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  2. 2. Pharmaceutical Industry -An Overview Pharmaceutical Industry the propeller for other Industries
  3. 3. HISTORY In around 1640 BC Dhanvantari wrote a treatise on Medicine, Pharmaceutics, & surgery. AYURVEDA SUSHRUTHA CHARAKA During around 500 BC Buddhist Monks spread to the rest of the world The History of Pharmaceutical Indus can be traced to 1600 BC
  4. 4. Modern day Medication  Modern day Medication more than 350 years old  In 1901 Acharya P.C. Ray started first Indian Pharmaceutical company  1970s saw the emergence of Indian Pharmaceutical Industry. Research & Development in later part of 19th Century and 20th Century.  This led to the expansion of Bulk Drug Industry  Present global market size $ 825 Billion growing @ 4 to 6 %  India 3rd largest producer of Pharmaceuticals having 10% of the global share.  Cardiovascular segment dominates the sales with 50% share and Anti Diabetic segment has a share of 22 %
  5. 5. Pharmaceutical Education • Pharmaceutical biotechnology, pharmacogenomics, combinatorial chemistry, screening technologies, and bioinformatics are major advances that give a new direction to pharmaceutical sciences. • Pharmaceutical education has to set new priorities to keep pace with the challenges related to genomic technologies. • Educators and pharmacy school members have the responsibility of deciding how, to what extent, by which methods, and/or in which way these changes and new directions in the education programs should be developed. • Need to better integrate internationally educated pharmacists within the domestic workforce and professional development and maintenance of competency of practitioners.
  6. 6. Reasons of strong education system • Changes in medical environments such as collapse of doctors' paternalism • To meet these social needs the education of students in pharmaceutical colleges should be reconstructed extensively from a traditional research-oriented system to a patientcentered system, applied pharmacotherapy is to be strengthened and enforced. • The pharmacy academy is well positioned to prepare graduates to become more proactive in creating a safer health care environment for patients. A drastic reform of pharmacist education should be brought in effect.
  7. 7. Indian Pharmaceutical Evolution Phase V Phase IV Phase III Development Phase •Process development Phase II Government Control Early Years •Market share domination by foreign companies •Relative absence of organized Indian companies •New IP law •Rapid expansion of domestic market •Discovery Research •International market development •Indian Patent Act – 1970 Phase I Innovation and Research Growth Phase •Production infrastructure creation •Drug prices capped •Convergence •Export initiatives •Research orientation •Local companies begin to make an impact 1970 1980 1990 2000 2010
  8. 8. Pharmacists Roles in Patient Care • Pharmacists as drug therapy managers • Assessing, counseling and monitoring drug therapy • Dealing with medication misadventures: $177 billion drug morbidity/mortality • Overseeing medication management systems • Delivering pharmaceutical care: could save over $105 billion annually if universally available • Continued creation of opportunities for new service development in the community: • Residency programs in community practice • Participation in demonstration projects, e.g. Patient Self-Management: Diabetes • Partnerships with education and practice organizations
  9. 9. Market Structure • Indian - Bulk Drugs & Formulation M/S Market Share
  10. 10. Pharmacist Supply Current and Projected Need for Pharmacists 2001: 200,000 active pharmacists 2020 projection: 260,000 active pharmacists 2001 Estimated Deployment 2020 Forecast Need 136,400 100,000 Order fulfillment (Dispensing) Based on new graduates, adjusted for those leaving; assumes 20% enrollment growth existing schools and 3 new ones in addition to those slated to open Outpatient prescriptions: 7,500,000,000 (+5%/yr) Hospital drug orders: 3,000,000,000 (+2.5%/yr) Patient Care 48,000 295,000 Other 12,300 22,000 Total Need 196,700 417,000 Total Supply Projected Shortfall 260,000 157,000 Community Pharmacy, 2020: 7,500,000,000 prescriptions 172,000 community pharmacists 43,604 Rx/pharmacist/year One prescription every 2 ¾ minutes Hospital Pharmacy, 2020: 3,000,000,000 orders 65,000 hospital pharmacists 46,154 Rx/pharmacist/year One order every 2 minutes
  11. 11. Challenges for Educators • . Faculty needs: new models & partnerships with practice • Training sites: new models, residencies • Curriculum to address distributive/patient care roles • Technology application to both: e.g. distance education • Sharing resources across institutions • Financing for expansion in era of state budget issues • A strong background in basic science is sufficient for an entry level since materials science, processing and product development experiences Research enterprise
  12. 12. Implications for Educators: How to Expand the Profession? • Good news: today’s graduates are being educated at level consistent with profession’s long-term patient care vision • Many new opportunities for pharmacists, especially with doctoral level training
  13. 13. Enrollments by Expected Graduation Year 10000 9000 8000 7000 6000 PharmD BS Pharmacy 5000 4000 3000 2000 1000 0 2000 2001 2002 2003 Year* 2004 2005 2006 *Data for expected graduation for years 2003-06 from Profile of Pharm acy Students Fall 2002. For years 2000-02 from Profile of Pharm acy Students Fall 1999.
  14. 14. Challenges for Industry  Regulatory obstacles  Lack of proper infrastructure  Lack of qualified professionals  Expensive research equipments  Lack of academic collaboration  Underdeveloped molecular discovery program  Divide between the industry and study curriculum
  15. 15. Indian - Bulk Drugs Formulation Large Sales Turnover and Reported Net Profit on 2010 (in Rs. Crore) Source: Capitalline
  16. 16. There is a current shortage of entry-level scientists with an appropriate background in product development and pharmaceutical technology.
  17. 17. Government Initiatives The government of India has undertaken several including policy initiatives and tax breaks for the growth of the pharmaceutical business in India. Some of the measures adopted are: 1. Pharmaceutical units are eligible for weighted tax reduction at 150% for the research and development expenditure obtained. 2. Two new schemes namely, New Millennium Indian Technology Leadership Initiative and the Drugs and Pharmaceuticals Research Program have been launched by the Government. 3. The Government is contemplating the creation of SRV or special purpose vehicles with an insurance cover to be used for funding new drug research 4. The Department of Pharmaceuticals is mulling the creation of drug research facilities which can be used by private companies for research work on rent
  18. 18. Indian - Bulk Drugs & Formulation Large • Market Share at Present TOP TEN INDIAN COMAPNIES 1. Ranbaxy Labs 2. Cipla 3. Dr Reddy’s Labs 4. Aurobindo Pharma 5. Piramal Health 6.Sun Pharma Inds. 7. Wockhardt 8. Cardila Heath 9. Ipca Labs 10. Torrent Pharma
  19. 19. Indian Pharma Industry – Future Scenario • The Indian pharma industry is still trying to come to terms with the new patent regime. • Over the next 5 years, will continue to grow by at least twice the rate of global growth. • Retail segment will be the fastest growing segment. • There will be a significant increase in the clinical trials and diagnostics outsourcing. • A significant window of opportunity will be available expiring patents.
  20. 20. R&D Expenditure(in Rs. Crore) over 10 years
  21. 21. To meet future professional needs- also requires Foreign Investment – Indian drug industry has in the last five years seen half a dozen big takeovers by foreign companies. – $3.6 billion acquisition of promoters’ stake in Ranbaxy Laboratories by Japan’s Daiichi Sankyo Co. Ltd. – US drug maker Mylan Inc. paid $734 million to acquire Hyderabad-based Matrix Laboratories – German health care group Fresenius SE spent $219 million to take over Dabur Pharma . – US drug and nutrition firm Abbott Laboratories paid $3.72 billion to acquire Piramal Healthcare Ltd’s domestic drug formulation business and spent $726 million to buy out Ahmedabad-based consumer health company Paras Pharmaceuticals. – French drug multinational Sanofi-Aventis SA acquired a majority stake in Indian vaccines company Shanta Biotech for €550 million
  22. 22. VISION 2020 • • • • Essential drugs at affordable prices are available and also continue providing employment for millions. Major global player in the field of pharmaceuticals exports and as a provider of quality medicines at low costs. Major player in the generic drugs market in USA and Europe. Attain new heights in herbal drugs research in shaping Indian Systems of Medicine into a popular system of medicine of the future for holistic health care and ensuring health care for all - especially for the welfare of the poor.