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A STUDY ON PHARMACEUTICAL INDUSTRY OF NEPAL
Report submitted to CMS Business School (Jain University) in partial fulfilment of the requirements
for the Degree of Masters in Business Administration
Submitted by
ABHISHEK MISHRA
14MBA63002
December 26th
2015
Under the guidance of
Prof. KRISHNA KOPPA
No. 319, 17th Cross, 25th Main, JP Nagar 6th Phase, Bangalore - 560078
Bangalore, INDIA
E-mail: mba@cms.ac.in, Website: www.bschool.cms.ac.in
DECLARATION
I, Abhishek Mishra with Reg. No: 14MBA63002, declare that this report on the Use of
Osterwalder's Framework in Online Health Care Companies is undertaken by me and is submitted to
CMS Business School, in partial fulfilment of the Master of Business Administration programme
offered by the Jain University Bangalore is a record of original and independent work done during the
academic year 2015.
Abhishek Mishra
ACKNOWLEDGEMENT
I especially like to thank Prof. Krishna Koppa faculty of Marketing Jain University who helped me
lot for the successful accomplishment of this report. I thank him for being my mentor for this study
and guiding me at various stages to achieve my objective.
Finally, I also like to thank him for providing me everything that I needed for this study.
I am glad and lucky enough to have mentor like him. Thank you sir.
Thank you.
Abhishek Mishra
CHAPTER ONE
INTRODUCTION
1.1 Background of the study
A healthy manufacturing sector is very essential for the development of any economy. But talking
about pharmaceutical manufacturing then it is not something which everyone and every economy can
perform. Nepal as being naturally rich country it have some advantage and competitiveness in this
industry if the capacities are utilized. due to which there are many foreign Ayurvedic companies
which made their way to Nepal to have such herbs. A well developed pharmaceutical system
promotes investment by the identified investors in the country leading to various business
opportunities, mobilizing funds and effective utilization of resources.
Nepal Pharmaceuticals industry we have 44 companies all playing vital role in the economic
development of the country. In Nepal, pharmaceuticals are considered as one of the few very
successful business which is contributing and have bright future. In Nepal presently we have
companies manufacturing medicines for both humans as well as animals. In Nepal Pharmaceutical
industry there are few companies who have just started formulating the medicine compositions, there
are companies manufacturing best qualities of bands and band-aids. And of all Nepal Pharmaceutical
will always be known for its huge and best qualities Ayurvedic products of their own.
The main focus of this report is to let the readers know about the strength of Nepal's Pharmaceutical
Industry knowing and overcoming its weakness. And also to aware my readers about impact of WTO
and Provisions of TRIPS 2016.
1.2 Objective
There are three main objectives for this study as:
 to identify strategies to be adopted by Nepalese Pharmaceutical Industry to grow and harness
their strengths for tapping the opportunities
 to identify ways in facilitating Nepalese Pharmaceutical Industry to gear up for the WTO
regime (assigned by company)
 This study is also initiated for self awareness and understanding of the pharmaceutical
industry and companies
1.3 Scope
The scope of the study is to cover the followings aspects:
i. Overview of the Nepalese Pharmaceuticals Industry:
 Industry Structure
 SWOT analysis of Nepalese Pharmaceutical Industry
 Critical success factors.
1.4 Methodology
The methodology adopted for this study is as;
 Collection of the primary data interacting with some of the experienced person in the industry,
interacting with the persons in the DDA (Drug Department Administration of Nepal), and
interaction with the Managing Director of the chosen company
 Data collection and analysis is also based on the desk research
1.5 Limitations:
The limitations are:
i. Lack of time obstructed for better and deeper study.
ii. Study mainly focuses on the Pharmaceutical Industry and companies. So it can't be used
for other studies.
iii. Report includes only data collected from DDA and study of operating procedure of only
one company. So very difficult to apply over all the companies (small and medium) in the
industry.
iv. The recommendations given are based on perspective of the present status of the Nepalese
pharmaceutical industry and the opportunities vis-à-vis and the changing regulatory
environment in the context of WTO. So the report is mainly of short term in nature
although it covers macro environment but can't be equally important after 5-10 years. As
the period of 10 years is a considerable time frame for any industry in changing its
dynamics.
v. Most of the Nepalese Pharmaceutical Companies were not able to clear the threats the
industry is currently facing and the impact of WTO regime on them. Therefore, the study
of WTO relating to Nepalese pharmaceutical industry is taken parallel from the other
markets, where WTO agreements were recognized.
1.6 Organization selection:
For the specialization in the field of marketing, I had certain options to choose from the
Pharmaceutical organizations that offers the most of the information. So I chose Amtech Med as it
has the best offerings to the students.
1.7 Duration of Study:
In order to attain my objective following the guidelines of the Jain University, this study program
was successfully accomplished from Friday, 23 October 2015 to 15 January 2015 in Biratnagar
Nepal. There are various activities performed by the intern during these period which will be dealt in
detail in Chapter 4.
CHAPTER TWO
INTRODUCTION OF INDUSTRY
2.1 Background
Nepal has become a WTO member on April 23, 2004. Accession of Nepal to WTO has brought both
opportunities and challenges to Nepalese pharmaceutical industries. World market of pharmaceutical
products is now open to Nepalese industries and simultaneously Nepalese market is open to industries
worldwide. In this context Nepalese pharmaceutical industries should be able to explore the
opportunities and make best use of the opportunities. In addition, Nepalese industries should also
identify the external threats for them and make efforts to overcome the threats. Therefore, it has
become imperative for individual Nepalese pharmaceutical industries and Pharmaceutical Industry as a
whole to formulate the strategies which could lead them to their growth and how they could harness
their strengths for exploiting the opportunities before stepping into WTO/TRIPS regime in 2016.
Since majority of pharmaceutical industries in Nepal are SMEs, there is a necessity for a facilitating
role by the government for gearing-up Nepalese industries to utilize the opportunities under WTO
regime. Therefore, it is also imperative to identify the roles to be played by the government to facilitate
the Nepalese pharmaceutical sector to enter WTO regime. With a view to fulfil these needs this study
has been carried out.
2.2 Global Scenario
The usage of pharmaceuticals is governed by the underlying medical science. The four primary
medical sciences are as Allopathy or modern medicine has gained global popularity, Ayurveda, an
ancient Indian Science, mainly uses herbal remedies, Unani, having Chinese origin, is prevalent in
South East Asia, and Homeopathy, founded by a German Physician, was fairly popular in the early
19th century.
World-over the pharmaceuticals industry is focused on Allopathy, the most modern medical science.
Other modes of medical treatment such as Homeopathy, Ayurveda and Unani are more prevalent in
their world countries.
2.3 OVERVIEW OF NEPALESE PHARMACEUTICAL INDUSTRY
Industry Structure
2.3.1 Domestic Pharmaceutical Industries
As per DDA there are 44 pharmaceutical industries in operation at present in Nepal. According to the
Industrial Enterprise Act 1997 and subsequent amendments, industries with the capital investment up
to Rs 30 million is considered as small scale industries and those between Rs 30 million to 100
million is considered as medium scale industries. The industries with capital investments more than
Rs 100 million are categorized as large scale industries. Of the above 44 industries, 7 units are of
small scale, 32 units in medium scale, and the rest 5 in large scale.
Majorities of these units are located in Kathmandu Valley and Narayani Zone, while the rest are
scattered in places like Janakpur, Biratnagar, Bhairahawa, Dharan. Except the Royal Drugs Limited,
all the pharmaceutical units are in private sector and registered as private limited company. The list
of recognized pharmaceutical units along with their location is presented in Table No, 1.6.1.
Alive Pharmaceutical Pvt.Ltd Biratnagar
Amtech Med Pvt.Ltd Biratnagar
Alliance Pharmaceuticals Pvt. Ltd Simra, Birgunj
Amie Pharmaceuticals Pvt.Ltd Janakpur
Apex Pharmaceuticals Pvt.Ltd Parwanipur, Birgunj
Arya Pharmalab Pvt.Ltd Rampur, Kokani, Parwanipur, Birgunj
Asian Pharmaceuticals Pvt. Ltd. Padsari, VDC-9 Rupendehi, Bhairahawa
Birat Pharma Lab Pvt. Ltd Biratnagar
Chemi Drug Industries Pvt.Ltd Kathmandu
Concept Pharmaceutical (N) Pvt.Ltd Birgunj
CTL Pharmaceutical Pvt.Ltd Bhaktapur
Curex Pharmaceutical Pvt,Ltd Janagal, Benepa, Kavera
Danium Laboratories (P) Ltd. Birgunj
Deurali-Janata Pharmaceuticals Pvt. Ltd. Dhapasi,Kathmandu
Dingla Pharmaceuticals (P) Ltd Biratnagar
Everest Pharmaceuticals Pvt. Ltd Kathmandu
Florid Laboratories Pvt.Ltd Lalitpur
G.D Pharmaceutical Pvt.Ltd Birgunj
Hukum Pharmaceutical Pvt.Ltd Bhaktapur
Lomus Pharmaceutical Pvt.Ltd Kathmandu
Mark Laboratory Thankot
Maruti Pharmaceuticals Pvt.Ltd Kathmandu
Manoj Pharmaceutical Works Pvt.Ltd Dharan
National Health Care Pvt.Ltd Bara
National Pharmachem Janakpur
Nepal Pharmaceuticals Lab Pvt.Ltd Parsa
Ominica Laboratories Pvt.Ltd Bhaktapur
Pharmaceutical Company of Nepal
Pvt.Ltd
Bara
Pharmaco Industries Pvt.Ltd Kathmandu
Quest Pharmaceutical Pvt.Ltd Bara
Royal Drug Ltd. Kathmandu
Shiv Pharmaceutical Laboratories Pvt.Ltd Dharan
Siddhartha Pharmaceutical Pvt.Ltd Madhyawaliya, Rupundehi, Bhairahawa
Simca Laboratories Pvt.Ltd Bhaktapur
SR Drug Laboratories Pvt.Ltd Kathmandu
Summy Pharmaceutical Pvt.Ltd Nawalparasi
Time Pharmaceutical Pvt.Ltd Mukundapur WNO 5
Unique Pharmaceutical (P) Ltd. Birgunj
Vijaydeep Pharmaceutical P.Ltd Lalitpur
Vijaydeep Laboratory Lalitpur
Source: Drug Bulletin Published by DDA
All pharmaceutical industries produce pharmaceutical products in tablet and capsule forms while a
limited number of units produce products in liquid, ointment, dry syrup, powder forms. Of those only
two units produces IV Fluid and a another one the injectables. Majority of the industries are
producing same group of products, but some have started producing cardiovascular, psychotropic and
anti-diabetic products too. Only two industries are producing I V Fluid i.e. Dextrose. And most of
these companies as urged by DDA, have already acquired WHO-GMP Certificate and are also ISO
9001:2000,14000 certified companies.
2.3.2 Market
Major Companies in Market
The Nepalese pharmaceutical market has one of the highest brands Per capita and is highly import
driven. The market is highly dependent on import from domestic and multinational companies of
India, Bangladesh, and others. The top 10 companies hold 33% of the total retail pharmacy market by
sales value and the next top 30 companies hold 62% of the market. The top 10 pharmaceutical
companies in retail market are given in Table No. 1.6.2.
1 Lomus Pharmaceuticals Nepal
2 Nepal Pharmaceuticals Nepal
3 Deurali-Janata Nepal
4 Aristo India
5 Dabur India
6 National H.C Nepal
7 Knoll MNC
8 Ranbaxy India
9 Nicholas India
10 Alkem India
Soucre: DDA
Major Products In Market
The top 10 pharmaceutical products based on sales value in the market are largely dominated by
those of the Indian companies. Those have earned this position by virtue of being in the market the
longest. In addition, better marketing and promotion, and an impression of superior quality have kept
them on the top 10 list. Off late the Nepalese pharmaceutical companies are able to make their entry
into the top 20 products with brands like Nemox, De Cold, Brucet, Reymoxis, etc. produced by
National Healthcare Private Limited, Lomus Pharmaceuticals, Nepal Pharmaceutical Laboratories
Ltd, Deurali Janata.
Sales and Distribution System
All pharmaceutical industries are marketing their products solely within the country. Their
pharmaceutical products reach the end users through a four– tier distribution system consisting of
distributors, stockiest, sub stockiest and retailers. According to the recent statistics of the DDA, there
are 2,350 medical wholesalers and 18,255 pharmacies that are operating in the country.
Main and Auxiliary Raw Materials
Nepalese pharmaceutical industries are dependent of import for bulk drugs and active pharmaceutical
ingredients. The major source for importing bulk drug and active pharmaceutical ingredients for
medicines is India. The others are China, Belgium, South Korea, Australia, Denmark, Holland and
Switzerland. Other requirements of the domestic producers like binders, diluents, disintegrates,
glidants for tablets, capsule shells for capsules, suspending agent for suspensions, sweetening agents,
colors, preservatives, antioxidants and other auxiliary materials are also met from India.
Technology
The technologies used to manufacture pharmaceutical products in Nepalese industries differ from
semi-automatic to automatic depending upon the form of pharmaceutical product. – Tablets,
capsules, liquid, ointment, dry syrup, powder, injectables etc. The machineries used to manufacture
pharmaceutical product are mostly from India. But instruments and equipment for quality control and
quality assurance are mostly from third countries like Singapore, Japan, Germany, etc. All the
industries have incorporated quality control in its production process, but only a few have system for
quality assurance. With a view to enhance technology and quality of the sector, two industries have
come forward and developed linkages with academia. Only one industry has technical collaboration
with Bangladesh Company.
Human Resources
Except highly skilled technical manpower there are enough human resources available for Nepalese
pharmaceutical industries to carry out pharmaceutical formulation, production and marketing of
formulated finished products, as Nepal has sufficient number of qualified pharmacist, chemist and
skilled technical manpower required for above. Therefore, all domestic pharmaceutical industries are
having Nepalese production and marketing manpower. But in case of highly skilled technical
manpower capable of undertaking R & D, quality assurance, and complex formulations; the
requirement is met from India and abroad.
Research and Development
Research & development in Nepalese pharmaceutical industries is limited to pharmaceutical
formulation and testing only. No industry has enough capability for carrying out R & D for reverse
engineering of new molecules. Even the Royal Drugs Research – a governmental laboratory
established three decade ago to carry out researches in drug is limiting its activities only in drug
testing. Three laboratories under the private sector are capable of drug testing activity in a limited
scale.
2.3.3 SWOT Analysis
SWOT Analysis of Nepalese Pharmaceutical Industry is as;
Strengths
a. Production Facilities
Production facilities of most of the Nepalese pharmaceutical industries are upgraded and updated as
per the market and GMP requirements. With a view to be able to address the market needs
manufacturing research and development & QC activities are regularly carried out.
b. Product Quality
Quality of Nepalese pharmaceutical products is good and therefore, those have received well
recognition from the medical doctors and medical practioners. As a result of this Nepalese industries
have acquired 30% market share within a short span of time.
c. Human Resources
The human resources involved in production, quality control, manufacturing, R & D, and marketing
are well qualified and experienced in their respective areas. Human resources involved in this sector
are taken as an asset and therefore, majorities of industries are putting their emphasis on human
resources development.
d. Knowledge of Market Including Interior and Micro-Interior
Pharmaceutical industries have acquired a good knowledge about domestic market including interior
and micro-interior enabling it to enhance its agility. This has enhanced the industry to perform
marketing functions: formulate and implement strategies, distribution, promotion, customer relations,
etc.
e. High Private Sector Participation
All the industries except one are under the private sector and therefore, are relatively quick in
decision making and flexible as per the market need .
Weaknesses
a. Poor Capacity Utilization/Economies of Scale
The capacity utilization of 39 Nepalese pharmaceutical industries varies from 25 to 80%. Of these
large scale industries (five in number) and a few having wide range and forms of products have it
over 60%. The majorities have fairly low capacity utilization. The basic reasons behind it are
identified as less product range and form of products compared to industries having higher capacity
utilization and also installation of plant and machineries of higher capacity than required due to lack
of knowledge and information on industry at the time of establishment.
b. Inability to Generate Enough Income to Invest in:
• R & D
• Quality Assurance System
• Human Resources Development for Highly Skilled Technical Personnel
• Productivity and competitiveness enhancement measures
c. Limited R & D Activities
Only a few industries are carrying out manufacturing R & D, that too with low level of spending.
This is forcing a large number of industries to outsource formulation for new products, which can
cost even the credibility/corporate image of the industries, if it fails.
d. Lack of Highly Skilled Technical Personnel
Industries lack highly skilled and experienced pharmaceutical personnel, who are capable of carrying
out complex formulations and reverse engineering of new molecules
e. Limited Quality Assurance Systems
Only 5 companies have acquired WHO-GMP certification and three have ISO 9001:2000; and ISO
14000 certifications. Numbers of industries which don’t have acquired certification also have quality
assurance but not all industries. Acquiring of above certificates and up-gradation of production
facilities by only a few industries is affecting the whole sector.
f. Poor Institutionalization in Industries
Although establishment of pharmaceutical industries in the country begun decades ago,
institutionalization of those industries with vision, mission, objectives, management systems,
procedures, and others is still in the initial stage. Therefore, most of those industries are still being
run with entrepreneurial drive and not managerial drives. It is because majorities of the
pharmaceutical industries are owned and/or managed by the people, who were either traders of
pharmaceutical products or an individuals who were marketing pharmaceutical products of Indian or
multinational companies in Nepal, lack managerial knowledge and experience necessary for
managing and operating industrial enterprises. Possession of entrepreneurial/trading knowledge and
skills and not the managerial ones is limiting the institutionalization of pharmaceutical industries for
their long term sustainability and growth.
g. Adoption of Unethical Marketing Practices
There exists a practice of adopting unethical marketing practices by industries to retain or increase
market and market share. Cut throat competitions among industries are often noticed increasing
bargaining power of buyers and middlemen. Push marketing strategy is also noticed to be adopted
which is common for consumer goods.
h. Sticking to Me-too (Similar)Products
Majority of industries are engaged in producing “me-too” (Similar) products and are noticed to avoid
producing other new necessary products for fear of losses. This poor risk taking capability is
affecting a large number of Nepalese pharmaceutical industries.
i. Abuse of Co-Operation and Common Understanding among Pharmaceutical Industries
Absence of common understanding and mutual co-operation amongst industries is affecting in having
common goal of sectoral development and promotion. Malpractices like recruiting trained manpower
from competitor’s industries are very common.
j. Poor Linkages with Academia
Only recently a pharmaceutical industry has developed and maintained relationships with academia
for development of the sector through research and development, human resources development and
other developmental works and another one has developed relationship with academia for research.
Very weak or non existence of tri-partite work relationships among pharmaceutical industry,
academia and government is hindering in undertaking of research and development in pharmacy at
the academic institutions with the governmental support and then commercialization of successful
developments by the pharmaceutical industries.
k. Poor Business Relationship with Government
Only a few industries have good and well maintained business relationships with government health
institutions, and are short listed to participate in government procurements of medicine. A bulk of
the government procurement is done from drug producing companies, which are from India and
abroad.
l. Weak Supply Chain
Although all the basic and auxiliary raw materials need to be imported regularly from outside the
country, the majority of pharmaceutical industries has weak supply chain management affecting
availability of the products in market and reduces in their productivity and return. This holds true
even in distributing products in hilly and mountainous regions. The industries are still unable to reach
many places where there exists potential market for their products.
m. Knowledge on WTO/TRIPS
Majorities of industries are unaware of provisions of WTO/TRIPS and their consequences to their
business.
Opportunities
a. Favourable Government Policy
Government has categorized pharmaceutical sector as one of the priority sectors. The government is
providing monetary and fiscal facilities and incentives to the sector for its development. It is
providing incentives to the pharmaceutical industry like levying only one per cent customs duty for
input materials, machineries, etc. No Value Added Tax is levied for the industry.
b. Existence of Domestic Market and Export Potential
There is enough domestic market for Nepalese pharmaceutical industries as those are catering only
about 30% of the domestic demand. Similarly, there exists export potential for Nepalese products in
non-regulatory markets and Non-WTO member countries. Nepal lies between two big economies,
India and China, which are having large pharmaceutical markets with sizes of US $ 9.5 billion and
US $ 6.5 billion respectively. With the increase in quality of products, domestic industries could start
looking towards the export markets and also, become a contract manufacturer.
c. New Openings due to Provisions of WTO/TRIPS
As per the provisions of WTO/TRIPS, Least Developed Countries (LDCs) are obliged to provide
patent only from January 2016. As per this provision Nepal needn’t adhere to recognition of product
patents and therefore, has the choice of exporting the drugs which are in patent period to other LDC
and Non-WTO member countries. The transition period would be an opportunity for the domestic
companies to transform into vibrant pharmaceutical companies as the opportunities in the domestic
generic market itself are enormous (i.e., domestic companies account for only 30% of the total
market). The domestic companies can introduce in the market the new molecules that are developed
by the research based pharmaceutical companies and even can export to the LDC countries. Thus the
companies have the option of doing the business with the least risk of investments till 2016. There
are also facilities for parallel import and compulsory license, and Bolar’s provision, which Nepal can
exploit.
d. New Openings due to SAFTA
SAFTA has open new venues for Nepalese pharmaceuticals industries to take benefit from the
regional markets e.g. Bhutan, Maldives, which depend on import of medicine and others from
SAARC members countries.
e. Restriction on Imports
The government has imposed restriction on importing pharmaceutical products produced by
industries without WHOGMP Certification limiting competition by such industries in domestic
market.
f. Rise in Awareness about Healthcare
Nepalese have become more aware of healthcare needs and modern medicine developing good
market potential to industries. Rise in literacy level among Nepalese has also increased demand by
many folds.
g. Development and Growth in Health Institutions
Gradual development and growth in public as well as private health institutions in the country are
generating good business outlook for pharmaceutical industries.
h. Emergence of Facilitating and Supporting Institutions
Emergence of institutions to assist and support industries to enhance their competitiveness supporting
through provision of information etc. like SAWTEE.
Threats
a. Emergence of Competition
WTO regime opens up the climate for entry of foreign companies including MNCs into the domestic
pharmaceutical market. The domestic companies have to compete with well established companies.
Companies from LDCs with advanced technology like Bangladesh could also easily enter Nepalese
pharmaceutical market.
b. Restriction to Produce Generic Versions of Patented Products
Restriction to produce generic versions of patented products is to begin from January 2016 due to
TRIPS agreement.
c. Unethical Marketing Practices by Foreign Competitors
Adoption of unethical marketing practices by foreign competitors like provision of incentives e.g.
giving equivalent quantities of products free to wholesalers or distributors and others. Incentives of
that nature drive wholesalers or distributors to promote the sales of low quality drug manufactured by
those foreign competitors. This results in substitution of good quality products by inferior products
with higher margins by them
d. Short Product Life
Fast development of new molecules shortens the life of existing generic products. In such a situation
MNCs will play a dominant role in new molecules, because of their investment and risk taking
capability.
e. Weak Implementation of Government Policy
There are number of governmental policies, acts and regulations for development, promotion and
regulation of pharmaceutical sector in the country. The pertinent ones with regards to pharmaceutical
industries are Patent, Design and Trade Mark Act BS 2022 and its recent amendments; Drug Act
1978 and its regulations; National Health Policy 1991; and National Drug Policy 1995. Weak
implementation of above policies, acts, regulations and others by the government is affecting the
genuine industries to take full benefits from those.
f. Inadequate/Poor Support of Government
Government procurement policy is giving priority to price with no special concessions for domestic
companies. To make the domestic industry more competitive Government has not introduced any
compulsory measures to the Department of Health Services necessitating to purchase
pharmaceuticals from domestic industries for distribution/supply to governmental health institutions
like hospitals, primary healthcare centres, etc. It is procuring medicines through the open market at
competitive prices, wherein the participation of the foreign companies is high. The major areas where
the government support is lacking are in technology transfer assistance, financial assistance in terms
of soft loans and subsidies, setting up a world class research laboratory, provision of necessary
logistics for exports, provision of infrastructure and facilities for industrial expansion, establishment
of institutions for development of highly skilled human resources, enhancement of productivity,
quality, competitiveness and information centre.
2.2 Critical Success Factors
The critical success factors for pharmaceutical industries are:
• Marketing and Promotional Activities
• Quality of Products
• Broader Product Portfolio
• WHO-GMP Certification of Plant Facilities and Quality Management System
• Capability to Cater Domestic Market
• Economies of Scale
• Research and Development
Based on the information, it is hard to isolate success factors individually as the critical success
factors for Nepalese pharmaceutical, but the above success factors in combination could be identified
as success factors for the industries.
CHAPTER THREE
INTRODUCTION OF AMTECH MED
3.1 Introduction
Amtech Med is one of the listed company in DDA and is very well recognized in market, fulfilling
all sorts of quality standards. It was established on 2004 but formal operation was started only in
2005 and it is located in morang district, katahari VDC-9. Amtech Med (P). Ltd is committed
towards producing high quality pharmaceutical products as per international specifications and to be
a leader in Nepal by satisfying all customers through following statutory and regulatory requirements
with a continual improvement of an established QMS.
Amtech Med factory is build up in the area of 8500 sq. feet having proximity to all modes of
transportation. It is within the range of 0.5 km from main highway, 15 km from railway station and
12 km from airport. So the factory location is very well selected. And it is also well equipped all type
of modern manufacturing infrastructure which made it a WHO GMP recognized company. Since
very beginning of its operation, Amtech Med is committed towards producing high quality
pharmaceutical products. To carry on such activities significant steps has been taken to assure the
quality of products. These steps includes advance training of personnel, procurement of state of art,
inspecting and analytical equipments and modernization of quality area. Its objectives are as:
 to develop validated manufacturing process
 to reduce complaints
 to increase customer satisfaction
 to upgrade skills of available men power
 to increase company sales
 to introduce new products as per market demand
 to validate use of machine and equipments
 quality supply
 creating awareness of quality management
Its quality pyramid is:
Fig. 3.1: Quality Pyramid
Quality
Manual
Quality
Format
Quality
Procedure
Quality
Plan
Due to these reasons it is also successful to be an ISO 9001:9004:2000:2004 certified company.
3.1.1 Mission:
To put into action those activities through a continual improvement of an established QMS to
benefit society and a nation as a whole, and a commitment to build our stakeholders value by making
Amtech Med a truly sustainable company.
3.1.2 Vision:
To be a leader in Nepal by satisfying our customers and stakeholders through following all types
of statutory and regulatory requirements and being committed for producing high quality
pharmaceutical products as per international specification with a continual improvement of an
established QMS.
3.1.3 Goal:
S = Strategic Shift, Innovation
P = Productivity
E = Enhancement
A = Assertion
R = Reach
3.1.4 Objectives:
 to develop validated manufacturing process
 to increase customer satisfaction
 to upgrade skill of available men power
 to increase company sales
 to introduce new products as per market demand
 to validate use of machines and equipments
 quality supply
 creating awareness of quality management
3.1.5 Business Model:
Business model mainly defines how company is earning its return from market, what activities are
carried out to earn money. So Amtech, it is in pharmaceutical industry producing various range of
quality medicines of international standard that satisfies various need of customers. And this is how it
earns return.
3.1.6 Business Definition:
Customer needs: It satisfies various needs of medicines from a common Iron tablets or capsules to
medicines for some chronic diseases as Liver tonics etc. It mainly satisfies the need of medicines.
Customer Group: Main target customer group are doctors and some big stockists.
Technology: It satisfies those needs by producing different medicines for different use of high quality
which are approved as per WHO GMP and ISO standards and making it available to market using
various levels of distribution channels.
3.1.7 Organizational Chart:
Customer Need
Customer Group
Technology
Managing
Director
Marketing
Manager
Area
Manager
Plant
Manager
Quality
Assurance
Quality Control
Manager
Quality Control
Officer
Quality Control
Trainee
Production
Manager
Store
Manager
RM Dept.
PM Dept.
Ointment
Section
Capsule
Section
Tablet Section Packaging
Section
Operator Operator Operator Operator
Fig.3.2: Business Definition, Abell's Framework
Chief of Finance &
Accounts
Legal
Depart
ment
R & D
Dept.
Management Team:
The management team of Amtech consists of all the managers and the department heads. They are
the one who supervise their subordinates and guide them to accomplish their work efficiently.
Management of organization play a major role in achieving organizational goal. As the head of
organization i.e. managing director formulates the vision, mission and objectives for the organization,
where as managers formulate action plan to achieve those objectives. The members of management
team are as:
Table: 3.1 Management Team of AMTECH MED
Manish Agrawal Managing Director
Bal Krishna Mishra Chief Marketing Officer
Jay Narayan Plant & Production Manager
Narayan Dahal Chief of Finance & Accounts
3.1.8 Future Plans
Amtech Med believes in safe and sustainable growth as the major driving factor behind all its future
plans. Some of the important goals that the company would be looking to achieve in the medium
term are as follows:
1) Continue to reinforce Amtech as a franchise in order to supplement its business and
reputation in the market.
2) Raise the size of the balance sheet to generate the advantage of scale. However the
expansion will be based upon judicious selection of business both in terms of product
verities and market coverage.
3) Focus on high yield leading business opportunities in both segments i.e. chronic and acute
segments.
4) To increase the present annual sales of Rs.50,00,000 to Rs. 80,00,000 in next 3 years.
3.2 Departments at Amtech Med
Amtech Med comprises of departments where each department looks after their own area of activity
and with its sound and efficient capabilities assists the other departments also moving whole
organization towards the positive prospects. The major departments of Amtech are discussed below:
A. HR Department:
Human resource department is closely related to company's employees such as recruitment,
selection, development, promotions, transfer, performance appraisal, etc. Before selection of
staffs all the candidates have to go through a medical examination by the organization doctor.
Mainly production staffs are medically examined by the registered organization's doctor at the
time of recruitment. Personnel suffering from any contagious or obnoxious work are not
allowed to work or visit the production area. For the purpose of improving the skills, abilities
and knowledge of the staff members, human resource development of Amtech Med provides
various job related trainings. Trainings covers all employees as per the need. Need is
recognized as per the information or felt by the employees ultimate supervisors. The newly
appointed staff has to undergo a introductory training regarding company profile, premises,
sanitation, and hygiene and depending upon the work the training is done regarding WHO
GMP and GLP, training is also given on installation of new machines, change development in
manufacturing, analytical procedures, production of new products etc. The training provided
to the staffs is generally in house and are repeated in every six months, but there is also
arrangement for external training by sending employees to other institutions. Evaluation of
training is done by the questionnaire details during and outside the training section.
B. Internal Audit Department:
This department is responsible for maintaining and verifying the individual account of the day
to day basis like the expenses of staff salary, expenses of staff lunch and other miscellaneous
expenses.
C. Finance & Accounts:
This department is responsible for maintaining and preparing whole accounts and budget of
the bank. This department also prepares final financial statement of the company.
D. Legal Department:
The main function of this department is to look after the legal aspects of the company.
Formulation of laws and policies for the company also lies in this department. This
department takes all the legal actions on the behalf of the company as required according to
the situation.
E. Marketing Department:
The main function of this department is to formulate the marketing & promotional plans for
the product. As the company's sales is totally dependent on personal selling, so how better to
divide the market as per the sales force abilities are also the responsibilities of the marketing
manager. This department formulates plans, divide the whole geographical market areas,
plans the marketing budget, controls the medical representatives, handles the customer
compliance, understands the market demand and always focus on increasing the company's
sales and work with quality assurance department to handle quality related problems.
Managing compliance as per figure 4:
Area representatives collect the materials and bring back to the organization and QA
department takes control of such products and are labelled as RECALL products and are
stored separately until they are checked and approved for resupply in market. The distribution
channel used by the company is shown in the figure 4.1:
Quality Assurance
Marketing Manager
Area Representatives
F. Production Department:
Production department is sole responsible for production of the quality products and quality
work practice in factory. Production department is controlled by production manager who is
in direct contact with company's managing director. Under production manager there are
quality assurance department manager and store manager. Production manager or Plant
manager is responsible for managing human resource in factory and he is also responsible for
recruiting people in factory.
G. R & D Department:
Actually in Amtech it is not R & D department, it is FR & D i.e. Formulation , Research and
Development. This department is responsible for studying those products which is already
available in market and develop its composition and establish the product and suggest
company's managing director about those products which can be produced and is feasible to
produce by having some changes.
AMTECH MED
Chemist Store
Stockists
Hospitals ( Target
Customers)
Doctor's Clinics ( Target
Customers)
Patients (End Consumers)
Figure 4.1: Distribution Channel
3.3 Major Products of Company:
S.N Products Name S.N Products Name
1. DICLOBACK PLUS 32. P-MOL TABLET
2. HEM-F TAB 33. P-SPAZ
3. CODOCET TAB 34. QUINOTECH-250MG
4. MEDAZOLE-200 TAB 35. RABIFAST-20
5. AMSONE 36. REVIVE ORS
6. MEDAZOLE-400 37. SILGARD-25GM
7. COOL LITIO-100ML 38. TERITOP
8. BESTDIN-50 ML 39. TERITOP-250
9. INOX 40. ACETOP
10. HYO-AM 41. A-DOX 100CAP
11. EXTINA 42. AFLAM PLUS
12. AMTRIM D.S. 43. ALASKA
13. AMTRIM-PED 44. AMBROX-30
14. BESTDIN-GM 45. AMCEF-100DT
15. BESTDIN LIQUID 46. AMCEF-200
16. AMTRIM 47. AMCIDE FORTE
17. MEGACAL 48. AMCOBAL-1500DT
18. AMNOVATE-N 49. AZITECH-250 TABLET
19. MEGADERM 50. AZITECH-500 TABLET
20. AMFOL PLUS 51. CARDILAN-10 TABLET
21. COOL LITION-30 ML 52. CETRON
22. AMFIELD-30 GM 53. DIACID TABLET
23. MOVERAN GEL (20GM) 54. DICLOBACK-100
24. ACETOP GEL 55. FLUC-AM
25. AFLAM 56. LEVOHIST
26. AMFEN-200 57. MEDAZOLE-DF
27. AMFOL 58. NIMID
28. DICLOBACK-50 59. OFLACIN
29. NIMID GEL 60. OME CAP-20
30. OFLACIN-400 61. QUINOTECH-500
31. PANPRAZ 62. WORMCARE
The above table 4.1 shows some the major products of the company. Besides these medicines
currently company is also working on some new products as Liquid syrups and in this syrups there
are several range as from a normal cough syrup to antibiotics and also VITA-PLUS syrups and
LIVER-TON. Besides syrups company is also working on developing sugar free cubes.
CHAPTER FOUR
ANALYSIS OF ACTIVITY DONE AND PROBLEM SOLVED
During organization study period, internee worked and visited in different departments. Inside the
block of the company, internee got chance to work in production plant, marketing department mainly.
An internee was given a brief overview about the work of the particular department and allowed to
observe and learn the work procedure but was never allowed to be involved in actual work procedure
as per their SOP. However, internee learned by asking questions to the staffs of the departments and
also by observing their daily work.
The different types of activities performed in different department are:
4.1 Production Department:
Production department is considered as one of the crucial department in pharmaceutical industry in
handling the quality of medicines and fulfilling the demand of medicines in market. In today's highly
competitive and fast growing business field and increasing pressure on Nepal Pharmaceutical
Industry there is a need of developing this department for production of better products. Currently
Nepal is facing pressure from WTO and in such situation in order to save this industry it is very
essential to develop production department.
In general, production department plays very important role as it is related to medicines a slight
mistake can lead to great damage. So production department it is very important.
4.1.1 Activities Performed in Production Department:
Different activities that internee had carried out during the placement in production department are as
follows:
 Inspection of store or inventory department which comes under production department and
watch out the inventory management system of the company. In store room also before
storing the materials, materials have to move through various test to know about its quality
and store temperature. In store room storage section were different for different chemicals
and were stored in cool and dry place in controlled room temperature of 18°C to 25°C. None
of the materials are stored without test and from store department also none of the materials
are moved forward into production area without test.
 After inspection of the inventory system, internee was moved to actual production area.
There internee was expected to watch the production process and suggest something if
needed. In production site internee came to know about the production process of tablets,
capsules and ointment. Company mainly used PROCESS LAYOUT for all types of
medicines. Production process of different medicines are as:
 For Tablets:
Mixing of raw materials
Granulation using aqueous or non aqueous binder
Equalizing the size of the granules
Drying
Lubrication
Coating
Sorting and Packing
 For Capsules:
Mixing
Filling
Polishing
Sorting
Packing
 For Ointment:
Preparation of oil phase
Preparation of water phase
Mixing of oil & water phase
Cooling
Milling
Filling & Crimping
Packing
 After production packaging. In packaging also all the process carried out was as per the WHO
GMP standard. In packaging both labour as well as human power are used for packaging.
Mainly men power is used for printing the dates and batch numbers and keeping record of the
weights of accepted finished goods and rest things were done by machine.
So these are some of the activities performed in the production department. But internee really
enjoyed being in marketing and also suggesting some ways of marketing and establishing some
digital platforms of the company.
4.2 Marketing Department:
After production main role is played by marketing. Here in this industry always they use Personal
Selling as one promotional mix and some time for some medicines they may use direct marketing but
till now it is not used by the company. Company is mainly using personal selling. The selling process
with doctors are as:
 Taking appointment may be by cold calling or through friends
 Meeting with doctor
 Information about company and product presentation
 Handling objections
 Closing sales and
 Follow-up
And for selling products to stockists they carry out almost same procedure but instead for taking
appointment they believe in building relationship, cold calling, and reference from others through
these Medical Representatives they prepare their list of qualified stockists and have some pre-
approaches before visiting them in order to have better closing of sales. Internee being part of the
marketing department here he understood about core of marketing of pharmaceutical company and
very important 4P's as well as 7P's for pharmaceutical company.
 7P's as:
Product- Medicines, Health awareness educations
Price- Pricing is mainly done on the basis of market prevailing rate and premium pricing
Place- Two and Three level of distribution channel is used
Promotion- Personal selling
People- Well qualified men power at work having employees with minimum of 2 years of
experience before coming to this company in same pharmacy sector
Process- All the process for manufacturing and service carried out are as per WHO GMP
guidelines and also company it have its own SOP
Physical Evidence- Factory location is facilitated with all types of basic facilities for smooth
production process and is certified by WHO GMP & GLP
 STP:
Segmentation: Demographic Segmentation
Targeting: Targeting is mainly done on the basis of segment attractiveness along with
company's objective and strategy used id differentiated marketing.
Positioning: "We understand your Health", a company for complete health solution
4.3 Analysis of Effect of WTO on Nepal’s pharmaceutical industry
The impact of WTO on Nepal’s pharmaceutical industry can be identified by studying the affect of
each agreement of WTO that has impact on the pharmaceutical industry.
TRIPS
The main impact of TRIPS agreement of WTO will be felt on two areas. They are:
1. Domestic manufacturers who are producing and commercializing products covered by patents will
be forced to go for licensing agreements with the patent holders resulting in the royalty payments and
in some situations there would be an increase in prices of the drugs. By the time Nepal recognizes the
patents of products related to the pharmaceutical industry, most of the drugs that were approved for
marketing from 2002 would be still in patent period as on January 1, 2016. For these drugs either the
innovators will distribute these drugs themselves through his own distribution channels or give
license for the players who are operating in the domestic market by charging a royalty on the sales.
As per the mail box provision of TRIPS, the patent holder has to file his application for patent in the
Nepal market with the concerned regulatory agency in order to get patents recognized in the market.
2. TRIPS inhibit the advantages the players are currently deriving through reverse engineering and
there would be increased investments in R&D. Here the domestic pharmaceutical companies which
are currently progressing well with the generic versions of the patented drugs with lesser costs would
lose the opportunity of coming out with the newer drugs within a period of 1 to 2 years from the
launch of the innovator product in the international markets. So the option for them would be to
remain completely a generic player or slowly move to a research based pharmaceutical company or
be a contract manufacturer for the innovative and generic companies. With such scenario the business
and revenue models of the pharmaceutical companies would be witnessing a change. As the options
for the companies to sustain will be few, there would be increased investments in research &
development by the companies and the investments would go from the current levels of less than 1
per cent of sales to near about 5 to 8 per cent by the time the patents are recognized in the
pharmaceutical industry from 2016.
3. With the introduction of TRIPS, most of the MNC players would be eyeing the market in a major
way as the product patents are recognized and they come out with their complete portfolio of drugs
which are of highest quality produced in plants that are certified by regulatory agencies globally with
the economies of scale(in most of the cases the plants from which the drugs are produced for the
Nepal market would be located outside until unless there is a distinct cost advantage in the domestic
market and the market is so huge in 2016). Moreover with the growth of the market, there would be
tougher competition from the generic MNC’s to the domestic companies. This results in the domestic
players also making their drugs in the internationally certified plants to have better quality with
higher capacity utilizations and increase their budgets for the marketing and promotional activities to
sustain in the market. Looking at the impact of the patent recognition of the drugs (molecules) on the
pharmaceutical industry in the various market, it was found that the industry has grown overall in
terms of growth, increased domestic players presence and increased Alliances/Joint ventures/
technology transfers, etc.
Technological Barriers to Trade
As per the Agreement of Technological Barriers to Trade, the Articles 2.8, 2.9 & 2.11 specifying the
Technical Regulations and the Article 5 dealing with the conformity assessment can be the
restrictions for trade. The other issues that can be of importance with this agreement are the
transparency of the regulations framed by the members, the protection of data submitted for the
approval of new drugs and the granting of market access including the drug registration and re-
imbursements. Currently Nepal pharmaceutical industry wouldn’t face any restriction to trade with
this agreement, but this can turn into a restrictive agreement once the companies from the industry
starts looking at the export markets.
Agreement on the Application of Sanitary and Phytosanitary Measures
As per the Sanitary and Phytosanitary measures, export potential of the pharmaceutical firms in the
Least Development Countries will be hindered as most of the production plants in these countries are
not in compliance with the Agreement on the applications of Sanitary and Phytosanitary Measures.
Pharmaceutical companies has to follow current Good Manufacturing Practices as determined by
WHO which needs much of the investments into the production plant which most of the
pharmaceutical companies in the LDC’s like Nepal are not in a position to invest. But the production
plant has to confer to the national standards, rules. The national rules standards have to confer to the
SPS agreement.
4.4 Problem Solved
Although Amtech is able to meet the changing need of the market, some problem have been analysed
and possible measures have been taken to minimize the problem and solved them while working in
Amtech. Following are some of the advice given and steps taken by intern to solve the problems
during his internship:
1) Development of digital platform for promotion of company as well as its product.
2) Advice given to have adjustments in order minimize operating cost.
3) Lead time management by suggesting the appropriate use of the workers in organization.
When intern was in organization as intern, what intern saw was pharmacists in one
department was sitting as his work was finished and now no more work to do where in other
department production was stopped due to lack of pharmacists. So intern suggested to
minimize the lead time by increasing the responsibilities and have better use of limited
resources by having cross functional departmental work approach and by that approach
pharmacists can be transferred to that department where there was shortage of pharmacist.
4) Got chance to develop the distribution channel for the company.
4.5 Observed Gap
The students are selected as internee in different organization so that they can present themselves as
skilful person on related field on which they have been appointed. The organization gives the
environment for internee to fulfil certain responsibilities. Regarding this internee can show their
capability and intelligence. While working in the company internee observed and evaluated the
theoretical knowledge he has gained and what actually happened in the work situation. Theoretical
knowledge helps a lot in understanding the actual working environment, but not exactly cent percent.
CHAPTER FIVE
CONCLUSION AND RECCOMENDATION
Recommendations
Competitiveness of a sector or industries under the sector can be enhanced through the enhancement of
quality and productivity of the sector or its industries. Therefore, the steps to be taken by the Nepalese
pharmaceutical industries to enable them to capitalize on the opportunities and face up to the
challenges would be those measures, which would enhance quality and productivity of the industries
in isolation or in combination. The steps are as follows:
5.1 Quality Enhancement:
Quality Assurance of Products through Plant Facility Certification:
WHO-GMP certification ensures the quality of plant facilities and pharmaceutical products produced
at the plant. Such assurance develops trust of the medical doctors as well as general practioners and
end customers on pharmaceutical products, and this ultimately assist in capturing the domestic and
export markets. Presently five industries have WHO-GMP Certification and do have good market
recognition and are doing good business. A significant number of industries are under going through
the certification process. One of the considerations medical doctors take while prescribing foreign or
domestic brands is the quality of medicines. By assuring the quality products domestic industries can
overcome the biasness and apprehensions usually associated with them, this could result in increased
prescriptions from medical professionals. As the quality certification opens-up the door to
international markets and domestic markets, the industries having certification would be more
competitive. The Nepalese industries with quality assured product can expand their business in
domestic market at first and then enter export markets.
Quality Assurance through Quality Management System and Environment Management Systems:
Having ISO 9001:2000 Series and ISO 14000 Certification will not only improve the corporate image
of the industries but also guide the industry to have management systems which could lead them to
their long term sustainability and growth; and fulfil the environmental responsibilities. These
certifications can also assist industries to have systems, procedures, data/information base and others
where these are lacking especially in industries run and managed by owner managers leading to
enhancement in quality, productivity and competitiveness.
Adoption of Stringent Quality Standards
Quality assurance is possible by improving quality assurance systems of industries and it could be
carried out without any certification. Nepalese industries need adopt measures for quality assurance
and adopt stringent quality standards. This could restrict unfair competition in domestic market from
the low quality producers by pressurizing and assist the Government in regulating quality control
measures and thus minimize the unfair competition from low quality products of both domestic and
foreign industries.
5.2 Enhancing Productivity
Enhancing Productivity by Attaining Economy of Scale/Efficiency
Attainment of economies of scale by industries helps in enhancing their productivity, which is possible
through various measures. These measures, which in isolation or in combination could lead those
industries to attain their economies of scale, are:
a. Higher Capacity Utilization
The capacity utilization of Nepalese industries varies from 25% to 80% depending upon investment
scale and others. Small scale industries have capacity utilization of 25 to 40%, medium scale 40 to
60% and large scale above 60 percent. Small and medium scale industries need to increase their
capacity utilizations by rationalizing the product mix and even outsourcing to the large scale industries
for the benefit of both. Increased capacity utilizations bring better utilization of physical resources to
the industries and bring better margins; if products having market potential could be produced. The
industries having export potential could look for export markets in order to grab foreign market and to
increase their capacity utilization. Especially, the large scale industries having WHO-GMP
certification(s) and operating at higher than 80% may look to the international markets for exports
apart from increasing the domestic market share. The first step towards this will be to identify the
LDCs, where the WHO-GMP practices are sufficient for exports. After possessing an “investible
surplus” from those markets, the industries may explore to get their plants approved by agencies in
regulated markets like USA, Japan, Germany, France, etc. With the option of the export income,
income generating sources for the companies will increase and dependence on the domestic market
will come down enabling the company to hold out in times of fluctuations in the market.
b. Increase Breadth of Product Portfolios
The industries could attain operational economies of scale by increasing the breadth of their product
portfolios. Only a few industries are producing medicines to life style relating diseases like cardiac,
CNS, diabetic, ophthalmology, etc. Therefore, there exists demand for such products and efforts need
to be made by other industries to
produce those pharmaceuticals by fulfilling the pre-requisites for their production, if possible. It is
because these are the segments, demand for which is growing faster and lasts for longer period.
c. Acquire Technical Manpower
The industries could attain their economies of scale by developing human resources either by
providing opportunities to its personnel or recruiting new ones, if the limitation is due to the constraint
of highly skilled technical personnel. With the personnel of that nature Nepalese industries could
initiate process of reverse engineering and chemical synthesis.
d. Increase Share in Domestic Market
Currently, imports account for about 70% of the domestic market and the share of the domestic
industries is only about 30%, which needs to be increased. With the increase in sales and market
share, industries could optimize the use of their plants.
Enhancing Productivity by Reduction in Cost of Production
a. Efficient Utilization of Inputs
Productivity of pharmaceutical industries could be improved with the betterment in utilization of
inputs like ingredients, utilities, labour and others. This could also result in wastage minimization in
industries. The cost savings made by these would definitely enhance the competitiveness of industries.
b. Supply-Chain Management
By having effective and efficient supply-chain management industries could reduce their cost of
production enhance productivity and competitiveness.
c. Backward Integration
Producing the bulk drugs or active pharmaceutical ingredients by domestic industries by acquiring the
process development knowledge and skills could reduce the cost of those materials leading to drop in
cost of production for industries. Such producers could look at supplying to the other domestic
formulation manufacturers apart from their in-house consumption. Apart from domestic market, there
could be an export potential for those with the certified plant. This brings in better margins for the
companies by integrating operations backward. The purposes of such integration is to achieve control
on costs, quality and delivery period of inputs.
d. Common Infrastructure and Facilities
Having common infrastructure and facilities could also reduce in cost of production and waste disposal
leading to the improvement in productivity and then to competitiveness of industries using common
infrastructure and facilities. It is because majority of Nepalese pharmaceutical industries are small and
medium scale having limited investment capabilities.
5.3 Competitiveness through Innovation
a. Undertaking Innovative Research and Development
Investment in research & development of pharmaceuticals by Nepalese industry is relatively very low;
less than one percent of the total sales. The industry could enhance its competitiveness by investing in
R&D, mainly into organic synthesis for the reverse engineering of the molecules and minimizing the
number of steps in the manufacture of the bulk drugs and final products. The increased capability in
the reverse engineering of the molecules could gradually lead to the expertise in molecule research. It
could improve their long term sustainability either through contract research or cost effective products
with vibrant in-house R&D.
b. Institutionalization of Industries
Gradual institutionalization of Nepalese industries would be necessary for enhancing the
competitiveness of the sector as a whole. It would provide vision and mission for the industries, where
those should head for and also organizational systems, procedures, processes, and others. A few
industries might have to undergo even restructuring and reengineering processes.
c. Collaboration
Collaboration with foreign or domestic companies could enhance competitiveness due to improvement
in productivity and quality of self or due to comparative advantages of collaborating partner(s).
5.4 Enhancing Effectiveness
a. Marketing and Promotions
The industries need to be aggressive in marketing and employ innovative marketing strategies and
promotional measures to counter the well established foreign companies. Sales and the marketing
representatives have to adopt a professional approach, for which regular training and up gradation of
sales forces and medical representatives will
for better coverage of the doctors, which in turn will augment the demand through increased
prescriptions.
b. Explore Export Markets
Looking at the export market is vital for the Nepalese industries as the domestic market is small
compared to world market. The industries could explore the opportunities of exporting formulated
products and active pharmaceutical ingredients, if produced. This can be started with the neighbouring
markets of Bangladesh and other LDCs. To capture these opportunities the plants should be upgraded
to international standards. As the large industries have already the WHO-GMP certified plants those
could look towards export markets. The major constraint for exports is the need for airlifting of
products for industries, which is affecting in their competitiveness. Therefore, efforts need to be made
to solve by appealing to the government and garnering required assistance to make exports
competitive.
c. Increase Linkages with the Academia
There is an urgent need for the domestic companies to interact with the academia or the research
institutions in the country to utilize their resources productively for the development of better process
of manufacturing through qualified technical manpower with the good expertise in fields related to
pharmacy. This to a greater extent can also overcome the constraint of technical manpower along with
the sharing of the costs.
d. Increase Work Relationship with Professional and Business Associations
With a view to enhance the effectiveness of business, industries need to develop, review and maintain
work relationships with professional associations like NMA, and business/trade associations FNCCI,
APPON, NCDA, etc. These could influence the doctors to prescribe the drugs for which the domestic
brands are available. The pharmaceutical sector as a whole needs to address this issue and
communicate the message to the doctors. This kind of work relations could publicize Nepalese
pharmaceutical products. A strong franchise developed with the doctors and the chemists could avoid
substitution of pharmaceuticals.
Conclusion
Accession of Nepal to WTO has brought both opportunities and challenges to Nepalese
pharmaceutical industries. World market of pharmaceutical products is now open to Nepalese
industries and simultaneously Nepalese market is open to industries worldwide. In this context
Nepalese pharmaceutical industries need to be able to explore the opportunities and make best use of
those. In addition, those industries also need to identify the external threats for them and make efforts
to overcome the threats. Therefore, Nepalese pharmaceutical industries have to undertake measures
that would enhance their competitiveness, which could lead them to harness their strengths for
exploiting the opportunities before stepping into WTO/TRIPS regime in 2016. Since competitiveness
of industries under the sector could be enhanced through the enhancement of quality and productivity
of the industries, the measures to be taken in isolation or in combination by the Nepalese
pharmaceutical industries would be to enhance quality and productivity of the industries which would
enable them to capitalize on the opportunities and face up to the challenges. Based on the study of
present status; and analyses of opportunities and challenges for Nepalese pharmaceutical industries in
the wake of WTO, recommendations are made for government, private sector industries, and
associations related to pharmaceutical industry for enhancing the competitiveness of pharmaceutical
industries.
BIBLOGRAPHY
Shrestha, B.K., & Bhandari, D.B. (2013). Drug Markets & Institutions. Kathmandu:
Asmita Books and Distributors Pvt. Ltd.
Department of Drug Administration (2013/14). Annual Report. Kathmandu: DDA
Matrix Services Plc. In association with Centre for Gender & Management and Cygnus
(2012). Research Report on Nepal Pharmaceutical industry. Kathmandu:
www.google.com
www.dda.gov.np
www.ekantipur.com
Appendix 1
Number of the pharmaceutical companies by country of origin registered at DDA
Country Number of Companies
1. India 168
2. Nepal 39
3. Korea 6
4. Bangladesh 5
5. Belgium 4
6. France 4
7. Germany 3
8. Switzerland 3
9. UK 3
10. China 2
11. Holland 2
12. Japan 2
13. Malta 2
14. Australia 1
15. Bulgaria 1
16. Italy 1
17. Malaysia 1
18. Mexico 1
19. Pakistan 1
20. Sweden 1
21. Taiwan 1
22. Thailand 1
23. USA 1
Source: DDA, Nepal
Appendix 2
Brands Available in Nepal by Therapeutic Groups
Therapeutic Groups No. of Brands
Anti-Infectives 628
Respiratory 337
Vitamins/Minerals 238
Gastrointestinal 402
Pain/Analgesics 325
Dermatologicals 278
Gynaecologicals 147
Cardiac 182
Neuro/Cns 207
Anti-Parasitic 189
Ophthal/Otolog 153
Anti-Diabetics 49
Others 238
Source: Org – IMS Retail sales audit

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Study on Pharmaceutical Industry of Nepal

  • 1. A STUDY ON PHARMACEUTICAL INDUSTRY OF NEPAL Report submitted to CMS Business School (Jain University) in partial fulfilment of the requirements for the Degree of Masters in Business Administration Submitted by ABHISHEK MISHRA 14MBA63002 December 26th 2015 Under the guidance of Prof. KRISHNA KOPPA No. 319, 17th Cross, 25th Main, JP Nagar 6th Phase, Bangalore - 560078 Bangalore, INDIA E-mail: mba@cms.ac.in, Website: www.bschool.cms.ac.in
  • 2. DECLARATION I, Abhishek Mishra with Reg. No: 14MBA63002, declare that this report on the Use of Osterwalder's Framework in Online Health Care Companies is undertaken by me and is submitted to CMS Business School, in partial fulfilment of the Master of Business Administration programme offered by the Jain University Bangalore is a record of original and independent work done during the academic year 2015. Abhishek Mishra
  • 3. ACKNOWLEDGEMENT I especially like to thank Prof. Krishna Koppa faculty of Marketing Jain University who helped me lot for the successful accomplishment of this report. I thank him for being my mentor for this study and guiding me at various stages to achieve my objective. Finally, I also like to thank him for providing me everything that I needed for this study. I am glad and lucky enough to have mentor like him. Thank you sir. Thank you. Abhishek Mishra
  • 4. CHAPTER ONE INTRODUCTION 1.1 Background of the study A healthy manufacturing sector is very essential for the development of any economy. But talking about pharmaceutical manufacturing then it is not something which everyone and every economy can perform. Nepal as being naturally rich country it have some advantage and competitiveness in this industry if the capacities are utilized. due to which there are many foreign Ayurvedic companies which made their way to Nepal to have such herbs. A well developed pharmaceutical system promotes investment by the identified investors in the country leading to various business opportunities, mobilizing funds and effective utilization of resources. Nepal Pharmaceuticals industry we have 44 companies all playing vital role in the economic development of the country. In Nepal, pharmaceuticals are considered as one of the few very successful business which is contributing and have bright future. In Nepal presently we have companies manufacturing medicines for both humans as well as animals. In Nepal Pharmaceutical industry there are few companies who have just started formulating the medicine compositions, there are companies manufacturing best qualities of bands and band-aids. And of all Nepal Pharmaceutical will always be known for its huge and best qualities Ayurvedic products of their own. The main focus of this report is to let the readers know about the strength of Nepal's Pharmaceutical Industry knowing and overcoming its weakness. And also to aware my readers about impact of WTO and Provisions of TRIPS 2016. 1.2 Objective There are three main objectives for this study as:  to identify strategies to be adopted by Nepalese Pharmaceutical Industry to grow and harness their strengths for tapping the opportunities  to identify ways in facilitating Nepalese Pharmaceutical Industry to gear up for the WTO regime (assigned by company)  This study is also initiated for self awareness and understanding of the pharmaceutical industry and companies 1.3 Scope The scope of the study is to cover the followings aspects: i. Overview of the Nepalese Pharmaceuticals Industry:  Industry Structure  SWOT analysis of Nepalese Pharmaceutical Industry  Critical success factors.
  • 5. 1.4 Methodology The methodology adopted for this study is as;  Collection of the primary data interacting with some of the experienced person in the industry, interacting with the persons in the DDA (Drug Department Administration of Nepal), and interaction with the Managing Director of the chosen company  Data collection and analysis is also based on the desk research 1.5 Limitations: The limitations are: i. Lack of time obstructed for better and deeper study. ii. Study mainly focuses on the Pharmaceutical Industry and companies. So it can't be used for other studies. iii. Report includes only data collected from DDA and study of operating procedure of only one company. So very difficult to apply over all the companies (small and medium) in the industry. iv. The recommendations given are based on perspective of the present status of the Nepalese pharmaceutical industry and the opportunities vis-à-vis and the changing regulatory environment in the context of WTO. So the report is mainly of short term in nature although it covers macro environment but can't be equally important after 5-10 years. As the period of 10 years is a considerable time frame for any industry in changing its dynamics. v. Most of the Nepalese Pharmaceutical Companies were not able to clear the threats the industry is currently facing and the impact of WTO regime on them. Therefore, the study of WTO relating to Nepalese pharmaceutical industry is taken parallel from the other markets, where WTO agreements were recognized. 1.6 Organization selection: For the specialization in the field of marketing, I had certain options to choose from the Pharmaceutical organizations that offers the most of the information. So I chose Amtech Med as it has the best offerings to the students. 1.7 Duration of Study: In order to attain my objective following the guidelines of the Jain University, this study program was successfully accomplished from Friday, 23 October 2015 to 15 January 2015 in Biratnagar Nepal. There are various activities performed by the intern during these period which will be dealt in detail in Chapter 4.
  • 6. CHAPTER TWO INTRODUCTION OF INDUSTRY 2.1 Background Nepal has become a WTO member on April 23, 2004. Accession of Nepal to WTO has brought both opportunities and challenges to Nepalese pharmaceutical industries. World market of pharmaceutical products is now open to Nepalese industries and simultaneously Nepalese market is open to industries worldwide. In this context Nepalese pharmaceutical industries should be able to explore the opportunities and make best use of the opportunities. In addition, Nepalese industries should also identify the external threats for them and make efforts to overcome the threats. Therefore, it has become imperative for individual Nepalese pharmaceutical industries and Pharmaceutical Industry as a whole to formulate the strategies which could lead them to their growth and how they could harness their strengths for exploiting the opportunities before stepping into WTO/TRIPS regime in 2016. Since majority of pharmaceutical industries in Nepal are SMEs, there is a necessity for a facilitating role by the government for gearing-up Nepalese industries to utilize the opportunities under WTO regime. Therefore, it is also imperative to identify the roles to be played by the government to facilitate the Nepalese pharmaceutical sector to enter WTO regime. With a view to fulfil these needs this study has been carried out. 2.2 Global Scenario The usage of pharmaceuticals is governed by the underlying medical science. The four primary medical sciences are as Allopathy or modern medicine has gained global popularity, Ayurveda, an ancient Indian Science, mainly uses herbal remedies, Unani, having Chinese origin, is prevalent in South East Asia, and Homeopathy, founded by a German Physician, was fairly popular in the early 19th century. World-over the pharmaceuticals industry is focused on Allopathy, the most modern medical science. Other modes of medical treatment such as Homeopathy, Ayurveda and Unani are more prevalent in their world countries. 2.3 OVERVIEW OF NEPALESE PHARMACEUTICAL INDUSTRY Industry Structure 2.3.1 Domestic Pharmaceutical Industries As per DDA there are 44 pharmaceutical industries in operation at present in Nepal. According to the Industrial Enterprise Act 1997 and subsequent amendments, industries with the capital investment up to Rs 30 million is considered as small scale industries and those between Rs 30 million to 100 million is considered as medium scale industries. The industries with capital investments more than Rs 100 million are categorized as large scale industries. Of the above 44 industries, 7 units are of small scale, 32 units in medium scale, and the rest 5 in large scale. Majorities of these units are located in Kathmandu Valley and Narayani Zone, while the rest are scattered in places like Janakpur, Biratnagar, Bhairahawa, Dharan. Except the Royal Drugs Limited,
  • 7. all the pharmaceutical units are in private sector and registered as private limited company. The list of recognized pharmaceutical units along with their location is presented in Table No, 1.6.1. Alive Pharmaceutical Pvt.Ltd Biratnagar Amtech Med Pvt.Ltd Biratnagar Alliance Pharmaceuticals Pvt. Ltd Simra, Birgunj Amie Pharmaceuticals Pvt.Ltd Janakpur Apex Pharmaceuticals Pvt.Ltd Parwanipur, Birgunj Arya Pharmalab Pvt.Ltd Rampur, Kokani, Parwanipur, Birgunj Asian Pharmaceuticals Pvt. Ltd. Padsari, VDC-9 Rupendehi, Bhairahawa Birat Pharma Lab Pvt. Ltd Biratnagar Chemi Drug Industries Pvt.Ltd Kathmandu Concept Pharmaceutical (N) Pvt.Ltd Birgunj CTL Pharmaceutical Pvt.Ltd Bhaktapur Curex Pharmaceutical Pvt,Ltd Janagal, Benepa, Kavera Danium Laboratories (P) Ltd. Birgunj Deurali-Janata Pharmaceuticals Pvt. Ltd. Dhapasi,Kathmandu Dingla Pharmaceuticals (P) Ltd Biratnagar Everest Pharmaceuticals Pvt. Ltd Kathmandu Florid Laboratories Pvt.Ltd Lalitpur G.D Pharmaceutical Pvt.Ltd Birgunj Hukum Pharmaceutical Pvt.Ltd Bhaktapur Lomus Pharmaceutical Pvt.Ltd Kathmandu Mark Laboratory Thankot Maruti Pharmaceuticals Pvt.Ltd Kathmandu Manoj Pharmaceutical Works Pvt.Ltd Dharan National Health Care Pvt.Ltd Bara National Pharmachem Janakpur Nepal Pharmaceuticals Lab Pvt.Ltd Parsa Ominica Laboratories Pvt.Ltd Bhaktapur Pharmaceutical Company of Nepal Pvt.Ltd Bara Pharmaco Industries Pvt.Ltd Kathmandu Quest Pharmaceutical Pvt.Ltd Bara Royal Drug Ltd. Kathmandu Shiv Pharmaceutical Laboratories Pvt.Ltd Dharan Siddhartha Pharmaceutical Pvt.Ltd Madhyawaliya, Rupundehi, Bhairahawa Simca Laboratories Pvt.Ltd Bhaktapur
  • 8. SR Drug Laboratories Pvt.Ltd Kathmandu Summy Pharmaceutical Pvt.Ltd Nawalparasi Time Pharmaceutical Pvt.Ltd Mukundapur WNO 5 Unique Pharmaceutical (P) Ltd. Birgunj Vijaydeep Pharmaceutical P.Ltd Lalitpur Vijaydeep Laboratory Lalitpur Source: Drug Bulletin Published by DDA All pharmaceutical industries produce pharmaceutical products in tablet and capsule forms while a limited number of units produce products in liquid, ointment, dry syrup, powder forms. Of those only two units produces IV Fluid and a another one the injectables. Majority of the industries are producing same group of products, but some have started producing cardiovascular, psychotropic and anti-diabetic products too. Only two industries are producing I V Fluid i.e. Dextrose. And most of these companies as urged by DDA, have already acquired WHO-GMP Certificate and are also ISO 9001:2000,14000 certified companies. 2.3.2 Market Major Companies in Market The Nepalese pharmaceutical market has one of the highest brands Per capita and is highly import driven. The market is highly dependent on import from domestic and multinational companies of India, Bangladesh, and others. The top 10 companies hold 33% of the total retail pharmacy market by sales value and the next top 30 companies hold 62% of the market. The top 10 pharmaceutical companies in retail market are given in Table No. 1.6.2. 1 Lomus Pharmaceuticals Nepal 2 Nepal Pharmaceuticals Nepal 3 Deurali-Janata Nepal 4 Aristo India 5 Dabur India 6 National H.C Nepal 7 Knoll MNC 8 Ranbaxy India 9 Nicholas India 10 Alkem India Soucre: DDA Major Products In Market The top 10 pharmaceutical products based on sales value in the market are largely dominated by those of the Indian companies. Those have earned this position by virtue of being in the market the longest. In addition, better marketing and promotion, and an impression of superior quality have kept them on the top 10 list. Off late the Nepalese pharmaceutical companies are able to make their entry into the top 20 products with brands like Nemox, De Cold, Brucet, Reymoxis, etc. produced by
  • 9. National Healthcare Private Limited, Lomus Pharmaceuticals, Nepal Pharmaceutical Laboratories Ltd, Deurali Janata. Sales and Distribution System All pharmaceutical industries are marketing their products solely within the country. Their pharmaceutical products reach the end users through a four– tier distribution system consisting of distributors, stockiest, sub stockiest and retailers. According to the recent statistics of the DDA, there are 2,350 medical wholesalers and 18,255 pharmacies that are operating in the country. Main and Auxiliary Raw Materials Nepalese pharmaceutical industries are dependent of import for bulk drugs and active pharmaceutical ingredients. The major source for importing bulk drug and active pharmaceutical ingredients for medicines is India. The others are China, Belgium, South Korea, Australia, Denmark, Holland and Switzerland. Other requirements of the domestic producers like binders, diluents, disintegrates, glidants for tablets, capsule shells for capsules, suspending agent for suspensions, sweetening agents, colors, preservatives, antioxidants and other auxiliary materials are also met from India. Technology The technologies used to manufacture pharmaceutical products in Nepalese industries differ from semi-automatic to automatic depending upon the form of pharmaceutical product. – Tablets, capsules, liquid, ointment, dry syrup, powder, injectables etc. The machineries used to manufacture pharmaceutical product are mostly from India. But instruments and equipment for quality control and quality assurance are mostly from third countries like Singapore, Japan, Germany, etc. All the industries have incorporated quality control in its production process, but only a few have system for quality assurance. With a view to enhance technology and quality of the sector, two industries have come forward and developed linkages with academia. Only one industry has technical collaboration with Bangladesh Company. Human Resources Except highly skilled technical manpower there are enough human resources available for Nepalese pharmaceutical industries to carry out pharmaceutical formulation, production and marketing of formulated finished products, as Nepal has sufficient number of qualified pharmacist, chemist and skilled technical manpower required for above. Therefore, all domestic pharmaceutical industries are having Nepalese production and marketing manpower. But in case of highly skilled technical manpower capable of undertaking R & D, quality assurance, and complex formulations; the requirement is met from India and abroad.
  • 10. Research and Development Research & development in Nepalese pharmaceutical industries is limited to pharmaceutical formulation and testing only. No industry has enough capability for carrying out R & D for reverse engineering of new molecules. Even the Royal Drugs Research – a governmental laboratory established three decade ago to carry out researches in drug is limiting its activities only in drug testing. Three laboratories under the private sector are capable of drug testing activity in a limited scale. 2.3.3 SWOT Analysis SWOT Analysis of Nepalese Pharmaceutical Industry is as; Strengths a. Production Facilities Production facilities of most of the Nepalese pharmaceutical industries are upgraded and updated as per the market and GMP requirements. With a view to be able to address the market needs manufacturing research and development & QC activities are regularly carried out. b. Product Quality Quality of Nepalese pharmaceutical products is good and therefore, those have received well recognition from the medical doctors and medical practioners. As a result of this Nepalese industries have acquired 30% market share within a short span of time. c. Human Resources The human resources involved in production, quality control, manufacturing, R & D, and marketing are well qualified and experienced in their respective areas. Human resources involved in this sector are taken as an asset and therefore, majorities of industries are putting their emphasis on human resources development. d. Knowledge of Market Including Interior and Micro-Interior Pharmaceutical industries have acquired a good knowledge about domestic market including interior and micro-interior enabling it to enhance its agility. This has enhanced the industry to perform marketing functions: formulate and implement strategies, distribution, promotion, customer relations, etc. e. High Private Sector Participation All the industries except one are under the private sector and therefore, are relatively quick in decision making and flexible as per the market need . Weaknesses a. Poor Capacity Utilization/Economies of Scale The capacity utilization of 39 Nepalese pharmaceutical industries varies from 25 to 80%. Of these large scale industries (five in number) and a few having wide range and forms of products have it over 60%. The majorities have fairly low capacity utilization. The basic reasons behind it are identified as less product range and form of products compared to industries having higher capacity
  • 11. utilization and also installation of plant and machineries of higher capacity than required due to lack of knowledge and information on industry at the time of establishment. b. Inability to Generate Enough Income to Invest in: • R & D • Quality Assurance System • Human Resources Development for Highly Skilled Technical Personnel • Productivity and competitiveness enhancement measures c. Limited R & D Activities Only a few industries are carrying out manufacturing R & D, that too with low level of spending. This is forcing a large number of industries to outsource formulation for new products, which can cost even the credibility/corporate image of the industries, if it fails. d. Lack of Highly Skilled Technical Personnel Industries lack highly skilled and experienced pharmaceutical personnel, who are capable of carrying out complex formulations and reverse engineering of new molecules e. Limited Quality Assurance Systems Only 5 companies have acquired WHO-GMP certification and three have ISO 9001:2000; and ISO 14000 certifications. Numbers of industries which don’t have acquired certification also have quality assurance but not all industries. Acquiring of above certificates and up-gradation of production facilities by only a few industries is affecting the whole sector. f. Poor Institutionalization in Industries Although establishment of pharmaceutical industries in the country begun decades ago, institutionalization of those industries with vision, mission, objectives, management systems, procedures, and others is still in the initial stage. Therefore, most of those industries are still being run with entrepreneurial drive and not managerial drives. It is because majorities of the pharmaceutical industries are owned and/or managed by the people, who were either traders of pharmaceutical products or an individuals who were marketing pharmaceutical products of Indian or multinational companies in Nepal, lack managerial knowledge and experience necessary for managing and operating industrial enterprises. Possession of entrepreneurial/trading knowledge and skills and not the managerial ones is limiting the institutionalization of pharmaceutical industries for their long term sustainability and growth. g. Adoption of Unethical Marketing Practices There exists a practice of adopting unethical marketing practices by industries to retain or increase market and market share. Cut throat competitions among industries are often noticed increasing bargaining power of buyers and middlemen. Push marketing strategy is also noticed to be adopted which is common for consumer goods. h. Sticking to Me-too (Similar)Products Majority of industries are engaged in producing “me-too” (Similar) products and are noticed to avoid producing other new necessary products for fear of losses. This poor risk taking capability is affecting a large number of Nepalese pharmaceutical industries.
  • 12. i. Abuse of Co-Operation and Common Understanding among Pharmaceutical Industries Absence of common understanding and mutual co-operation amongst industries is affecting in having common goal of sectoral development and promotion. Malpractices like recruiting trained manpower from competitor’s industries are very common. j. Poor Linkages with Academia Only recently a pharmaceutical industry has developed and maintained relationships with academia for development of the sector through research and development, human resources development and other developmental works and another one has developed relationship with academia for research. Very weak or non existence of tri-partite work relationships among pharmaceutical industry, academia and government is hindering in undertaking of research and development in pharmacy at the academic institutions with the governmental support and then commercialization of successful developments by the pharmaceutical industries. k. Poor Business Relationship with Government Only a few industries have good and well maintained business relationships with government health institutions, and are short listed to participate in government procurements of medicine. A bulk of the government procurement is done from drug producing companies, which are from India and abroad. l. Weak Supply Chain Although all the basic and auxiliary raw materials need to be imported regularly from outside the country, the majority of pharmaceutical industries has weak supply chain management affecting availability of the products in market and reduces in their productivity and return. This holds true even in distributing products in hilly and mountainous regions. The industries are still unable to reach many places where there exists potential market for their products. m. Knowledge on WTO/TRIPS Majorities of industries are unaware of provisions of WTO/TRIPS and their consequences to their business. Opportunities a. Favourable Government Policy Government has categorized pharmaceutical sector as one of the priority sectors. The government is providing monetary and fiscal facilities and incentives to the sector for its development. It is providing incentives to the pharmaceutical industry like levying only one per cent customs duty for input materials, machineries, etc. No Value Added Tax is levied for the industry. b. Existence of Domestic Market and Export Potential There is enough domestic market for Nepalese pharmaceutical industries as those are catering only about 30% of the domestic demand. Similarly, there exists export potential for Nepalese products in non-regulatory markets and Non-WTO member countries. Nepal lies between two big economies, India and China, which are having large pharmaceutical markets with sizes of US $ 9.5 billion and US $ 6.5 billion respectively. With the increase in quality of products, domestic industries could start looking towards the export markets and also, become a contract manufacturer.
  • 13. c. New Openings due to Provisions of WTO/TRIPS As per the provisions of WTO/TRIPS, Least Developed Countries (LDCs) are obliged to provide patent only from January 2016. As per this provision Nepal needn’t adhere to recognition of product patents and therefore, has the choice of exporting the drugs which are in patent period to other LDC and Non-WTO member countries. The transition period would be an opportunity for the domestic companies to transform into vibrant pharmaceutical companies as the opportunities in the domestic generic market itself are enormous (i.e., domestic companies account for only 30% of the total market). The domestic companies can introduce in the market the new molecules that are developed by the research based pharmaceutical companies and even can export to the LDC countries. Thus the companies have the option of doing the business with the least risk of investments till 2016. There are also facilities for parallel import and compulsory license, and Bolar’s provision, which Nepal can exploit. d. New Openings due to SAFTA SAFTA has open new venues for Nepalese pharmaceuticals industries to take benefit from the regional markets e.g. Bhutan, Maldives, which depend on import of medicine and others from SAARC members countries. e. Restriction on Imports The government has imposed restriction on importing pharmaceutical products produced by industries without WHOGMP Certification limiting competition by such industries in domestic market. f. Rise in Awareness about Healthcare Nepalese have become more aware of healthcare needs and modern medicine developing good market potential to industries. Rise in literacy level among Nepalese has also increased demand by many folds. g. Development and Growth in Health Institutions Gradual development and growth in public as well as private health institutions in the country are generating good business outlook for pharmaceutical industries. h. Emergence of Facilitating and Supporting Institutions Emergence of institutions to assist and support industries to enhance their competitiveness supporting through provision of information etc. like SAWTEE. Threats a. Emergence of Competition WTO regime opens up the climate for entry of foreign companies including MNCs into the domestic pharmaceutical market. The domestic companies have to compete with well established companies. Companies from LDCs with advanced technology like Bangladesh could also easily enter Nepalese pharmaceutical market. b. Restriction to Produce Generic Versions of Patented Products Restriction to produce generic versions of patented products is to begin from January 2016 due to TRIPS agreement.
  • 14. c. Unethical Marketing Practices by Foreign Competitors Adoption of unethical marketing practices by foreign competitors like provision of incentives e.g. giving equivalent quantities of products free to wholesalers or distributors and others. Incentives of that nature drive wholesalers or distributors to promote the sales of low quality drug manufactured by those foreign competitors. This results in substitution of good quality products by inferior products with higher margins by them d. Short Product Life Fast development of new molecules shortens the life of existing generic products. In such a situation MNCs will play a dominant role in new molecules, because of their investment and risk taking capability. e. Weak Implementation of Government Policy There are number of governmental policies, acts and regulations for development, promotion and regulation of pharmaceutical sector in the country. The pertinent ones with regards to pharmaceutical industries are Patent, Design and Trade Mark Act BS 2022 and its recent amendments; Drug Act 1978 and its regulations; National Health Policy 1991; and National Drug Policy 1995. Weak implementation of above policies, acts, regulations and others by the government is affecting the genuine industries to take full benefits from those. f. Inadequate/Poor Support of Government Government procurement policy is giving priority to price with no special concessions for domestic companies. To make the domestic industry more competitive Government has not introduced any compulsory measures to the Department of Health Services necessitating to purchase pharmaceuticals from domestic industries for distribution/supply to governmental health institutions like hospitals, primary healthcare centres, etc. It is procuring medicines through the open market at competitive prices, wherein the participation of the foreign companies is high. The major areas where the government support is lacking are in technology transfer assistance, financial assistance in terms of soft loans and subsidies, setting up a world class research laboratory, provision of necessary logistics for exports, provision of infrastructure and facilities for industrial expansion, establishment of institutions for development of highly skilled human resources, enhancement of productivity, quality, competitiveness and information centre. 2.2 Critical Success Factors The critical success factors for pharmaceutical industries are: • Marketing and Promotional Activities • Quality of Products • Broader Product Portfolio • WHO-GMP Certification of Plant Facilities and Quality Management System • Capability to Cater Domestic Market • Economies of Scale • Research and Development
  • 15. Based on the information, it is hard to isolate success factors individually as the critical success factors for Nepalese pharmaceutical, but the above success factors in combination could be identified as success factors for the industries.
  • 16. CHAPTER THREE INTRODUCTION OF AMTECH MED 3.1 Introduction Amtech Med is one of the listed company in DDA and is very well recognized in market, fulfilling all sorts of quality standards. It was established on 2004 but formal operation was started only in 2005 and it is located in morang district, katahari VDC-9. Amtech Med (P). Ltd is committed towards producing high quality pharmaceutical products as per international specifications and to be a leader in Nepal by satisfying all customers through following statutory and regulatory requirements with a continual improvement of an established QMS. Amtech Med factory is build up in the area of 8500 sq. feet having proximity to all modes of transportation. It is within the range of 0.5 km from main highway, 15 km from railway station and 12 km from airport. So the factory location is very well selected. And it is also well equipped all type of modern manufacturing infrastructure which made it a WHO GMP recognized company. Since very beginning of its operation, Amtech Med is committed towards producing high quality pharmaceutical products. To carry on such activities significant steps has been taken to assure the quality of products. These steps includes advance training of personnel, procurement of state of art, inspecting and analytical equipments and modernization of quality area. Its objectives are as:  to develop validated manufacturing process  to reduce complaints  to increase customer satisfaction  to upgrade skills of available men power  to increase company sales  to introduce new products as per market demand  to validate use of machine and equipments  quality supply  creating awareness of quality management Its quality pyramid is: Fig. 3.1: Quality Pyramid Quality Manual Quality Format Quality Procedure Quality Plan
  • 17. Due to these reasons it is also successful to be an ISO 9001:9004:2000:2004 certified company. 3.1.1 Mission: To put into action those activities through a continual improvement of an established QMS to benefit society and a nation as a whole, and a commitment to build our stakeholders value by making Amtech Med a truly sustainable company. 3.1.2 Vision: To be a leader in Nepal by satisfying our customers and stakeholders through following all types of statutory and regulatory requirements and being committed for producing high quality pharmaceutical products as per international specification with a continual improvement of an established QMS. 3.1.3 Goal: S = Strategic Shift, Innovation P = Productivity E = Enhancement A = Assertion R = Reach 3.1.4 Objectives:  to develop validated manufacturing process  to increase customer satisfaction  to upgrade skill of available men power  to increase company sales  to introduce new products as per market demand  to validate use of machines and equipments  quality supply  creating awareness of quality management 3.1.5 Business Model: Business model mainly defines how company is earning its return from market, what activities are carried out to earn money. So Amtech, it is in pharmaceutical industry producing various range of quality medicines of international standard that satisfies various need of customers. And this is how it earns return.
  • 18. 3.1.6 Business Definition: Customer needs: It satisfies various needs of medicines from a common Iron tablets or capsules to medicines for some chronic diseases as Liver tonics etc. It mainly satisfies the need of medicines. Customer Group: Main target customer group are doctors and some big stockists. Technology: It satisfies those needs by producing different medicines for different use of high quality which are approved as per WHO GMP and ISO standards and making it available to market using various levels of distribution channels. 3.1.7 Organizational Chart: Customer Need Customer Group Technology Managing Director Marketing Manager Area Manager Plant Manager Quality Assurance Quality Control Manager Quality Control Officer Quality Control Trainee Production Manager Store Manager RM Dept. PM Dept. Ointment Section Capsule Section Tablet Section Packaging Section Operator Operator Operator Operator Fig.3.2: Business Definition, Abell's Framework Chief of Finance & Accounts Legal Depart ment R & D Dept.
  • 19. Management Team: The management team of Amtech consists of all the managers and the department heads. They are the one who supervise their subordinates and guide them to accomplish their work efficiently. Management of organization play a major role in achieving organizational goal. As the head of organization i.e. managing director formulates the vision, mission and objectives for the organization, where as managers formulate action plan to achieve those objectives. The members of management team are as: Table: 3.1 Management Team of AMTECH MED Manish Agrawal Managing Director Bal Krishna Mishra Chief Marketing Officer Jay Narayan Plant & Production Manager Narayan Dahal Chief of Finance & Accounts 3.1.8 Future Plans Amtech Med believes in safe and sustainable growth as the major driving factor behind all its future plans. Some of the important goals that the company would be looking to achieve in the medium term are as follows: 1) Continue to reinforce Amtech as a franchise in order to supplement its business and reputation in the market. 2) Raise the size of the balance sheet to generate the advantage of scale. However the expansion will be based upon judicious selection of business both in terms of product verities and market coverage. 3) Focus on high yield leading business opportunities in both segments i.e. chronic and acute segments. 4) To increase the present annual sales of Rs.50,00,000 to Rs. 80,00,000 in next 3 years. 3.2 Departments at Amtech Med Amtech Med comprises of departments where each department looks after their own area of activity and with its sound and efficient capabilities assists the other departments also moving whole organization towards the positive prospects. The major departments of Amtech are discussed below: A. HR Department: Human resource department is closely related to company's employees such as recruitment, selection, development, promotions, transfer, performance appraisal, etc. Before selection of staffs all the candidates have to go through a medical examination by the organization doctor. Mainly production staffs are medically examined by the registered organization's doctor at the time of recruitment. Personnel suffering from any contagious or obnoxious work are not allowed to work or visit the production area. For the purpose of improving the skills, abilities and knowledge of the staff members, human resource development of Amtech Med provides various job related trainings. Trainings covers all employees as per the need. Need is recognized as per the information or felt by the employees ultimate supervisors. The newly appointed staff has to undergo a introductory training regarding company profile, premises,
  • 20. sanitation, and hygiene and depending upon the work the training is done regarding WHO GMP and GLP, training is also given on installation of new machines, change development in manufacturing, analytical procedures, production of new products etc. The training provided to the staffs is generally in house and are repeated in every six months, but there is also arrangement for external training by sending employees to other institutions. Evaluation of training is done by the questionnaire details during and outside the training section. B. Internal Audit Department: This department is responsible for maintaining and verifying the individual account of the day to day basis like the expenses of staff salary, expenses of staff lunch and other miscellaneous expenses. C. Finance & Accounts: This department is responsible for maintaining and preparing whole accounts and budget of the bank. This department also prepares final financial statement of the company. D. Legal Department: The main function of this department is to look after the legal aspects of the company. Formulation of laws and policies for the company also lies in this department. This department takes all the legal actions on the behalf of the company as required according to the situation. E. Marketing Department: The main function of this department is to formulate the marketing & promotional plans for the product. As the company's sales is totally dependent on personal selling, so how better to divide the market as per the sales force abilities are also the responsibilities of the marketing manager. This department formulates plans, divide the whole geographical market areas, plans the marketing budget, controls the medical representatives, handles the customer compliance, understands the market demand and always focus on increasing the company's sales and work with quality assurance department to handle quality related problems. Managing compliance as per figure 4: Area representatives collect the materials and bring back to the organization and QA department takes control of such products and are labelled as RECALL products and are stored separately until they are checked and approved for resupply in market. The distribution channel used by the company is shown in the figure 4.1: Quality Assurance Marketing Manager Area Representatives
  • 21. F. Production Department: Production department is sole responsible for production of the quality products and quality work practice in factory. Production department is controlled by production manager who is in direct contact with company's managing director. Under production manager there are quality assurance department manager and store manager. Production manager or Plant manager is responsible for managing human resource in factory and he is also responsible for recruiting people in factory. G. R & D Department: Actually in Amtech it is not R & D department, it is FR & D i.e. Formulation , Research and Development. This department is responsible for studying those products which is already available in market and develop its composition and establish the product and suggest company's managing director about those products which can be produced and is feasible to produce by having some changes. AMTECH MED Chemist Store Stockists Hospitals ( Target Customers) Doctor's Clinics ( Target Customers) Patients (End Consumers) Figure 4.1: Distribution Channel
  • 22. 3.3 Major Products of Company: S.N Products Name S.N Products Name 1. DICLOBACK PLUS 32. P-MOL TABLET 2. HEM-F TAB 33. P-SPAZ 3. CODOCET TAB 34. QUINOTECH-250MG 4. MEDAZOLE-200 TAB 35. RABIFAST-20 5. AMSONE 36. REVIVE ORS 6. MEDAZOLE-400 37. SILGARD-25GM 7. COOL LITIO-100ML 38. TERITOP 8. BESTDIN-50 ML 39. TERITOP-250 9. INOX 40. ACETOP 10. HYO-AM 41. A-DOX 100CAP 11. EXTINA 42. AFLAM PLUS 12. AMTRIM D.S. 43. ALASKA 13. AMTRIM-PED 44. AMBROX-30 14. BESTDIN-GM 45. AMCEF-100DT 15. BESTDIN LIQUID 46. AMCEF-200 16. AMTRIM 47. AMCIDE FORTE 17. MEGACAL 48. AMCOBAL-1500DT 18. AMNOVATE-N 49. AZITECH-250 TABLET 19. MEGADERM 50. AZITECH-500 TABLET 20. AMFOL PLUS 51. CARDILAN-10 TABLET 21. COOL LITION-30 ML 52. CETRON 22. AMFIELD-30 GM 53. DIACID TABLET 23. MOVERAN GEL (20GM) 54. DICLOBACK-100 24. ACETOP GEL 55. FLUC-AM 25. AFLAM 56. LEVOHIST 26. AMFEN-200 57. MEDAZOLE-DF 27. AMFOL 58. NIMID 28. DICLOBACK-50 59. OFLACIN 29. NIMID GEL 60. OME CAP-20 30. OFLACIN-400 61. QUINOTECH-500 31. PANPRAZ 62. WORMCARE The above table 4.1 shows some the major products of the company. Besides these medicines currently company is also working on some new products as Liquid syrups and in this syrups there are several range as from a normal cough syrup to antibiotics and also VITA-PLUS syrups and LIVER-TON. Besides syrups company is also working on developing sugar free cubes.
  • 23. CHAPTER FOUR ANALYSIS OF ACTIVITY DONE AND PROBLEM SOLVED During organization study period, internee worked and visited in different departments. Inside the block of the company, internee got chance to work in production plant, marketing department mainly. An internee was given a brief overview about the work of the particular department and allowed to observe and learn the work procedure but was never allowed to be involved in actual work procedure as per their SOP. However, internee learned by asking questions to the staffs of the departments and also by observing their daily work. The different types of activities performed in different department are: 4.1 Production Department: Production department is considered as one of the crucial department in pharmaceutical industry in handling the quality of medicines and fulfilling the demand of medicines in market. In today's highly competitive and fast growing business field and increasing pressure on Nepal Pharmaceutical Industry there is a need of developing this department for production of better products. Currently Nepal is facing pressure from WTO and in such situation in order to save this industry it is very essential to develop production department. In general, production department plays very important role as it is related to medicines a slight mistake can lead to great damage. So production department it is very important. 4.1.1 Activities Performed in Production Department: Different activities that internee had carried out during the placement in production department are as follows:  Inspection of store or inventory department which comes under production department and watch out the inventory management system of the company. In store room also before storing the materials, materials have to move through various test to know about its quality and store temperature. In store room storage section were different for different chemicals and were stored in cool and dry place in controlled room temperature of 18°C to 25°C. None of the materials are stored without test and from store department also none of the materials are moved forward into production area without test.  After inspection of the inventory system, internee was moved to actual production area. There internee was expected to watch the production process and suggest something if needed. In production site internee came to know about the production process of tablets, capsules and ointment. Company mainly used PROCESS LAYOUT for all types of medicines. Production process of different medicines are as:  For Tablets: Mixing of raw materials Granulation using aqueous or non aqueous binder Equalizing the size of the granules Drying
  • 24. Lubrication Coating Sorting and Packing  For Capsules: Mixing Filling Polishing Sorting Packing  For Ointment: Preparation of oil phase Preparation of water phase Mixing of oil & water phase Cooling Milling Filling & Crimping Packing  After production packaging. In packaging also all the process carried out was as per the WHO GMP standard. In packaging both labour as well as human power are used for packaging. Mainly men power is used for printing the dates and batch numbers and keeping record of the weights of accepted finished goods and rest things were done by machine. So these are some of the activities performed in the production department. But internee really enjoyed being in marketing and also suggesting some ways of marketing and establishing some digital platforms of the company. 4.2 Marketing Department: After production main role is played by marketing. Here in this industry always they use Personal Selling as one promotional mix and some time for some medicines they may use direct marketing but till now it is not used by the company. Company is mainly using personal selling. The selling process with doctors are as:  Taking appointment may be by cold calling or through friends  Meeting with doctor  Information about company and product presentation  Handling objections  Closing sales and  Follow-up And for selling products to stockists they carry out almost same procedure but instead for taking appointment they believe in building relationship, cold calling, and reference from others through these Medical Representatives they prepare their list of qualified stockists and have some pre-
  • 25. approaches before visiting them in order to have better closing of sales. Internee being part of the marketing department here he understood about core of marketing of pharmaceutical company and very important 4P's as well as 7P's for pharmaceutical company.  7P's as: Product- Medicines, Health awareness educations Price- Pricing is mainly done on the basis of market prevailing rate and premium pricing Place- Two and Three level of distribution channel is used Promotion- Personal selling People- Well qualified men power at work having employees with minimum of 2 years of experience before coming to this company in same pharmacy sector Process- All the process for manufacturing and service carried out are as per WHO GMP guidelines and also company it have its own SOP Physical Evidence- Factory location is facilitated with all types of basic facilities for smooth production process and is certified by WHO GMP & GLP  STP: Segmentation: Demographic Segmentation Targeting: Targeting is mainly done on the basis of segment attractiveness along with company's objective and strategy used id differentiated marketing. Positioning: "We understand your Health", a company for complete health solution 4.3 Analysis of Effect of WTO on Nepal’s pharmaceutical industry The impact of WTO on Nepal’s pharmaceutical industry can be identified by studying the affect of each agreement of WTO that has impact on the pharmaceutical industry. TRIPS The main impact of TRIPS agreement of WTO will be felt on two areas. They are: 1. Domestic manufacturers who are producing and commercializing products covered by patents will be forced to go for licensing agreements with the patent holders resulting in the royalty payments and in some situations there would be an increase in prices of the drugs. By the time Nepal recognizes the patents of products related to the pharmaceutical industry, most of the drugs that were approved for marketing from 2002 would be still in patent period as on January 1, 2016. For these drugs either the innovators will distribute these drugs themselves through his own distribution channels or give license for the players who are operating in the domestic market by charging a royalty on the sales. As per the mail box provision of TRIPS, the patent holder has to file his application for patent in the Nepal market with the concerned regulatory agency in order to get patents recognized in the market. 2. TRIPS inhibit the advantages the players are currently deriving through reverse engineering and there would be increased investments in R&D. Here the domestic pharmaceutical companies which are currently progressing well with the generic versions of the patented drugs with lesser costs would lose the opportunity of coming out with the newer drugs within a period of 1 to 2 years from the launch of the innovator product in the international markets. So the option for them would be to remain completely a generic player or slowly move to a research based pharmaceutical company or be a contract manufacturer for the innovative and generic companies. With such scenario the business
  • 26. and revenue models of the pharmaceutical companies would be witnessing a change. As the options for the companies to sustain will be few, there would be increased investments in research & development by the companies and the investments would go from the current levels of less than 1 per cent of sales to near about 5 to 8 per cent by the time the patents are recognized in the pharmaceutical industry from 2016. 3. With the introduction of TRIPS, most of the MNC players would be eyeing the market in a major way as the product patents are recognized and they come out with their complete portfolio of drugs which are of highest quality produced in plants that are certified by regulatory agencies globally with the economies of scale(in most of the cases the plants from which the drugs are produced for the Nepal market would be located outside until unless there is a distinct cost advantage in the domestic market and the market is so huge in 2016). Moreover with the growth of the market, there would be tougher competition from the generic MNC’s to the domestic companies. This results in the domestic players also making their drugs in the internationally certified plants to have better quality with higher capacity utilizations and increase their budgets for the marketing and promotional activities to sustain in the market. Looking at the impact of the patent recognition of the drugs (molecules) on the pharmaceutical industry in the various market, it was found that the industry has grown overall in terms of growth, increased domestic players presence and increased Alliances/Joint ventures/ technology transfers, etc. Technological Barriers to Trade As per the Agreement of Technological Barriers to Trade, the Articles 2.8, 2.9 & 2.11 specifying the Technical Regulations and the Article 5 dealing with the conformity assessment can be the restrictions for trade. The other issues that can be of importance with this agreement are the transparency of the regulations framed by the members, the protection of data submitted for the approval of new drugs and the granting of market access including the drug registration and re- imbursements. Currently Nepal pharmaceutical industry wouldn’t face any restriction to trade with this agreement, but this can turn into a restrictive agreement once the companies from the industry starts looking at the export markets. Agreement on the Application of Sanitary and Phytosanitary Measures As per the Sanitary and Phytosanitary measures, export potential of the pharmaceutical firms in the Least Development Countries will be hindered as most of the production plants in these countries are not in compliance with the Agreement on the applications of Sanitary and Phytosanitary Measures. Pharmaceutical companies has to follow current Good Manufacturing Practices as determined by WHO which needs much of the investments into the production plant which most of the pharmaceutical companies in the LDC’s like Nepal are not in a position to invest. But the production plant has to confer to the national standards, rules. The national rules standards have to confer to the SPS agreement. 4.4 Problem Solved Although Amtech is able to meet the changing need of the market, some problem have been analysed and possible measures have been taken to minimize the problem and solved them while working in
  • 27. Amtech. Following are some of the advice given and steps taken by intern to solve the problems during his internship: 1) Development of digital platform for promotion of company as well as its product. 2) Advice given to have adjustments in order minimize operating cost. 3) Lead time management by suggesting the appropriate use of the workers in organization. When intern was in organization as intern, what intern saw was pharmacists in one department was sitting as his work was finished and now no more work to do where in other department production was stopped due to lack of pharmacists. So intern suggested to minimize the lead time by increasing the responsibilities and have better use of limited resources by having cross functional departmental work approach and by that approach pharmacists can be transferred to that department where there was shortage of pharmacist. 4) Got chance to develop the distribution channel for the company. 4.5 Observed Gap The students are selected as internee in different organization so that they can present themselves as skilful person on related field on which they have been appointed. The organization gives the environment for internee to fulfil certain responsibilities. Regarding this internee can show their capability and intelligence. While working in the company internee observed and evaluated the theoretical knowledge he has gained and what actually happened in the work situation. Theoretical knowledge helps a lot in understanding the actual working environment, but not exactly cent percent.
  • 28. CHAPTER FIVE CONCLUSION AND RECCOMENDATION Recommendations Competitiveness of a sector or industries under the sector can be enhanced through the enhancement of quality and productivity of the sector or its industries. Therefore, the steps to be taken by the Nepalese pharmaceutical industries to enable them to capitalize on the opportunities and face up to the challenges would be those measures, which would enhance quality and productivity of the industries in isolation or in combination. The steps are as follows: 5.1 Quality Enhancement: Quality Assurance of Products through Plant Facility Certification: WHO-GMP certification ensures the quality of plant facilities and pharmaceutical products produced at the plant. Such assurance develops trust of the medical doctors as well as general practioners and end customers on pharmaceutical products, and this ultimately assist in capturing the domestic and export markets. Presently five industries have WHO-GMP Certification and do have good market recognition and are doing good business. A significant number of industries are under going through the certification process. One of the considerations medical doctors take while prescribing foreign or domestic brands is the quality of medicines. By assuring the quality products domestic industries can overcome the biasness and apprehensions usually associated with them, this could result in increased prescriptions from medical professionals. As the quality certification opens-up the door to international markets and domestic markets, the industries having certification would be more competitive. The Nepalese industries with quality assured product can expand their business in domestic market at first and then enter export markets. Quality Assurance through Quality Management System and Environment Management Systems: Having ISO 9001:2000 Series and ISO 14000 Certification will not only improve the corporate image of the industries but also guide the industry to have management systems which could lead them to their long term sustainability and growth; and fulfil the environmental responsibilities. These certifications can also assist industries to have systems, procedures, data/information base and others where these are lacking especially in industries run and managed by owner managers leading to enhancement in quality, productivity and competitiveness. Adoption of Stringent Quality Standards Quality assurance is possible by improving quality assurance systems of industries and it could be carried out without any certification. Nepalese industries need adopt measures for quality assurance and adopt stringent quality standards. This could restrict unfair competition in domestic market from the low quality producers by pressurizing and assist the Government in regulating quality control measures and thus minimize the unfair competition from low quality products of both domestic and foreign industries.
  • 29. 5.2 Enhancing Productivity Enhancing Productivity by Attaining Economy of Scale/Efficiency Attainment of economies of scale by industries helps in enhancing their productivity, which is possible through various measures. These measures, which in isolation or in combination could lead those industries to attain their economies of scale, are: a. Higher Capacity Utilization The capacity utilization of Nepalese industries varies from 25% to 80% depending upon investment scale and others. Small scale industries have capacity utilization of 25 to 40%, medium scale 40 to 60% and large scale above 60 percent. Small and medium scale industries need to increase their capacity utilizations by rationalizing the product mix and even outsourcing to the large scale industries for the benefit of both. Increased capacity utilizations bring better utilization of physical resources to the industries and bring better margins; if products having market potential could be produced. The industries having export potential could look for export markets in order to grab foreign market and to increase their capacity utilization. Especially, the large scale industries having WHO-GMP certification(s) and operating at higher than 80% may look to the international markets for exports apart from increasing the domestic market share. The first step towards this will be to identify the LDCs, where the WHO-GMP practices are sufficient for exports. After possessing an “investible surplus” from those markets, the industries may explore to get their plants approved by agencies in regulated markets like USA, Japan, Germany, France, etc. With the option of the export income, income generating sources for the companies will increase and dependence on the domestic market will come down enabling the company to hold out in times of fluctuations in the market. b. Increase Breadth of Product Portfolios The industries could attain operational economies of scale by increasing the breadth of their product portfolios. Only a few industries are producing medicines to life style relating diseases like cardiac, CNS, diabetic, ophthalmology, etc. Therefore, there exists demand for such products and efforts need to be made by other industries to produce those pharmaceuticals by fulfilling the pre-requisites for their production, if possible. It is because these are the segments, demand for which is growing faster and lasts for longer period. c. Acquire Technical Manpower The industries could attain their economies of scale by developing human resources either by providing opportunities to its personnel or recruiting new ones, if the limitation is due to the constraint of highly skilled technical personnel. With the personnel of that nature Nepalese industries could initiate process of reverse engineering and chemical synthesis. d. Increase Share in Domestic Market Currently, imports account for about 70% of the domestic market and the share of the domestic industries is only about 30%, which needs to be increased. With the increase in sales and market share, industries could optimize the use of their plants. Enhancing Productivity by Reduction in Cost of Production a. Efficient Utilization of Inputs
  • 30. Productivity of pharmaceutical industries could be improved with the betterment in utilization of inputs like ingredients, utilities, labour and others. This could also result in wastage minimization in industries. The cost savings made by these would definitely enhance the competitiveness of industries. b. Supply-Chain Management By having effective and efficient supply-chain management industries could reduce their cost of production enhance productivity and competitiveness. c. Backward Integration Producing the bulk drugs or active pharmaceutical ingredients by domestic industries by acquiring the process development knowledge and skills could reduce the cost of those materials leading to drop in cost of production for industries. Such producers could look at supplying to the other domestic formulation manufacturers apart from their in-house consumption. Apart from domestic market, there could be an export potential for those with the certified plant. This brings in better margins for the companies by integrating operations backward. The purposes of such integration is to achieve control on costs, quality and delivery period of inputs. d. Common Infrastructure and Facilities Having common infrastructure and facilities could also reduce in cost of production and waste disposal leading to the improvement in productivity and then to competitiveness of industries using common infrastructure and facilities. It is because majority of Nepalese pharmaceutical industries are small and medium scale having limited investment capabilities. 5.3 Competitiveness through Innovation a. Undertaking Innovative Research and Development Investment in research & development of pharmaceuticals by Nepalese industry is relatively very low; less than one percent of the total sales. The industry could enhance its competitiveness by investing in R&D, mainly into organic synthesis for the reverse engineering of the molecules and minimizing the number of steps in the manufacture of the bulk drugs and final products. The increased capability in the reverse engineering of the molecules could gradually lead to the expertise in molecule research. It could improve their long term sustainability either through contract research or cost effective products with vibrant in-house R&D. b. Institutionalization of Industries Gradual institutionalization of Nepalese industries would be necessary for enhancing the competitiveness of the sector as a whole. It would provide vision and mission for the industries, where those should head for and also organizational systems, procedures, processes, and others. A few industries might have to undergo even restructuring and reengineering processes. c. Collaboration Collaboration with foreign or domestic companies could enhance competitiveness due to improvement in productivity and quality of self or due to comparative advantages of collaborating partner(s). 5.4 Enhancing Effectiveness a. Marketing and Promotions
  • 31. The industries need to be aggressive in marketing and employ innovative marketing strategies and promotional measures to counter the well established foreign companies. Sales and the marketing representatives have to adopt a professional approach, for which regular training and up gradation of sales forces and medical representatives will for better coverage of the doctors, which in turn will augment the demand through increased prescriptions. b. Explore Export Markets Looking at the export market is vital for the Nepalese industries as the domestic market is small compared to world market. The industries could explore the opportunities of exporting formulated products and active pharmaceutical ingredients, if produced. This can be started with the neighbouring markets of Bangladesh and other LDCs. To capture these opportunities the plants should be upgraded to international standards. As the large industries have already the WHO-GMP certified plants those could look towards export markets. The major constraint for exports is the need for airlifting of products for industries, which is affecting in their competitiveness. Therefore, efforts need to be made to solve by appealing to the government and garnering required assistance to make exports competitive. c. Increase Linkages with the Academia There is an urgent need for the domestic companies to interact with the academia or the research institutions in the country to utilize their resources productively for the development of better process of manufacturing through qualified technical manpower with the good expertise in fields related to pharmacy. This to a greater extent can also overcome the constraint of technical manpower along with the sharing of the costs. d. Increase Work Relationship with Professional and Business Associations With a view to enhance the effectiveness of business, industries need to develop, review and maintain work relationships with professional associations like NMA, and business/trade associations FNCCI, APPON, NCDA, etc. These could influence the doctors to prescribe the drugs for which the domestic brands are available. The pharmaceutical sector as a whole needs to address this issue and communicate the message to the doctors. This kind of work relations could publicize Nepalese pharmaceutical products. A strong franchise developed with the doctors and the chemists could avoid substitution of pharmaceuticals.
  • 32. Conclusion Accession of Nepal to WTO has brought both opportunities and challenges to Nepalese pharmaceutical industries. World market of pharmaceutical products is now open to Nepalese industries and simultaneously Nepalese market is open to industries worldwide. In this context Nepalese pharmaceutical industries need to be able to explore the opportunities and make best use of those. In addition, those industries also need to identify the external threats for them and make efforts to overcome the threats. Therefore, Nepalese pharmaceutical industries have to undertake measures that would enhance their competitiveness, which could lead them to harness their strengths for exploiting the opportunities before stepping into WTO/TRIPS regime in 2016. Since competitiveness of industries under the sector could be enhanced through the enhancement of quality and productivity of the industries, the measures to be taken in isolation or in combination by the Nepalese pharmaceutical industries would be to enhance quality and productivity of the industries which would enable them to capitalize on the opportunities and face up to the challenges. Based on the study of present status; and analyses of opportunities and challenges for Nepalese pharmaceutical industries in the wake of WTO, recommendations are made for government, private sector industries, and associations related to pharmaceutical industry for enhancing the competitiveness of pharmaceutical industries.
  • 33. BIBLOGRAPHY Shrestha, B.K., & Bhandari, D.B. (2013). Drug Markets & Institutions. Kathmandu: Asmita Books and Distributors Pvt. Ltd. Department of Drug Administration (2013/14). Annual Report. Kathmandu: DDA Matrix Services Plc. In association with Centre for Gender & Management and Cygnus (2012). Research Report on Nepal Pharmaceutical industry. Kathmandu: www.google.com www.dda.gov.np www.ekantipur.com
  • 34. Appendix 1 Number of the pharmaceutical companies by country of origin registered at DDA Country Number of Companies 1. India 168 2. Nepal 39 3. Korea 6 4. Bangladesh 5 5. Belgium 4 6. France 4 7. Germany 3 8. Switzerland 3 9. UK 3 10. China 2 11. Holland 2 12. Japan 2 13. Malta 2 14. Australia 1 15. Bulgaria 1 16. Italy 1 17. Malaysia 1 18. Mexico 1 19. Pakistan 1 20. Sweden 1 21. Taiwan 1 22. Thailand 1 23. USA 1 Source: DDA, Nepal
  • 35. Appendix 2 Brands Available in Nepal by Therapeutic Groups Therapeutic Groups No. of Brands Anti-Infectives 628 Respiratory 337 Vitamins/Minerals 238 Gastrointestinal 402 Pain/Analgesics 325 Dermatologicals 278 Gynaecologicals 147 Cardiac 182 Neuro/Cns 207 Anti-Parasitic 189 Ophthal/Otolog 153 Anti-Diabetics 49 Others 238 Source: Org – IMS Retail sales audit