ASSIGNMENT-1

Case Study
Biocon: India’s Largest Biopharmaceutical
Company
SUBJECT: Business Ethics & CSR(MBDS5022)

Submitted By: Sajal Mishra

Course: MBA Business Analytics
Admission no.: 19GSOB2020009
Q.1- What is the case about?

The Case shows the inception of Biocon in 1978 and its rise in the past 30 years. It also
outlines the evolution of Biocon from an enzyme manufacturing unit to a fully integrated
biopharmaceutical company that focusses on healthcare.
Key features-
 Company’s expertise to develop innovative technologies and products and to rapidly
leverage them to adjacent domains.
 Floating three subsidiaries, namely; Syngene, Clinigene, and Biocon Biopharmaceuticals
Private Limited (BBCL).
 Manufacturing of biopharmaceuticals like anti-diabetic agents, industrial enzymes, food
additives.
 Custom and clinical research has also been the main focus of Biocon. Along with these it
did a whole lot of CSR activities under Biocon foundation in which the company
focusses on providing better healthcare to people.
 Along with these, Biocon was also involved in some illegal drug testing and clinical trials
that also ed to eight deaths. However, after the public outcry, the Indian government
adopted stricter ethical guidelines for clinical research.
 Biocon was involved in some environmental infractions like running the research plant
without an effluent treatment plant which caused a huge amount of marine pollution.
 Manor procedural lapses in manufacturing a form of vitamin B12, methyl cobalamin by
using some intermediate drugs which were imported in India from china without a
licence.

Q.2 Discuss the singular characteristics of Biocon as India’s fast-growing technology

enterprise, while tracing its growth.

 Biocon limited is a fast-growing biotechnology company which came into existence in

the late 1980s and came into limelight as the field of biotechnology was never
previously heard of in Indian market.
 The company transformed from a mere industrial enzyme manufacturing company to
an integrated bio pharmaceutical company and a holistic biotech enterprise.
  Biocon is the first Indian company to receive the US funding for proprietary
technologies. It also was he first Indian company to manufacture and export enzymes to
the United States and Europe.
 Today, the biotech firm is developing anti diabetic agents, anti-hypertensive and anti-
inflammatory agents, antioxidants, and various other products.
 Biocon’s highly successful IPO in march 2004 (with a market value of 1 billion dollars)
exceeded the 1-billion-dollar mark on the day of listing.
 It gained global recognition for the Indian biotech sector by becoming the most
successful IPO.
 The company ranked no. 1 in market capitalisation and revenue generation (among
biotechnology companies) in Asia and 16th globally.
 Biocon bought a US based start-up “IATRICa” Inc in a sub 10million$ deal. It also bought
70% stake in German pharma “AxiCorp” in a €30 million deal to market its injectable
insulin generics, biosimilars and biologics.
 Recently, in 2007 it went into the joint venture with Dubai’s Neopharma. Also entered
into licensing agreement with Abraxis Bioscience of US to sell its “Abraxeme”, an anti-
breast cancer drug in India. In the same year Biocon also launched India’s first cancer
drug “BIOMAbEGFR”.

Q.3 What are the problems associated with conducting clinical trials in India?

To conduct clinical trials in India, companies face these key issues:

No informed consent: One of the most important problems is that the consent of the
participants in the clinical trials is not taken. It is due to a large proportion of participants in
India is illiterate and lured into trials by offers of free healthcare but they are not informed of
the difference between research and treatment.
Problem with ethics committee: Ethical committees are constituted to monitor the ongoing
drug trials. However, it is often found that in most cases ethics committee is not constituted.
Further people on such committees are not well trained nor these committees work
independently.
Non registry of trials: Clinical Trials Registry of India calls for registration of all clinical trials
conducted in India. However, since its launch less than 70% trials have been registered.
Registration is mostly done for positive trial cases. Consequently, there is lack of transparency
regarding current trial practices.
Unethical practices of CROs: The companies outside India get their clinical trials conducted
through clinical research organisations (CROs)—independent companies hired by sponsor to
undertake clinical trials. They are chosen primarily because of their ability to form
partnerships with local research organizations, recruit large numbers of participants and
quickly conduct trials. However, they are found to be conducting trials in most irresponsible
and unethical manner.
Delay in approval: Three tier approval mechanisms has led to considerable delays in approval.
This is attributed to the unpredictability in the SEC and Technical and Apex Committee
meetings. Consequently, India became less competitive in comparison with other emerging
markets for the conduct of clinical trials.