PHARMACY EDUCATION AND PRACTISE CHALLENGES TO MEET FUTURE PROFESSIONAL NEEDS

By-

JAIDEEP SARKAR

JAIPUR NATIONAL

UNIVERSITY

Pharmaceutical Industry -An Overview

Pharmaceutical Industry the propeller for other Industries

HISTORY

The History of Pharmaceutical Indus can be traced to 1600 BC

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

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 %

• 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.

Pharmaceutical Education

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 patient-centered 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.

Phase II

Government Control

•Indian Patent Act –1970

•Drug prices capped

•Local companies begin to make an impact

Phase III Development Phase

•Process development

•Production infrastructure creation

•Export initiatives

Phase IV

Growth Phase

•Rapid expansion of domestic market

•International market development

•Research orientation

Phase V

Innovation and Research

•New IP law

•Discovery Research

•Convergence

1970 1980 1990 2000 2010

Phase I

Early Years

•Market share domination by foreign companies

•Relative absence of organized Indian companies

Indian Pharmaceutical Evolution

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

Market Structure• Indian - Bulk Drugs & Formulation M/S Market

Share

Pharmacist Supply

2001: 200,000 active pharmacists

2020 projection: 260,000 active pharmacists

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)

Community Pharmacy, 2020: 7,500,000,000 prescriptions

172,000 community pharmacists 43,604 Rx/pharmacist/year

One prescription every 2 ¾ minutesHospital Pharmacy, 2020:

3,000,000,000 orders

65,000 hospital pharmacists

46,154 Rx/pharmacist/year

One order every 2 minutes

Current and Projected Need for Pharmacists

2001 Estimated Deployment

2020 Forecast Need

Order fulfillment(Dispensing) 136,400 100,000

Patient Care48,000 295,000

Other 12,300 22,000Total Need

196,700 417,000

Total Supply260,000

Projected Shortfall 157,000

..

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

• Research enterprise

A strong background in basic science is

sufficient for an entry level since materials

science, processing and product development

experiences

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

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

10000

2000 2001 2002 2003 2004 2005 2006

Year*

Enrollments by Expected Graduation Year

PharmD

BS Pharmacy

*Data for expected graduation for years 2003-06 from Profile of Pharmacy Students Fall 2002. For years 2000-02 from Profile of Pharmacy Students Fall 1999.

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

Source: Capitalline

Indian - Bulk Drugs Formulation LargeSales Turnover and Reported Net Profit on 2010 (in Rs. Crore)

There is a current shortage of entry-level scientists There is a current shortage of entry-level scientists with an appropriate background in product with an appropriate background in product

development and pharmaceutical technology.development and pharmaceutical technology.

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

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

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.

R&D Expenditure(in Rs. Crore) over 10 years

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

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.