Форум IPhEB - Манда Венката Редди, директор, Hitech Inst. Of Adv Pharmaceutical Sciences, Индия

PHARMACY EDUCATION IN INDIA

Dr.M.Venkata Reddy, M.Pharm., Ph.DMember, Pharmacy Council of India

Advisor, Natco Pharma LtdHYDERABAD, INDIA

IPhEB – St.Petersburg, Russia., 27-04-2011

• INDIA is the largest country in South Asia

• Second most populous country in the world with a population of 1.2 billion

• 28 States and 7 union territories

Education in India• Education is on the concurrent list of the

Central and State Governments• Both Central and State Governments can bring

laws & frame policies on education• While every State has its own Secondary

Education Board and is responsible for setting up state Universities and Colleges and maintaining them

• Central Government acts as coordinator and help to maintain uniform standard of education in the country

Pharmacy in India –

--- Academic Perspective

Present levels of Pharmacy Education in India

Profession

D.Pharm2 Years

B.Pharm4 Years

Pharm.D6 Years

M.Pharm2 Years

Ph.D

Present registrable qualifications under the Pharmacy Act 1948 : Pharm D., B. Pharm, D. Pharm (minimum qualification)

Source : PCI

Pharmacy CoursesS.No Course of Study Degree Duration

1 Diploma in Pharmacy D.Pharm 2 yrs didactic, 500 hrs(3months)Practical Training

2 Bachelor of Pharmacy B.Pharm 4 yrs Institutional

3 Master of Pharmacy M.Pharm 2yrs Institutional

4 Master of Science M.S(Pharm) 2 yrs Institutional

5 Master of Technology in Pharmacy

M.Tech (Pharm)

2yrs Institutional

6 Doctor of Pharmacy Pharm D 5 yrs Institutional & 1 yr hospital training

7 Doctor of Philosophy in Pharmacy

Ph.D 2 yrs Institutional & 1 yr hospital training

Admission / Eligibility criteria for different courses

Course EligibilityD.Pharm Higher Secondary after 12 yrs Schooling

Separate common Entrance test in some States

B.Pharm Higher Secondary & Merit list of various Entrance examinations prescribed

M.Pharm B.Pharm and Merit list of prescribed Entrance exam

Pharm D Higher Secondary and Merit in prescribed Entrance examB.Pham graduates can seek admission directy to 4th

yr of 6 yr course

PHARMACY INSTITUTIONS (Pre-independence period)

• Modern Pharmacy Education started in 1937 at

Banares Hindu University

• Andhra University 1937

• Madras University 1938

• Bombay University 1943

• Punjab University 1944

• LM College of Pharmacy 1947

Source : PCI

Growth of Pharmacy Institutions(Degree in Pharmacy)

1945-1960 : 7 institutions

1960-1970 : 34 institutions

1970-1990 : 232 institutions

1990-2000 : 290 institutions

2000-2005 : 312 institutions

2006-2010 : 1083 institutions

D.Pharm B.Pharm M.Pharm Pharm.D(Post Bacc)S.No. State

PCI PCI AICTE AICTE PCI PCI1 ANDHRA PRADESH 58 66 270 54 23 72 ASSAM 3 1 2 1 0 03 BIHAR 2 1 5 1 0 04 CHANDIGARH 2 1 1 1 0 05 CHATTISGARH 12 6 12 4 0 06 DELHI 8 5 6 2 0 07 GOA 1 1 2 1 0 08 GUJARAT 13 21 89 22 1 09 HARYANA 17 13 37 7 0 010 HIMACHAL PRADESH 3 0 12 0 0 011 JHARKHAND 3 1 1 1 0 012 JAMMU & KASHMIR 1 0 1 0 0 013 KARNATAKA 95 68 75 40 19 1114 KERALA 23 25 31 9 6 215 MADHYA PRADESH 31 31 101 35 1 016 MAHARASTRA 152 70 141 49 2 117 MANIPUR 1 0 0 0 0 018 MIZORAM 1 1 1 0 0 019 ORISSA 34 14 17 13 0 020 PONDICHERRY 0 1 1 1 0 021 PUNJAB 33 19 38 10 1 022 RAJASTHAN 27 21 50 7 0 023 SIKKIM 1 1 1 1 0 024 TAMILNADU 42 41 43 25 15 925 TRIPURA 1 1 1 0 0 026 UTTAR PRADESH 18 36 115 19 0 027 UTTARAKHAND 15 6 18 1 0 028 WEST BENGAL 10 11 12 3 0 0

Total No. of Colleges

607 462 1083 307 68 30

TOTAL INTAKE

36420 27720 62797 8013 2040 300Source : PCI & AICTE

STUDENTS OUT PUT

Nearly 9,000 M. Pharm

65,000 B. Pharm

36,000 D. Pharm

2040 Pharm. D

300 Pharm D. (P.B)

Pharmacy Education –Role of Regulatory Bodies

Pharmacy Education is regulated by THREERegulatory Bodies• Pharmacy Council of India - PCI• All India Council for Technical Education –

AICTE • Universities

LEGISLATIVE CHANGES (Proposed)

PHARMACY COUNCIL OF INDIA

STATUTORY REGULATION OF PHARMACY INSTITUTIONS

Pharmacy Council of India The statutory regulation of pharmacy institutions in the country was established with the enactment of the Pharmacy Act, 1948 on 04.03.1948

The Pharmacy Council of India (PCI) was established

on 09.03.1949, under the Pharmacy Act 1948. PCI

frames education regulations under section 10 of the

Act.

Education Regulations E.R-1953, E.R-1973,

E.R-1981, E.R-1991

Pharmacy Education – Role of Regulatory Bodies

• All India Council of Technical Education (AICTE) under AICTE Act 1987 regulates D.Pharm, B.Pharm and M.Pharm courses

• Accreditation of facilities by Nation Board of Accreditation ( NBA ) for Quality Assurance of Study programme

Universities

• India has 427 universities, some single campus, most with many affiliated / autonomous colleges.

• The nodal accrediting body is the University Grants Commission(UGC)

• All accredited universities are members of the Association of Indian Universities (AIU)

• Deemed Universities –Institutions of excellence which have been granted degree granting authority eg: IIT, IIM

D.PHARM CURRICULUM

• Topics lost relevance as extemporaneous dispensing is largely replaced by Ready to use dosage forms

• Remained only as a formal qualification for registration

B.PHARM CURRICULUM• Though industry and product orient most institutions are

far removed from Industry and lack interaction• No uniformity in Syllabus and content across the

Universities• Course content is a mix of Basic Sciences-Mathematics,

Physical Chemistry, Inorganic & Organic Chemistry, Physiology and Microbiology

Advanced Topics: Bio-Chemistry, Medicinal Chemistry and Analytical Chemistry and Basic Pharmaceutical Sciences (Pharmaceutics, Pharmaceutical Engineering, Pharmacology, Pharmacognosy, Pharmacy law, Biotechnology)

CURRICULUM

Syllabus is more Industry oriented and mainly designed to cater the needs of the Pharma Industry and successful

in developing the Indian Pharma industry. Source : PCI

Due to lucrative jobs offered by the industry and growth of the Pharma Industry as innovative

Industry, Pharmacy has become course of choice in recent years

STUDENT PERSPECTIVE

Source : IPA-Ed

Post Graduate specilizations (M.Pharm)

• Pharmaceutics• Pharmaceutical Chemistry• Pharmacology• Pharmaceutical Analysis• Pharmacognosy & Phytochemisty• Pharmaceutical Biotechnology• Pharmacy practices• Hospital Pharmacy• Indusrial Pharmacy• PharmacyRegulatory Affairs• Quality Assurance

Industry Centered Curriculum

• Pharmacy education in India for the past several decades has been industry centered. It does not meet the requirements of patient care & Pharmacy practice

• WHO & the Common Wealth Pharmaceutical Association have highlighted the need for graduate level education followed by one year practical training before one is capable of affectively performing the role of a pharmacist

INDUSTRIAL SCENARIO

Import dependent industry till 1950

Started with 10 crore only and progressed fast. From 1991 important supplier of low-cost high utility generic drugs in the global market.

4.2 mn employment in more than 20,000 units

Leading 250 companies control 70% of market

Exports to more than 200 countries

Patent law ( 2005 ) changed –destination for pharma research and development

Present position in globe is

- 3rd by volume (9.5%)

- 13th by value (1.8%)

Over 23,000 units 260 organized sectors

6,000 to 8,000 small scale sectors with 60,000 formulations

Turn over in 2009-10 is $ 21.3 bn

Exports growing at CAGR of 22.9% and Domestic at 9%

INDUSTRIAL SCENARIO

INDUSTRIAL SCENARIO

India has highest number of USFDA approved

manufacturing plants outside USA (>135)

(setting up of USFDA approved plant is 30%

cheaper in India)

IDPL-THE PHARMA CONNECT between RUSSIA and INDIA

• Indian Drugs and Pharmaceuticals Ltd (IDPL) a public sector undertaking was set up in Hyderabad with generous help and Technical co-operation of RUSSIAN Government, in 1961

• Giving shape to the vision of Late Jawaharlal Nehru, the First Prime Minister of India, to make most of the essential drugs available to the public at affordable prices

Acknowledgement to Russian Pharma experts

• This State of art plant at Hyderabad had been the spawning ground for bulk drug Industry in and around the city of Hyderabad, making it the Bulk Drug Capital of India

• Many of the Industry experts fondly recall their early training at IDPL and always great fully acknowledge the contribution by RUSSIAN experts

RESEARCH

• The 2nd millennium saw a spurt of research activity in many large Pharmaceutical Houses and sponsored Research in Universities in the post GATT era

• Research publications saw a sharp rise by 80% during 2000-2007

Top 10 performers based on publicationsS.No Name of the Institute Publications

1 H.G University, Sagar 860

2 Jamia Hamdard, Delhi 791

3 Punjab University, Chandigarh 788

4 MCOPS, Manipal 568

5 M.S.University, Baroda 501

6 Jadavpur University, Kolkata 497

7 LMCP, Ahmedabad 465

8 Kakatiya University, Warangal 379

9 Poona COP, Pune 377

10 Bombay COP, Mumbai 359

FAVOURABLE FACTORS

Vast technical pool & skilled man power

Well established state-of-art manufacturing plants

Low cost factor & ability to retain cost age

High-level of competence and expertise

Introduction of advanced technology by MNCs

Assured compliance with global norms

By 2012 nearly US$ 80 billion worth of patent-protected drugs to go off patent (inc 30 of the best selling US patent-protected drugs) :

Indian companies are positioning themselves to tap the generic versions of these drugs with its reverse engineering skills and relatively low cost structure

(Generics - $ 11 bn - expected $ 50 bn by 2012)

Pharma Industry oriented training

• In view of rapid growth of export oriented Pharma Industry, there is a great need for graduates and post graduates in Pharmacy with good professional orientation

• To fill the gap between academic courses and Industries needs, we have started Hitech-Institute to conduct a Bridge Course in association with Natco Pharma involving lectures on various industry oriented topics

Pharma Industry oriented training

• GMP, GLP, Process and Product development, regulatory affairs etc., by Industry and Regulatory experts, followed by visit to various manufacturing units

• So far we have conducted 40 batches with an average 40 students per batch. More than 90% trainees got immediate employment in the Industry

• We wish to extent this facility to overseas students also in the near future

Quality in Pharmacy Education

• Pharmacy Council of India constituted a multisectoral co-ordination mechanism called National Task force for quality assurance in Pharmacy Education, primarily an accreditation body, but advises and guides to facilitate achieving high quality

Community Pharmacy in IndiaBusiness per anum – 36,000 crores

Apollo, Hetero, Med Plus, --- in south

Medicine Shoppe, Reliance --- in west

& recently : Zydu’s - Dial for health, Ranbaxy’s - Fortis

Lifeken, Trust, Pill & Powder, Med plus,

Religere, Life sping, Planet Health, Tulsi etc.,

entered as pharma chains & successful by providing the quality of services to the consumers

(customers are more health conscious now and demanding better value added services)

NIPER CENTRES IN INDIA

• NIPER’s thrust to pharma education• Hyderabad• Ahmedabad• Raebareli• Hajipur• Kolkata• Guwahati

NIPER - Objectives

• Enhancement of creativity, motivation, drive and inculcate professionalism

• To bring synergy between academic, R&D, technology and industry through training and exposure for such environment.

• To Bridge collaborations between Pharmacy, Biotechnology, information technologies and prepare for meeting global challenges.

Global Harmonization

Harmonization of Pharmacy Education to include developments in basic medical and Pharmaceutical Sciences at a global level will make qualified Pharmacists more responsive to the needs and expectations of the Society

Pharm D Programme in INDIA

( Doctor in Pharmacy )

PHARM D (Doctor in Pharmacy - 6 yrs)

Aim : To equip the future Pharmacist of India with skills of not only dispensing medicines but also to serve as counselor of medicines with focus towards the Patients and Prescriber of Drugs

Objective : Knowledge and understanding

Skills, Attitude

Pharm D Programme

• The course was introduced in 2008• 6 yrs Pharm D course after Higher Secondary

or D Pharm• 3 yrs Pharm D (post-Baccalaureate) course for

B.Pharm graduates• Focuses on Clinical & Community aspects• Practical training only at Practice sites• 5 yrs of study and 1 yr residency at Practice site

viz. 6 months in General Medicine Department followed by 2 months each in 3 other specialties

Pharm D Colleges in India

• 67 private Institutes and one Government University are offering Pharm. D with intake of 30 students each

• Total seats in Pharm D course are 1410

• 20 of the above provide limited seats for lateral entry into 4th year as post baccalaureate Pharm. D (Total seats 200)

Course Content

Certificate of passing

Pharm D- 5 yrs study (Th.+Pr.)Pharm D (B) - 2 yrs study (Th.+Pr.)

Emphasis on• Community Pharmacy• Clinical Toxicology• Pharmacotherapeutics• Clinical Research etc.

One yr. Internship/residency

Clinical Pharmacy Service in wards and ward rounds under preceptor • 6 months–general medicine • 6 months – 2 months each in any three specialty depts.. (surgery, orthopedics etc.)

Committee to supervise trainingRepresentatives of • college• university• hospital

Registration by State Pharmacy Council

Mode of training

Ward rounds

Patient medication counseling

Pharmacy

Pharm D. students in ward rounds – JSSCP, Ooty

Pharm D. students in patient counseling – SRMC, Chennai

Pharm D. students in interaction with hospital doctors in a patient counseling – SRMC, Chennai

MAJOR PROPOSED AMENDMENTS

• Regulation of Pharmacy education and profession at

all levels (B. Pharm, Pharm D., M. Pharm) by PCI only

• Minimum qualification for registration to be upgraded

from Diploma to Degree

• Up gradation of qualification of practicing pharmacists

by introducing pharmacy practice regulations

(Bridge course)

EDUCATION

PRACTICEINDUSTRY

EXPORTS& REGULATORY

HERBAL

IPR & WRITING

C R OR & D VISION-2020

Welcome to7171stst International Congress International Congress

3-8, Sept 2011, Hyderabad www.fip.org

Welcome to

63rd IPC – 2011, Bangalore

16th ,17th, 18th December 2011, Venue: B I E C

THANK YOU

Contact address:

Prof. M.Venkata ReddyDirector ,

Shree Dattha College of Pharmacy,

Sheriguda, Ibrahimpatnam, RR Dist., Andhra Pradesh, INDIA

E-mail: venkat_manda [email protected]