A. Company Certificate
B. Declaration ............... (i)
C. Acknowledgment ..... (ii)
D. Preface...................................................................................... (iii)
E. Executive Summary . (iv)
1. CHAPTER 1: Introduction.. 3 39
1.1. Overview of the Industry. 3
1.1.1. Pharmaceutical Industry in India
1.2. Company Profile.. 9
1.2.1. About the Company
1.2.2. Mission
1.2.3. Vision
1.2.4. Our Specialization
1.2.4.1. Ayurvedic / Herbal Products
1.2.4.2. Nutraceutical products
1.2.5. Our Services
1.2.6. Our Manufacturing Process
1.3. Organization Structure .. 36
1.4. Glimpse of our clients ...................................................37
2. CHAPTER 2: Introduction to Project ..40 43
3. CHAPTER 3: Conceptual Discussion.....44 45
3.1. How Business Development takes place in Pharma Company
4. CHAPTER 4: SWOT Analysis... 46 47
5. CHAPTER 5: Major Challenges faced by the Industry ....... 48 49
6. CHAPTER 6: Appendix & Bibliography 50 51
1
the World Market Policy and the establishment of the Software Technology
Parks of India (STP) scheme. In addition, to attract foreign direct investment,
the Indian Government permitted foreign equity of up to 100 percent and duty
free import on all inputs and products.
Current Scenario The industry has enormous growth potential. Factors listed
below determine the rising demand for pharmaceuticals.
The growing population of over a billion.
Increasing income.
Demand for quality healthcare service.
Changing lifestyle has led to change in disease patterns, and
increased demand for new medicines to combat lifestyle related
diseases.
More than 85 per cent of the formulations produced in the country are sold in
the domestic market. India is largely self-sufficient in case of formulations.
Some life saving, new generation under-patent formulations continue to be
imported, especially by MNCs, which then market them in India. Overall, the
size of the domestic formulations market is around Rs160 billion and it is
growing at 10 per cent per annum.
Competent workforce: India has a pool of personnel with high managerial and
technical competence as also skilled workforce. It has an educated work force
and English is commonly used. Professional services are easily available.
Cost-effective chemical synthesis: Its track record of development,
particularly in the area of improved cost-beneficial chemical synthesis for
various drug molecules is excellent. It provides a wide variety of bulk drugs
and exports sophisticated bulk drugs.
Legal & Financial Framework: India has a 53 year old democracy and hence
has a solid legal framework and strong financial markets. There is already an
established international industry and business community.
Information &Technology: It has a good network of world-class educational
institutions and established strengths in Information Technology.
Globalization: The country is committed to a free market economy and
globalization. Above all, it has a 70 million middle class market, which is
continuously growing.
Consolidation: For the first time in many years, the international
pharmaceutical industry is finding great opportunities in India. The process of
consolidation, which has become a generalized phenomenon in the world
pharmaceutical industry, has started taking place in India.
The government started to encourage the growth of drug manufacturing by
Indian companies in the early 1960s, and with the Patents Act in 1970.
However, economic liberalization in 90s by the former Prime Minister P.V.
NarasimhaRao and the then Finance Minister, Dr. Manmohan Singh
enabled the industry to become what it is today. This patent act removed
composition patents from food and drugs, and though it kept process patents,
these were shortened to a period of five to seven years.
The lack of patent protection made the Indian market undesirable to the
multinational companies that had dominated the market, and while they
streamed out. Indian companies carved a niche in both the Indian and world
markets with their expertise in reverse-engineering new processes for
manufacturing drugs at low costs. Although some of the larger companies
have taken baby steps towards drug innovation, the industry as a whole has
been following this business model until the present.
The Indian pharmaceutical sector has come a long way, being almost nonexistent before 1970 to a prominent provider of healthcare products, meeting
almost 95 per cent of the country's pharmaceuticals needs. The Industry today
is in the front rank of Indias science-based industries with wide ranging
capabilities in the complex field of drug manufacture and technology. It ranks
very high in the third world, in terms of technology, quality and range of
medicines manufactured. From simple headache pills to sophisticated
antibiotics and complex cardiac compounds, almost every type of medicine is
now made indigenously.
Playing a key role in promoting and sustaining development in the vital field
of medicines, Indian Pharma Industry boasts of quality producers and many
units approved by regulatory authorities in USA and UK. International
companies associated with this sector have stimulated, assisted and
spearheaded this dynamic development in the past 53 years and helped to put
India on the pharmaceutical map of the world.
The Indian Pharmaceutical sector is highly fragmented with more than 20,000
registered units with severe price competition and government price control. It
has expanded drastically in the last two decades. There are about 250 large
units that control 70 per cent of the market with market leader holding nearly 7
per cent of the market share and about 8000 Small Scale Units together which
form the core of the pharmaceutical industry in India (including 5 Central
Public Sector Units). These units produce the complete range of
pharmaceutical formulations, i.e., medicines ready for consumption by
patients and about 350 bulk drugs, i.e., chemicals having therapeutic value and
used for production of pharmaceutical formulations.
Following the de-licensing of the pharmaceutical industry, industrial licensing
for most of the drugs and pharmaceutical products has been done away with.
Manufacturers are free to produce any drug duly approved by the Drug
Control Authority. Technologically strong and totally self-reliant, the
pharmaceutical industry in India has low costs of production, low R&D costs,
innovative scientific manpower, strength of national laboratories and an
increasing balance of trade.
The number of purely Indian pharma companies is fairly low. Indian pharma
industry is mainly operated as well as controlled by dominant foreign
companies having subsidiaries in India due to availability of cheap labor in
India at lowest cost. Most pharma companies operating in India, even the
multinationals, employ Indians almost exclusively from the lowest ranks to
high level management. Mirroring the social structure, firms are very
hierarchical. Homegrown pharmaceuticals, like many other businesses in
India, are often a mix of public and private enterprise. Although many of these
companies are publicly owned, leadership passes from father to son and the
founding family holds a majority share.
The total Indian production constitutes about 13 per cent of the world market
in value terms and, 8 per cent in volume terms. The per capita consumption of
drugs in India, stands at US$3, is amongst the lowest in the world, as
compared to Japan- US$412, Germany- US$222 and USA- US$191.
Dr. Sharma has executed many major corrections in the infrastructure required
for the better business execution. The first step in the direction was sharing his
personal knowledge of herbs found in the Himalayan region with the
manufacturing technical team of Company, which proved to be a boon in the
form of Herbal/ Ayurveda medicines to the society. A wide range of New
Herbal/ Ayurveda products/ Formulations has been developed to cure various
ailments. Many new manufacturing procedures have been incorporated to
further increase the product efficacy. His dream is to make people aware of the
medicinal utility of these plants and to promote Herbal/ Ayurveda. The
management aims to make people aware that Herbal/Ayurveda medicines give
long term fitness as against the allopathic medicines, also these medicines
have less toxicity and no side effects and are very well absorbed in the human
body and provide permanent cure to many ailments.
diligence of the entire team has yielded brilliant results and has helped us
flourish as a profound name in the Herbal/Ayurveda industry. It is one of the
few manufacturing plant which blend modern production technology and
advanced quality measures into the area of Herbal/ Ayurveda healthcare
medicines and nutraceutical. On the commercial front, we have presented
many new dimensions in packing, which is still not very prevalent in Ayurveda
Industry, e.g. Alu-Alu facility with Print Registration Control feature, Metpat finish products etc.
Companys Mission:
We want to offer products of highest quality standards at the most competitive
prices in India. We are on a never ending research, development and
manufacturing of a broad spectrum of Herbal/ Ayurvedic and nutraceutical
products and thriving to fulfill the needs of our valued customers in terms of
product range, quality, efficacy, safety and price.
Companys Vision:
We aspire to work on our consistent self-improvising mind-set and be the best
manufacturer and supplier of high quality Herbal/ Ayurvedic and Nutraceutical
products in the country. We also aim at satisfaction and reliability of our
associates for quality and purity of the product for lifetime.
Our Specialization:
I.
The Ayurveda medicinal system was based on herbs which are taken forward
in forming the herbal medicines. These herbal medicines includes herbs,
herbal materials, herbal preparation & finished herbal products that contains as
active ingredients parts of plants or other plant materials or combination.
II.
Nutraceuticals
10
I.
Medicinal products that are made from these substances are known as "herbal
medicinal products". Even though they are natural, a number of these products
may be dangerous for patients. This is why they are covered by
pharmaceutical legislation, which aims to protect public health by ensuring the
safety, efficacy and quality of medicinal products. Within the group of herbal
medicinal products, some have a long tradition of use.
Some examples of herbals used in traditional herbal medicinal products are:
Calendula
officinalis
L;
Echinacea
purpurea
L.,
Moench;
Advantages
There are a number advantages associated with using herbal medicines as
opposed to pharmaceutical products. Examples include the following:
Reduced risk of side effects: Most herbal medicines are well tolerated
by
the
patient,
with
fewer
unintended
consequences
than
Disadvantages
Herbs are not without disadvantages, and herbal medicine is not
appropriate in all situations. These are a few of the disadvantages to
consider:
12
Poison risk associated with wild herbs: Harvesting herbs in the wild is
risky, if not foolhardy, yet some people try to identify and pick wild
herbs. They run a very real risk of poisoning themselves if they don't
correctly identify the herb, or if they use the wrong part of the plant.
Medication
interactions: Herbal
treatments
can
interact
with
medications. Nearly all herbs come with some warning, and many, like
the herbs used for anxiety such as Valerian and St. John's Wort, can
interact with prescription medication like antidepressants. It's
important to discuss your medications and herbal supplements with
your doctor to avoid dangerous interactions.
2.
13
14
1)
Natural products
The name itself suggests that herbal cosmetics are natural and free from all
the harmful synthetic chemicals which otherwise may prove to be toxic to
the skin. Instead of traditional synthetic products different plant parts and
plant extracts are used in these products, e.g. aloe-vera gel and coconut oil.
They also consist of natural nutrients like Vitamin E that keeps skin
healthy, glowing and beautiful. For example, Aloevera is a herbal plant
species belonging to liliaceae family and is naturally and easily available
[8]. There are a rising number of consumers concerned about ingredients
such as synthetic chemicals, mineral oils who demand more natural
products with traceable and more natural ingredients, free from harmful
chemicals and with an emphasis on the properties of botanicals [9].
2)
Safe to use
Compared to other beauty products, natural cosmetics are safe to use. They
are hypo-allergenic and tested and proven by dermatologists to be safe to
use anytime, anywhere. Since they are made of natural ingredients, people
dont have to worry about getting skin rashes or experience skin itchiness.
Example
BHA
(ButylatedHydroxyanisole)
and
BHT
concern with individual coal tar a color (whether produced from coal tar or
synthetically) is they can cause cancer [14]. But natural colors that are
obtained from herbs are safer.
4) Wide selection to choose from
Natural cosmetics may still be a new type in the beauty industry but they
already offer a variety of beauty products for all make up crazy people out
there to choose from. One will find a variety of foundation, eye shadow,
lipstick, blush, mascara, concealer and many more which are all naturally
formulated. Furthermore, one will find locally made natural cosmetics or
those made by famous designers worldwide. There exist a large variety of
herbal extracts, to name a few AndrographisPaniculata (Kalmegh),
Asparagus Racemosus (Shatawari), BoswelliaSerrata (SalaiGuggal),
Asphalt (Shilajit) etc [15].
5) Fits your budget
Natural cosmetics are not that expensive. In fact, some of these products
are more affordable than synthetic ones. They are offered at discounted
prices and are sold for a cheap price during sales. Just need to survey
enough to look for great deals. An estimate of WHO demonstrates about
80% of world population depends on natural products for their health care,
because of side effects inflicted and rising cost of modern medicine. World
Health Organization currently recommends and encourages traditional
herbal cures in natural health care programs as these drugs are easily
available at low cost and are comparatively safe [16].
6) Not tested on animals
Some cosmetics are initially tested on animals to ensure that they are safe
and effective to use for human. However, natural cosmetics need not be
tested on animals. These natural formulations are tested by experts in
laboratories using state of the art equipment with no animals involved [7].
16
7) No side effects
The synthetic beauty products can irritate your skin, and cause pimples.
They might block your pores and make your skin dry or oily. With natural
cosmetics, one need not worry about these. The natural ingredients used
assure no side effects; one can apply them anytime, anywhere. For
example herbal cosmetics are free from parabens that are the most widely
used preservative in cosmetics and can penetrate the skin [17]. And are
suspected of interfering with hormone function (endocrine disruption)
[10].
2) Antiaging
Gingko:In China and Japan, the leaves and nuts of the Ginkgo
biloba(G. biloba) tree have been used for thousands of years to treat
various medical conditions, including poor blood circulation;
hypertension; poor memory, and depression, particularly among the
elderly; male impotence. In addition, it is gaining a similar reputation
as an antioxidant and anti-inflammatory agent. Ginkgo bilobabelongs
to family Ginkgoaceae, which grows to a huge size [30]. The G.
bilobaextractEGb 761, prepared from the tree's leaves, is a natural
mixture containing flavone glycosides (33%), mostly quercetin and
kaempferol derivatives, and terpenes (6%), which has exhibited the
capacity to reduce the number of ultraviolet B (UVB)-induced sunburn
cells in mice.
3) Dandruff treatment
Ayurveda has numerous natural medications wherein the most
common herbs include Neem, Kapoor (naphthalene), and Henna,
Hirda, Behada, and Amalaki, Magic nut, Bringaraj, Rosary Pea, Sweet
Flag, Cashmere tree and Mandor.
19
Green tea: The tea plant (Camellia sinensis) has been cultivated in
Asia for thousands of years [35]. The 4 major polyphenoliccatechins
present in green tea leaves are (2)-epicatechin (EC), EGC, (2)-EC-3gallate, and EGCG, which is the most abundant [36,37]. It was found
that green tea extracts or an individual green tea polyphenol (GTPP),
especially epigallocatechin (EGC)-3-gallate (EGCG), inhibited twostage
chemical
carcinogenesis
(eg,
induced
by
7,12-di-
including,
demethoxycurcumin,
anti-inflammatory,
antioxidant,
antimalarial,
insect-
6) Essential oils
damascenaMill.,R.
gallicaL.,
R.
moschataHerrm.
andR.
centifoliaL. Rose oil and rose water have many therapeutic effects.
Rose oil helps soothe the mind and heals depression, grief, nervous
stress and tension. It also helps to heal wound and skin.
cough
syrups,
ointments,
toothpaste
and
also
as
oil
sports
chromatographic
profile:
1,8-cineole
Tamarind:Tamarind
or
TamarindusindicaL.
of
the
Fabaceae,
I.
NUTRACEUTICALS
The term nutraceuticals was coined from nutrition and
pharmaceutical by Stephen Defelice MD, founder and
chairman of the foundation for innovation in medicine (FIM)
Cranford, New Jersy, in 1989. According to Defelice
Nutraceuticals are food or part of a food that provides
medical or health benefits including the prevention and/or
treatment of a disease. Greek physician HIPPOCRATES
(known as father of medicines) said let food be your
medicine The philosophy behind is focus on prevention
Other words used in the context are Dietary supplements,
functional food, multi-functional food, etc. Functional foods
are ordinary foods that have components, ingredients that
incorporated into give them a specific medicinal or health
benefit moreover nutritional effect.
23
Health Benefits
May increase the health value, our diet and improve medical condition
of human.
intestine.
5. Enhance the absorption and/or stability of essential nutrients.
6. Selective growth factor for beneficial bacteria.
7. Fermentation substrate for beneficial bacteria.
8. Selective inhibitors of deleterious intestinal bacteria.
9. Scavengers of reactive or toxic chemicals.
10. Ligands that agonize or antagonize cell surface or intracellular
receptors.
Classification
Nutraceuticals or functional foods can be classified on the basis of their
natural sources, pharmacological conditions, or as per chemical
constitution of the products.
1. On the basis of natural source, it can be classified as the products
Category of Nutraceuticals
25
The nutraceutical industry lies under three main segments which include
functional foods, dietary supplements, and herbal/natural products. Global
nutraceutical market is estimated as USD 117 billion (INR 5148 billion).
In 2007, nutraceuticals sale is projected to reach $74.7 billion at an AAGR
of 9.9%. This assumes a world economic recovery in 2003 and an end to
price competition.
Regulations
A food stuff (as a fortified food or a dietary supplement) that provides
health benefits, if indeed a claim was made that implied medicinal benefit
regarding a nutraceutical product, the product would be required to comply
with the regulatory requirements for medicinal products, in respect of
safety, efficacy, and quality testing and marketing authorization
procedures. For decades, FDA regulated dietary supplements as foods to
ensure that they were safe and wholesome and that their labeling was
truthful and not misleading. In 2006, the Indian government passed Food
Safety and Standard Act to integrate and streamline the many regulations
covering nutraceuticals, foods, and dietary supplements. The act calls for
the creation of the Food Safety and Standards Authority (FSSA).
Benefits of Implementation of FSSAI Acts
Science-based standards.
Unlike the US, where the DSHEA is in place to regulate these products, in
India the Government is in the process of drafting a law to regulate
manufacturing, importing, and marketing of health foods, dietary
supplements, and other nutraceuticals and finally Indian food safety
standard bill 2005 signed into law, promising a major impact on Indian
27
food processing industry. The Indian Food Safety and Standard Act came
into enforcement in 2006 with the following two main objectives:
Benefits of Regulation
Our Services
We can offer the following services:
28
Manufacturing Facility
The company is headquartered at Indore (MP) and has GMP approved
manufacturing facility in Industrial area of Pithampur Dist. Dhar along
with ISO 9001 accreditation. It is about 35 Km from the corporate office
located at Indore. The facility already has GMP and ISO 9001
accreditation and will have WHO-GMP accreditation shortly by the end of
Jan 2015. It is serving as a contract manufacturer for a number of reputed
pharmaceutical companies in India. The company has been successful
audited and approved by the major Indian Companies, naming few:
a. Manufacturing Range
Tablets
Capsules
Liquids
Oils
Topicals Ointments and Gels
Powders
30
Quality Policy:Our quality policy is to ensure that the quality of the product
is to satisfy the customer and society according to the current good laboratory
and manufacturing practices.
Quality Objectives:To achieve the desired quality of the product, the quality
objectives are:
Quality Control
31
2. Production Process: Your order must match the sample approved by the
buyer. To assure this, it is essential to maintain counter samples of the sample
sent to the buyer. This will avoid confusion of what the buyer is expecting.
Production of the order should be compared to the counter sample several
times during the production process, not just once the product is finished.
Some buyers may request that a production sample (photo or actual product)
be sent to them for their approval to assure that matches their specifications
before it is shipped. Quality control throughout production can help identify
mistakes and correct them before they result in costly errors. Use a
thorough quality control check list for monitoring consistency and quality of
your production.
order, to assure that artisans can cover the costs of purchasing materials and
producing the products. Finally, good quality production also depends on
workshop conditions. Work areas should be kept clean and artisans should
have the minimal tools needed. Sometimes something as simple as making
sure the artisans have tape measurers can make a big difference.
Provide check list for all stages of production and make sure all
artisans know how to check for quality issues as they make the
products.
33
34
Defining Quality
Quality assurance relies on a strict definition of what is acceptable and not
acceptable from a product or service. If a customer has ordered a widget
from your company that is to be cut into three-inch pieces, then a four-inch
piece does not meet the quality standard. A cleaning service may have a
standard that calls for bathroom mirrors to be cleaned free of smudges; a
fingerprint left behind falls outside of the standard.
It is your responsibility to your company's success to make sure that every
employee understands the quality definitions and how he is to make
certain those standards are met.
Measuring Quality
Measuring the quality that is delivered is critical for consistent results.
Managers and supervisors should check an employee's work as it relates to
quality standards. When quality falls short, supervisors are responsible for
making the change required to bring quality back to the proper standard.
Improving Quality
The old expression, "There is always room for improvement," rings true
when it comes to quality assurance. To keep your business on the cutting
edge, you should always be asking the question, "How can we make this
better?" By tweaking the process here and there or by raising standards a
small bit each year, you will see your overall business quality improve to
levels greater than you ever imagined.
35
36
Our Clients
Glenmark Pharma
37
Alkem Pharma
Emcure
Kopran
38
Lupin
Troikaa Pharma
39
TTK Healthcare
Introduction to Project
The Pharmaceutical industry is a dynamic industry, with new products are
launched every three months. The business development division of the
company acts as the first interface to the existing and the prospective clients.
As intern in a Business development division of this company my
responsibilities were.
1. Act as liaison between existing clients and manufacturing
facility.
2. Prospect qualifying and Consultative sales.
3.
4. Clientele extension.
5. RFP/RFI/Bid preparation
6. Contract and deal negotiation and closing.
7. Sales management
40
Target, plan and prepare for any trade shows that are attended.
Ensuring that sales support tools and follow up information are in line
with objectives at shows.
41
Interpersonal Skills
Teamwork
To work with other areas of business ensuring necessary lead times are
understood in order to deliver a quality proposal.
Communication
42
To maintain skills in the use of tools for the role e.g. Sage, spread
sheets, document preparation.
General
Personal Qualities
Minimum
3-5
years
exhibition
experience
within
43
business
Business development is the creation of longterm value for an organization from customers,
markets, and relationships.
Business development (BD) comprises a number of tasks and processes
generally aiming at developing and implementing growth opportunities within
and between organizations. It is a subset of the fields of business, commerce
and organizational theory. Business development is the creation of long-term
value for an organization from customers, markets, and relationships.
44
Sales
Finance
Marketing
Legal
Strategic management
The "pipeline" refers to flow of potential clients which a company has started
developing. Business-development staff assigned to each potential client in the
pipeline with objective of converting prospect into a successful client, with
projected sales-volumes attached. Planners can use the weighted average of all
the potential clients in the pipeline to project staffing to manage the new
activity when finalized. Enterprises usually support pipelines with some kind
of customer relationship management (CRM) tool or CRM-database, either
web-based solution or an in-house system. Sometimes business development
45
sales of services/products
SWOT Analysis
The SWOT analysis of the industry reveals the position of the Indian
pharmaceutical industry in respect to its internal and external environment.
a) Strengths
Higher GDP growth leading to increased disposable income in the hands
of general public and their positive attitude towards spending on healthcare.
46
Low-cost, highly skilled set of English speaking labor force and proven
track record in design of high technology manufacturing devices.
Growing treatment naive patient population.
Low cost of innovation, manufacturing and operations.
b) Weaknesses
Stringent pricing regulations affecting the profitability of pharma
companies.
Poor all-round infrastructure is a major challenge.
Presence of more unorganized players versus the organized ones, resulting
in an increasingly competitive environment, characterized by stiff price
competition.
Poor health insurance coverage.
c) Opportunities
Global demand for generics rising.
Rapid OTC and generic market growth.
Increased penetration in the non - metro markets.
Large demand for quality diagnostic services.
Significant investment from MNCs.
Public-Private Partnerships for strengthening Infrastructure.
Opening of the health insurance sector and increase in per capita income the growth drivers for the pharmaceutical industry.
India, a potentially preferred global outsourcing hub for pharmaceutical
products due to low cost of skilled labor.
d) Threats
Wage inflation.
Government expanding the umbrella of the Drugs Price Control Order
(DPCO).
47
49
BIBLIOGRAPHY
Makin Laboratories Private Limited is a Private Company incorporated on 29
April 1987. It is classified as Indian Non-Government Company and is
registered at Registrar of Companies, Gwalior. Its authorized share capital is
Rs. 7,500,000 and its paid up capital is Rs. 5,980,000.It is involved in
Veterinary activities.
50
Company Information
Company Name
RoC
RoC-Gwalior
Registration Number
3930
Activity
Company Category
Indian Non-Government
Company
Class of Company
Private Company
7,500,000
5,980,000
Number of
Members(Applicable only in
case of company without
Share Capital)
Date of Incorporation
29 April 1987
Email ID
maknassociates@gmail.com
Address 1
Address 2
Pithampur
51
City
INDORE
State
Madhya Pradesh
Country
INDIA
PIN
454774
Unlisted
30 September 2014
52