CERTIFICATE

Page 4

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

Page 5

Page 6

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

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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.

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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

Page 9

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

Page 10

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

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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

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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

Page 13

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

Page 14

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

Page 15

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

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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

Page 17

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/

Page 18

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

Page 19

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

Page 20

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

Page 21

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.

Page 22

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

Page 23

3.5 INDIAN GENERIC DRUGS [33]

Table No. - 3.5.1.

[33] - INDIAN DRUGS & PHARMACEUTICALS LIMITED w.e.f- 10.01.2013

Table Continues...

Page 24

Page 25

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).

Page 26

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

Page 27

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.

Page 28

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.

Page 29

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. ,

Page 30

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.

Page 31

4.9.7 COMPANY PRODUCT PROFILE:-

I. Branded Product List:-

Page 32

II. Generic Product List:-

Page 33

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

Page 34

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

Page 35

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.

Page 36

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.

Page 37

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.

Page 38

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

Page 39

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

Page 40

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

Page 41

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

Page 42

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.

Page 43

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.

Page 44

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

Page 45

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

Page 46

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.

Page 47

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.

Page 48

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.

Page 49

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.

Page 50

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

Page 51

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

Page 52

Q.15 Do you store Generic drugs?

Table no. 15

Row Labels

Count of

YES

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.

Page 53

Q. 16 - Do you receive Prescriptions for Generic drugs?

Table no. 16

Row Labels

Count of

YES

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.

Page 54

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.

Page 55

Q. 18 Do you get discount on purchasing Generic drugs from distributors?

Table no. 18

Row Labels

Count of

YES

NO 24

YES 104

Grand Total 128

Fig no. 19

Inferences:

More than 81 % chemist get discount on purchasing generic drugs, from distributors.

Page 56

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

Page 57

Q. 21 Is there any effect of taxation on purchasing & selling Generic drugs?

Table no. 21

Row Labels

Count of

YES

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.

Page 58

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.

Page 59

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

Page 60

Q. 24 Do you store Generic drugs?

Table no.24

Row Labels

Count of

YES

YES 15

Grand Total 15

Fig no. 24

Inferences:

All distributors stores generic drugs.

Page 61

Q. 25 Do you receive orders for Generic drugs?

Table no.25

Row Labels

Count of

YES

YES 15

Grand Total 15

Fig no. 25

Inferences:

All distributors receive orders for generic drugs.

Page 62

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.

Page 63

Q.27 Do certain doctors purchase Generic drugs?

Table no. 27

Row Labels

Count of

YES

NO 2

YES 13

Grand Total 15

Fig no. 27

Inferences:

86% doctors purchases generic drugs.

Page 64

Q. 28 Do you suggest to doctors or chemist for purchasing Generic drugs?

Table no. 28

Row Labels Count of YES

NO 4

YES 11

Grand Total 15

Fig no. 28

Inferences:

73% distributors suggest to chemist & doctors for purchasing generic drugs.

Page 65

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

Page 66

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.

Page 67

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.

Page 68

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.

Page 69

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.

Page 70

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.

Page 71

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 : ____________________________

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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)

Page 73

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:

Page 74

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 : ____________________________

Page 75

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%

c) 10-15% d) 15 and above

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

Page 76

Q. 16 - Do you feel Internet Marketing is beneficial to you?

a) YES b) No

Q.17 - 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.18 - Any suggestion?

Date: Sign:

Page 77

QUESTIONNAIRAE FOR DISTRIBUTOR

Q.1 - How many chemists 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 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

c) 50-75 d) 75 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 Distributors : ____________________________ Qualification : ___________________________

Page 78

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%

Page 79

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%

c) 10-15% d) 15 and above

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%

Q. 20 - Do you feel Internet Marketing is beneficial to you?

a) YES b) No

Q.21 - 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%

Page 80

Q.22 - Any suggestion?

Date: Sign:

Page 81

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

Page 82

(IMS Health, 2004

http://www.tevagenerics.com/assets/base/pdf/Savings,AnEconomicAnalysis.pdf

http://www.cci.gov.in/images/media/presentations/ComIssGenPharmIndusIndia_201

00401142346.pdf

www.ijpcbs.com/ THE IMPORTANCE OF GENERIC DRUGS IN INDIA

INDIAN DRUGS & PHARMACEUTICALS LIMITED w.e.f- 10.01.2013

4. ENCYCLOPEDIA

Wikipedia