Table of Contents

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

Overview of the Industry

The Indian Pharmaceutical industry is a success story providing employment
for millions and ensuring that essential drugs at affordable prices are
available to the vast population of this sub-continent.
Richard Gerster

Pharmaceutical Industry in India

The Pharmaceutical industry in India is the world's third-largest in terms of
volume and stands 14th in terms of value.
The Indian pharmaceutical industry currently tops the chart amongst India's
science-based industries with wide ranging capabilities in the complex field of
drug manufacture and technology. A highly organized sector, the Indian
pharmaceutical industry is estimated to be worth $ 4.5 billion, growing at
about 8 to 9 percent annually. It ranks very high amongst all the third world
countries, in terms of technology, quality and the vast range of medicines that
are manufactured. It ranges from simple headache pills to sophisticated
antibiotics and complex cardiac compounds, almost every type of medicine is
now made in the Indian pharmaceutical industry. The Indian pharmaceutical
sector is highly fragmented with more than 20,000 registered units. It has
expanded drastically in the last two decades. The Pharmaceutical and
Chemical industry in India is an extremely fragmented market with severe
price competition and government price control. The Pharmaceutical industry
in India meets around 70% of the country's demand for bulk drugs, drug
intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals
and injectibles. There are approximately 250 large units and about 8000 Small
Scale Units, which form the core of the pharmaceutical industry in India
(including 5 Central Public Sector Units). The Government has also played a
vital role in the development of the India Software Industry. In 1986, the
Indian government announced a new software policy which was designed to
serve as a catalyst for the software industry. This was followed in 1988 with
2

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.

Demand for drugs for treatment of lifestyle-related diseases such as diabetes,

cardiovascular diseases, and central nervous system are on the increase. There
are around 700,000 new cases of cancer each year and total of around 2.5
million cases. It is estimated that there are around 40 million people in India
with diabetes and the number is rising, 5.1 million. HIV/AIDS patients, and 14
million tuberculosis cases. According to industry reports, while the Indian
pharmaceutical industry witnessed a growth of 7 percent, the cardio-vascular
segment recorded 15 to 17 percent growth and anti-diabetes segment of over
10-12 percent growth.
Diagnostic Outsourcing/ Clinical Trails the Indian diagnostic services are
projected to grow at a CAGR of more than 20 per cent during 2010-2012.
Some of the major Indian pharmaceutical firms, including Sun Pharma,
Cadilla Healthcare and Piramal Life Sciences, had applied for conducting
clinical trials on at least 12 new drugs in 2010, indicating a growing interest in
new drug discovery research.
Generics India tops the world in exporting generic medicines worth US$ 11
billion and currently, the Indian pharmaceutical industry is one of the world's
largest and most developed. Moreover, the Indian generic drug market to grow
at a CAGR of around 17 per cent between 2010-11 and 2012-13. Union
Minister of Commerce and Industry and Minister for Trade and Industry,
Singapore, have signed a 'Special Scheme for Registration of Generic
Medicinal Products from India' in May 2010, which seeks to fast-track the
registration process for Indian generic medicines in Singapore.
Advantage India The Indian Pharmaceutical Industry, particularly, has been
the front runner in a wide range of specialties involving complex drugs'
manufacture, development and technology. With the advantage of being a
highly organized sector, the pharmaceutical companies in India are growing at
the rate of $ 4.5 billion, registering further growth of 8 - 9 % annually. More
than 20,000 registered units are fragmented across the country and reports say
that 250 leading Indian pharmaceutical companies control 70% of the market
share with stark price competition and government price regulations.
4

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.

ABOUT THE COMPANY

Makin Laboratories Pvt. Ltd. is a renowned and one of the fastest growing
companies in India involved exclusively into the manufacturing of Herbal/
Ayurveda products along with Dietary/ Nutraceutical supplements. The
foundation stone of the company was laid down in year 1984 and the
manufacturing operations started in the year 1987 (The Company was
incorporated in the year 1987). The major change in the company started
immediately after the New Management took over, under the leadership and
guidance of a team of Doctors headed by Dr. O.P. Sharma. Dr. Sharma
carries the experience of conducting clinical trials on herbal medicines for
over a period of three decades. The company which initially started on a small
scale has now become a reputed herbal products manufacturer in the industry.

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.

The company is managed under the leadership of young & dynamic

entrepreneur, Managing Director Mr. Yash Sharma along with his team of
qualified scientists and technocommercial people to manage the day to day
operations of the company. We, at Makin Laboratories make use of the latest
manufacturing technologies and produce the highest quality products. The
8

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.

Ayurvedic / Herbal Products

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

Nutraceuticals is a broad umbrella term that is used to describe any

product derived from food sources with extra health benefits in addition to
the basic nutritional value found in foods. They can be considered nonspecific biological therapies used to promote general well-being, control
symptoms and prevent malignant processes.
The term nutraceutical combines two words nutrient (a nourishing
food component) and pharmaceutical (a medical drug). The name was
coined in 1989 by Stephen DeFelice, founder and chairman of the
Foundation for Innovation in Medicine, an American organization located
in Cranford, New Jersey.
The philosophy behind nutraceuticals is to focus on prevention, according
to the saying by a Greek physician Hippocrates (known as the father of
medicine) who said let food be your medicine. Their role in human
nutrition is one of the most important areas of investigation, with wideraging implications for consumers, health-care providers, regulators, food
producers and distributors.

10

Ayurvedic / Herbal Products

I.

Ayurvedic products are of two types:

1. Herbal Medicinal
2. Herbal Cosmetics
1.

Herbal Medicinal Products

Some plants contain substances that may be used to treat diseases.

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;

Eleutherococcussenticosus (Rupr. Et Maxim.) Maxi; Foeniculumvulgare

Miller subsp. vulgare var. vulgare; Foeniculumvulgare Miller subsp. vulgare
var. dulce (Miller) Thellung; Hamamelisvirginiana L; Mentha x piperita L. and
Pimpinellaanisum L.
A herbal product will be considered a medicinal product where presented as
having properties for treating or preventing disease in human beings or where
it has a pharmacological, immunological or metabolic action. It is the
competence and responsibility of national authorities to decide, on a case-bycase basis, whether a herbal product fulfills the definition of medicinal
product.
However, herbal products may be classified and placed on the market as food
provided that they do not fulfill the definition of medicinal products and that
they do comply with the applicable food law. In particular, herbal products
marketed in the form of food supplements should comply with Directive
11

2002/46/EC on food supplements and Regulation (EC) No 1924/2006 on

nutrition and health claims made on foods.

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

pharmaceutical drugs. Herbs typically have fewer side effects than

traditional medicine, and may be safer to use over time.

Effectives with chronic conditions: Herbal medicines tend to be more

effective for long-standing health complaints that don't respond well to
traditional medicine. One example is the herbs and alternative
remedies used to treat arthritis. Vioxx, a well-known prescription drug
used to treat arthritis, was recalled due to increased risk of
cardiovascular complications. Alternative treatments for arthritis, on
the other hand, have few side effects. Such treatments include dietary
changes like adding simple herbs, eliminating vegetables from the
nightshade family and reducing white sugar consumption.

Lower cost: Another advantage to herbal medicine is cost. Herbs cost

much less than prescription medications. Research, testing, and
marketing add considerably to the cost of prescription medicines.
Herbs tend to be inexpensive compared to drugs.

Widespread availability: Yet another advantage of herbal medicines are

their availability. Herbs are available without a prescription. You can
grow some simple herbs, such as peppermint and chamomile, at home.
In some remote parts of the world, herbs may be the only treatment
available to the majority of people.

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

Inappropriate for many conditions: Modern medicine treats sudden and

serious illnesses and accidents much more effectively than herbal or
alternative treatments. An herbalist would not be able to treat serious
trauma, such as a broken leg, nor would he be able to heal an
appendicitis or a heart attack as effectively as a conventional doctor
using modern diagnostic tests, surgery, and drugs.

Lack of dosage instructions: Another disadvantage of herbal medicine

is the very real risks of doing yourself harm through self-dosing with
herbs. While you can argue that the same thing can happen with
medications, such as accidentally overdosing on cold remedies, many
herbs do not come with instructions or package inserts. There's a very
real risk of overdose.

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.

Lack of regulation: Because herbal products are not tightly regulated,

consumers also run the risk of buying inferior quality herbs. The
quality of herbal products may vary among batches, brands or
manufacturers. This can make it much more difficult to prescribe the
proper dose of an herb.

2.

Herbal Cosmetic Products

Herbal Cosmetics, referred as Products, are formulated, using various

permissible cosmetic ingredients to form the base in which one or more

herbal ingredients are used to provide defined cosmetic benefits only, shall

13

be called as Herbal Cosmetics. Herbs do not produce instant cures. They

offer a way to put the body in proper tune with nature [3]. A huge number
of cosmetic and toiletry formulations have been designed and developed
based u p o n Indian Herbs recently. Other than traditionally documented
applications, some modern trials have also been using the utility of Indian
herbs in Personal Care products. The demand of herbal medicines is
increasing rapidly due to their skin friendliness and lack of side effects.
The best thing of the herbal cosmetics is that it is purely made by the herbs
and shrubs and thus is side-effects free. The natural content in the herbs
does not have any side effects on the human body; instead provide the
body with nutrients and other useful minerals [4]. The term
Cosmoceuticals was first used by Raymond Reed founding member of
U.S Society of Cosmetics Chemist in 1961. He actually used the word to
brief the active and science based cosmetics. The above term was further
used by Dr Albert Kligman in the year 1984 to refer the substances that
have both cosmetic and therapeutic benefits [5]. Cosmoceuticals are
cosmetic-pharmaceutical hybrids intended to enhance health and beauty
through ingredients that influence the skin's biological texture and
function.

Advantages of Herbal Cosmetics over Synthetic

Herbal cosmetics are the modern trend in the field of beauty and fashion.
These agents are gaining popularity as nowadays most women prefer
natural products over chemicals for their personal care to enhance their
beauty as these products supply the body with nutrients and enhance health
and provide satisfaction as these are free from synthetic chemicals and
have relatively less side-effects compared to the synthetic cosmetics.
Following are some of the advantages of using natural cosmetics which
make them a better choice over the synthetic ones:

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

(ButylatedHydroxytoluene) are closely related synthetic antioxidants and

are used as preservatives in lipsticks and moisturizers [10]. BHA and BHT
can induce allergic reactions in the skin [11]. The international Agency for
Research on Cancer classifies BHA as a possible human carcinogen [12].
Herbal cosmetics contain natural antioxidants like vitamin C [13].
3) Compatible with all skin types
Natural cosmetics are suitable for all skin types. No matter if you are dark
or fair, you will find natural cosmetics like foundation, eye shadow, and
lipstick which are appropriate irrespective of your skin tone. Women with
oily or sensitive skin can also use them and never have to worry about
degrading their skin condition. Coal tar-derived colors are used extensively
in cosmetics, Coal tar is recognized as a human carcinogen and the main
15

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].

Herbs Used in Cosmetics/Cosmeceuticals

There are numerous herbs available naturally having different uses in
cosmetic preparations for skincare, hair care and as antioxidants, fragrant
etc. Some of the important examples are as follows:
1) Skincare

Coconut oil:It is produced by crushing copra, the dried kernel, which

contains about 60-65% of the oil. Coconut oil contains a high amount
of glycerides of lower chain fatty acids. Coconut oil is derived from
the fruit or seed of the coconut palm tree Cocosnucifera, family
Arecaceae. The melting point of coconut oil is 24 to 25C (75-76F)
and thus can be used easily in liquid or solid forms and is often used in
cooking and baking. Coconut oil is excellent as a skin moisturizer and
softener.

Sunflower oil:It is the non-volatile oil extracted from sunflower seeds

obtained from Helianthus annuus, family Asteraceae. Sunflower oil
contains lecithin, tocopherols, carotenoids and waxes. It has smoothing
properties and is considered non-comedogenic [4]. A simple yet costeffective oil, well tried and tested for generations in a wide variety of
emulsions formulated for face and body Products.
17

Jojoba oil:It is a mixture of long chain, linear liquid wax esters

extracted from the seeds of the desert shrub simmondsiachinenesis,
family simmondsiaceae. Jojoba oil is easily refined to remove any
odor, color it is oxidative stable, and is often used in cosmetics as a
moisturizer and as a carrier oil for exotic fragrances. Human sebum
and jojoba oil are virtually identical. Sebum protects and moisturizes
the skin and hair but is stripped away by chemicals, pollutants, sun and
the aging process, resulting in dry skin and hair. Jojoba oil replenishes
what skin and hair lose and restores them to their natural pH balance.

Olive oil:This oil is a fixed oil extracted from the fruits of

oleaeuropaea, family oleaceae. The major constituents are triolein,
tripalmitin, trilinolein, tristearate, monosterate, triarachidin, squalene,
-sitosterol and tocopherol. It is used as skin and hair conditioner in
cosmetics like lotions, shampoos etc. It is a potent fatty acid
penetration enhancer.

Aloevera:Aloevera is aherbal plant species belonging to liliaceae

family that is found only in cultivation, having no naturally occurring
populations, although closely related aloes do have presence in
northern Africa [8]. It is an ingredient in many cosmetics because it
heals, moisturizes, and softens skin. Simply cut one of the aloe vera
leaves to extract the soothing gel [4]. Aloe vera contains amino acids
like leucine, isoleucine, saponin glycosides that provide cleansing
action, vitamins A,C,E,B, choline, B12 and folic acid and provide
antioxidant activity.

2) Antiaging

Carrot:It is obtained from the plant Daucuscarotabelonging to family

Apiaceae. It is a valuable herb since ages as due to its richness in
Vitamin A along with other essential vitamins. Carrot seed oil is used
as anti-aging, revitalizing and rejuvenating agent [4]. The carrot gets
its characteristic and bright orange colour from -carotene, and lesser
18

amounts of -carotene and -carotene. and -carotenes are partly

metabolized into vitamin Ain humans.

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.

Henna:Hennacomes from the plant awsoniainermisfamilyLythraceae,

which contain a dye molecule called Lawsone, which when processed
produces Henna powder. Besides lawsone other constituents present
are gallic acid, glucose, mannitol, fats, resin (2%), mucilage and traces
of an alkaloid. Leaves yield hennatannic acid and an olive oil green
resin, soluble in ether and alcohol [32]. Lawsone isolated from the
leaves of L.inermishas shown significant antifungal antibiotic effect.

19

Neem:Neem or Margosa is a botanical relative of mahogany. It

belongs to the family Meliaceae. The Latinized name of NeemAzadirachtaindica-is derived from the Persian.

The common treatment for the dandruff is Neem as it produces antifungal,

antibacterial, pain-relieving, and anti- compounds that would treat dandruff.
4) Skin Protection

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-

methylbenz(a)anthracene [DMBA] and 12-O-tetra-decanoylphorbol

13-acetate [TPA]), and photocarcinogenesis (induced by UVB).

Calendula:Calendulaofficinalisis reported to have a remarkable

antioxidant activity, anti- inflammatory activity and wound healing
activity [39]. A previous study demonstrated that the essential oil of
Calendula consists mainly of -thujene, -pinene, 1,8-Cineole,
dihydrotagetone and T-muurolol .

Turmeric:It is a deep yellow-to-orange powder that comes from the

underground stems of the tropical perennial herb Curcuma longa of the
family Zingiberaceae[41]. Turmeric contains a wide range of
phytochemicals

including,

demethoxycurcumin,

bisdemethoxycurcumin, zingiberene, curcumol, curcumenol, eugenol,

tetrahydrocurcumin, triethylcurcumin, curcumin, turmerin, turmerones,
and turmeronols. Curcumin is the phytochemical that gives a yellow
color to turmeric and is now recognized as being responsible for most
20

of the therapeutic effects [42]. Uses of turmeric include antiseptic,

analgesic,

anti-inflammatory,

antioxidant,

antimalarial,

insect-

repellant, and other activities associated to turmericigure 13).

5) Haircare

Amla:Amla is the name given to the fruit of a small leafy tree

(EmblicaOfficinalis), which grows throughout India and yields an
edible fruit. It is highly praised both for its high vitamin C content and
for the precious oil, which is extracted from its seeds and pulp and
used as a treatment for hair and scalp problems. It is used in eye
syndromes, hair loss, and children ailments etc.

Shikakai:Acaciaconcinna Linn. (Leguminosae) is a medicinal plant

that grows in tropical rainforests of southern Asia. The fruits of this
plant are used for washing hair, for improving hair growth, as an
expectorant, emetic, and purgative. The powder of Acacia Concinna
Linn shows the presence of saponins, alkaloid, sugar, tannin,
flavanoids, anthraquinone glycosides.

6) Essential oils

Rose oil:Roses are widely referred to as the worlds favorite flower in

part due to their vast diversity in plant habitat and floral characteristics.
There are mainly four species of roses for oil production. These are
Rosa

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.

Eucalyptus oil:There are around 700 different species of Eucalyptus

in the world, of which at least 500 produce a type of essential oil. It is
produced by steam distillation from the leaves of Eucalyptus species
21

(E. cinerea F. Muell., E. baueriana F. Muell., E. smithii R. T. Baker, E.

bridgesiana R. T. Baker, E. microtheca F. Muell., E. foecundaSchau.,
E. pulverulenta Sims, E. propinqua Deane and Maiden, E. erythrocorys
F. Muell.) etc. They are widely used in the preparation of liniments,
inhalants,

cough

syrups,

ointments,

toothpaste

and

also

as

pharmaceutical flavors. The European Pharmacopoeia monograph for

Eucalyptus

oil

sports

chromatographic

profile:

1,8-cineole

(eucalyptol; not less than70%), limonene (4- 12%), -pinene (2-8%),

- phellandrene (less than 1.5%), -pinene (less than 0.5%), camphor
(less than 0.1%).
7) Antioxidants

Tamarind:Tamarind

or

TamarindusindicaL.

of

the

Fabaceae,

subfamily Caesalpinioideaeconsists of amino acids, fatty acids and

minerals of tamarind plant parts. The most distinguished characteristic
of tamarind is its sweet acidic taste due to tartaric acid. Besides being a
rich source of sugars, tamarind fruit is also an excellent source of
vitamin B and contain minerals, exhibit high antioxidant capacity that
appear to be associated with a high phenolic content, and thus can be
an important food source.

Vitamin C:Vitamin C is necessary for the hydroxylation of proline,

procollagen, and lysine. Vitamin C improves the changes caused by
photo damage. Vitamin C has been used effectively to stimulate
collagen repair, thus removing some of the effects of photo-aging on
skin [13].

Vitamin E:(Alpha-tocopherol) is the major lipophilic antioxidant in

plasma membranes and tissues. The term vitamin E collectively refers
to 30 naturally occurring molecules (4 tocopherols and 4 tocotrienols),
all of which exhibit vitamin E activity. Its major role is generally
considered to be the arrest of chain propagation and lipid peroxidation
22

by scavenging lipid peroxyl radicals, hence protecting the cell

membrane from destruction.

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.

According to Dietary Supplement, Health and Education Act (DSHEA),

dietary supplements are products intended to supplement the diet that bears
or contains one or more of the following dietary ingredients: a vitamin, a
mineral, an herb or other botanical, an amino acid, a dietary substance for
use by man to supplement the diet by increasing the total daily intake, or a
concentrate, metabolite, constituent, extract, or combinations of these
ingredients. It may be taken in the form of pill capsule, tablet, or liquid
form. It is not represented for use as a conventional food or as the sole
item of a meal or diet. It is labeled as a dietary supplement. Under the
DSHEA (1994), the manufacturer of a dietary supplement is responsible
for ensuring that the dietary supplement is safe before it is marketed.

23

Simply, Nutraceuticals means, NUTRITIVE + PHARMACEUTICAL: A

food stuff (as a fortified food or dietary supplement) that provides health
benefits.

The functional food concept can be defined as Food products to be taken

as part of the usual diet in order to have beneficial effects that go beyond
basic nutritional function

Health Benefits

Avoid the side effect.

May increase the health beneficial effect.

May have naturally dietary supplement, so do not have unpleasant side

effect.

May increase the health value, our diet and improve medical condition
of human.

May easily be available and economically affordable.

Nutritional therapy is a healing system using dietary therapeutics or

nutraceuticals as a complementary therapy. This therapy is based on the
belief that foods can not only be sources of nutrients and energy but could
also provide medicinal benefits.

According to nutraceutical and nutritional therapy theory, it achieves this

goal by using efficacy of such nutraceuticals in detoxifying the body,
avoiding vitamin and mineral deficiencies, and restoring healthy digestion
and dietary habit. Phytonutrients basically is plant nutrients with particular
biological activities in supporting human health.

The phytochemical work by following way:

1. Substrate for biochemical reactions.
2. Cofactors of enzymatic reactions.
3. Inhibitors of enzymatic reactions.
24

4. Absorbents that bind to and eliminate undesirable constituent in the

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

obtained from plants, animals, minerals, or microbial sources.

2. Nutraceuticals as per the chemical groupings.

Category of Nutraceuticals

Substances with established nutritional functions, such as vitamins,

minerals, amino acids, and fatty acidsNutrients.

Herbs or botanical products as concentrates or extractsHerbals.

Reagents derived from other sources (e.g., pyruvate, chondroitin

sulfate, steroid hormone precursors) serving specific functions, such as
sports nutrition, weight-loss supplements, fortified conventional foods,
and meal replacementsDietary supplements.

Dietary supplements are not intended to treat or cure disease, whereas

nutraceuticals more emphasize the expected results of these products, such
as prevention or treatment of diseases.

25

Some of the most common ways of classifying nutraceuticals can be based

on food sources, mechanism of action, chemical nature, etc. The food
sources used as nutraceuticals are all natural and can be categorized as
1. Dietary Fiber.
2. Probiotics.
3. Prebiotics.
4. Polyunsaturated fatty acids.
5. Antioxidant vitamins.
6. Polyphenols.
7. Spices

Nutraceutical can be broadly classified into the following 2 groups:

i) Potential nutraceuticals.
ii) Established nutraceuticals.

A potential nutraceutical could become an established one only after

efficient clinical data of its health and medical benefits are obtained.

Global Demand of Nutraceutical

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.

Nutraceutical market in different countries

According to a recent report, the total market for nutraceuticals in India is
growing at 21 percent per annum. It is currently valued at INR 44bn (621
m), but could be worth more than INR 95bn in four years.
26

As a concept, Nutraceuticals is still in its stage of infancy in India. But it

has been growing much faster than global rates at CAGR of 18% for the
last 3 years driven by functional food and beverages categories. The most
rapidly growing segments of the industry were dietary supplements (19.5
percent per year) and natural/herbal products (11.6 percent per year).

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

Unification of eight laws, i.e. steps to Harmonization.

Alignment of international regulations.

Science-based standards.

Clarity and uniformity on novel food areas.

Help curb corruptions.

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:

To introduce a single statute relating to food, and

To provide for scientific development of the food processing 2009

industry.

Government Regulations - NLEA 1990

Nutrition Labeling and Education Act of 1990 (NLEA) defines how food
is labeled, including nutrition labeling, in accordance with definitions
established by FDA, and providing for the use of claims about the
relationship between nutrients and diseases or health-related condition.

Benefits of Regulation

Allows greater legal security and more predicable environment.

Supports innovation (food and drink products).

Prevents unfair competition from manufactures using false or

misleading claims.

If positive claims cannot be made, the regulation does not oblige

anyone to make negative claims about the product.

Our Services
We can offer the following services:

Offer our brands for Domestic as well as International Sales.

Contract manufacturing of our brands in your label and packaging.

Contract manufacturing of your brands in your label and packaging.

Contract manufacturing under neutral code customized for end user

packaging.

28

Develop and manufacture new herbal products or supplements in your

brand and packaging.

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

Makin Laboratories Pvt. Ltd. is equipped with the most modern

state-of-the-art plant to manufacture therapeutic dosage forms like:

Tablets
Capsules
Liquids
Oils
Topicals Ointments and Gels
Powders

Our Manufacturing Policy

Raw materials / Herbal Extracts used in the manufacturing of
products are from authentic and reputed sources, of prescribed quality
and are free from any contamination
29

 The manufacturing process complies with SOPs as prescribed to

maintain the standards
Adequate quality control measures are adopted. Quality control
measures including IPQC are stringent.
The manufactured products released for sale are of highest
international quality.

b. Quality Control and Quality Assurance

We believe in total quality management and total quality compliance,

we provide validation through independent laboratory testing also.

Our Manufacturing Process

30

Quality Management System

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:

To manufacture the product remembering the requirements of

the customer and society.
To achieve the quality with current good manufacturing and
laboratory practices.
To maintain the work place and environment neat and clean.
To apply the corrective changes for implementing the system.

Quality Control

1. Raw materials: The first step in maintaining quality is careful selection of

the materials to be used. Materials should be of the same quality as the sample
that was sent to the buyer. If the same materials are unavailable or need to be
substituted, the buyer must be notified. All materials should also be examined
for quality. Wood should be properly dried or final products will crack.
Textiles should be checked for color fastness and shrinking. Fittings and
fasteners should function properly and withstand use. All materials used
should be consistent in quality and color. In general, it is not a good idea to
compromise quality for cost by using inexpensive, but poorly made materials.
Paying a little more for good quality materials will pay off in the long run by
building buyers confidence in your products.

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.

3. Training of artisans: Handcrafts are often made in small workshops, and

large orders may be filled by a number of different producers. In this case,
extra care must be taken to make sure that the final products are all alike and
are the same as the sample. Training and good communication with the
artisans is essential. Artisans should understand what is involved in producing
crafts for export and how to meet quality requirements. All artisans should be
trained in how to check for quality issues as they make the products and be
provided with a check list of what to look for when monitoring the quality of
their production.

4. Working conditions: Good quality is also a factor of the working conditions

of the artisans. Working conditions include things like fair wages, proper work
areas and equipment, and worker incentives. The price paid to the artisan can
impact the quality of production, as does the time they have to fulfill an order.
If artisans have to produce a large order in a short amount of time, this could
result in quality being compromised. If artisans are paid a low wage, they have
little incentive to invest time into making a good quality item. Artisans also
need to have access to funds to purchase raw materials of the quality desired.
Some artisan organizations have developed a savings and loan program, to
lend money to artisans for the purchase of raw materials when they need it.
Most fair trade organizations should offer pre-financing when placing an
32

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.

5. Proper packing: Quality can also be compromised if products are not

properly packed for shipping. A product may have been made well, but be
damaged during shipping, resulting in losses. Entire boxes of products can
arrive damaged because they were packed when still wet, were packed too
tightly or without adequate protection. Quality control also includes packing
products so that they are protected from damages until they reach the buyer.
Proper packing is the responsibility of the producer. For more on packing, see
the Packing and Packaging section.

Effective Quality Control

Maintain counter sample originals of the same quality sample sent to

buyer.

Check quality control at multiple points throughout production

process.

Use a thorough quality control check list for monitoring consistency

and quality of your production.

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

Quality Assurance Process & Procedures

Meeting customer expectations comes from consistently meeting standards.

Your company is only as good as its last customer experience. If your
employees do not meet your standard, your patrons may seek out the
competition the next time a need arises. Delivering consistent results is at the
core of quality assurance procedures. Whether you are manufacturing a
million widgets or fixing computers for local clients, every employee needs to
know the company's quality standards and how to achieve them.

The Shewhart Cycle

To deliver products and services with consistent results, you can
implement the Shewhart Cycle, which uses four steps: Plan, Do, Check
and Act (PDCA). In the Plan step, state the desired goals for your product
and how they will be achieved. The Do step is your implementation of the
plan. Once the product is in production, it is time to Check to make sure it
is meeting the standard you set in the Plan step. Act requires you and your
team to make necessary corrections when the product is not meeting the
correct standards.

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

Structure of the Organization

36

Our Clients

Glenmark Pharma

37

Alkem Pharma

Emcure

Kopran

38

Lupin

Micro Labs Ltd.

Troikaa Pharma

39

TTK Healthcare

Unichem Laboratories Ltd.

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.

Managing relationship with existing clients, Client retention.

4. Clientele extension.
5. RFP/RFI/Bid preparation
6. Contract and deal negotiation and closing.
7. Sales management
40

Objective of the Study

1. Academic Objective: Submission of internship report to fulfill
degree completion requirements.
2. Knowledge Objective: To understand practical implications of
theoretical concepts of business development activities
Major Learning
ROLE DIMENSIONS AND SPECIAL FEATURES
This is a full-time role with the purpose of developing new businesses from
clients in the pharmaceutical sector. This will be achieved through building,
maintaining and increasing a client contact base. It fosters client interaction
through client meetings, briefing and presentations. New products will be
introduced to existing and prospective clients. Product is developed as per the
product requirements given by the client. In changing business environment
the decision makers are also required to make dynamic decisions and business
development teams often need to face challenging scenarios. The role reports
into and will support the Business Development Director.
Requirements
To meet/exceed sales targets, win ratios, contract values and activity in line
with sales strategy.
Planning and Organization

To manage workload effectively in line with overall sales strategy,

target sectors, target shows, weekly plan and changing business
priorities.

Maintain accurate records of all calls made and customer contact

information on Stage.

Performance monitoring of sales targets and revenue.

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

To plan and diarize regular contact with prospective clients in order to

maintain relationship and gain information about their goals and
objectives and competitive activities.

To be aware of departmental workloads and manage client expectations

accordingly.

Interpersonal Skills

To effectively sell in the 2heads brand services to clients to gain

commitment to tender for business.

To form relationships with key personals in the client companies.

To understand clients relationships such that key information required

for qualifying the opportunity is obtained early on.

To track and review with BD Director personal development objectives

to build selling skills.

Teamwork

To work across business managing relationships with other

departments at all stages of the sales process.

To work with other areas of business ensuring necessary lead times are
understood in order to deliver a quality proposal.

To help other departments achieve their goals at all times and

especially during peak workload.

To hold half yearly and annual appraisals with management to identify

performance achievement, personal goals and development goals.

Communication

To ensure that all communication with prospective clients is focused

and appropriate for their business sector.

42

To prepare client briefs and brief other departments effectively (new

and existing clients).

To provide feedback to departments on interim designs and costs such

that client needs are met.

To prepare and present high quality client proposals in a clear,

structured and customer focused format.

To provide client feedback to all department heads in a positive and

constructive way on wins/losses.

To maintain skills in the use of tools for the role e.g. Sage, spread
sheets, document preparation.

General

To ensure that all administrative processes and procedures are adhered

to and completed in a timely manner.

To operate within allotted budgetary parameters e.g. with travel and

attendance at shows.

To understand and adopt safe working practices.

To adhere to all company policies and guidelines as stipulated in

contract of employment.

Personal Qualities

To project a smart and professional image at all times.

To be proactive in all aspects of the job role.

Be responsible for own self-development, especially keeping abreast of

current happenings.

Relevant Skills, Knowledge and Experience

Minimum

3-5

years

exhibition

experience

within

development role or equivalent telesales environment

Good communication, presentation & interpersonal skills.

Ability to influence and gain agreement of prospective clients

Good Planning & organisational skills

43

business

Good written and verbal communication skills

Self-Motivated and hard working.

Annual, Quarterly and Monthly Objectives will be set by the Business

Development Director and reviewed regularly against performance
measures detailed against the objectives.

Ability to lead a team creatively, nurturing team members.

Good analytical skills combined with ability to recognise and

implement plans.

Excellent planning & organisational skills.

Excellent technical & creative skills.

How Business Development takes place in the manufacturing unit

of Pharmaceutical Company

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

The business developer is concerned with the analytical preparation of

potential growth opportunities for the senior management or board of
directors as well as the subsequent support and monitoring of its
implementation. Both in the development phase and the implementation
phase, the business developer collaborates and integrates the knowledge and
feedback from the organizations specialist functions. Examples are R&D,
production, marketing, and sales to assure that the organization is capable of
implementing the growth opportunities successfully. The business developers'
tools to address the business development tasks are the business model of
continuous evaluation of business objectives.
Business development professionals frequently have had earlier experience in
sales, financial services, investment banking or management consulting;
although some find their route to this area by climbing the corporate ladder in
functions such as operations management. Skill set and experience for
business-development specialists usually consist of a mixture of the following
(depending on the business requirements):

Sales

Finance

Marketing

Mergers and acquisitions

Legal

Strategic management

Proposal management or capture 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

specialists manage and analyze the data to produce sales management

information (MI). Such MI could include:

reasons for wins/losses

progress of opportunities in relation to the sales process

top performing sales people/sales channels

sales of services/products

For larger and well-established companies, especially in technology-related

industries, the term "business development" often refers to setting up and
managing strategic relationships and alliances with other, third-party
companies. In these instances the companies may leverage each
other's expertise, technologies or other intellectual property to expand their
capacities for identifying, researching, analyzing and bringing to market new
businesses and new products. Business-development focuses on
implementation of the strategic business plan through equity financing,
acquisition/divestiture of technologies, products, and companies, plus the
establishment of strategic partnerships where appropriate.

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

 Other low-cost countries such as China and Israel affecting outsourcing

demand for Indian pharmaceutical products
Entry of foreign players (well-equipped technology-based products) into
the Indian market.

Major Challenges Faced By the Industry

The Indian pharmaceutical industry was on a strong growth trajectory in the
last decade. It has achieved several milestones and is well positioned to
leverage emerging opportunities. However, the industry needs to tackle
various issues related to its operations and regulations. It faces several
challenges in the form of pricing of pharmaceutical products and impact of
some agreements. This section touches upon several key issues and challenges
faced by the industry:
48

Impact of GATT-TRIPS agreement: The General Agreement on

Tariffs and Trade1 (GATT) and Trade Related aspects of Intellectual
Property Rights (TRIPS) have an adverse impact on pricing of
pharmaceutical products. Pharmaceutical companies are not allowed to
re-generate existing drugs and formulations and change the existing
process and manufacture the same drug. New investments are required
to perform research. This is a major obstacle for pharma companies,
especially the micro, small and medium enterprises. Moreover, transfer
of technology from abroad is difficult and expensive. Consequently,
revenue of the pharma companies is impacted. Hence, adequate
measures should be taken to support the industrys revenue and
minimize losses.

Pricing: At present, pricing of 74 bulk drugs and their formulations,

which account for a large share in the retail pharma market, are
controlled by the Drug Price Control Order (DPCO)-1995. The
Government had considered reducing the number of regulated drugs,
but it has not been implemented. There is a need to reduce the number
of regulated drugs to facilitate the growth of the pharmaceutical
industry.

Drug diversions by institutions: Most of the institutional clients of

the Indian pharmaceutical companies comprise government hospitals,
the Indian defense service and private hospitals; the defense sector is
mandated to buy drug stocks through tenders in quantities twice as
large as the projected demand for those drugs in the following year at a
discounted price. At the year-end, surplus available at the institutions is
pushed to regular channels by leveraging the price discounts, resulting
in a loss for companies through the regular distribution channel.

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

Makin Laboratories Private Limited's Annual General Meeting (AGM) was

last held on 30 September 2014 and as per records from Ministry of
Corporate Affairs (MCA).

Company Information
Company Name

MAKIN LABORATORIES PRIVATE

LIMITED

RoC

RoC-Gwalior

Registration Number

3930

Activity

Veterinary activities [including

clinico-pathological and other
diagnostic activities pertaining
to animals and birds].

Company Category

Company limited by shares

Company Sub Category

Indian Non-Government
Company

Class of Company

Private Company

Authorized Capital (in Rs.)

7,500,000

Paid up capital (in Rs.)

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

Plot no 48, Sector III

Address 2

Pithampur
51

City

INDORE

State

Madhya Pradesh

Country

INDIA

PIN

454774

Whether listed or not

Unlisted

Date of Last AGM

30 September 2014

52