Business Ethics in Pharmaceutical Industry

Presented by: Saurabh Akare (02) Chetan chorge (06) Rachana Sawant (45) Sneha Kolge (89) Chinmay shankar Sagar Kamble

PHARMACEUTICAL INDUSTRY
The Pharmaceutical Industry develops, produces, and markets drugs or pharmaceuticals licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices. They are subject to a variety of laws and regulations regarding the patenting, testing and ensuring safety and efficacy and marketing of drugs.

The word pharmaceutical comes from the Greek word Pharmakeia. The modern transliteration of Pharmakeia is Pharmacia.

 Origins

Rhine Valley of Switzerland Drug Store

Key discoveries ( 1920s-1930s)

insulin and penicillin Switzerland, Germany, Italy, UK, US, Belgium and Netherlands, had strong industries.

 New Innovation (1960s)

The industry expanded rapidly in the sixties, benefiting from new discoveries.

Attempts were made by the U.S. Food and Drug Administrati on (FDA) to increase regulation of pharmaceutical industries and to limit financial links between companies and prescribing physicians.

World Medical Association set standards for clinical research. Pharmaceutical companies were required to prove efficacy and safety of the drug in clinical trials before marketing them.

 Regulation (1970s)

Tighter regulatory controls were introduced . The new regulations revoked permanent patents and established fixed periods on patent protection for branded products. Legislation was enacted to test and approve drugs and to require appropriate labeling. Prescription and nonprescription drugs became legally distinguished from one another as the pharmaceutical industry matured.

 Leaders

The leading companies in this industry are referred to as Big Pharma. Headquartered in the United States, United Kingdom, Switzerland, Germany, and France. Johnson & Johnson and Abbott Laboratories - United States GlaxoSmithKline - United Kingdom Bayer - Germany

 Trends

Investment The complexities of the regulatory and approval process Big Pharma teaming with smaller pharmaceuticals has become more pronounced. Expanding regulatory forces are driving an urgent need for pharmaceutical companies to develop practical and effective solutions for meeting the challenges of integrating governance, risk, and compliances on a global level.
Technology The newest technological trends have been with the

 Future Outlook

The chemicals and drugs industry has a promising future. With an aging population consuming three times as many drugs as younger people, demand is expected to rise and opportunities to increase. Drug spending is expected to triple from 2000 to 2050.

Many new drugs are expected to be developed in the coming years. Advances in technology and the knowledge of how cells work will allow pharmaceutical and medicine manufacturing makers to become more efficient in the drug discovery process. Further, there is a direct relationship between gene discovery and identification of new drugs- the more genes identified the more paths available for drug discovery. New genetic technology is being explored to develop vaccines to prevent or treat diseases that have

 Ranbaxy Labs

With total net sales of Rs 7686.59 crore, Ranbaxy is the largest pharmaceutical company in India. Cipla Second largest with total net sales of Rs 6,977.50 crore Dr Reddys Labs Third largest with total net sales of Rs 6,686.30 crore Lupin Fourth largest pharma company in India with the total net sales of Rs 5,364.37 crore. Aurobindo Pharma Aurobindo Pharma is on 5th position with the total net sales of Rs 4,284.63 crore.

 Sun Pharma

Sixth largest with Net Sales of Rs 4,015.56 crore Cadila Health Seventh largest pharma company with the total sales revenue of Rs 3,152.20 crore. Jubilant Life Eight largest company with Net Sales Rs 2,641.07 crore. Wockhardt Ninth largest pharmaceutical company in India with net sales of 2,560.16 crore Ipca Laboratories Revenue of Rs 2,352.59 crore makes Ipca India's 10th largest pharma firm by sales.

Ethical Business Practices

Investors: Ensuring safety of their money and timely

payment of interest.
Employees: Provision of fair opportunities in

promotions and training, good working conditions, and timely payment of salaries.
Customer: Complete information of the service and

product should be made available. Personal information of the customers should not be used for personal gain.

Ethical Business Practices

Competition: Unscrupulous tactics and methods

should be avoided while handling competitors.

Government: Rules and regulations regarding

taxes, duties, restrictive and monopolistic trade practices, and unlawful activities like corruption and bribing should be adhered to.
Environment: Polluting industries should ensure

compliance with the government norms regarding air, water and noise pollution.

Unethical Business Practices

Resorting to dishonesty, trickery or deception. Distortion of facts to mislead or confuse. Manipulating people emotionally by exploiting their

vulnerabilities.
Greed to amass excessive profit. Creation of false documents to show increased

profits.

Unethical Business Practices

Avoiding penalty or compensation for unlawful act. Lack of transparency and resistance to investigation. Harming the environment by exceeding the

government prescribed norms for pollution.

Invasion of privacy used as leverage, for obtaining

personal or professional gains.

Sexual discrimination

Examples of violation of Ethics

In April 2012 Johnson & Johnson was fined 1.2

billion dollars in Arkansas for marketing practices of their drug Risperdal.

In May 2012 the drug firm Abbott Laboratories

was fined 1.6 billion dollars for illegally promoting their drug Depakote.

UNETHICAL CLINICAL TRIAL IN ARGENTINA CASE

COMPANY INVOLVED:GLAXOSMITKLINE

BREIF OVERVIEW OF COMPANY CHARGES ON THE COMPANY PROTOCOL CAMPUS DRUG USED IN CARRYING OUT CLINICAL

TRIAL

UNETHICAL CLINICAL TRIAL IN ARGENTINA CASE

WAY OF CONDUCTING THE CLINICAL TRIAL

EFFECT OF DRUG:DEATH OF 14 BABIES OUTCOME

Thank You !!!!