PHARMACY EDUCATION
TPR
Pharmacy Practice and Education in India: Current Issues and Trends Subal C Basak*, D Sathyanarayana
Abstract: In the history of mankind, social development has always been closely interlinked with healthcare achievements. Therefore pharmacy education and practice has a significant impact on the health improvements of a nation. Pharmacists represent the third largest healthcare professional group in the world. Pharmacists work in the community, in hospitals, and in other medical facilities as members of the health care team and have special responsibilities for the safe use of medicines. In developed nations, in addition to traditional dispensing, pharmacists monitor the health and progress of patients in response to drug therapy and provide patient care that focuses on prevention of diseases and patient outcomes, and accordingly educational curriculum is designed. In India, like in many Asian countries, pharmacists are the most accessible healthcare professionals and also play an important role in the use of medicines. Formal pharmacy education in India started (B. Pharm. in BHU in 1937) long before the enactment of Pharmacy Act, 1948 and the formulation of the Education Regulations in the year 1953. India has made rapid progress in pharmacy education over the last two decades. This paper seeks to sketch the status of pharmacy practice in India vis-à-vis pharmacy education, standards of education, and changes are being undertaken, and then pay particular attention to the need for required actions to strengthen the curriculum and the profession. Sixty years ago, there were no restrictions on the practice of pharmacy in India. The practice of prescribing and dispensing was an integral unit performed by doctors. In addition, most doctors trained their clinic assistants to dispense medicines and assist in compounding of medicinal preparations. The assistants were popularly known as "compounders." Persons, having experience of working with physician who could read a prescription and could assist in compounding and dispensing, were allowed to work in pharmacy settings. As in the case of many Asian countries, pharmacy practice profession in India, therefore, developed from the concept of extemporaneous preparations and selling of medicines. The pharmacy practice concept was realized with the dawn of independence in 1947. The Pharmacy Act,1 1948 was the first landmark, which came into existence in response to recommendations of Drugs Enquiry Committee2 (Chopra committee) constituted in 1930, and report of Health Survey and Development Committee, 1943 (Bhore committee).The Chopra committee in its report recommended among others setting up of courses for training in pharmacy and prescribing minimum qualifications for registration as a pharmacist. The Bhore committee emphasized the need of government to control
practice of pharmacy and provide educational facilities for licentiate pharmacists. The education regulations framed in 1953, under the Pharmacy Act, 1948 laid down a 2 year course and 750 hours practical training after matriculation as minimum qualification for registration of pharmacists. Additionally, the regulations allowed a 1 year course for the students with intermediate in science qualifications. Further, the regulations permitted a condensed course without practical training for students possessing matriculate qualification and having 2 years experience in dispensing of drugs. The Education Regulations were amended in 1972, 1981, and 1991 (Table 1). The duration of the course remained unchanged in the first two revisions, but there were revisions in course content and contact hours. Diploma in Pharmacy: The present Education Regulations framed in 1991 (ER91) prescribes 10+2 in science stream or equivalent as a minimum qualification for admission to Diploma course. The Pharmacy Council of India3 (PCI), a statutory body formed under the Pharmacy Act, has sole responsibilities for the regulation of practice of pharmacy. The Diploma in Pharmacy (D. Pharm.) involves a minimum of 2 years of study besides practical training of 500 hours spread over a period of 3 months in a
Readers in Pharmacy, Annamalai University, Annmalainagar, T.N. Author for correspondence E-mail:
[email protected] THE PHARMA REVIEW n DECEMBER 2008
71
TPR
PHARMACY EDUCATION
hospital, dispensary or pharmacy. Therefore, the regulation is in force today succeeded in upgrading the minimum qualification for registration for pharmacists to the level of 10+2+2 from either 10+2 or 12+1 educational qualification. Prerequisites for admission into the D. Pharm. Course under the ER 1991 include physics, chemistry, and biology or mathematics in the entry level qualification. The curriculum is divided into two academic years with each academic year spread over a period of not less than 180 working days and 500 hours practical training spread over a period of not less than 3 months. The first year curriculum is comprised of pharmaceutics, pharmaceutical chemistry, pharmacognosy, biochemistry and clinical pathology, human anatomy and physiology, and health education and community pharmacy. In contrast to the modern developments, the pharmaceutics course content consists of mostly trivial basic concepts. Pharmaceutical chemistry deals largely with inorganic medicinal substances. Coursework during the second year includes pharmaceutics, pharmaceutical chemistry, pharmacology and toxicology, jurisprudence, and hospital and clinical pharmacy. Pharmaceutics encompasses age old dispensing of mostly irrelevant medications, and is of little relevance in an era where manufactured ready to dispense medicines are widely used and accepted. Chemistry consists of study of only organic medicinal substances. Jurisprudence includes pharmacy law and regulations but less ethics and ethics applications. Bachelor of pharmacy: The formal pharmacy education at degree level in India dates back 1932, when pharmaceutical chemistry was introduced as one of the subjects for Bachelor of Science course in Banaras Hindu University (BHU). Thereafter, a regular 3 year course leading to Bachelor of Pharmacy (B. Pharm.) was introduced in 1937. The objective of B. Pharm. course those days was to train students in quality control and standardization of drugs. Since then there has been a continuous
growth in number of institutions imparting pharmacy educations at both degree and post graduate levels. Until early 1980's, there were 13 Universities and about an equal number of Government colleges offering pharmacy education at bachelor's and master's levels. Currently, there are 854 AICTE approved (as on 31.08. 2007) institutions that admit 52334 students in BPharm course.4 In twenty years, the increase has been significant and this rise is expected to continue. Most of the institutions, however, are privately funded colleges or privately funded Universities (Universities u/s 3 of UGC Act). Moreover, a very large number of such private institutions are concentrated in 6 states (Tamilnadu, Kerala, Karnataka, Andhra Pradesh, Maharashtra and Gujrat). It is estimated that Andhra Pradesh alone produces about 20% of B. Pharm. graduates and south India educates around 40-45% of pharmacy graduates in India. Bachelor of Pharmacy is a 4 year course of study with 10+2 in science stream as minimum qualification for admission. It may include 2 months' practical training in a drug manufacturing unit or hospital pharmacy, and is designed to do away 6 months' experience out of total 18 months required for becoming competent technical staff for employment in drug manufacturing industries. The B. Pharm. syllabus of most of the Universities overemphasizes extra-biological areas without much needed importance on the biomedical and social sciences. A detailed Curriculum of B. Pharm. Programme of a well known University5 is presented in Table 2. The curriculum has 18 practical components out of 22 subjects (i.e. a whooping 82% is practical subjects). In addition, it devotes 36% for chemistry and analysis subjects, whereas importance given on Indian healthcare system, pharmacy services, biomedical sciences and social sciences is significantly less.
Orientation of B. Pharm. Course: Historically, the B. Pharm. course was designed in such a way to satisfy the requirement of pharmaceutical industries, drug control laboratories Table 1: Education Regulations of the PCI and drug regulatory bodies. The orientation of B. ER Entry level Duration (years) Practical training (hours) Pharm. course even now remains same. It has no 1953 [A] Matriculates (10) [A] 2 [A] 750 statutory exclusivity like D. Pharm. course. [B] I. Sc. (10+2) [B] 1 [B] 750 Institutions (mainly private sector) imparting degree [C] Matriculates with 2yrs [C] condensed [C] Nil in pharmacy are volunteered to have PCI experience in dispensing 1972 A, B, and C same as 1953 A, B, and C same as 1953 A, B, and C same as 1953 recognition, after essential features of the Diploma requirements are inspected and satisfied by the [D] First year pass in B.Sc. [D] Same as B [D] Same as B 1981 A, B, C & D same as 1972 A, B, C & D same as 1972 A, B, C & D same as 1972 PCI. In the last one decade, the pharmacy [E] 10+2 in Science [E] 1 [E] 50 curriculum at bachelor level was strongly debated across India to revamp its content. However, our 1991 I. Sc., First year pass in 2 500 B.Sc., 10+2 in Science or academic bodies have failed to change much any equivalent exam. needed metamorphosis in pharmacy education.
72
THE PHARMA REVIEW n DECEMBER 2008
PHARMACY EDUCATION It is common belief that the bachelor and higher studies in pharmacy education have industrial leaning. It has been further argued that the curriculum is more or less designed for preparing students towards industry than for practice in community and hospital settings. This argument lacks ground as B. Pharm. does fulfill the minimum standard of education for registration by the PCI. This is proved by the fact that B. Pharm. and M. Pharm. holders are successfully managing a few positions in hospital pharmacy section of Government district hospitals (especially Karnataka state) and at various corporate hospitals, and charitable hospitals like Ramakrishna Mission and Christian Missionary hospitals. In fact many of these hospital pharmacists are responsible for establishment of hospital manufacturing units.
TPR
Pharmacy (M. Pharm.) course in various specializations. An M. Pharm. in pharmacy practice was started first time in the year 1997 with an objective to patient oriented services. Thus, there are two distinctly separate courses at post graduate level; M. Pharm.-clinical and M. Pharm.industrial and others. However, questions have been raised regarding lack of job opportunities of these postgraduates as a clinical pharmacist in hospitals where no such post exists.6 Additionally, regulatory framework does not recognize the need for clinical pharmacist at the national level.
Important Issues: Although pharmacy education has expanded several times since the enactment of the Pharmacy Act in 1948, the issues of recognition by the government and quality and status of pharmacists continue to be the areas Table 2: Overview of B.Pharm. Curriculum of an Indian University of great concern. The pay structure in the YEAR 1 2 3 4 government position is significantly lower than that of similar professionals. In the past, Pharmaceutical Biochemistry Pharmacognosy Pharmaceutical S Inorganic Chemistry and Phytochemistry Biotechnology repeated demands for similar pay with Diploma Pharmaceutical Advanced Medicinal Formulative engineers were declined by the government U Organic Chemistry Pharmaceutical chemistry I Pharmacy and citing the shorter duration of D. Pharm. course Organic Chemistry Biopharmaceutics after school education. Currently, the D. Pharm. Pharmaceutical DF Advanced B Anatomy, Physiology Pharmaceutical Structure continues to be different from other and Health analysis and and Cosmetic Pharmacognosy education physical chemistry Technology technical courses (Table 3). J Physical Pharmaceutical Pharmacology I Pharmacology II It is observed that, structures of bachelor and of pharmaceutics Technology master in pharmacy currently are in close E Pharmacy Practice Hospital and Modern Methods agreement with AICTE norms; however, it was and Clinical Pharmacy of Pharmaceutical not same earlier. The D. Pharm. Structure Pathophysiology Analysis C always maintains a distance from engineering Biostatistics and Forensic Pharmacy Medicinal Computer and Business chemistry II counterparts. The quality of education offered T Applications Management by pharmacy institutions vary widely. The private technical institutions including Bachelor of Pharmacy in pharmacy practice - a difficult task: pharmacy suffer from large quality variation in so much so that a B. Pharm holders are not in great numbers in practice settings due recent NASSCOM (National Association of Software and Service to lack of proper remuneration. Pharmacists' scale of pay in both Companies) report, 2005 has found that just one in four Indian state and central governments is much less and placed with lower technical graduates were properly qualified to begin work (i.e. division clerks. In contrast, D. Pharm. holders are not in significant employable).7 The main drawback is that pharmacy graduate not numbers in the industries since the industries are able to appoint only lacks adequacy for pharmacy practice but also a weak degree holders with salary much less than engineering industrial pharmacist. The course curriculum, teaching and counterparts, and also due to regulatory requirements. However, training have not received adequate attention. there is no attempt so far to make projections about our graduate Course curriculum: a roadblock: The first author of this article and diploma manpower requirements. Therefore the difference lies in the duration of course and not orientation. The Table 3: Comparative Chart of Structure of Pharmacy and Engineering courses Diploma Level Degree Level Postgraduate level additional subjects in the B. Pharm., as compared to Periods D. Pharm. are just an extension of many extraEngineering Pharmacy Engineering Pharmacy Engineering Pharmacy biological papers. 1980's 11 + 3 11 + 2 11 + 5 11 + 4 +2 + 1 or 2 Master of Pharmacy: A Bachelor of Pharmacy Intermediate 10 + 3 10 + 3 holder becomes eligible for two year Master of Current
12 + 1
12 + 4
12 + 4
+ 1.5
+ 1.5 or 2
12 + 2
12 + 4
12 + 4
+2
+2
THE PHARMA REVIEW n DECEMBER 2008
73
TPR
PHARMACY EDUCATION
started his career in the year 1977 by joining Diploma in Pharmacy course in Jalpaiguri (WB). Since then there is no qualitative change of pharmaceutics practical at all levels. The mightiest of roadblock is presence of practical component in most of the subjects and its evaluation. A detailed examination of the syllabus of western countries has shown the curriculum contains on an average one integrated laboratory component per semester. Even in India Engineering curriculum has 1 or 2 laboratory practices per annum and a few technological University has no practical examination. In sharp contrast we have 4/5 Laboratory components per semester that clearly indicates we spend more time conducting and evaluating practical subjects, practically hindering students to gain problemsolving abilities and critical thinking abilities. Some practical components have although different names but the substance and content have little difference among them. In pharmaceutics, preparation and evaluation of Milk of Magnesia experiment is conducted from diploma to postgraduate level. The evaluation so called advanced experiments: dissolution of drug or kinetic order, among others is usually done by qualitative method on the basis of simple completion of work and presentation of graph. In Chemistry, elemental or volumetric analyses in details are still carried out, which has no significance in an era of HPLC, LC-MS methods of estimations. Incompatibilities, extraction and galenical products, dispensing of various mixtures as a part of 100 prescriptions still occupy prominently in pharmaceutics. Microencapsulation, Suppositories, sugar coating of tablets, among others overshadow the topics such as advanced dosage forms, drug delivery devices, polymer used in drug delivery, individualization of dosage forms, and bioequivalence studies. In short much of what is taught today, though didactically relevant, does not offer graduates a level of skill for what to expect in industry or practice settings. Quality considerations: The quality of education and training can be improved through the process of accreditation. Currently all the courses in pharmacy are accredited by NBA, AICTE. However, a vast majority of private institutions remain outside the ambit of accreditation. In pharmacy 8% of the total pharmacy programmes have been accredited (as on 11.01.2008) in contrast to 36% of the same in engineering4. We rate the quality of pharmacy education by quantitative factors: size of the building and laboratory, number of refrigerators, pressure cookers, and autoclaves, number of teachers and teachers with Ph.D., and sometimes number of publications, among others. It is a necessity of incorporating the factors of how many instruments are being effectively used, effective teaching methodology, peer reviewed publications, input of students and faculty strength. 74
THE PHARMA REVIEW n DECEMBER 2008
Pharm. D. Programme: In March 2008, Indian Health Ministry has approved the 6-year Pharm. D. course regulations, to be regulated by the PCI. Eligibility for admission to this programme is after 10+2 with physics, chemistry, biology or mathematics or D. Pharm. The Pharm. D. (Post Baccalaureate) will be direct admission to 4th year meant for B. Pharm. students. Both Pharm. D. and Pharm. D. (Post Baccalaureate) are expected to begin from 2008 academic year. Annamalai University is the first institution in the country to start Pharm. D. programme in September 2008. The first five years consist of mostly didactic course work and the sixth year is full time internship or residency. The major aim behind this course is to raise the standard of pharmacy profession in India in terms of pharmacy practices as well as making pharmacy degree acceptable to the US, which will help to obtain a licence to practice pharmacy without much difficulty. This action is reportedly appreciated by many and hailed as a milestone of practice oriented model in pharmacy. It is a positive step to uplift pharmacy practice education and to graduate pharmacist who can work in various practice settings and provide patient care through proper drug therapy management. Major differences in Pharm. D. between US and India are summarized in Table 4. There is some concern that this Pharm. D. programme, although aimed specifically for practice settings, will have implications for industrial placements. Many are apprehensive that these graduates will neither get higher paid jobs in practice settings nor justify their positions in industries. The coming years will show as to what extent the programme fulfils the hopes the profession and the graduates change pharmacy practice scenario in our country. Need for modifications of pharmacy curriculum: Pharmacy council of India revised the minimum registrable -D. Pharm. Table 4: Comparison of Pharm. D. between US and India Items
US8
India
Entry level
High school
10+2
Prerequisites Classes in high school and pharmacy college admission test (PCAT) score
Pass in 10+2 No admission test
Pre-pharmacy At least 2 years undergraduate Nil study (most students enter the Pharm. D. with 3 or more years of college experience) Pharmacy study
4 academic years (or 3 calendar years)
6 academic or calendar years
Job outlook
Demand for pharmacist is widespread in US Median salary in 2004 was USD 89,723
Unknown
PHARMACY EDUCATION
Way forward: It is well recognized that pharmacists' contribution as a part of the healthcare team is central to advancing health in
any population. There is a greater need for quality pharmacy education, can be established only through improved teaching and training utilizing up-to-date and relevant curriculum. Revamping of pharmacy curriculum requires a serious thinking and commitment from all stakeholders at all levels of pharmacy education. There is a growing recognition that educational outcomes assessment should be the basis of curriculum change. The main objective is that the graduates possess the knowledge and skills needed to perform optimally to man the pharmaceutical services. These minimum goals of graduates at all levels are: l Dispense right (effective and safe) medicines at right prices l Educate patients on prescription and OTC drugs l Give advice on health services, family planning, drug misuse and abuse, and other related topics l Act as a member of drug information services l Participate ADR monitoring l Produce medicines of highest quality and safety in the pharmaceutical industries l Ensure medicines meet the standards before releasing to the market
MACHINERY FOR
PHARMACEUTICALS, FOOD & BEVERAGE INDUSTRY RANGE OF MACHINERY ALSO AVAILABLE FOR CHEMICAL & COSMETIC INDUSTRY
Belt Conveyor
Packing Table
SPECIALLY FABRICATED EQUIPMENT ALSO AVAILABLE
Drying Oven Membrane Filter Holder
S.S. Tank Drum Mixer
Lable Cumming
Jacketed Vessel Planetary Mixer
Washing brushing
Sifter Pressure Vessel
Printing Machine
Filter Press
Tablet Machine
Ointment Mixer
Multi Mill
Mass Mixer
Homogenizer
Friability Tester Stirrer
Hardness Tester
Disintegration Test Apparatus
Granulator
D / T M/C
Polish pan / Coating Pan
C/o Collage Communications 2, Mandar, 153, Turner Road, Bandra (W), Mumbai-400 050 Phones: 09820001555, 09867301555 E-mail:
[email protected] Work: 22, Kardar Compound, Dr. S.S. Rao Road, Parel, Mumbai - 400 012 Mobile: 9820001555 Web: www.keimachines.com THE PHARMA REVIEW n DECEMBER 2008
Food Pharmaceutical & Cosmetic Machinery Food Pharmaceutical & Cosmetic Machinery
course way back in 1991. The two year course after 10+2 has consisted of professional and related subjects. Undergraduate pharmacy curriculum of many Universities was framed over a decade ago. In contrast to other countries, pharmacy education in India lack harmony and uniformity, and is governed by Medical, Technical or Science University. The preparative and dispensing pharmacy components of pharmaceutics-I & II, hospital and clinical pharmacy subjects are unrelated to contemporary needs because most of the preparations (mainly practical exercises) have become obsolete a long time ago, are hardly utilized as medications in the pharmacy. The hospital pharmacy subject consists of study of western system from American text book and does not have topics such as Indian health care delivery, drug distribution, health insurance and reimbursement. Very little importance is given on mathematical orientation of most of the subjects. The current regulations do not require pharmacists to periodically to update their knowledge and skills. In addition, pharmacists in India do not have any laid down norms or competencies and quality services.
TPR
75
TPR l
l
l
l
l
PHARMACY EDUCATION
Involve in research and development of better and cost effective dosage form The general consensus in India is that all the pharmacy programmes (Diploma, Degree and Postgraduate) are required to satisfy the requirements of industries and practice settings in the prevailing socioeconomic scenario. Strategies for revamping curriculum should focus on the following: Restructuring of pharmacy programmes with the aim of seeking better government salary structure comparable with diploma in engineering, and practice requirement - D. Pharm. - change of pattern from 10+2+2 to 10+3 - B. Pharm. - separated into non practicing; and practicing with additional training Reviewing of subjects - Reduction of load by limiting 1 or 2 integrated practical subjects per semester - Reduction of chemistry and non related subjects - Strengthen mathematical orientation of every subject - Distribution of subjects as a percentage of total load (core, basic, elective and optional subjects) Building of image by preventing dilution of degree - Promotion of B. Pharm. holders for employment in
l
l
l
industry as engineering counterparts - Promotion of postgraduate for R&D in industry and faculty position (many postgraduates are engaged in industrial assignment for which degree holders would suffice) Establishing requirements of competencies to practice pharmacy - Define benchmark for registration criteria (graduates and postgraduates employed in industry need not be registered) - Introduction of pre-registration examination Framing quality assurance - Input of students - Competent faculty with adequate communication skill - Infusion of knowledge of contemporary issues Becoming exemplary citizen - Observe pharmaceutical ethics - Fulfill professional and social obligations
Conclusion: Pharmacist is not only a key member of healthcare delivery system but also contribute equally in research, manufacture, distribution, regulation and management of all types of medicines used for drug therapy. The conclusion is that pharmacy education has not succeeded in creating pharmacist as a member of healthcare team that fails to figure in National Health Policy 20029, and fails to be recognized by the population; this proves that the pharmacy education programmes in India need modification. There is a need for all out efforts from all stakeholders to promote pharmacy practice and build up public perception of pharmacist as in many of the developed countries.
References 1. The Pharmacy Act, 1948 (8 of 1948), Government of India, Ministry of Law, Justice and Company Affairs. 2. Report of Drugs Enquiry Committee (1930-31), Government of India Press, New Delhi 1931. 3. Pharmacy Council of India. http://pci.nic.in/ (accessed 2008 Mar 31). 4. http://www.ukieri.org/docs/chennai-conference-march2008/QualityAssurance-of-technical-Education-in%20India-Prasad-Krishna.pps (accessed 2008 Sept 6). 5. The Tamilnadu Dr. M.G.R. Medical University, BPharm Regulations and Syllabus from 2004-2005 onwards available at http://www.tnmmu.ac.in/ pdf/bpharmrs0405.pdf (accessed 2008 Aug 31). 6. Mangasuli S, Surulivel R and Ahmed Khan S. A decade of pharmacy practice education in India [letter]. Am J Pharm Educ 2008;72:16. 7. Morris R. The India skills gap. Available at http://www.simple-talk.com/opinion/opinion-pieces/the-india-skills-gap (accessed 2008 July 9). 8. American Association of Colleges of Pharmacy. Available at http://www.aacp.org (accessed 2008 August 29). 9. National Health Policy -2002. http://.mohfw.nic.in/np2002htm (accessed 2008 Mar 30).
76
THE PHARMA REVIEW n DECEMBER 2008
