A PROJECT REPORT ON

TOTAL QUALITY MANAGEMENT

AT

HETERO DRUGS

HYDERABAD

A PROJECT REPORT SUBMITTED TO

College / University

Logo

XXXXX UNIVERSITY
HYDERABAD
IN PARTIAL FULFILLMENT OF THE REQUIREMENTS
FOR THE AWARD OF THE DEGREE IN
MASTER OF BUSINESS ADMINISTRATION
SUBMITTED
BY
_________________________________
_______________________________
XXXXX PG COLLEGE
XXXXXXXX- XXXXXX
2018-2020
By
DEPARTMENT OF BUSINESS ADMINISTRTION
XXXXXXX COLLEGE,
XXXXXXXXXXXX
(Affiliated to XXXXXX University)
2018 - 2020
 CERTIFICATION

This is to certify that the Project Report title Total Quality Management (TQM) at

Hetero Drugs, Hyderabad submitted in partial fulfilment for the award of BBA Programme of

Department of Business Management, XXXXXX College, XXXXX University, was carried

out by XXXX under my guidance. This has not been submitted to any other University or

Institution for the award of any degree/diploma/certificate

Name and address of the Guide Signature of the Guide

 DECLARATION

I the undersigned solemnly declare that the report of the summer training work entitled

study on “_____________________________________________” is based on my work

carried out during the course of my study under the supervision of

________________________________ , _____________________________________& Mr

/ Mrs_______________________________, Faculty, Department of Management, XXXX

College

I assert that the statements made and conclusions drawn are an outcome of the project

work. I further declare that to the best of my knowledge and believe the project report does not

contain any part of any work which has been submitted for the award of any other degree/

diploma/ certificate in this university or any other university.

_______________________

(Signature of the student)

DATE:

PLACE:
 ACKNOWLEDGEMENT

I am extremely grateful to Principal and Head of the Department Dr. XXXXXXXX of M.B.A
for giving me the opportunity of learning through this research project. It has been an excellent
and rewarding experience, and has immensely increased my knowledge.

I wish to express my sincere gratitude and appreciation to my project guide and mentor,
Ms.____________________, Head of Department, Department of Business Administration,
for her support, guidance and encouragement.

I would also like to extend special thanks to my family and friends who have been a constant
source of support and encouragement. Without them, this project would not have been
materialized.

_______________________

(Signature of the student)

DATE:

PLACE:
 TABLE OF CONTENTS

Chapter No. Description

Introduction

Introduction

Need of study

Chapter I
Scope of study

Objectives of the study

Research Methodology

Limitations of the study

Chapter -II Review of literature

Chapter - III Industry Profile & Company Profile

Chapter - IV Data Analysis and Interpretation

Chapter - V Conclusion & recommendations

Bibliography

Annexure
 Abstract

Total Quality Management is a new mantra in ever organization. It is defined involvement of

all the employees in organization towards achieving quality product on a continual

improvement basis. The present study was conducted in a cement industry in Hyderabad Viz.

Hetero Drugs, Hyderabad. For collecting the data and input . One of the quality philosophy is

adopted by Toyota Company in Japan, General Motors in USA, Honda company in Japan,

Maruti Udyog in India, Tata Steel, TVS Group of companies, Mahindra and Mahindra group

of Companies has adopted Total Quality Management principles in their organizations. There

are so many intellectuals working towards the principles of Quality management system.

Edward Deming, Shewart, Juran are pioneers for implementing the quality management

principles and given number of demonstrations throughout the world for development of

quality systems in organization. The Total Quality Management principles not only applicable

to organizations and it can be adopted in service organizations as well. Applo Hospitals, Sun

Rise Hospitals, in Hyderabad has adopted Total Quality Management System in their service

organizations.
 Chapter – I
Introduction
Introduction:

Total quality management has evolved from the quality assurance methods that were first

developed around the time of the First World War. The war effort led to large scale

manufacturing efforts that often produced poor quality. To help correct this, quality

inspectors were introduced on the production line to ensure that the level of failures due to

quality was minimized.

Total quality management is a management’s approach towards the quality; it can be in

regard to products, customer satisfaction an employee’s satisfaction. This concept is for

improving the quality of various products and services. Earlier it was just related with the

quality of products which an organization is producing but now other concepts like

marketing, finance design, customer service has also joined the area. TQM works on one

belief that mistakes can be avoided and defects can be prevented. And management should

believe in watching each and every step. It is the process designed to focus external/internal

customer expectation preventing problems building, commitment to quality in the workforce

and promoting to open decision making.

Objectives of the Study:

1) Understand what total quality management (TQM) and why it is important.

2) Outline the various definitions of quality and project TQM’s viewpoint about Quality

3) Bring out the characteristics features of TQM

4) Give special attention the way TQM has been presented as a model.

5) Guiding the organization by its values, vision, mission, and goals set through ‘strategic planning
processes.
6) Changing the organization from function focused to customer focused, where customer priorities
come first in all activities.

7) Making the organization flexible and learning oriented to cope with change

8) Provide confidence to its internal management and other employees that the
requirements of quality are being fully filled.

9) Provide confidence to the customer and other stakeholders

10) Improve the quality of its own operations.

11) Achieve, maintain, and continuously improve the quality of products

12) Reduction of the lead times

13) Increase of the flexibility and profitability

14) Early mistake recognition

15) Mistake prevention as a preventive step

Need of the Study:

1.Reduction in wastage
It ensures things are done right and first time ok, so this reduces wastage and defects Quality
Assurance TQM guarantees that all the products and even operations in the org. are of a
certain quality standard. This promotes trust to the consumers and also maintains a healthy
environment for employees.

2. Customer-based
TQM focuses on the needs of the customers and can be used effectively, to make changes to
the existing product design to meet such needs.

3. Failure Analysis
TQM is a statistical tool also. Hence provides a learned person with the faults and failures in
various processes. This in turn can be used to make corrective progress.
4. Make Continuous Improvement
A TQM organization will also view change positively whether the change involves a process
change or a change in customer needs and expectations. This is because changes will enable
the organization to develop and explore quality.

5. Managing Supplier Quality

Company Concepts must extend to company suppliers Employee empowerment Increased
employee involvement in design and planning. Process improvement Reduced waste and
cycle times in all areas through cross departmental process analysis.

6. Employee empowerment
Increased employee involvement in design and planning.

7. Process improvement
Reduced waste and cycle times in all areas through cross departmental process analysis.

Scope of the Study:

The Scope of the study is not only confined to understand the concepts of Total Quality
Management but also the practical implementation and the implementation of Kaizen, Just In
Time Practices along with ISO documentation were also observed in my study at Hetero Drugs.
It is an pharmaceutical manufacturing where the scope is huge to understand do project and
come up with findings, suggestions and conclusion.

Research Methodology:

Towards the accomplishment of said objectives information is obtained from both

primary as well as secondary data sources.

Primary data is generated through questionnaires by way of meeting different

executives concerned with training and development programs and seminar & survey with few
departmental heads and few employees of Hetero.

Secondary data is collected from in-house magazines, journals, newspapers, websites

and any other published material and mainly from the previous records of Hetero.
 The information has been collected mainly from various books however the
information pertaining to Hetero Drugs has been obtained from the following two sources.

Primary data

This is done by personal discussion with various officials in Logistics, Supply Chain,
Material Management, Production, Packing and warehouse departments. Questionnaires were
prepared by keeping in view of the objective of the study. The first one is being management
questionnaire covering all the aspects as per the requirements of objectives of the Project. The
second one was the canvass among the sampled employers to find out their opinion on TQM.
The questionnaire was distributed to 250 and the response were limited to 200. The study is
confined to a sample of 200 only.

Secondary datata:

The secondary data is from various publications on TQM, JIT, Kaizen, Operational excellence
etc.,

The Analysis was done in percentage model and based on the results the findings, Suggestions
and Conclusion were drawn.

Limitations:
Every study is conducted under some limitations. Some of the limitations of the study are as
follows.

 During the project period most of the staff members are busy with auditing and other
works. So they could not afford give full information
 Since officials, executives and others were busy the study was primarily focused on
secondary data.
 Time was a constraint for the study.
 Chapter – II
Review of Literature
Total quality management has evolved from the quality assurance methods that were first
developed around the time of the First World War. The war effort led to large scale
manufacturing efforts that often produced poor quality. To help correct this, quality
inspectors were introduced on the production line to ensure that the level of failures due to
quality was minimized.

Total quality management is a management’s approach towards the quality; it can be in

regard to products, customer satisfaction an employee’s satisfaction. This concept is for
improving the quality of various products and services. Earlier it was just related with the
quality of products which an organization is producing but now other concepts like
marketing, finance design, customer service has also joined the area. TQM works on one
belief that mistakes can be avoided and defects can be prevented. And management should
believe in watching each and every step. It is the process designed to focus external/internal
customer expectation preventing problems building, commitment to quality in the workforce
and promoting to open decision making.

QUALITY:-

1. Quality means fitness for intended use.

2. Quality means productivity, competitive cost, and timely delivery, total customer
satisfaction.

3. Quality means conformance to specification and standard.

4. Conformance to requirements.

5. Quality is what the customer says

6. Quality means getting every one to do what they have agreed to do and to do it right the first
time and every time.
TOTAL QUALITY :-

It means all the people of the organization are committed to product quality by doing right
things right, first time, every time by employing organization resource to provide value to
customer.

TOTAL QUALITY MANAGEMENT: -

It is the process designed to focus external/internal customer expectation preventing problems

building ,commitment to quality in the workforce and promoting to open decision making

TOTAL:

Every one associated with the company is involved in continuous improvement, in all
functional area, at all level.

QUALITY:

Customer express and implied requirement is met fully.

MANAGEMENT:

Executive are fully committed

Decision in a planned way.

To maintain existing lever of quality.

To improve existing lever of quality.

Effective utilization of resource.

1.2 PRINCIPLES OF TQM:-

1.Delight the customer

2. Management by fact

3. People based management

4. Continuous improvement

5. Strong leadership

6. Quality system measure& record

7. Team work, Team accountable, correct problem

8. People oriented technology, speed.

FOUR C’S OF TQM

1. Commitment 2. Competence

3. Communication 4. Continuous improvement

FACTOR AFFECTED THE COMMITMENT OF THE EMPLOYEES:-

General worker attitude toward the company.

General worker attitude toward the supervisor.

Lever of satisfaction toward job standard.

The lever of consideration the supervisor shows to his subordination.

The workload & work pressure level.

The treatment of individual by the management

The lever of worker’s satisfaction with the salaries

The level of worker pride in the company and its activity

Worker reaction to the formal communication network in the organization.

Intrinsic job satisfaction level of the worker.

Worker attitude toward the fellow worker.

TQM is the way of managing for the future, and is far wider in its application than just assuring
product or service quality – it is a way of managing people and business processes to ensure
complete customer satisfaction at every stage, internally and externally. TQM, combined with
effective leadership, results in an organization doing the right things right, first time.

The core of TQM is the customer-supplier interfaces, both externally and internally, and at
each interface lie a number of processes. This core must be surrounded by commitment to
quality, communication of the quality message, and recognition of the need to change the
culture of the organisation to create total quality. These are the foundations of TQM, and they
are supported by the key management functions of people, processes and systems in the
organisation.

What is quality?

A frequently used definition of quality is “Delighting the customer by fully meeting their needs
and expectations”. These may include performance, appearance, availability, delivery,
reliability, maintainability,cost effectiveness and price. It is, therefore, imperative that the
organisation knows what these needs and expectations are. In addition, having identified them,
the organisation must understand them, and measure its own ability to meet them.

Quality starts with market research – to establish the true requirements for the product or
service and the true needs of the customers. However, for an organisation to be really effective,
quality must span all functions, all people, all departments and all activities and be a common
language for improvement. The cooperation of everyone at every interface is necessary to
achieve a total quality organization, in the same way that the Japanese achieve this with
company wide quality control.

Customers and suppliers

There exists in each department, each office, each home, a series of customers, suppliers and
customer supplier interfaces. These are “the quality chains”, and they can be broken at any
point by one person or one piece of equipment not meeting the requirements of the customer,
internal or external. The failure usually finds its way to the interface between the organization
and its external customer, or in the worst case, actually to the external customer.

Failure to meet the requirements in any part of a quality chain has a way of multiplying, and
failure in one part of the system creates problems elsewhere, leading to yet more failure and
problems, and so the situation is exacerbated. The ability to meet customers’ (external and
internal) requirements is vital

Customers (internal and external)

• Who are my customers?

• What are their true needs and expectations?

• How do, or can, I find out what these are?

• How can I measure my ability to meet their needs and expectations?

• Do I have the capability to meet their needs and expectations?

(If not, what must I do to improve this capability?)

• Do I continually meet their needs and expectations?

(If not, what prevents this from happening when the capability exists?)

• How do I monitor changes in their needs and expectations?

Suppliers (internal and external)

• Who are my internal suppliers?

• What are my true needs and expectations?

• How do I communicate my needs and expectations to my suppliers?

• Do my suppliers have the capability to measure and meet these needs and expectations?

• How do I inform them of changes in my needs and expectations?

HISTORY AND DEVELOPMENT OF TQM

The origin of TQM can be traced to 1949, when The Union of Japanese Scientists and
Engineers (JUSE) formed a committee of scholars, engineers, and government officials
devoted to improving Japanese productivity and quality of life (Cole 1998, Powell 1995).
American firms began to take TQM seriously around 1980, when some observers argued that
Japanese manufacturing quality equaled or exceeded U.S. standards, and warned that Japanese
productivity would soon surpass that of American firms. Productivity trends supported these
assertions, predicting that Japanese and other Asian countries would soon dominate world trade
and manufacturing (Powell 1995). The reliability of certain Japanese made products (cars and
semiconductors) was 5-10 times better than comparable U.S. products. At the same time,
consumers started to pay attention to product quality. For example, quality was a low priority
among car buyers in the 1970s, yet in the early 1980s, it was the most significant (Cole 1998).
President Reagan signed the legislation for mandating national study (U.S) in 1982, with the
intent to encourage productivity and competitiveness. The final report from that study included
that “a national quality award similar to Deming Price; should be awarded annually…
requirements and the accompanying examination process should be very
similar to Deming Prize system to be effective”. This study led to the formation of a
committee to establish the national quality award in 1985 and to the creation of the
Malcolm Baldrige National Quality Improvement Act of 1987. The Malcolm Baldrige National
Quality Award was created to unify and focus on quality
management improvement efforts in the U.S. The quality award model, together with ISO 9000
series quality systems, has been the leading force in shaping and spreading the quality
management ideology and practices during the last decade. CPE represents the latest era in the
evolution of quality management discipline. This evolution process51 has four distinct stages
(Garwin 1988, Wiele 1998).
1) Inspection: In the early stages of the discipline, simple inspection processes were used
to ensure the quality of the product. Product and services were compared to pre-
determined standards to ensure the appropriate quality levels for customers. This
inspection process generally did not have any influence on production activities or in
the determination of those requirements.
(2) Quality control: Under quality control, statistical tools and methods are used to
control the manufacturing process. The focus shifted from inspection to reducing
process variability. However, the ultimate target had remained the same to meet the
requirements. Quality control activities also included a cause-and-effect analysis to understand
the immediate cause for variability and root causes for failure.
(3) Quality assurance: This stage began the era of quality planning. While quality
control was still a reactive approach for detecting problems and fixing them, quality assurance
focused upon proactively anticipating and avoiding those problems. Additional advances
planning for quality and improving the design of the products were required. These approaches
still relied heavily on statistical and cause-effect analyses which, contrary to the quality control
era, were used to plan for quality.
(4) Total quality management: The fourth stage of managing quality was introduced during the
last decade. The original approach to TQM53 relies on the approaches created in the previous
stages of the discipline but applies them on a wider scale.
The above development of the discipline demonstrates how total quality management has
evolved from being narrowly focused on statistical process control to encompass a variety of
technical and behavioral methods for improving organizational performance. Whereas
statistical process control is a precise set of quality improvement techniques, TQM extends
these methods to all functions and management levels of an organization (Grant et al. 1994).
The change of scope moved quality management to a completely new arena, a holistic approach
for the general management of an organization.
During the late 1990s, additional developments took place. Early analysis of TQM
identified the role of quality in strategy as one of the main differences between the TQM and
management theory perspectives (Dean and Bowen 1994; Cole 2000). This difference was
evident in the early years of the awards, but the modification of the award criteria in 1995
changed this limited scope of quality award criteria in the area of strategic planning. The
strategy development process was given a wider scope and included items beyond planning for
quality. If we consider CPE to be a holistic management discipline, this development is well
justified from a management theory standpoint. Quality is a potentially important source of
competitive advantage, but it is not the only one (Dean and Bowen1994, Cole 2000). However,
this development further separates TQM from its original application.
Grant et al. (1994) identifies four distinct features in the origin and the diffusion of TQM as a
management innovation: intellectual origin, sources of innovation, national origin, and
dissemination process. Modern management theory originates from social sciences,
microeconomics, psychology and sociology. On the contrary, TQM has origins in statistical
process control. The originators of TQM innovations have been pioneers of the discipline, who
worked in industry and had background mainly in engineering and physics. This foundation
contradicts the origin of most new management ideas as being developed by academia and
management consulting. Management innovations normally have been based on North
American national origin. TQM is based on the integration of management techniques, which
were developed in Japan and brought to North American industry. This dissemination process
was led originally by smaller companies such as Florida Power and Light

The History and early development of TQM is important for this study, because it can be
theorized that some of TQMs basic underlying assumptions are based on early applications of
TQM. Additionally, the content and structure of the discipline have been impacted by the fact
that it has been introduced as a training platform and/or consultant product to audiences having
a background in engineering. In this role it has formed into rational approach to management,
which brings forward only generally acceptable issues (such as the important role of customer).
TQM has rarely been presented in the context of complex social relations such as
organizational power and politics
TQM is only one of many approaches to getting work done and accomplishing goals. Several
experiences have shown that by using a TQM approach, organizations can increase their
capacity to do work, increase the quality of work done and, at the same time, hold staffing
levels and budgets at historical levels. This is possible because

2. The organization recognizes that the vast majority of problems are caused by people doing
the wrong things right: work that should never be done, even though it is done very well.

1. The organization recognizes that those problems are caused by ineffective systems and
procedures. That recognition extends to the belief that the people who do the work are
best able to fix these systems and procedures.
2. The organization recognizes that in order to unleash the talents of everyone in the
company, people must be provided with opportunities to learn new skills and to practice
those skills. The
3. organization also believes that given the opportunity, people willingly participate in
designing the organization of the future.

Philip Crosby (1979 ) argued that quality is neither intangible nor immeasurable. Instead it
is a strategic imperative that can be used to improve the bottom line. Quality is defined as
"conformance to requirements," not "goodness." Terms such as good, excellent, beautiful,
exclusive, are subjective and vague. When quality is defined as 3conformance to
requirements, subjectivity disappears. Any service, product or process that conforms to its
requirements is a quality service, product or process. If requirements are not met, non-
conformance results. Requirements define the output, the input or the process itself by
providing descriptions of process characteristics in a manner that promotes mutual
understanding and agreement between customers and their suppliers. Requirements are based
on customer expectations and are integrated into each of the activities of a work process flow.
Often, customer expectations are expressed in terms of convenience, comfort, ease of use,
and aesthetics. For example, a customer may want a piece of equipment that is "state of the
art" or information that is "up to date." When this happens, the suppliers must use the
knowledge of the processes involved to translate those needs or desires into specific
requirements. A researcher in the quality literature can experiences bafflement in the meaning
of TQM and the differences between TQM and qualityassociated activities such as quality
assurance, quality control and quality management. This confusion leads, in many cases, to
 the use of these expressions interchangeably. Therefore, it is very important to have a clear
definition and understanding of each of these concepts.

The American Society of Civil Engineers (ASCE) defines "quality assurance (QA) in its
publication “Quality in the Constructed Project” (1990) as "A program covering activities
necessary to provide quality in the work to meet the project's requirements. QA involves
establishing project-related policies, procedures, standards, training, guidelines, and systems
necessary to produce quality. The design professional and constructor are responsible for
developing an appropriate program for each project." On the other hand, ASCE defines
quality control (QC) as "The specific implementation of the QA Program and it includes
checking and reviewing design and construction related activities. Effective QC reduces 4the
possibility of changes, mistakes and omissions, which in turn results in fewer conflicts and
disputes." The most common problem with a quality assurance program is that the
contractor/vendor assumes that his QA program is not based on 100% assurance. As long as
this is the impression of the contractor/vendor, he will never have a working QA program.
One element of quality, which the contractor/vendor seems to always forget, is the element
that requires him to examine any problem fully and determine the cause of the problem for
complete elimination of the same problem in the future. If this element of quality was
fulfilled, then eventually the contractor/vendor would have a 100% defect-free quality
assurance program. As long as a contractor/vendor aims for anything less than 100%, his
quality assurance program will never attain a status of 100%, nor will it ever be a fully
implemented quality assurance program. In addition, as long as owners expect less than 100%
from the contractor/vendor, they will never be supplied with the quality required, and as long
as owners continue to waive the required quality by allowing anything less than the
requirements in the specifications, they will continue to receive sub-standard, or sub-
specfication materials.

The keywords of the TQM concept are:

quality, total, and management.

“Quality” has been defined in many different ways. Among these definitions are the following
(Flood, 1993):

1. ASCE defines quality as the conformance to predetermined 5requirements.

2. The British Standard defines quality as the totality of features and characteristics of a
product, service or process, which bear on its ability to satisfy a given need from the customer's
viewpoint.

3. Crosby (1979) defines quality as conformance to requirements. This can be achieved by

"doing it right the first time."

4. Deming (1986) defines quality as a predictable degree of uniformity and dependability, at

low cost and suited to the market.

5. Taguchi defines quality as the minimum loss imparted by the product to society from the
time the product is shipped.

6. Feigenbaum (1991) defines quality as a way of managing the organization.

7. Juran defines quality as fitness for use.

8. Hoshin defines quality as correcting and preventing loss, not living with loss.

9. Flood, (1993) in his book "Beyond TQM," defines quality as "meeting The customer's
(agreed) requirements, formal and informal, at the lowest cost, first time, every time." This
definition consolidates different definitions of quality in one, more or less, comprehensive
statement.

The second important term is “total”. The term total quality indicates how TQM is a company-
wide effort. In fact, TQM involves everyone's effort in the organization in order to improve
performance. This makes TQM an instrument that considers quality as a strategic objective for
an organization (Burati, 1990). In other words, TQM can be achieved through an integrated
effort among personnel at all levels, to increase customer satisfaction by continuously
improving performance. The integrated effort among personnel can be achieved by having
effective and comprehensive management. This leads to the third keyword “management." The
responsibility for management is everyone's, as "total" implies. In other words, everyone
6should be responsible for managing their own jobs and this integrates managers with their
workers and everyone else in the organization.

The essence of TQM is to achieve customer satisfaction, cost effectiveness, and defect-free
work. TQM does this through focusing on process improvement, customer and supplier
involvement, teamwork, training and education.
TQM is a culture advocating a total commitment to customer satisfaction, through continuous
improvement and innovation in all aspects of the business.

The customer, in the TQM culture, does not mean only the final recipient of the organization's
end product or services. The customer is also every individual or department within the
organization (Logothetis, 1992). The TQM culture varies from one company to another and
from one industry to another. However, the TQM culture, regardless of its differences from
one company to another, aims to achieve common objectives; namely removal of waste,
reduction of costs, improvement of reputation and increased market share. As can be observed,
TQM objectives are dynamic in their nature and this dictates continuous updating and
upgrading (Logothetis,1992).

2.2 Benefits of Introducing TQM

The most important benefits of introducing TQM into a company are the following (Fox, 1993):

1. It makes the company focus clearly on the needs of its market. This is essential for a company
to survive in the competitive market.

2. It helps in achieving a top quality performance in all areas, not only in the final product or
service quality. In fact, achieving top quality performance in all areas reflects substantially on
the final product or service quality, since quality is a continuous chain.

3. It assists in implementing the simple procedures necessary for the achievement of quality
performance.

4. It helps, critically and continuously, in examining all processes to remove non-productive

activities and waste.

5. It determines the required improvements and develops a measure of performance.

6. It provides full, detailed understanding of the competition and develops an effective

competitive strategy.

7. It develops the team approach to problem solving.

8. It develops good procedures for communication and recognition of outstanding work.

9. It reviews continuously the processes to develop the strategy of never ending improvement

10. Management objectives, such as customer satisfaction, meeting specifications, larger

market share, higher productivity, zero defects, increase in sale and decrease in costs, can be
achieved by embodying TQM ethics in all aspects of the organization.

2.3 The Difficulties of Implementing TQM

The implementation of TQM into an organization requires fundamental organizational culture

change. Changing an organization's culture is a very difficult task, which often faces resistance.

The challenge of implementing TQM is due to the fact that TQM is not a slogan, nor a tool,
nor a program; it is an organization paradigm. The concept of TQM is broad enough to be the
framework or foundation of an organization's culture. Therefore, implementing TQM might be
dealing with replacing, rather than 8modifying, the organization's culture. Furthermore, the
transformation from the traditional Western paradigm to the TQM paradigm is a radical
change.

Glover, (1992) showed the significant differences between the two management approaches.

A study conducted by Longenecker and Scazzero, (1993) revealed that managers and
supervisors in the organization that they surveyed were reluctant to change their behavior to
support the critical organizational endeavor of implementing TQM.

The reason for this is that it is difficult, even in normal times, for managers in any organization
to change their management style and behavior.

The main reasons for their reluctance to change include the following:

1. senior management's lack of commitment to the process, as evidenced by their failure to

practice TQM.

2. too many changes in too short a time.

3. mixed signals in terms of the pressure to get immediate results without reduced production
output.

4. too little assistance in redefining roles.

5. little positive feedback on individual performance, while criticism and negative feedback are
plentiful.

Among the other difficulties in implementing TQM is the failure to have some means of
monitoring and managing the overall progress of TQM implementation, and the failure to
provide skills training immediately before TQM is applied. Finally, regarding TQM as only an
internal process and thus failing to involve suppliers, subcontractors, and others in the process
chain creates a major difficulty in implementing TQM.

Brown, et al., (1994) identified what they believe are the reasons for TQM implementation
failure. Organizations go through three identifiable phases during the pursuit of TQM. These
phases are:

1. Start-up: This is the initial stage where workers at all levels get themselves acquainted with
the basic principles of TQM. This phase involves, also, implementing quality improvement
projects using the tools and techniques of TQM.

2. Alignment: In this phase, the organization realizes that it must align its organizational
systems and practices to support quality and team work.

3. Integration: In the third phase, the organization integrates TQM principles into every aspect
of the organization's operations. Each phase has its own challenges and common mistakes.
Table 1 lists the common reasons for TQM failure in each phase.

Table 1. Reasons for TQM failure (Brown, et al 1994)

No. Phase Reasons for TQM failure

I. Start-up

1. Lack of management commitment

2. Poor training and pacing

3. Wasted education and training

4. Lack of short-term, bottom line result.

II. Alignment

1. Divergent strategies
2. Inappropriate measures

3. Outdated appraisal methods

4. Inappropriate rewards

III. Integration

1. Failing to transfer true power to employees

2. Maintaining outmoded management practices

3. Poor organization and job design

4. Outdated business systems

Lakhe and Mohanty (1994a) discussed a case study of TQM implementation. The major
obstacles of implementation were:

a. inadequate knowledge and information about TQM;

b. doubts of employees about management's intentions;

c. failure of management to maintain interest and commitment over

a long period of time;

d. difficulty in measuring the effectiveness of TQM;

e. poor internal communication;

f. difficulty in assessing customer expectations and satisfaction;

g. insufficient training resources.

2.4 THE ROLE OF QUALITY IMPROVEMENT TEAMS IN TQM STRATEGY

One of the major obstacles that have bedeviled the successful implementation of TQM is the
non – recognition of quality teams in organizations in the quest for a successful strategy that
will lift the organization above its competitors (Stanford, 2005). Team effectiveness is crucial
to the implementation of TQM because the development of people and their involvement in
the operations of an organization through teamwork is very essential ,and for it not to be seen
 as such ,will only ruin the collective effort of inputs towards the actualization of a functional
quality delivery strategy like the TQM(Lewis,2004)
Quality improvement teams cuts across employees of organizations, representatives of
customers and suppliers with a major objective of meeting the set target of achieving quality.
In doing this, it is pertinent to note that certain criteria have to be fulfilled in order to get the
desired result from a quality improvement team, since it embraces almost all the stakeholders
that lay claim to a business, and these criteria, according to Geirhybein (2004) include choosing
the leader and members of the team. In doing this, the team leader must:

 Possess effective Leadership Behaviour

 Possess the attributes of effective conflict management

 Should have the ability of encouraging innovation

 Have adequate knowledge of effective meeting management

 Manage and send out schedule of events and activities.

 Make certain that the team members are conversant with the modus operandi of team
meetings/activities.

 Endeavour to make certain that meeting venues are secured well ahead of time.

 Engage in meeting with front line managers on favourable times for team meetings.

 Should be prompt and alert to time.

 Ability to record activities of team meetings in minutes as well as collation of data.

 Sets an agreed time for the next meeting as well as communicates minutes and ensure that
action is taken for matters raised.

 Ability to identify training needs of the quality team in addition to be a good contributor and
listener, and this can be achieved by being dedicated to the intended purpose of the team
through effective commitment.

 Similarly, Geirhybein (2004) suggested what members need to have in order to be effective in
quality delivery teams:

 Members must be willing, not forced or coerced to join a quality team for the fun of it.

 Members need to be passionate about what the quality team sets out to achieve at all times as
the direct result of such commitment is the outright benefit of quality service.
 Members should be prepared to share their experiences with the team leader as well as among
themselves, for the overall benefit of the team.

 Members should be able to buy into shared team vision

 Present in the members should be the spirit of natural collaboration

 Need to respect the views of other members when they speak, listen to them when they have
issues to raise as well as, be able to communicate effectively with both the team leader and
members.

 Members should equally be ready to take down minutes at the request of the team leader, be
prepared to follow up actions when directed and never be afraid to say ‘I don’t understand’
when situations arise .

 Members need also to be able to contribute meaningfully to discussions on the floor during
meetings as well as being effective listeners.

Quality improvement initiatives typically involve the directed efforts of quality improvement
teams. Making adequate use of quality improvement teams and empowering employees to
solve quality-related issues using such tools as AMO(Ability, Motivation and Opportunity) as
exemplified in the work of Purcell et al.( 2003) can serve as a leverage for the implementation
of a TQM system. The effective use of quality improvement teams, and the TQM system as a
whole, can be strengthened by the basic application of principles of motivation, especially the
the recognition of team achievements as against those of individual employees, and the
effective use of goal setting for team efforts, are crucial in driving the process of TQM. The
HRM department is in a vantage position to help institutionalize team approaches to TQM by
designing appraisal and reward systems that focus on team performance, Fran, (2002).

2.5 INSTITUTING TQM CULTURE IN ORGANISATIONS: EMPLOYEE

INVOLVEMENT
People can be better managed to embrace TQM by institutionalizing TQM organizational
culture in the employees, so as to be able to deliver quality products and services to customers,
Collinson et al, (2003). Human resource management can play a crucial role in the i
mplementation of TQM strategy. HR managers or practitioners are responsible for recruiting
and selecting high-quality employees, the continuous training and development of these
employees, and the creation and sustenance of reward systems. Therefore, TQM sees to the
control of processes that are pivotal to the accomplishment of cultural changes often required
for TQM to be successfully implemented, Haigh and Morris, (2002). Directing the TQM
cultural development initiatives to the organisations’ conditions is important in subduing
opposition to change and moving beyond simple compliance toward a total commitment to
TQM processes.
According to De Wit and Mayers, (2005), holding a significant connecting role between top
management and employees, HRM has many avenues to institute communication channels
between top management and other members of the organization. Using these channels, HRM
practitioners can ensure that employees realize that they are the organization's number one
priority in implementing TQM. Engendering trust and confidence through an open interchange
of purposeful ideas can help eliminate fears regarding the work-role changes that TQM needs.
This can provide the building block for all employees to be trained to see their colleagues in
other divisions as equal internal customers to the organisation. This is another avenue for HRM
to highlight this new outlook by example. Through this means, that is, focusing on satisfying
the needs and wants of the customer first and foremost, HRM can institute a departmental view
of service throughout the entire hierarchy of an organization.
A major function of HRM’s expertise is its capability to scrutinize and provide assessment for
employee attitudes. This expertise can be significantly essential in driving the process for a
proper implementation of TQM, since getting it right from the onset (conceptualization stage)
entails having adequate data/information about current performance level. Therefore, a
preliminary action is to implement an employee assessment, targeting two prime areas. One
requires the identification of the difficult parts of organizations’ current operations, where
innovations in quality can have the most significant impact on an organizations’ performance
level. The other part, targets the perceptions and attitudes of employees towards quality as a
fundamental issue, so as to ensure that, the implementation of TQM can be revitalized, for
better effectiveness and efficiency, Collinson et al.,( 2003).
Achieving assistance from other divisions in an organization in the use of surveys to a great
extent depends largely on their perception of HRM's position in the survey process. The
challenge is to ensure that HRM is not having an over bearing influence on other departmental
functions, but rather, to be seen as an important ally in making their own quality improvements.
Achieving this status, can be accomplished in the participative nature of the TQM philosophy
by involving other divisions in the organization, towards the development of the survey
instrument to be used. This involvement begins the process of carrying each division in the
organization along, so as to see TQM as a strategy to be embraced by all employees of an
organization (Haigh and Morris, 2002).
 Chapter – III
Industry Profile & Company Profile
“The Indian pharmaceutical industry is a success story providing employment for millions
and ensuring that essential drugs at affordable prices are available to the vast population of
this sub-continent.”

Richard Gerster

The Indian Pharmaceutical Industry today is in the front rank of India’s science-based
industries with wide ranging capabilities in the complex field of drug manufacture and
technology. It ranks very high in the third world, in terms of technology, quality and range of
medicines manufactured. From simple headache pills to sophisticated antibiotics and
complex cardiac compounds, almost every type of medicine is now made indigenously.

Playing a key role in promoting and sustaining development in the vital field of medicines,
Indian Pharma Industry boasts of quality producers and many units approved by regulatory
authorities in USA and UK. International companies associated with this sector have
stimulated, assisted and spearheaded this dynamic development in the past 53 years and
helped to put India on the pharmaceutical map of the world.

Growth Scenario in 2010

India's pharmaceutical industry is now the third largest in the world in terms of volume. Its
rank is 14th in terms of value. Between September 2008 and September 2009, the total
turnover of India's pharmaceuticals industry was US$ 21.04 billion. The domestic market was
worth US$ 12.26 billion. This was reported by the Department of Pharmaceuticals, Ministry
of Chemicals and Pharmacys. As per a report by IMS Health India, the Indian pharmaceutical
market reached US$ 10.04 billion in size in July 2010. A highly organized sector, the
Indian Pharma Industry is estimated to be worth $ 4.5 billion, growing at about 8 to 9 percent
annually. Know more out this in our article on Indian Pharmaceutical Industry- Future
Trends Also check outPharmaceutical Market Trends 2010
 Leading Pharmaceutical Companies

In the domestic market, Cipla retained its leadership position with 5.27 per cent share.
Ranbaxy followed next. The highest growth was for Mankind Pharma (37.2%). Other leading
companies in the Indian pharma market in 2010 are:

 Sun Pharma (25.7%)

 Abbott (25%)
 Zydus Cadila (24.1%)
 Alkem Laboratories (23.3%)
 Pfizer (23.6 %)
 GSK India (19%)
 Piramal Healthcare (18.6 %)
 Lupin (18.8 %)

For details check out List of Top 10 Pharmaceutical Companies in India

Future Prospects

The Indian pharmaceuticals market is expected to reach US$ 55 billion in 2020 from US$
12.6 billion in 2009. This was stated in a report title "India Pharma 2020: Propelling access
and acceptance, realising true potential" by McKinsey & Company. In the same report, it was
also mentioned that in an aggressive growth scenario, the pharma market has the further
potential to reach US$ 70 billion by 2020

Due to increase in the population of high income group, there is every likelihood that they
will open a potential US$ 8 billion market for multinational companies selling costly drugs
by 2015. This was estimated in a report by Ernst & Young. The domestic pharma market is
estimated to touch US$ 20 billion by 2015. The healthcare market in India to reach US$
31.59 billion by 2020. The sale of all types of pharmaceutical drugs and medicines in the
country stands at US$ 9.61 billion, which is expected to reach around US$ 19.22 billion by
2012. Thus India would really become a lucrative destination for clinical trials for global
giants.

There was another report by RNCOS titled "Booming Pharma Sector in India" in which it
was projectedt that the pharmaceutical formulations industry is expected to prosper in the
same manner as the pharmaceutical industry. The domestic formulations market will grow at
an annual rate of around 17% in 2010-11, owing to increasing middle class population and
rapid urbanisation. Read More in Future Prospects of Indian Pharma Industry.

Characteristics of Indian Pharmaceutical Industry

The Indian Pharmaceutical sector is highly fragmented with more than 20,000 registered
units. It has expanded drastically in the last two decades. The leading 250 pharmaceutical
companies control 70% of the market with market leader holding nearly 7% of the market
share. It 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. There are about 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). These units produce the complete range of pharmaceutical formulations, i.e.,
medicines ready for consumption by patients and about 350 bulk drugs, i.e., chemicals having
therapeutic value and used for production of pharmaceutical formulations.

Following the de-licensing of the pharmaceutical industry, industrial licensing for most of the
drugs and pharmaceutical products has been done away with. Manufacturers are free to
produce any drug duly approved by the Drug Control Authority. Technologically strong and
totally self-reliant, the pharmaceutical industry in India has low costs of production, low
R&D costs, innovative scientific manpower, strength of national laboratories and an
increasing balance of trade. The Pharmaceutical Industry, with its rich scientific talents and
research capabilities, supported by Intellectual Property Protection regime is well set to take
on the international market.

Why India?

Competent workforce: India has a pool of personnel with high managerial and technical
competence as also skilled workforce. It has an educated work force and English is
commonly used. Professional services are easily available.
Cost-effective chemical synthesis: Its track record of development, particularly in the area of
improved cost-beneficial chemical synthesis for various drug molecules is excellent. It
provides a wide variety of bulk drugs and exports sophisticated bulk drugs.

Legal & Financial Framework: India has a 53 year old democracyand hence has a solid legal
framework and strong financial markets. There is already an established international
industry and business community.

Information & Technology: It has a good network of world-class educational institutions and
established strengths in Information Technology.

Globalisation: The country is committed to a free market economy and globalization. Above
all, it has a 70 million middle class market, which is continuously growing.

Consolidation: For the first time in many years, the international pharmaceutical industry is
finding great opportunities in India. The process of consolidation, which has become a
generalized phenomenon in the world pharmaceutical industry, has started taking place in
India.

Steps to strengthen the Industry

Indian companies need to attain the right product-mix for sustained future growth. Core
competencies will play an important role in determining the future of many Indian
pharmaceutical companies in the post product-patent regime after 2005. Indian companies, in
an effort to consolidate their position, will have to increasingly look at merger and acquisition
options of either companies or products. This would help them to offset loss of new product
options, improve their R&D efforts and improve distribution to penetrate markets.

Research and development has always taken the back seat amongst Indian pharmaceutical
companies. In order to stay competitive in the future, Indian companies will have to refocus
and invest heavily in R&D.

The Indian pharmaceutical industry also needs to take advantage of the recent advances in
biotechnology and information technology. The future of the industry will be determined by
how well it markets its products to several regions and distributes risks, its forward and
backward integration capabilities, its R&D, its consolidation through mergers and
acquisitions, co-marketing and licensing agreements.
The Indian pharmaceutical industry is the world's second-largest by volume and is likely to
lead the manufacturing sector of India.1India's bio-tech industry clocked a 17 percent growth
with revenues of Rs.137 billion ($3 billion) in the 2009-10 financial year over the previous
fiscal. Bio-pharma was the biggest contributor generating 60 percent of the industry's growth
at Rs.8,829 crore, followed by bio-services at Rs.2,639 crore and bio-agri at Rs.1,936
crore.2 The first pharmaceutical company are Bengal Chemicals and Pharmaceutical Works,
which still exists today as one of 5 government-owned drug manufacturers, appeared
in Calcutta in 1930. For the next 60 years, most of the drugs in India were imported
by multinationals either in fully formulated or bulk form. The government started to
encourage the growth of drug manufacturing by Indian companies in the early 1960s, and
with the Patents Act in 1970, enabled the industry to become what it is today. This patent act
removed composition patents from food and drugs, and though it kept process patents, these
were shortened to a period of five to seven years. The lack of patent protection made the
Indian market undesirable to the multinational companies that had dominated the market, and
while they streamed out, Indian companies started to take their places. They carved a niche in
both the Indian and world markets with their expertise in reverse-engineering new processes
for manufacturing drugs at low costs. Although some of the larger companies have taken
baby steps towards drug innovation, the industry as a whole has been following this business
model until the present.

Statistics

Top 10 Pharmaceuticals in India, as of 2018

Revenue Revenue
Rank Company
2017(Rs crore) 2018(Rs billion)

1 Ranbaxy Laboratories 4,198.96 41.989

2 Dr. Reddy's Laboratories 4,162.25 41.622

 3 Cipla 3,763.72 37.637

4 Sun Pharmaceutical 2,463.59 24.635

5 Lupin Ltd 2,215.52 22.155

6 Aurobindo Pharma 2,081.19 20.801

7 GlaxoSmithKline 1,773.41 17.734

8 Cadila Healthcare 1,613 16.13

9 Aventis Pharma 983.80 9.838

10 Ipca Laboratories 980.44 9.8044

In 2017, over 20,000 registered drug manufacturers in India sold $9 billion worth of
formulations and bulk drugs. 85% of these formulations were sold in India while over 60% of
the bulk drugs were exported, mostly to the United States and Russia25. Most of the players
in the market are small-to-medium enterprises; 250 of the largest companies control 70% of
the Indian market 1. Thanks to the 1970 Patent Act, multinationals represent only 35% of the
market, down from 70% thirty years ago20.

Most pharma companies operating in India, even the multinationals, employ Indians almost
exclusively from the lowest ranks to high level management. Mirroring the social structure,
firms are very hierarchical. Homegrown pharmaceuticals, like many other businesses in
India, are often a mix of public and private enterprise. Although many of these companies are
publicly owned, leadership passes from father to son and the founding family holds a
majority share.
In terms of the global market, India currently holds a modest 1-2% share, but it has been
growing at approximately 10% per year27. India gained its foothold on the global scene with
its innovatively engineered generic drugs and active pharmaceutical ingredients (API), and it
is now seeking to become a major player in outsourced clinical research as well as contract
manufacturing and research. There are 74 U.S. FDA-approved manufacturing facilities in
India, more than in any other country outside the U.S, and in 2005, almost 20% of all
Abbreviated New Drug Applications (ANDA) to the FDA are expected to be filed by Indian
companies21,27. Growth in other fields notwithstanding, generics are still a large part of the
picture. London research company Global Insight estimates that India’s share of the global
generics market will have risen from 4% to 33% by 2018.

Product development

Indian companies are also starting to adapt their product development processes to the new
environment. For years, firms have made their ways into the global market by researching
generic competitors to patented drugs and following up with litigation to challenge the patent.
This approach remains untouched by the new patent regime and looks to increase in the
future. However, those that can afford it have set their sights on an even higher goal: new
molecule discovery. Although the initial investment is huge, companies are lured by the
promise of hefty profit margins and the recognition as a legitimate competitor in the global
industry. Local firms have slowly been investing more money into their R&D programs or
have formed alliances to tap into these opportunities.

Small and medium enterprises

As promising as the future is for a whole, the outlook for small and medium enterprises
(SME) is not as bright. The excise structure changed so that companies now have to pay a
16% tax on the maximum retail price (MRP) of their products, as opposed to on the ex-
factory price. Consequently, larger companies are cutting back on outsourcing and what
business is left is shifting to companies with facilities in the four tax-free states - Himachal
Pradesh, Jammu & Kashmir, Uttaranchal and Jharkhand.12Consequently a large number of
pharmaceutical manufacturers shifted their plant to these states, as it became almost
impossible to continue operating in non tax free zones. But in a matter of a couple of years
the excise duty was revised on two occasions, first it was reduced to 8% and then to 4%. As a
result the benefits of shifting to a tax free zone was negated. This resulted in, factories in the
tax free zones, to start up third party manufacturing. Under this these factories produced
goods under the brand names of other parties on job work basis.

As SMEs wrestled with the tax structure, they were also scrambling to meet the July 1
deadline for compliance with the revised Schedule M Good Manufacturing Practices (GMP).
While this should be beneficial to consumers and the industry at large, SMEs have been
finding it difficult to find the funds to upgrade their manufacturing plants, resulting in the
closure of many facilities. Others invested the money to bring their facilities to compliance,
but these operations were located in non-tax-free states, making it difficult to compete in the
wake of the new excise tax.

Challenges

All of these changes are ultimately good for the Indian pharmaceutical industry, which
suffered in the past from inadequate regulation and large quantities of spurious drugs. They
force the industry to reach a level necessary for global competitiveness. However, they have
also exposed some of the inadequacies in the industry today. Its main weakness is an
underdeveloped new molecule discovery program. Even after the increased investment,
market leaders such as Ranbaxy and Dr. Reddy’s Laboratories spent only 5-10% of their
revenues on R&D, lagging behind Western pharmaceuticals like Pfizer, whose research
budget last year was greater than the combined revenues of the entire Indian pharmaceutical
industry13, 37. This disparity is too great to be explained by cost differentials, and it comes
when advances in genomics have made research equipment more expensive than ever. The
drug discovery process is further hindered by a dearth of qualified molecular biologists. Due
to the disconnect between curriculum and industry, pharmas in India also lack the academic
collaboration that is crucial to drug development in the West.

R&D

Both the Indian central and state governments have recognized R&D as an important driver
in the growth of their pharma businesses and conferred tax deductions for expenses related to
research and development. They have granted other concessions as well, such as reduced
interest rates for export financing and a cut in the number of drugs under price control.
Government support is not the only thing in Indian pharma’s favor, though; companies also
have access to a highly developed IT industry that can partner with them in new molecule
discovery

Labor force

India’s greatest strengths lie in its people. India also boasts of well-educated, English-
speaking labor force that is the base of its competitive advantage. Although molecular
biologists are in short supply, there are a number of talented chemists who are equally as
important in the discovery process. In addition, there has been a reverse brain drain effect in
which scientists are returning from abroad to accept positions at lower salaries at Indian
companies. Once there, these foreign-trained scientists can transfer the benefits of their
knowledge and experience to all of those who work with them13,25. India’s wealth of people
extends benefits to another part of the drug commercialization process as well. With one of
the largest and most genetically diverse populations in any single country, India can recruit
for clinical trials more quickly and perform them more cheaply than countries in the West47.
Indian firms have just recently started to leverage.

Biotechnology

Relationship between pharmaceuticals and biotechnology

Unlike in other countries, the difference between biotechnology and pharmaceuticals remains
fairly defined in India. Bio-tech there still plays the role of pharma’s little sister, but many
outsiders have high expectations for the future. India accounted for 2% of the $41 billion
global biotech market and in 2003 was ranked 3rd in the Asia-Pacific region and 11th in the
world in number of biotechs.45 In 2004-5, the Indian biotech industry saw its revenues grow
37% to $1.1 billion.2,9 The Indian biotech market is dominated by biopharmaceuticals; 75%
of 2004-5 revenues came from biopharmaceuticals, which saw 30% growth last year. Of the
revenues from biopharmaceuticals, vaccines led the way, comprising 47% of sales46.
Biologics and large-molecule drugs tend to be more expensive than small-molecule drugs,
and India hopes to sweep the market in biogenerics and contract manufacturing as drugs go
off patent and Indian companies upgrade their manufacturing capabilities.
 Top 10 Pharmaceuticals in India, as of 2010

Revenue Revenue
Rank Company
2010(Rs crore) 2010(Rs billion)

1 Ranbaxy Laboratories 4,198.96 41.989

2 Dr. Reddy's Laboratories 4,162.25 41.622

3 Cipla 3,763.72 37.637

4 Sun Pharmaceutical 2,463.59 24.635

5 Lupin Ltd 2,215.52 22.155

6 Aurobindo Pharma 2,081.19 20.801

7 GlaxoSmithKline 1,773.41 17.734

8 Cadila Healthcare 1,613 16.13

9 Aventis Pharma 983.80 9.838

10 Ipca Laboratories 980.44 9.804

Patents

As it expands its core business, the industry is being forced to adapt its business model to
recent changes in the operating environment. The first and most significant change was the
January 1, 2005 enactment of an amendment to India’s patent law that reinstated product
patents for the first time since 1972. The legislation took effect on the deadline set by the
WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which
mandated patent protection on both products and processes for a period of 20 years. Under
this new law, India will be forced to recognize not only new patents but also any patents filed
after January 1, 1995.3 Indian companies achieved their status in the domestic market by
breaking these product patents, and it is estimated that within the next few years, they will
lose $650 million of the local generics market to patent-holders42.

In the domestic market, this new patent legislation has resulted in fairly clear segmentation.
The multinationals narrowed their focus onto high-end patients who make up only 12% of the
market, taking advantage of their newly bestowed patent protection. Meanwhile, Indian firms
have chosen to take their existing product portfolios and target semi-urban and rural
populations

Top 20 Biotechnology Companies in India, 2018

Revenue Revenue
Rank Company
2018(Rs crore) 2018(USD millions)

1 Biocon 646 148.6

2 Serum Institute of India 565 129.9

3 Panacea Biotec 217 50.0

4 Venky's (India) Limited 188 43.2

5 Mahyco Monsanto 166 38.3

6 Novo Nordisk 135 31.0

7 Rasi Seeds 87 20.0

8 Aventis Pharma 84 19.4

9 Bharat Serums 81 18.6

10 Chiron Behring Vaccines 78 17.9

11 GlaxoSmithKline 78 17.9

12 Indian Immunologicals 72 16.6

13 Shantha Biotechnics 70 16.1

14 Novozymes 69 15.9

15 Eli Lilly and Company 68 15.7

16 Wockhardt 67 15.4

17 Bharat Immunological & Biological Corp. 53 12.3

 18 Bharat Biological International 41 9.4

19 Advanced Biochemicals 40 9.1

20 Biological E 36 8.3

USD 1 = Rs 43.5
Source: BioSpectrum Top 20: A threshold crossed

Most companies in the biotech sector are extremely small, with only two firms breaking 100
million dollars in revenues. At last count there were 265 firms registered in India, over 75%
of which were incorporated in the last five years.2,47 The newness of the companies explains
the industry’s high consolidation in both physical and financial terms. Almost 50% of all
biotechs are in or around Bangalore, and the top ten companies capture 47% of the market.
The top five companies were homegrown; Indian firms account for 62% of the biopharma
sector and 52% of the industry as a whole.4,46 The Association of Biotechnology-Led
Enterprises (ABLE) is aiming to grow the industry to $5 billion in revenues generated by 1
million employees by 2009, and data from the Confederation of Indian Industry (CII) seem to
suggest that it is possible.7,47

Comparison with the U.S.

The Indian biotech sector parallels that of the U.S. in many ways. Both are filled with small
start-ups while the majority of the market is controlled by a few powerful companies. Both
are dependent upon government grants and venture capitalists for funding because neither
will be commercially viable for years. Pharmaceutical companies in both countries have
recognized the potential effect that biotechnology could have on their pipelines and have
responded by either investing in existing start-ups or venturing into the field themselves.36 In
both India and the U.S., as well as in much of the globe, biotech is seen as a hot field with a
lot of growth potential.
Relationship with IT

Many analysts have observed that the hype around the biotech sector mirrors that of the IT
sector. Biotech colleges have been popping up around the country eager to service the pools
of students that want to take advantage of a growing industry.7 The International Finance
Commission, the private investment arm of the World Bank, called India the “centerpiece of
IFC’s global biotech strategy.” Of the $110 million invested in 14 biotech projects investment
globally, the IFC has given $43 million to 4 projects in India.29 According to Dr. Manju
Sharma, former director of the Department of Biotechnology, the biotech industry could
become the “single largest sector for employment of skilled human resource in the years to
come.”5 British Prime Minister Tony Blair was similarly impressed, citing the success of
India’s biotech industry as the reason for his own country’s own biotech opportunities.22
Malaysia is also looking to India as an example for growing its own biotech industry.41

Government support

The Indian government has been very supportive. It established the Department of
Biotechnology in 1986 under the Ministry of Science and Technology.47 Since then, there
have been a number of dispensations offered by both the central government and various
states to encourage the growth of the industry. India’s science minister launched a program
that provides tax incentives and grants for biotech start-ups and firms seeking to expand and
establishes the Biotechnology Parks Society of India to support ten biotech parks by 2010.
Previously limited to rodents, animal testing was expanded to include large animals as part of
the minister’s initiative.10 States have started to vie with one another for biotech business,
and they are offering such goodies as exemption from VAT and other fees, financial
assistance with patents and subsidies on everything ranging from investment to land to
utilities19.

Foreign investment

The government has also taken steps to encourage foreign investment in its biotech sector.
An initiative passed earlier this year allowed 100% foreign direct investment without
compulsory licensing from the government1.6 In April, a delegation headed by the Kapil
Sibal, the minister of science and technology and ocean development, visited five cities in the
U.S. to encourage investment in India, with special emphasis on biotech.32 Just two months
later, Sibal returned to the U.S. to unveil India’s biotech growth strategy at the BIO2005
conference in Philadelphia.9

Challenges

The biotech sector faces some major challenges in its quest for growth. Chief among them is
a lack of funding, particularly for firms that are just starting out. The most likely sources of
funds are government grants and venture capital, which is a relatively young industry in
India. Government grants are difficult to secure, and due to the expensive and uncertain
nature of biotech research, venture capitalists are reluctant to invest in firms that have not yet
developed a commercially viable product.26 As previously mentioned, India hopes to solve
its funding problem by attracting overseas investors and partners. Before these potential
saviors will invest significant sums in the industry, however, there needs to be better
scientific and financial accountability. India is slowly working towards these goals, but it will
be a while before they are up to the standards of Western investors.

India’s biotech firms share another problem with their pharmaceutical cousins: a lack of
qualified employees. Biotech has the additional disadvantage of competing against IT for
ambitious, science-minded students but not being able to guarantee the same compensation.
An aspiring researcher in India needs 7–10 years of education covering a range of specialties
in order to qualify to work in biotech. Even if a student does choose to go on the biotech path,
the ineffectual curriculum at many universities makes it doubtful as to whether he will be
qualified to work in the field once finished. One estimate shows that 10% of upper-echelon
biotech recruits have come from foreign countries. While this is not a problem, per se, it
drives up cost in a country whose competitive advantage is based on cheap, high-quality
labor. Far from ending with scientists, there is also a shortage of people with a knowledge of
biotechnology in related fields: doctors, lawyers, programmers, marketing personnel and
others.7,15,17

While little has been done about the latter half of the employee crunch, the government has
addressed the problem of educated but unqualified candidates in its Draft National Biotech
Development Strategy. This plan included a proposal to create a National Task Force that
would work with the biotech industry to revise the curriculum for undergraduate and graduate
study in life sciences and biotechnology. The government’s strategy also stated intentions to
increase the number of PhD Fellowships awarded by the Department of Biotechnology to 200
per year. These human resources will be further leveraged with a “Bio-Edu-Grid” that will
knit together the resources of the academic and scientific industrial communities, much as
they are in the U.S.5

Major players

Glenmark

Glenmark is a emerging leader of Indian Pharmaceutical market in sales as well in Research.

Soon new chemical entities will hit the market.

Ranbaxy Laboratories

Ranbaxy is the leader in the Indian pharmaceutical market, taking in $1.174 billion in
revenues for a net profit of $160 million in 2004. It was the first Indian pharmaceutical to
have a proprietary drug (extended-release ciprofloxacin, marketed by Bayer) approved by the
U.S. FDA, and the U.S. market accounts for 36% of its sales. 78% of Ranbaxy’s sales are
from overseas markets; its offices in 44 countries manage manufacturing in 7 countries and
distribution in over 100.

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in the world and
that it is the 15th fastest growing company. By 2012, Ranbaxy hopes to be one of the top 5
generics producers in the world, and it consolidated its position with the purchase of French
firm RGP Aventis in 2003. Ranbaxy also has higher aspirations, however, “to build a
proprietary prescription business in the advanced markets.” To this end, it keeps a dedicated
research facility in Gurgaon staffed with over 1100 scientists. They currently have two
molecules in Phase II trials and 3-5 in pre-clinical testing. It spent $75 million in R&D in
2004, a 43% increase over its 2003 expenditure.

Arun Puri is the chairman and CEO Brian Tempest is the only non-Indian on the senior
management team.38,39

Dr. Reddy's Laboratories

Founded in 1984 with $160,000, Dr. Reddy’s was the first Asia-Pacific pharmaceutical
outside of Japan and the sixth Indian company to be listed on the New York Stock Exchange.
It earned $446 million in fiscal year 2005, deriving 66% of this income from the foreign
market. In order to strengthen its global position, Dr. Reddy acquired UK-based BMS
Laboratories and subsidiary Meridian Healthcare. Anji Reddy is the chairman of Dr.Reddy's.

Although 58% of Dr. Reddy’s revenues come from generic drugs, the company was
committed to WTO-compliance long before the 2005 bill took effect, and most of these
products were already off patent. Dr. Reddy has long been a research-oriented firm,
preceding many of its peers in setting up a New Drug Development Research (NDDR) in
1993 and out-licensing its first compound just four years later. Dr. Reddy’s has since
outlicensed two more molecules and currently has three others in clinical trials.

Although Dr. Reddy’s is publicly traded, the Reddy family (including founder/chairman K.
Anji Reddy, son-in-law/CEO GV Prasad and son/COO Satish Reddy) holds a hefty 26%
share in the company.11,44

Nicholas Piramal

The company led by Asish Mishra grossing $350 million per year, Nicholas Piramal started
its existence with the 1988 acquisition of Nicholas Laboratories and grew through a series of
mergers, acquisitions and alliances. The company has formed a name for itself in the field of
custom manufacturing. It cites its 1700-person global sales force as another core strength;
with its acquisition of Rhodia’s inhalation anaesthetics business, Nicholas Piramal gained a
sales and marketing network spanning 90 countries34.

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath of product
patent protection. The company has respected intellectual property rights since its inception
and refused to "support generic companies seeking first-to-file or early-to-market strategies."
Instead, it decided to make its own intellectual property and opened a research facility last
November in Mumbai with hopes of launching its first drug in 2010 at a cost of
$100,000.24,33

Cipla

Cipla is one of the oldest drug manufacturers in India. It is led by Dr. Yusuf K. Hamied,
Chairman and Managing Director. Cipla burst into the international consciousness in 2000
with Triomune, an AIDS treatment costing between $300 and $800 per year that infringed
upon patents held by several companies who were selling the cocktail for $12,000 per year.
Long before this news, Cipla had been building a strong global presence, and it now
distributes its 800-odd products in over 140 countries. Privately held Cipla holds a prominent
spot in its home country as well; it is the leader in domestic sales, having just unseated
GlaxoSmithKline for the first time in 28 years. Revenue in 2004 totaled $552 million (using
Rs 43.472 = $1) about 75% of which was derived in India. Cipla did not report having a
research program.8,18

|Dr. Kiran Mazumdar-Shaw is the Chairman and Managing Director of BiocoIrish chemicals
company seeking to break into the Indian market, Biocon is now the leading biotech in India,
bringing in Rs 646.36 crore (almost $150 million) in revenue for fiscal year 2004. It initially
made its money by producing enzymes, but Biocon recently decided to become a research-
oriented company with the goal of bringing a proprietary new drug to market.

The company went public in March 2004, and "its shares were oversubscribed by 33 times on
opening day." Eight months later it launched Insugen, a bio-insulin that is its first branded
product. Biocon also has two wholly owned subsidiaries, Syngene and Clinigene, that
perform custom research and clinical trials.3,14,31

Serum Institute of India

Main article: Serum Institute of India

The Serum Institute of India can make the enviable claim that 2 out of every 3 children in the
world are immunized with one of their vaccines. It is the world’s largest producer of measles
and DTP vaccines, and its portfolio includes other vaccines, antisera, plasma products and
anticancer compounds. The Serum Institute earned Rs 565 crore ($130 million) in revenue in
fiscal year 2005, selling mainly to UN agencies and to the Indian government. The Serum
Institute is part of the Poonawalla Group, whose holdings include a horse stud farm and
manufacturers of industrial equipment and components. Dr. Cyrus Poonawalla is the
Chairman of the company.
 COMPANY PROFILE

Hetero Company Profile

Hetero is a research based global pharmaceutical company focused on development,

manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate
Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a
tradition of excellence and deep sense of commitment in developing cost effective processes
to offer wide range of affordable drugs.

Hetero is building on the strengths of vertical integration in discovery research, process

chemistry, API manufacturing, formulation development and commercialization. Hetero is a
leading international supplier with a rich portfolio of over 200 products from wide range of
therapeutic categories both in active pharmaceutical ingredients and finished dosages.

Hetero’s manufacturing facilities are cGMP compliant meeting global standards in terms of
infrastructure and systems. Majority of them are approved by the various regulatory
authorities of USFDA, WHO-Geneva, Australian TGA, Spanish agency of medicines &
health care products, ANVISA-Brazil, IDA-Netherlands etc.,

With full-fledged marketing capabilities, the company has been able to market its products in
over 138 countries across the globe.
Hetero Drugs, the parent company established in 1993 is one of the largest Indian
pharmaceutical companies with over 2000 crores in revenues and employs more than 5000
employees. Hetero is a vertically integrated pharmaceutical company and is a leading player
in API’s and finished dosages. Hetero supply’s API’s and finished dosages to major domestic
and international generic companies.

Hetero operates in more than 100 countries and its manufacturing facilities meet various
national and international standards including USFDA. Hetero has a portfolio of more than
200 products and is a leading company in bringing new generic molecules to the market.

About Founder.

A Visionary Scientist
"Where the future started yesterday........ works a day ahead of future...."

Dr. Bandi Parthasaradhi Reddy, Chairman & Managing Director of Hetero group is
academically endowed with a Post Graduate and Doctoral degrees with distinction in the field
of synthetic chemistry. Prior to founding of Hetero Drugs Limited, Dr. B.P.S Reddy had a
stint in leading pharmaceutical companies as the head of the Research & Development
division. His sharp analysis and ability to synthesize various chemical compounds lead to the
discovery of new processes, cost effective schemes for manufacturing of various
pharmaceutical products. During the said period Dr.B.P.S Reddy has the credit of introducing
many new molecules for the first time in Indian pharmaceutical market.

A visionary the world knows as Dr. B.P.S.Reddy, is the driving force behind this growing
pharmaceutical phenomenon called “HETERO”. Dr.B.P.S.Reddy’s dream child, Hetero was
born in the year 1993 as a small API unit. Today, 17 years later, the name is synonymous
with leadership in pharmaceuticals with more than 18 manufacturing units and 8000
employees. An entity that is grown in stature by virtue of its combined strength in research,
manufacturing and marketing.

Dr. B.P.S.Reddy steered Hetero towards the forefront of global pharmaceutical industry with
his vision to be recognised as an aggressive company that combines its strength of R&D and
manufacturing with definite advantages in terms of cost and chemistry with a strong
emphasis on quality of the products.

Dr. B.P.S.Reddy is now focusing on giving new dimensions to Hetero in terms of research
and innovation programs in discovery research to take the company to greater heights.

Awards & Accolades

Hetero has been scaling new heights on a continual basis. These achievements have been the
result of concerted efforts on the part of different functions within the organisation to achieve
the organisational goal of being a leader.

In its path to success, Hetero has seen many a milestone being crossed and achieved many
awards on various fronts. Awards for exemplary work in R&D and marketing are just a few
to name.
A track of few events that saw Hetero reaching its Zenith of glory are :

2009

• Top Pharmexcil Gold Patent award.

• Top Pharmexcil Outstanding Export Performance award in Drugs and

Pharmaceuticals.

2006

• Chemexil Trishul export award for outstanding export performance 2001 Excellence
& National Integration award in recognition of the efforts for excellence with affairs
connected with educational specialties and creating teaching skills besides promoting
harmony at all levels in the college.

1999

• Highest exporter award against stiff competition from internationally recognized

domestic competitors.

1998

• Top Chemexil award for Exports.

1996

• National award for "Best Efforts in Research and Development" from the Department
of Scientific and Industrial Research, Ministry of Science and Technology, Government of
India, in the year 1996.

Corporate Social Responsibility is our commitment

Hetero Group always believes in the concept of giving back to the society to uplift the living
standards in the surrounding society as one of the prime responsibilities and always took the
lead. The Group is committed for implementation of various CSR initiatives and contributes
substantially to the cause.

Hetero Group received appreciation from the Government of Andhra Pradesh, for its
outstanding contribution in the implementation of Corporate Social Responsibility. .

Environment Protection:

Completed One Million Plantation Programme.

Taking up Plantation in the surrounding Schools.

Completed Plantation in newly acquired 15 acres land and a total of 25000 Nos. of saplings
made.

Provided substantial amount to the industrial association for the development of

infrastructure and environment in Kazipally IDA.

Provision of Biomass Pellets for cooking purpose in place of LPG gas.

Research & Development

Research & Development is the foundation of Hetero’s philosophy of developing cost-

effective, high quality and safe medicines to society. Hetero Research Foundation is one of
the most innovative, productive, and respected scientific research organizations which is
recognized by the Department of Science & Technology, Government of India.

Hetero Research Foundation (HRF) has a team of over 400 dedicated scientists working in
the areas of Process, Analytical and Discovery Research. R & D centre conforms to
international standards and has advanced equipment for both basic and applied research.

Process R&D

HRF has developed process for 150 plus molecules for various markets. The R&D team
actively involved in process development, scaling-up technology transfer and associates with
manufacturing team through out life cycle of product.
HRF has always been emphasizing to ensure that the processes being adopted for the
products are cost effective, safe to handle and with optimum advantage in terms of yield and
quality.

Analytical R&D

Analytical research at HRF is equipped to conduct complete physical and chemical

characterisation of API’s/ NCE’s. Further, the team is well versed with regulatory filings and
has vast experience in documentation. The infrastructure includes advanced instruments like
LC-MS-MS, GC-MS, NMR, Powder XRD apart from several HPLC systems.

Having a strong commitment and experience in bringing quality

medicines to all, Hetero entered into the pharmacy services as
part of its integration strategy. Having a strong knowledge in this
space we believe we can provide high quality services to our
customers.

Less than year after the launch of Hetero Pharmacy in Hyderabad, we scaled up to more than
100+ pharmacies across AP. We are still growing aggressively to serve our customers better.

Hetero also has its outlets at the prestigious Nizam’s Institute of Medical Sciences (NIMS)
Punjagutta, Hyderabad and GMR international airport, Hyderabad.
At our pharmacy outlets we provide:

Qualified & trained Pharmacists

Helps you comply with prescription instructions. No scope for spurious drugs, expired
medicines and substitution
Availability of wide range of medicines
Pharmacy, surgical, disposables, ARV, anti-cancer, life saving and general
Healthcare products by Indian and International companies
 Chapter – IV

Data Analysis & Interpretation

1. Do you think the organization is quality conscious toward employees?

Response Respondents Percentage

Yes 147 73.5

No 53 26.5

Total 200 100

Respondents
147

53

yes no

Interpretation:-the above analysis is showing organization is quality conscious toward

employees are 147 are yes and 53 employees say no.

 2. Does the organization have the certification of ISO 9000?

Response Respondents Percentage

Yes 18 9

No 182 91

Total 200 100

Respondents
182

18

yes no

Interpretation :- the above analyses about the organization have the certification of ISO

9000 9% are say positive and 91% are say negative.

 3. Is the organization providing quality assurance system & operation?

Response Respondents Percentage

YES 168 84

NO 32 16

Total 200 100

persantage

NO
16%

YES
84%

Interpretation :- the above analyses about the organization providing quality assurance

system & operation 84% are say yes and 16% are say no.
 4. Does the organization have quality circle?

Response Respondents Percentage

YES 125 62.5

NO 75 37.5

Total 200 100

Percentage

62.5

37.5

YES NO

Interpretation:- the above analysis are showing organization have quality circle 62% are

aware of that ,37% are not aware of that .

 5. How many people are involved in quality circle?

Response Respondents Percentage

Below 10 83 41.5

above 10 15 7.5

above 15 11 5.5

can’t say 91 45.5

Total 200 100

Respondents
100
90
80
70
60
50
Respondents
40
30
20
10
0
Below 10 above 10 above 15 can’t say

Interpretation:-the above chart showing 41% are maintain below 10 employees are in

quality circle . 45% are can’t say any thing

 6. How frequently the organizations have the meeting of quality circle?

Response Respondents Percentage

Weekly 14 7

biweekly 25 12.5

monthly 79 39.5

yearly 82 41

Total 200 100

Percentage
41
39.5

12.5

Weekly biweekly monthly yearly

Interpretation:- the employees are frequently the organizations have the meeting of quality

circle 75 are weekly , 12.5% are biweekly ,39% are monthly, 41% are yearly in the total 200

members
 7. Do you know about the agenda of information or any other information?

Response Respondents Percentage

Yes 138 69

No 62 31

Total 200 100

Respondents
138

62

Yes No

Interpretation:-the above chart showing 69% are says yes know about the agenda of

information or any other information 31% no idea about the information

 8. Are the organization is going for the quality audit?

Response Respondents Percentage

YES 155 77.5

NO 45 22.5

can’t say 68 34

Total 200 100

Percentage
77.5

34

22.5

YES NO can’t say

Interpretation:-77% no idea about the organization is going for the quality audit, 22% no

idea about quality audit 34% are can’t say anything.

 9. Does your organization have quality information system?

Response Respondents Percentage

YES 116 58

NO 72 36

can’t say 12 6

Total 200 100

can’t say
6% Percentage

NO
36%
YES
58%

Interpretation:-that above survey about the organization has quality information system

58% told yes 36% say no 6% are not say anything about the quality information system.
 10.Are the information system is regularly updated?

Response Respondents Percentage

YES 82 41

NO 73 36.5

can’t say 45 22.5

Total 200 100

Percentage
Percentage

41
36.5

22.5

YES NO can’t say

Interpretation:- the above analysis about the information system is regularly updated 41%

say yes 36% are say no about the pupation about he information.
 11.Do you think the organization used bench marking?

YES NO Can’t say

Option Resp %

Yes 150 75%

No 20 10%

Can't Say 30 15%

Total 200 100%

160
140
75%
120
100
Series2
80 150 Series1
60
40
20 10% 15%
30
20
0
Yes No Can't Say

75% of the respondents shared their view that there is bench marking is there in Total

Quality Management in Hetero.

 CHAPTERV

CONCLUSIONS AND RECOMMENDATIONS

1. Total Quality Management plays important role for focusing improvement of quality

system and involvement of all people in the organization on continual basis

2. It is the basis for improve the quality characteristics both internal and external

customers. By implementing the TQM customer satisfaction has been improved and

paying way for implementation of ISO 9000 System in the organization.

3. Business process improved four fold after implementation of TQM

4. Rejection level is reduced by 40 to 60 % after implementing TQM

5. By forming the quality circles, employees are delighted for the ideas they are

generated and satisfaction of recognisation of the employees in decision making

process for improving the quality

6. Customers complaints has been reduced by 40%

7. Implementation of statistical tools in the shop floor quality has been improved by 60

to 70% and rework is reduced

8. Company has improved the exports orders after implementing the TQM

9. Shop floor utilization has improved substantially

 Bibliography

1. Anderson J., Rungtusanatham M., Schroeder, R., 1994. A Theory of Quality

Management underlying the Deming Management Method. The Academy of

Management Review. Vol. 19, No. 3,

2. Business Week, 1992. Quality: Small and midsize companies seize the challenge - not

a moment too soon. November, 66-75

3. Crosby P., 1979. Quality is Free: The Art of Making Quality Certain. McGraw-Hill.

4. Deming, E.W., 1986. Out of crisis. Cambridge University Press. MGrant, R.M., Shani

R., Krishnan R. 1994. TQM's challenge to management theory and practice. Sloan

Management Review. Vol. 35, No. 2, 25-35assachusetts, USA.

5. ISO 9000:2000: SFS-EN ISO 9000 collection of quality management standards

(Fundamentals and vocabulary, Requirements and Guidelines for performance

improvements). Finnish standards Association. Helsinki

6. Juran J.M., 1974. The Quality Control Handbook, 3rd edition. McGraw-Hill. New York.

7. Powell, T., 1995. Total Quality Management as Competitive Advantage: a Review and

empirical study. Strategic Management Journal, Vol. 16, 15-37.

 Questionnaire

1. Do you think the organization is quality conscious toward

employees? YES NO

2. Does the organization have the certification of ISO 9000?

a. YES NO

3. Is the organization providing quality assurance system & operation?

a. YES NO

4. Does the organization have quality circle?

a. YES NO

5. How many people are involved in quality circle?

a. Below 10 above 10 above 15 can’t say

6. How frequently the organizations have the meeting of quality circle?

a. Weekly biweekly monthly yearly

7. Do you about the agenda of information or any other information?

a. YES NO

8. Are the organization is going for the quality audit?

a. YES NO Can’t say

9. Does your organization have quality information system?

a. YES NO can’t say

10. Are the information system is regularly updated?

a. YES NO can’t say

11. Do you think the organization used bench marking ?

i. YES NO can’t say