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Biocon business ethics

Biocon is India's largest biopharmaceutical company, established in 1978. It has grown from an enzyme manufacturing unit to a fully integrated biopharmaceutical enterprise. Biocon has shown strong financial performance over the years, with increasing profits and revenues. However, it has also faced some ethical criticisms over unapproved clinical trials that led to deaths and not following proper procedures. While Biocon's work in biotechnology is innovative, it must focus on conducting all activities ethically to ensure patient safety and trust in its products.

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BIOCON – India’s Own Home- Grown Biotech Company
Two subsidiary companies – Syngene and Clinigene International Limited Integrated Innovation Approach Leading Indian Biopharmaceutical company, established in 1978 by Kiran Mazumdar-Shaw BIOCON – AN OVERVIEW Over the 30 years, have evolved from enzyme manufacturing unit to fully integrated biopharmaceutical enterprise, focusing on health care.
Biocon’s Performance Biocon, India’s home grown biotechnology company, has shown exemplary performance since its inception.
Biocon’s Performance Increase in its net profit at INR 475.1 million for 3rd qtr, 2006 Revenue and profit of INR 1080 million in 2006-07 Growth of Biocon scrip on both bourses Closing at 410.25 at BSE and 410.45 at NSE Passed phase I of human clinical trials and was about to enter phase II 44% INR 8630 Million 10% INR 75 Oral Insulin program
Biocon’s Performance Biocon becomes the first Indian biotech company to receive US funding for proprietary technologies. 1989 1993 1994 1997 ISO 9001 Certification from RWTUV, Germany, is given to Biocon’s R&D & Manufacturing facilities in Bangalore. Biocon establishes its subsidiary – Syngene International Pvt. Ltd. Biocon takes initiatives in human healthcare through a dedicated manufacturing facility. Biocon becomes the first company to manufacture and export enzymes to US and Europe. 1979 Biocon’s highly successful IPO in March 2004 exceeds the $1 billion mark on the day of listing a record 2004 2006 2012 2016 Biocon Ltd. Launches India’s first cancer drug BIOMABb EGFR Biocon reports revenue of Rs. 2087 Crore Biocon sets up another subsidiary – Clinigene, to pursue clinical research and development 2000 Becomes the first Indian company to launch a biosimilar Insulin Glargine pen in Japan
Biocon in news recently Chairperson- BIOCON India’s mother of invention India’s Biotech Queen Biocon’s Syngene enters into research partnership with Bristol-Myers Squibb on 14 March 2007 Biocon Limited unveiled comprehensive portfolio of renal therapy products on 8 March 2007 Biocon grants exclusive marketing license for BIOMAb EGFR for Pakistan on 18 January 2007.
Biocon in news recently Biocon Limited and Neopharma signed MoU for a joint venture on 5 January 2007 Biocon buys US-based start-up IATRICa Inc in a sub- $10 million deal. Biocon buys 70 per cent stake of the German pharma AxiCorp in a €30-million deal to market its injectible insulin, generics, biosimilars and biologics
Biocon & its subsidiaries • 99.99 Percent owned subsidiary of Biocon Incorporated. • Paid-up capital was INR 28.75 million. • 100 percent owned subsidiary of Biocon Ltd. • Paid-up capital was INR 5,00,000. • BBPL is a joint venture company of Biocon. • Paid-up capital of BBPL was INR 8.8 million.
Products & Services Kiran Mazumdar Shaw, the founder of Biocon, firmly believes that India should make full use of her intellectual capital. The policy perspective that trigged the growth of Biocon over the past three decades. Biocon’s range of products and partnered services continue to build a robust pipeline of biosimilar and discovery- led biological programs. Mazumdar Shaw announced on 18 June 2007 that the company decided to sell the division to the Danish firm Novozymes for $115 million. Biocon will put some of the sale proceeds into R&D and some for acquisitions.
Products & Services BIOPHARMACEUTICALS - Biocon manufactures a wide spectrum of biopharmaceuticals. ENZYMES - Biocon manufactures and markets a broad range of industrial enzymes, food additives and process aids. FOOD ADDITIVES - Food additives manufactured and marketed by Biocon include emulsifiers, hydrocolloids, natural colours, speciality fats and specialized proteins.
Services CUSTOM RESEARCH CLINICAL RESEARCH BIOCON’S CORPORATE SOCIAL RESPONSIBILITY (CSR) ACTIVITIES Leverages its synthetic chemistry skills to carry out custom research in early stage drug discovery and development Clinigene, conducts phases I– IV clinical trials and longitudinal research to discover novel biomarkers. Biocon Foundation that has been established with the aim of identifying and implementing projects that impact the social and economic scenario in the country. It main focus areas are to provide quality healthcare and health education for the betterment of Indian society
Clinical Trials & drug testing in India Biocon Outsourcing Clinical Trials Clinical research was estimated to be a $5–6 billion in market 2002 Clinical research was estimated to be a $20 billion in market 2007
$ 25.6 Billion 2006 2011 $32.1 billion 14%peryear 2006 2010 $ 300 Million $1.5-2 Billion •Human beings from developing countries are being used as guinea pigs and are paid a pittance for the huge losses in health and life suffered by them. This is because in countries like India, there are teeming millions of people who are extremely poor and could be paid a small compensation compared to the citizens of developed countries. The drug industry has also involved uninformed, non- consenting people from developing countries as human volunteers. Clinical Trials & drug testing in India
The Indian Advantage Cost Savings 40% of the drug development cost incurred in clinicals trials in India offers immense savings India’s 34 Million Diabetic population and the no. keeps increasing every year India’s Health Infrastructure Illegal Clinical Trials
Why are MNC Drug companies flocking to India ? Medical scientists mostly reverse- engineered drugs already developed in advanced countries. multinational pharmaceutical companies have assured profits in the Indian market, and the country has suddenly become a profitable location for the expensive tests required for FDA’s clearance of any drug. multinational drug companies are resorting to illegal clinical tests in India because of the ever increasing cost of drug research both in Europe and the United States India and China, governments are not too careful to ensure that such clinical tests do not lead to human suffering and death. the compensation paid to the victims’ families work out to be a small fraction of what it would have cost them in developed countries. Companies are attracted to India not only because of the huge patient pool and skilled workers, but also because many potential study volunteers are ‘treatment naive’. doctors here are easier to recruit for trials because they do not have to go through the same ethics procedures as their Western counterparts. in countries like India patients ask fewer questions about what is going on.
Unethical Practices of Biocon Rave reviews in the Media for innovative initiatives in Biotechnology It attracted adverse critical comments for underplaying ethical issues The ethical lapses have been reported in the media Biocon has accepted some lapses, justified some & contested others
Illegal clinical trails by Biocon Biocon + Shanta Biotech conducted illegal clinical trials leading to 8 deaths. Shanta failed to obtain proper consent from patients while testing a drug meant to treat heart attacks Biocon tested genetically modified insulin without approval of DCGI & GEAC
Environmental Infractions • Biocon set up a manufacturing facility at Vishakapatnam, Andhra Pradesh in 2007 • It had also decided to set up 10 acre plot in Hyderabad biotech SEZ by APIIC which has an advanced marine discharge facility with uninterrupted power & water supply • Biocon’s Bengaluru plant still runs without effluent treatment plant which is the alleged reason to move the company to Andhra Pradesh.
Biocon enhances trade operations in Bangladesh • Bangladesh has an increasing dependence on lifestyle disorder drugs e.g. Cardiovascular & anti-diabetics • It is an attractive destination for (API’s) Active Pharmaceutical ingredients • Biocon’s products are manufactured under ‘stringent standards’ & therefore company’s API’s are accepted globally by leading companies • Biocon’s statin portfolio, oral anti-diabetics and immuno-suppressants are on the list of exports to Bangladesh • 50% of Earnings constitute of Exports, for Biocon • Biocon finds ease in business establishment in Bangladesh due to lack of pollution norms and ease of conducting clinical trials without objection from the government
Procedural lapses at Biocon • Biocon skipped steps and changed the process of making Methylcobalamin, (a form of vitamin B12 used to treat nervous problems) by using an intermediate drug dimethyl benzimidazole imported from China • The State Drugs Controllerate cancelled Biocon’s license in January 2006 • On 10 February 2006, Biocon applied for a fresh licence and received it in March • Company admitted its procedural lapses and restarted production of Methylcobalamin with the new license
• Though Indians are happy about Biocon’s achievements, criticisms against unethical practices would tarnish the image of the country’s producers & their products. • Biocon must focus on providing affordable medicines available through its innovative practices. Conclusion
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