A PRACTICUM REPORT ON BIO PHARMACEUTICALS

BY N NEELIMA SAHITYA MBA IB ROLL NO 19

OBJECTIVE

 To give a overview of the biopharm industry.  To provide information regarding leading companies in the
industry.

 To focus on supply chain activities of bio pharma industry.  To identify governmental support, initiatives provided to the
industry.

 To focus on the activities relevant to the industry.  To provide with statistical data relevant to the industry for
the past 5 to 10 years.

METHODOLOGY ADOPTED

 I visited a bio pharma company as a part of my

practicum and collected the information regarding operations happening there

 Recorded information related to their imported and

exported products.

 Gathered information related to drug development

process, leading countries in importing their products

 Analyzed the Supply chain of the industry is identified.  Collected information related to overall activities being
happening in that organization.

INTRODUCTION

 Biopharmaceuticals are the drugs produced by making use

of biological sources by applying the bio technological techniques.

 Insulin is the first biopharmaceutical product produced

industrially.

 Any biopharmaceutical company for producing the drug

need to apply for manufacturing rights i.e. patents

 Patents are granted as per patent laws.  The patent laws vary from nation to nation depending on
the requirement.

 From 1970s only the biopharm sector started its activities

globally. And within near time it became a leading sector in India.

 The

drugs

are

manufactured

and

designed

as

per

regulations of food and drug administration FDA.

 Once the drug is manufactured it is subjected to some trials

to release into the market

 Drugs to be released into markets takes many years of

clinical trials.

CLASSIFICATION

BI P

ES

V CCI ES

BL D F CT S

G WT F CT S

E Z Y ES

DDITI L P D UCTS

DUCTS

INDIAN BIOPHARMACEUTICALS INDUSTRY REPORT

 The

Indian

biopharm

industry

is

fast

growing

and

developing tremendously.

 It is the industry that is dominating other sectors, thus it is

a leading sector.

 The Indian biopharm companies started operations globally

after liberalization of foreign trade.

 This is the sector contributing the major to the Indian

economy.

 Vaccines are major segment of biopharm industry.  The industry

has about 120 companies involved In

production of the vaccines, drugs.

 Vaccines accounts for most revenue generation.  Indian biopharm sector is the mostly the export oriented
sector.

TOP DOMESTIC BIO PHARMA COMPANIES

S.NO COMPANY 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Biocon Aventis pharma Eli lilly Shantha biotech Ranbaxy Dr reddys Biological e Serum Institute of India Panacea Biotech Nicholas Piramal Wockhadrt Limited Indian Immunologicals Zydus Cadila GlaxoSmithKline Bharat Serum Krebs Biochemicals and Industries Limited

TOP GLOBAL BIOPHARMA COMPANIES S.NO 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 COMPANY Pfizer Novartis Sanofi-Aventis GlaxoSmithKlin AstraZeneca Roche Johnson & Johnson Merck & Co Eli Lilly Abbott Teva Bayer Wyeth Amgen Boehringer Takeda Daiichi Sankyo Novo Nordisk

LEADING BIO PHARMA COMPANIES IN INDIA WITH THE FOCUS AREA

company Dr reddys Ranbaxy Cadila AstraZeneca Cipla Bharat Biotech Shanta Biotech Wockhardt

Focus area cancer Respiratory disorders. Biotechnology. Tuburculosis Autoimmune disorders Vaccines. Insulin, Antibiotics Anti-invectives.

SUPPLY OF BIO PHARMA PRODUCTS

supplier supplies raw materials

manufacturer manufactures the products

quality check is to be done

proper package in pharma products is neede to ensure safety of goods

products are moved to distributors,pharmists and druggists.

distributor distributes to the retail madical stores and also to the doctors for product promotion.

customer gets the drugs from retail stores or from doctors .

SUPPLY CHAIN

Pharma com any

customer

Distributor/agent s

Doctors

edical store

The biopharm products are highly sensitive to the temperature which requires utmost care in handling them. In case of exports the drugs are to be properly packed to ensure proper delivery of goods in the supply chain

RESEARCH A

EVE

PME
  

 Research and develop en is the key area o the pharma sector. ecause innovation is the basis o the industry and
 

spends maximum investments in the innovation.  Nearly up to 15 percent o the sales in the industry is spent on R& .
  

l ays investment in pharma is risk and

hi hly uncertain leadin to hi h returns ultimately.  It was observed that the pro it margins o
! # !

drug

manufacturing companies is 4 times the margins of top fortune 500 companies.

Series 1
140
120

100
80

60
40 20

eries 1

0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

"

R&

costs spent in us billion dollars

CHALLENGES The biopharm industry faced many challenges to survive in the industry. . The challenges are 1) Lack of infrastructure. 2) Lack of skilled manpower . 3) Highly expensive equipments. 4) Release of a new drug takes several years of trials. 5) Lack of warehousing . 6) Lack of proper srutiny of products. 7) Lack of proper care and precautions. 8) High competitions in both domestic as well as global markets. By facing many of these challenges also the industry is now leading the other industries interms of sales and revenues.

GOVERNMENTAL SUPPORT In the initial stages of biopharm industry the government encouraged the industry by providing certain incentives and benefits. Like 1) Reduction in the tax rates 2) New schemes were introduced by the government. 3) Insurance is provided. 4) Encouraged innovations through research and development. 5) Certain governmental regulations are made flexible. 6) Government encouraged bio pharma exports by lowering tariffs and customs duties. 7) Government focused on the quality of drugs. 8) Proper infrastructural facilities are been provided by the government.

INDUSTRIAL PRODUCTION OF BIOPHARMACEUTICALS Biopharmaceuticals are produced by making use of living cells from biological sources in the bioreactors. The major problem in the production is with contamination caused by living cells which leads to spoilage of drug

prod ction of bio pharmace ticals

fermentation
recombinant technology

genetically modified cells

DRUG DISCOVERY PROCESS

drug disc very

2 to 10 yrs

re c inic

es ing

dos ge c ec

c ec or e ec iveness nd side e ec s if ny

c ec for ong er us ge re c ions

fda a

roval after revie

arketing

BIO PHARMA INDUSTRY STATISTICS FOR THE YEARS 2003 TO 2010

YEAR

WORLD MARKET IN USD IN BILLIONS

PERCENTAGE GROWTH ON PREVIOUS YEAR 9.1

2003

500

561

2004

560

603

7.6

2005 2006

605 651

647 692

7.2 7.0

2007

720

740

6.9

2008

788

785

6.1

2009

819

840

7.1

2010

856

875

4.1

GROWTH OF I DIA

BIO PHARMA I DUSTRY FROM 2006

The industry faced many fluctuations in the sales from 2006 to 2011 In the below figure it is shown with the sales fluctuations graphically

YEARS A ONG X AXIS

$

SA ES A ONG Y AXIS

FACTORS THAT INFLUENCED THE HIGHER DEMAND FOR BIOPHARMACEUTICALS

1) Increased health conciousness 2) Incresed levels of incomes and standards of living 3) Lower side effects of biopharm products attracted customers globally. 4) It is the technological advancement in the pharma sector. 5) The demand in abroad for biopharmapoducts,ayurvedic medicines,herbal medicines is vey much higher than the demand in india.

OVERVIEW OF BIO PHARM INDUSTRY Industry size Today in India there are more than 350 Biotechnology companies in India .with an employment for over 20,000 scientists. Geographical distribution Most of the companies are located in the major cities of Delhi, Mumbai, Pune, Chennai, Bangalore,

Hyderabad and Ahmadabad

Output per annum

The Indian Biopharm crore

revenue is around Rs. 2960

Percentage in world market

India in 2003 was ranked 3rd in the Asia-Pacific region and 11th in the world in the number of biopharm enterprises.

Market

In the year 2008-09 Indian Biopharm Industrys

Capitalization overall turnover was Rs 12,137 crore

CONCLUSION

The practicum report on biopharmaceuticals gives us the overview of the industry. The statistical data gives an idea related to sales,growth of industry. Mainly the supply chain activities mentioned gives the framework of distribution The challenges faced by the industry is been overcomed with the governmenta support in the form of

incentives,benefits,tax infrastructural facilities.

reduction,sanctioning

required

The production of drugs industrially is mentioned in the report.

REFERENCES

1) WIKIPEDIA 2) CYGNUS INDIA.COM 3) INDUSTRY REPORTS 4) SRIBD.COM 5) BIOPHARMA REVIEW