BIOCON- India’s own home-grown biotech company

Biocon- An Overview

• Biocon 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 healthcare.

• It has subsidiaries like….

BBPL

syngene international limited

Clinigene international limited

Products• Biopharmaceuticals• Enzymes• Food Additives

Service• Custom Research• Clinical Research

Biocon’s CSR Activity

• The CSR centre of Biocon established with the aim of

identifying & implementing projects that impact the social &

economic scenario in the country.

• It main focus areas are to provide quality healthcare & health

education for the betterment of Indian society.

• They established “Arogya Raksha Yojna”, which aims to

provide high quality drugs at affordable prices to the masses

at all Biocare pharmacies & participating clinics.

Clinical trials & drug testing in India

• Any development of new drugs needs various tests before being released in the market commercially. These tests are called clinical trials.

The Indian “advantage”• India increasingly emerges as a

preferred destination for outsourcing clinical trials- testing of new drugs on human & the country may also be heading towards providing the greatest source of human “guinea pigs” for the global drug industry.

• However, human beings from developing countries are being used as guinea pigs & are paid a pittance for the huge losses in health & life suffered by them.

Why are MNC drug companies flocking to India??

• In India particularly, unethical & illegal clinical trials are most rampant & are

conducted without fear because , say critics, there is no law to safeguards the

interest of volunteers, while regulatory authorities, “by deign or default” fail to

take actions against such trials.

• Companies re attracted to India not only because of the huge patient pool but also

because many potential study volunteers are “treatment naïve”, meaning they

have not been exposed to the wide array of biomedical drugs that most Western

patients have. Besides, doctors here are easier to recruit for trials they do not

have to go through the same ethics procedures as their western counterparts.

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.

• 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 Bangalore's 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 licence.