Case Study: Biocon Indias

Own Home-Grown Biotech

Company

Overview of Biocon
Biocon, Indias own home- grown
biotechnology
company,
was
established in 1978 as India's leading
biotechnology company. It has evolved
over the past 30 years from an enzyme
manufacturing unit to a fully integrated
biopharmaceutical enterprise, focusing
on health care.
It has two subsidiary companies:
Syngene International Limited
Clinigene International Limited

Biocons Performance
December, 2006- 44% increase in net
profit at Rs. 475.1m for third quarter
where in previous year it was 327.9 m.
It earned a revenue Rs. 8630m, profit
of Rs. 1080m 2006-2007 and grew 23%
in first quarter of 2007-2008.
BSE - closing at Rs. 410.25
NSE - closing at Rs. 410.75
It gained Rs. 75 touching an intra-day
high of Rs. 445.65 on BSE.

Biocon in news Recently

Kiran Mazumder Shaw, the Chairperson
New York Times: Indias mother of invention
The Economist: Indias Biotech Queen
Marketing license for BIOMab EGFR for
Pakistan on 18 January 2007
Sign MoU with Neopharma for a joint venture
on 5 January 2007
Comprehensive portfolio of renal therapy
products on 8 March 2007
Research partnership with Bristol-Myers
Squibb on 14 March 2007

Biocon - Important Milestones

1978

Establishment of Biocon India

1979

Manufacture and export enzymes to the

USA and Europe

1989

US funding for proprietary technologies

1990

Set up in-house research program

1994

Establishment of Syngene

Biocon - Important Milestones

1996

Enter to biopharmaceuticals and statins,

leverage its technology platform

1998

Become an independent entity

2000

Set up Clinigene

2001

Approval of manufacturing lovastatin by US

Food and Drug Administration

2002

Clinigenes laboratory receives CAP

accreditation

Biocon - Important Milestones

2003

Develop human insulin on a Pichia expression system

2004

New research centre in Bangalore

Partnership with Vaccinex, Inc to discover 4 therapeutic antibody

2005

Sign commercial agreement to deliver insulin API in Asia, Africa

and the Middle East

2006

Launch Indias first cancer drug BIOMAb EGFR

2007

Agreement with Abraxis Bioscience of US to sell its Abraxeme

Biocon and its Subsidiaries

Syngene

Clinigene

99.99% owned
subsidiary

100% owned
subsidiary

Paid-up capital
Rs 28.75
million on 18
November
1993

Incorporated on
August 4, 2000
with an
authorized
capital of Rs 5
million

Paid-up capital
Rs 500,000

BBPL
Collaboration
with CIMAB
SA, Cuba
51% equity
participation by
Biocon
Paid-up capital
Rs 8.8 million

Biocon Product and Services

Biopharmaceuticals
Biocon manufacturers a wide spectrum of
Biopharmaceuticals ranging from small
molecules to biological and dosage forms
which include antidiabetic agent , anti
hypertensive and anti inflammatory
agent , anti- oxidants ,haemostatic agents,
cholesterol-lowering agents, digestive-aid
enzymes, hepatoprotective and
orthopedic agents.

 Enzymes
Biocon manufacturers and marketers a board
range of industrial Enzymes, food additives
and process aids which include amylases,
cellolases, lipases and proteases.

Food additives
Food additives manufactured and
marketed by Biocon include hydrocolloids,
natural colors, specialty fats and
specialized proteins.

Services
Custom Research
Biocon subsidiary, Syngene, leverages its synthetics
chemistry skills to carry out custom research in early
stage drug discovery and development.
Clinical Research
Clinigene is a clinical research organization that
offers global biotechnology and pharmaceutical major
strong clinical trial services, regulatory and laboratory
capabilities for clinical drug development.
The value added services include patient registries
and clinical database in diabetes, lipidemia, oncology,
and cardiovascular diseases.

Biocons Corporate Social Responsibilities

Biocons CSR activities center has been
established with the aim of identifying and
implementing projects that impact the social
and economic scenario in the country.
Its main focus areas are to provide quality
health care and health education for the
betterment of Indian society.
Through its initiatives, Biocon Foundation by
establishing Arogya Raksha Yojana, aims to
provide high quality drugs at affordable prices
to the masses at all BioCare Pharmacies and
participating clinics.

Clinical Trail And Drug Testing In India

A drug requires various testing before
testing- Clinical Testing
India as preferred destination
- Clinical Trails
- Billion dollar business

Poor people of India

- Small compensation

The Indian Advantage

Cost saving offering of India
Huge number of patients
Poor monitoring mechanism

Illegal Clinical Tests

Rampant practice of clinical tests

Public Outcry of regulatory failure

Unethical Practices of Biocon

Illegal clinical trials by Biocon
In 2004, Biocon & Shantha Biotech in
Hyderabad came under security for
conducting illegal clinical trials that led to
eight deaths.
Biocon tested a genetically modified form of
insulin without the proper approval from the
Drug Controller General of India (DCGI).
After the outcry against Shantha & Biocon,
The Indian Govt. adopted stricter ethical
guidelines for clinical research, but one
cannot be too sure that companies are
abiding by the new rules.

 Biocon Enhances Trade Operations in

Bangladesh
Biocon is on aggressive drive in Bangladesh
because of the countrys increasing
dependence on the lifestyle disorder drugs.
It is easier for companies like Biocon to put
up a plant in countries like Bangladesh since
the pollution norms are not strictly followed
there. Furthermore, clinical trials could be
easily conducted without any objection from
the government.

 Environmental Infractions
Company decides to set up a Rs. 10000
million manufacturing facility at Jawahar
Pharma City, SEZ, near Vishakhapatnam,
Andhrapradesh.
Andhrapradesh has been keen to get
Kiran Mazumdar Shaw to invest in the
state ever since it realized that Biotech
major is unhappy over Bangalores
infrastructure.

 Procedural lapses at Biocon

Issue is lapses in making the drug
methylcobalamin , a form of vitamin
B12, & it was followed a seven steps
procedure. However the company
skipped some steps & changed the
process by using an intermediate drug
imported without license.
The state drug control authorities
cancelled the license.

Conclusion
The above news indicates that the
company is not keen on the
procedures and is willing to correct
only when identified and informed.
This also indicates that Biocons shift
from Bangalore to Andhra Pradesh is
not only for the effluent treatment
facility, but for other reasons as well.

Thank You