A Review: Indian Pharmaceutical Education
and its Regulatory Authorities
S.
C. Shivhare1*, K.G. Malviya1, Dr Preeti
Srivastav1,Dr. U.D. Shivhare2 and Atneriya
U.K3
1MJRP College of Heath Care and Allied
Sciences, MJRP University, Jaipur India.
2Sharad Pawar College of Pharmacy, Nagpur
3BM College of Pharmaceutical Education and Research, Indore (M.P).
ABSTRACT:
The present
article aimed at focusing the different courses being conducted to prepare the
manpower for the pharmacy profession i.e. each and every field which is
directly or indirectly related to the production and sell of drugs. The article
also highlights the regulatory bodies involved in designing the syllabus also
the content of course at every stage of the course, the practical training that
a student should undergo at every level. The brief discussion has been made
about the functions of the regulatory bodies. A correlation has been made
between the theoretical and practical content of the course with the present
professional opportunities and the requirement of the Pharma
industries. A little attempt has been made and some views are put through this
platform for upgrading the standard of education to bridge the gape between the theoretical approach of the course and
present need of the pharmacy profession at the industrial as well as
educational level. Pharmacy education in India
traditionally has been industry and product oriented. The information presented
in this paper may stimulate discussion and critical analysis and planning, and
will be of value in further adaptation of the pharmacy education to desired
educational outcomes.
KEYWORDS: Pharmacy Education,
Regulatory Bodies, PCI, AICTE, India.
INTRODUCTION:
India, a developing nation that occupies the
greater part of South Asia, is a sovereign, secular republic consisting of 28
states and 7 union territories.1 With
a population more than 1.2 billion,1,2 India
is the second most populous country on the planet. And no doubt “education is
the empowerment”. It means to foster individual, social, professional and
economic development and its shapes the difference between the world of today
and that of tomorrow. In this article an attempt has been made to analyze the
field of pharmacy education on above lines in India. After analyzing the past
and the present field of pharmacy education, rather briefly the present article
tries to elaborate present scenario. Now A variety of pharmacy degree programs
are offered in India as, diploma in pharmacy (D Pharm),
bachelor of pharmacy (B Pharm), master of pharmacy (M
Pharm), master of science in pharmacy [MS(Pharm)] and master of technology in pharmacy [M Tech (Pharm)], doctor of pharmacy (Pharm
D), and doctor of philosophy in pharmacy (PhD).
Diploma
in Pharmacy (D-Pharm):
In India, higher secondary study is concluded
by a terminal examination, at the end of 12 years. Admission to the first year
D Pharm program in any pharmacy college is based on
performance on the higher secondary examination.
The D Pharm program
requires a minimum of 2 years of didactic coursework followed by 500 hours of
required practical training anticipated to be completed within 3 months in
either a hospital or community setting. The D Pharm
curriculum is framed through the education regulations of the Pharmacy Act. The
present education regulations framed way back in 1991 (ER91). The curriculum is
the same throughout the country. In the 1990s, the efforts of the pharmacy
council of India for upgrading the minimum qualification for registration from
D Pharm to B Pharm failed
due to lack of consensus.12.The D Pharm program was
developed and designed to train students to serve as institutional and
community pharmacists. Pharmacists with a D Pharm
degree have the opportunity to join a hospital (government or private) or
community pharmacy (mostly private). The majority of diploma-trained
pharmacists choose to work in government hospitals rather than private
hospitals or pharmacies. They are also considered for placements in the
pharmaceutical industry.
Bachelor
of Pharmacy (B-Pharm):
Admission to the first-year B Pharm program is made directly from higher secondary school
(12th) on the basis of marks obtained in the higher secondary examination or on
the basis of a merit list rank prepared based on scores on an entrance
examination administered by a state or individual institution. The B Pharm involves 4 years of study in colleges affiliated with
universities or in a university department by followed by 500 hours of required
practical training anticipated to be completed within 3 months in industry.
There is no standardized B Pharm curriculum and it
varies across the universities that offer this degree. It is industry and
product oriented course. The vast majority of pharmacists with a B Pharm degree normally seek positions (such as production,
quality control, quality assurance, packaging and
marketing) with the thriving pharmaceutical industries in which services are
well defined and industrial pharmacists are well remunerated. They also have
the opportunity to be appointed to drug regulatory agencies or quality control
laboratories as a Drug inspector or Chemical analyst by the state or central
government. The demand for pharmacists is further growing with the growth of
the pharmaceutical industry in India. After B Pharm some students also preferring the MBA with Different
specialization and M Tech of selective Branches.
Doctor of
Pharmacy (Pharm D) Program:
Admission to a Pharm
D degree program is on the basis of successful completion of the higher
secondary examination or the D Pharm program. Passing
the higher secondary examination with physics, chemistry, and biology or
mathematics entitles a student to enter the Pharm D
program. B Pharm degree holders can join the Pharm D program in the fourth year. The Pharm
D 6-year and 3-year post-baccalaureate program was introduced in 2008 with the
aim of producing pharmacists who had undergone extensive training in practice
sites and could provide pharmaceutical care to patients with focusing towards
clinical and community aspects of the profession and mandatory practical
training at practice sites. The Pharm D program is
comprised of 6 academic years, with 5 years of study and 1 year of internship
and residency at a practice site. Six months of the internship and residency
are spent in a general medicine department and 2 months each in 3 other
specialty departments. The clerkship, coupled with project work covering drug
utilization reviews, pharmacoepidemiology, pharmacovigilance or pharmacoeconomics,
was also in place. A detailed evaluation of the Pharm
D curriculum has shown that the basic science, chemistry, and pharmacy subjects
are an extension of the existing D Pharm and B Pharm programs. Although the curriculum emphasizes the
clinical and patient-oriented aspects of the profession, it overemphasizes
basic sciences (such as chemistry and analysis).
M Pharm Program:
The criterion for entry to an M Pharm program is academic performance in the B Pharm or an entrance test or both. An important criterion, a
high Graduate Pharmacy Aptitude Test (GPAT) qualifies a student to receive
government scholarship during the period of their M Pharm
study. This criterion is optional for admission to the first-year M Pharm program. However, many public institutions require
both past academic performance and GPAT score for application to the M Pharm program. Students holding a B Pharm
degree can earn an M Pharm degree in 2 years, of
which the second year is devoted to research leading to a dissertation in any
pharmaceutical discipline, for instance pharmaceutics, pharmacology,
pharmaceutical chemistry, or pharmacognosy. Recently,
M Pharm programs on industrial pharmacy, quality
assurance, pharmacy practices, and pharmaceutical biotechnology have been
introduced. The curriculum is divided into 2 parts. The first part consists of
1 year of didactic course work (both theory and laboratory) and the second part
involves completing a research project under the supervision of a pharmacy
faculty member in a chosen discipline. Students who pursue an M Pharm in industrial pharmacy may undertake research
projects in pharmaceutical industries during their second year of the
curriculum. An industrial expert is responsible for part of the research,
serving as the student's co-supervisor, to train the graduate pharmacist to
provide clinical-oriented services. M Pharm degree
holders in any discipline including an M Pharm in
clinical pharmacy may join industries in any of the above positions. Many M Pharm graduates entering the pharmaceutical industry choose
positions in areas such as research, formulation development, and clinical
trials. Additionally, they have the opportunity to work in the academic area,
typically as researchers or faculty members.
Doctor of
Philosophy in Pharmacy (Ph. D):
Students with an M Pharm
degree in any discipline additional minimum 3 years of study and research.
Pharmacists with a Ph. D mainly work in academia and in the research and
development section of pharmaceutical industries can work toward a PhD in pharmaceutical
science with an
Regulating
Authorities of Pharmacy Education in India:
Before independence, there were no regulations
for the profession and practice of pharmacy. Drug enquiry committee recommended
that the persons practicing pharmacy that is: the persons responsible for
compounding and dispensing of medicine should have a proper educational
background health survey and development, Committee also made similar type of
recommendation consequently the pharmacy act came into force in March 1948.
The pharmacy act 1948 is passed by the
Parliament of India with the main object to regulate the profession and
practice of pharmacy and to raise status of profession of pharmacy in India. To
achieve this object the act provides for the constitutions of pharmacy council
of India (central council) which is responsible for evolving educational
standards and regulations for diploma course in pharmacy through educational
regulations. The act in addition to central council provides for the
constitution of state pharmacy councils for the registrations of pharmacists
and for regulating their professional activities.
Pharmacy education in India is regulated by 2
organizations: the Pharmacy Council of India (PCI),6-8 under the
Pharmacy Act of 1948, and the All India Council for Technical Education
(AICTE),14-21 which
was established under the AICTE Act of 1987. As mentioned previously, the PCI
makes regulations regarding the minimum standard of education required for
qualification as a pharmacist. It is responsible for registration of persons
fulfilling the prescribed eligibility criteria (minimum DPharm)
and issuing a license permitting them to practice in an Indian state.
Registration activity is decentralized and the state pharmacy councils are
responsible for registering pharmacists in their respective states. Thus, the
PCI regulates the DPharm program and the recently
introduced PharmD program. The BPharm
program needs to be recognized by the PCI for the qualifications to be accepted
for registration purpose only. The PCI has no jurisdiction over MPharm and other higher-level degree programs.
Pharmacy education at
all levels excluding the PharmD is regulated by the
AICTE and all these programs must be approved by it. The AICTE is primarily
responsible for planning, formulating, and maintaining norms and standards in
technical education, which include pharmacy. Besides the Pharmacy Act, pharmacy
practice is also governed by the Drugs and Cosmetics Act of 194013-17 which
stipulates the manufacture, distribution, and sale of drugs. Currently,
there are no regulatory body and regulatory control for clinical pharmacy
practice.
The AICTE is also
responsible for quality assurance of pharmacy programs (D Pharm,
B Pharm and M Pharm)
through accreditation by National Board of Accreditation (NBA) constituted by
the AICTE. However, only 8% of pharmacy programs have been accredited.9-11
Accreditation is voluntary and also a stringent process; thus, few institutions
have applied for accreditation on their own. The voluntary accreditation seems
to serve little purpose for any of its stakeholders. Unlike other countries,
the current regulations do not require any continuing education to maintain
licensure once they are conferred. In addition, registered pharmacists do not
have any established norms on competencies or standards of services. There is
no categorization of practicing and non-practicing pharmacists.
Pharmacy Council of India (PCI):
The Pharmacy Act 1948
was enacted on 04.03.1948 with the following preamble: “An Act to regulate the
profession of pharmacy. Whereas it is expedient to make
better provision for the regulation of the profession and practice of pharmacy
and for that purpose to constitute Pharmacy Councils".
The PCI was constituted
on 09.08.1949 under section 3 of the Pharmacy Act.
Objectives:
Regulation
of the Pharmacy Education in the Country for the purpose of registration as a
pharmacist under the Pharmacy Act.
Regulation
of Profession and Practice of Pharmacy.
Functions and Duties
To prescribe minimum
standard of education required for qualifying as a pharmacist. (Ref.: section
10 of the Pharmacy Act).
Framing
of Education Regulations prescribing the conditions to be fulfilled by the
institutions seeking approval of the PCI for imparting education in pharmacy. (Ref.: section 10 of
the Pharmacy Act)
To
ensure uniform implementation of the educational standards throughout the
country. (Ref. : section 10 of the Pharmacy Act)
Inspection
of Pharmacy Institutions seeking approval under the Pharmacy Act to verify
availability of the prescribed norms. (Ref.: section 16 of the Pharmacy Act)
To
approve the course of study and examination for pharmacists i.e. approval of
the academic training institutions providing pharmacy courses. (Ref. :
section 12 of the Pharmacy Act)
To withdraw approval,
if the approved course of study or an approved examination does not continue to
be in conformity with the educational standards prescribed by the PCI. (Ref.:
section 13 of the Pharmacy Act)
To approve
qualifications granted outside the territories to which the Pharmacy Act
extends i.e. the approval of foreign qualification. (Ref. :
section 14 of the Pharmacy Act)
To
maintain Central Register of Pharmacists. (Ref. :
section 15 A of the Pharmacy Act)
All India Council for Technical Education (AICTE)27-29
The All India
Council for Technical Education (AICTE) is the statutory body and a
national-level council for technical education, under Department of Higher Education, Ministry of Human Resource
Development.2 Established in November 1945 first as an
advisory body and later on in 1987 given statutory status by an Act of
Parliament, AICTE is responsible for proper planning and coordinated
development of the technical education and management education system in India. The AICTE accredits postgraduate and
graduate programs under specific categories at Indian institutions as per its
charter.3
It is assisted by 10
Statutory Boards of Studies, namely, UG Studies in Eng. and Tech., PG and
Research in Eng. and Tech., Management Studies, Vocational Education, Technical
Education, Pharmaceutical Education, Architecture, Hotel Management and
Catering Technology, Information Technology, Town and Country Planning. The
AICTE has its headquarters in Indira Gandhi Sports
Complex, Indraprastha Estate, New Delhi,
which has the offices of the chairman, vice-chairman and the member secretary,
plus it has regional offices at Kolkata, Chennai, Kanpur, Mumbai, Chandigarh, Guwahati, Bhopal and Bangalore, Hyderabad and Gurgaon.4
Objectives:
The AICTE Act of 1987
AICTE is vested with
statutory authority for planning, formulation and maintenance of norms and
standards, quality assurance through school accreditation, funding in priority
areas, monitoring and evaluation, maintaining parity of certification and
awards and ensuring coordinated and integrated development and management of
technical education in the country as part of the AICTE Act No. 52 of 1987.
The AICTE Act, stated verbatim reads:
To provide for
establishment of an All India council for Technical Education with a view to
the proper planning and co-ordinated development of
the technical education system throughout the country, the promotion of
qualitative improvement of such education in relation to planned quantitative
growth and the regulation and proper maintenance of norms and standards in the
technical education system and for matters connected therewith.
Current objective.
In order to improve
upon the present technical education system, the current objective is to modify
the technical
curriculum as follows:
Greater emphasis on
design oriented teaching, teaching of design methodologies, problem solving
approach.
Greater
exposure to industrial and manufacturing processes.
Exclusion
of outmoded technologies and inclusion of the new appropriate and emerging
technologies.
Greater
input of management education and professional communication skills.
AICTE bureaus:
The AICTE comprises
nine bureaus, namely:
Faculty Development
(FD) Bureau
Undergraduate Education
(UG) Bureau
Postgraduate Education
and Research (PGER) Bureau
Quality Assurance (QA)
Bureau
Planning and
Co-ordination (PC) Bureau
Research and
Institutional Development (RID) Bureau
Administration (Admin)
Bureau
Finance (Fin) Bureau
Academic (Acad) Bureau
For each bureau,
adviser is the bureau head who is assisted by technical officers and other
supporting staff. The multidiscipline technical officer and staff of the
Council are on deputation or on contract from government departments,
University Grants Commission, academic institutions, etc.
CONCLUSION:
Pharmacy education in
India, both at the B Pharm and M Pharm
levels, is taught as an industry- and product-oriented profession with a focus
on the basic sciences.26 During the past decade, pharmacy education
has expanded significantly in terms of number of institutions offering pharmacy
program at various levels. However, pharmacy education in India continues to be
one of the last options for students aspiring to a university degree. The
pharmacists with a B Pharm or M Pharm
generally seek avenues other than pharmacy practice. While the Pharmacist
holding Pharma D or D Pharm are practicing pharmacists in the
clinical globally or in India
respectively.
In order to demonstrate
the requirements for pharmacists in India, it is necessary to undertake a
pharmacy workforce study, to review pharmacy education programs, and to compare
them with the roles that have been accepted internationally. Then,
to design and develop pharmacy degree programs perhaps one program exclusively
for industry and another for practice.
ACKNOWLEDGEMENT:
Authors are very much
thankful to the MJRP College of Heath Care and Allied Sciences, MJRP University
Jaipur, Sharad Pawar College of Pharmacy, Nagpur, BM College of
Pharmaceutical Education and Research Indore for providing necessary facilities.
REFERENCE:
1.
The National Portal of India, New Delhi
2009. Know India-States and Union Territories. http://india.gov.in/
knowindia/state_uts.php. Accessed
April 14, 2010.
2.
Central Intelligence Agency. The World
Fact Book - India. http://www.cia.gov/library/publications/the-world-factbook/geos/in.html.
Accessed April 14, 2010.
3.
Singh H. History of Pharmacy in
India and Related Aspects. Volume 2: Pharmaceutical Education.1st ed. Delhi: Vallabh Prakashan; 1994.
4.
Kaul
R. History of modern pharmacy in India: a review of the work of Professor Harkishan Sing.Pharm
Hist. 2009;54(1):34–42.
5.
The Pharmacy Act, 1948. Government of
India, Ministry of Law, Justice and Company Affairs.http://www.pci.nic.in /contents.htm. Accessed
April 14, 2010.
6.
Pharmacy Council of India. http://www.pci.nic.in/.
Accessed April 14, 2010.
7.
Lal
LS, Rao PG. Clinical pharmacy education in India. Am
J Health-Syst Pharm. 2005;62:1510–1511. [PubMed]
8.
Agarwal
P. Higher education in India: need for change.http://www.icrier.org/pdf/ICRIER_WP180__Higher_Education_in_India_.pdf.
Accessed April 14, 2010.
9.
Quality education of technical education
in India. http://www.ukieri.org/docs/chennai-conference-march2008/Quality-Assurance-of-technical-Education-in%20India-Prasad-Krishna.pps.
Accessed April 14, 2010.
10. Chengappa R. Higher education: How to clean the
mess. http://indiatoday.intoday.in/index.php?option=com_contentandtask=viewandid=49794andItemid=1andissueid=113andsectionid=30andpage=archieveandlimit=1andlimitstart=2.
Accessed April 14, 2010.
11. Basak SC, Sathyanarayana
D. Pharmacy practice and education in India: current issues and trends. Pharma Rev. 2008;7(37):71–76.
12. Singh
H. Pharmaceutical education and pharmacy practice: A historical
perspective. Pharma Times. 2009;41(2):16–18.
13. West Bengal Joint Entrance Board. Opening and closing rank.http://wbjeeb.in/download/ope%20closing.doc08.htm
. Accessed April 14, 2010.14. All India
Council for Technical Education. http://www.aicte-india.org/.
Accessed April 14, 2010.