BS Pharmaceuticals

1. BS Pharmaceuticals Daniel Arndt Wolfgang Arterberry Jessica Martin James Moehle Travis Thacker Joe Volsch

2. Who are we? • BS Pharmaceuticals is a 21st century company with 4000 employees working in both the United States and India. • We specialize in manufacturing in generic drugs, but also have a small research & development team to expand our prospects into obtaining new patents. • Our research and development site is located in New Brunswick, New Jersey. • Our manufacturing site is located in Mumbai, India. We relocated to this beautiful city in 1995, after weighing out many possible new locations, including Russia, South Africa, China and Brazil. We will now outline in detail our reasons for this important, global-minded move.

3. Option 1: Remain in the US • While the United States has the world’s top notch workers and equipment, manufacturing costs have skyrocketed in the past 20 years, and India simply produces a less expensive product. • The majority of our drugs are going to be sold in Asia and Africa, and relocation to India will reduce shipping costs. • Court costs in the American judicial system are very high, especially if there were ever an issue with hazardous side effects.

4. Option 2: Russia • Labor Law • Full time 40 hour work week • Part time not to exceed 20 hour week • Workers are paid a monthly salary • Taxes • Russia is in the process of modernizing its tax code for private business from a command economy to a more open market based economy. This has been met with mixed results. • Political Stability • Massive military with nuclear, chemical, and biological capability. Government appears crippled by Vladimir Putin’s regime of central control, has ongoing military operations in Georgia and Chechnya, and has on several occasions turned off natural gas to Europe.

5. Option 3: South Africa • South Africa’s national medical education system is lacking the public/private partnership that is so integral to American medical education’s success. • AIDS has decimated South Africa’s work force, hindered the ability of localities to maintain registered voters, and monopolized government funding of medical research and development. • South Africa also has a “National Drug Policy” that explicitly states a preference towards the manufacturing and selling of generic drugs in their national market, which would dampen our profit-making ability in the long run.

6. Option 4: China • Government Taxes • Government backed companies and regulations • Patent laws and businesses from other countries • Environmental Problems • Government Stability

7. Option 5: Brazil Pros Cons Too many labor laws to achieve maximum profit. Unstable government that could lead to the nationalization of company if democracy fell. The decriminalization of drugs may lead to a smaller market for pharmaceutical drugs. • Relatively inexpensive labor, 465 reais ($200.95) a month for the minimum wage. • Rainforest’s with most of the materials needed for drug production. • Large population

8. Why BS Pharmaceuticals took production to India

9. Labor Law •      Industrial Disputes Act (IDA), 1947Any employer with more than 100 employees must get state approval beforeretrenching workers.Gives Workers the right to strike, and gives employers right to lockout.Voluntary government arbitration, and mandatory adjudication.

10. Workers Rights • The Employees’ State Insurance Act, 1948- Mandates that employers and employeesmust contribute to insurance corporations then run hospitals. Payment of Gratuity Act,1972- Employees who have worked more than five yearsare entitled to a lump sum payment equal to fifteen days wages for every yearworked.Employees Provident Fund Act- Employer and employee make a 12% contribution toa retirement pension fund,Minimum Wages Act, 1948- Current minimum wage Rs 80 per day, or approximately$1.61.

11. Workforce • Preponderantly young workforce • Most skilled professions have a tough time retaining skilled employees due to a shortage of trained people • Those who are hired are usually trained on the job, and recruited from Indian universities who have substantial relationships with private companies • 14000 new doctors accredited in India in 2007, avg. 20000 new students at 250 Indian medical schools every year

12. Pharmaceutical Regulations • Much like the FDA in the United states, the Government of India has a similar government institution, the CDSCO (Central Drugs Standard Control Organization) and they are in charge of : 1.Laying down standards of drugs, cosmetics, diagnostics and devices. 2. To regulate market authorization of new drugs. 3.Testing of drugs by Central Drugs Labs

13. OPPI, the (organization of Pharmaceutical producers of India) • 1.OPPI identifies itself with the country's national healthcare objectives and encourages its members to make substantial contributions to social concerns and actively promotes Corporate Social Responsibility • OPPI Members Follow: • Good Manufacturing Practices (GMP)International Code of Pharmaceutical Marketing PracticesOPPI's position on Intellectual Property Rights (IPR)OPPI functions mainly on the following areas:      1. Continuous dialogue with the stakeholders     2. Actively engage in knowledge creation & knowledge sharing with value addition     3. Engage in 'Corporate Academia' Interaction

14. India and America’s Cooperation Improvements New Offices Delhi Mumbai Hyderabad • Regulating medical equipment and devices • Monitoring drugs for adverse reactions • Increasing its international reach

15. Patents • Re-patent pharmaceuticals with modifications-       Drug name covered, but not process • Patent Law time period • Largest producer of generic drugs-       85% of worlds drugs currently or are going out of patent • Covered under the World Trade Organization

16. Exports • India has made enormous gains in generic pharmaceutical sales abroad specifically in the Middle East, Africa, and parts of Europe. Though subsidies in the U.S. Indian pharmaceutical manufacturers were able to export the Hepatitis B vaccine into the United States when U.S. manufacturers were unable to meet the demand placed upon them. India has enormous potential to assist in Africa with generic AIDS drugs. However, due to WTO regulations this has not been able to transpire.