The pharmaceutical education in India has shown steady growth during the last fifty years. This is due to the growth of pharmaceutical industries in India and demand of pharmacy professionals.
Table-1 shows the growth of pharmaceutical institutions in India and intake of students from the academic years 2003-2004 to 2006-2007. Due to the growth of Indian pharmaceutical industries in India, which in turns due to the infrastructure development, technology base creation and a wide range of production. From the data shown in Table-1, we can see the zone-wise growth of institutions in India as shown in Figure-1.
Regulation of pharma education
The Pharmacy Council of India (PCI) was established in 1948. It is a statutory and apex body and constituted under the provisions of section 3 chapter II of the 'Pharmacy Act 1948 Act' No. 8 of 1948 with an aim to regulate the profession and practice of Pharmacy. Section 10 of the Pharmacy Act prescribes Education Regulation to provide a set of uniform regulation all over India at Diploma level. The inspectors are appointed by the PCI under section 16 of Pharmacy Act to inspect the institutions conducting approved courses of study and the examining authorities conducting approved examinations to monitor the standard of education. The PCI by virtue of the powers conferred upon it, under the provisions of section 12 of pharmacy conducting approved courses of study. Similarly the examining authorities and the practical training centres are also accorded approval by PCI, subject to fulfillment of stipulated conditions.
Currently, PCI is essentially managing and regulating the standard of pharmaceutical education at diploma (D. Pharm) level. In view of the changing scenario in the health care system there is a need to upgrade the minimum qualification from diploma to degree (B. Pharm) level, to improve the health care delivery system for effective patient friendly pharmaceutical care. For this, a new Act was enacted by Parliament namely 'The AICTE Act 1987" with a view to ensure proper planning and coordinated development of technical education system in India, qualitative improvement of such education in relation to planned quantitative growth, and regulation and proper maintenance of norms and standards in technical education system and for matters thereof. The norms and standards for pharmacy institution and other technical institutions are laid down, under clause 10(i) of chapter III of the AICTE Act 1987 (52 of 1987). The AICTE is given a mandate and is vested with a set of powers and functions to foster the planned growth and nurture quality in technical education. Several changes were made in the process of approval and the norms and standards. Some of the salient features of the approval process are: Clause 10(i) - Norms and standards for courses, curriculum, physical and infrastructural facilities, staff pattern, staff qualification, quality instructions assessment and examinations.
Clause 10(k) - Approval for starting new technical institutions and/or introduction of new courses in consultation with agencies concerned. Clause 10(n) -Steps to prevent commercialization of technical education. clause 11(i) - Inspection of institution in exercise of the powers conferred by sub section (i) of section 23 read with section 10(b), (g), (i), (k), (p) and (v) and section 11 of the AICTE Act and in super session of the regulations No. F37-/Legal/2004 dated 06.01.2005, the new regulations vide notification dated Nov 28, 2005 are notified with a purpose to provide for:
● Grant of approval for establishment of new technical institutions.
● Grant of extension of approval for the existing technical institution.
● Grant of approval for introduction of new courses or programmes and/or increase and/or variation in intake of seats in existing courses or programmes in technical institution.
Ensuing maintenance of norms and standards in Universities including deemed to be Universities imparting technical education. Consequent to the implementation of the AICTE Act, the pharmacy institutions in India are under the purview of an additional statutory body namely AICTE besides the existing statutory body of PCI.
There is a visible dichotomy in the regulations of the two statutory bodies in the following areas:
● Requirement of land and financial commitment.
● Norms and standards for infrastructural facilities, room sizes, list of equipments, library facilities and other amenities.
● AICTE norms and standards for existing new institutions.
● Standard inspection form of PCI and the compliance report / formats of AICTE.
● Staff pattern, faculty norms, staff etc.
● Process of inspection by PCI and AICTE
● Volume of information to be furnished to AICTE
● Volume of information to be furnished to AICTE
● Duration of B. Pharma course
● PCI norms and AICTE norms
● Complications in the approval system of two bodies - legal implications
As such, there is a distinct dichotomy in the regulation of pharmacy education in India by the two statutory bodies namely, AICTE and the PCI besides the additional regulations of the respective Universities, State Government, UGC etc., which is causing unnecessary hardships. Since both the bodies are associated with the same process of according permission to the pharmacy institutions throughout the country. This leads to several contentious issues leading to differences in the approval matters, for which both the authorities at times, are to wait for the final verdict of the honourable High court or the Apex court. Now, the question may arise, who should regulate the pharmacy education? The answer should be the PCI or AICTE? The answer is a matter of debate. In view of the existing powers of AICTE to sanction financial assistance under various schemes to the selected Pharmacy Institution, a segment of education providers are inclined towards AICTE with the unsettled point of discussion at various levels that, PCI is neither an autonomous council nor has sufficient funds to give to Universities for research activities and to other demands, and as such who will fund the on going and up coming research activities and to meet other demands?
The other section of professionally committed and conscious intellectuals is in favour of PCI with a defending and a strong argument that, the financial assistance is not provided to all the pharmacy institutions across the country. It is only limited to a very small fragment of institutions which are accredited or Govt. Institutions or University Institutions, where as a large number of institutions are private no grant affiliated institutions, which are deprived of the financial considerations. This has become a contentions issue. It has to be resolved at the level of Parliament, by enlarging the scope of pharmacy practice. By and large, it is felt that pharmacy profession should be governed by pharmacists only, pharmacy profession should be independent, united and work hand in glove to maintain the spirit of the noble profession. The flag of pharmacy profession should fly higher and higher. The existing set-up needs a radical upward reformation for a metamorphosis. There is a dire need to strengthen the hands of PCI so that it can regulate its own profession with desired dignity and autonomy, so as to achieve our cherished mission for the pharmacy fraternity by the year 2020 as envisaged under the charter Pharmacy Vision 2020 which was inaugurated by Dr. A P J. Abdul Kalam former president of India at the pre-conference session of 55th Indian Pharmaceutical Congress 2003 held at Chennai on 17th December 2003 "An independent profession which can grow further globally and achieve drug production with a target of 20 per cent from the current 08 per cent in total volume of production in the world" This needs a total redrafting of the existing Pharmacy Act with an amendment in the Parliament to give more teeth to PCI for effective regulation and up gradation of pharmacy education at all levels with emphasis on quality and International accreditation.
Table - 1: State-wise growth of pharmacy institutions in India
View Table Information
Present system
India has three levels of formal education in pharmacy - Diploma, Degree and Post-graduation. Minimum qualification for registration is diploma, while graduates and post-graduates often take jobs in pharma industry. In the rest of the world, there is only graduation and PG level education with minimum qualification for registration being a degree. Globally, pharmacy education curriculum is more clinical in orientation, while in India it is having an industrial orientation. Nearly 55 per cent of the jobs are available in the industry sector while 30 per cent in education. There are only three per cent jobs in healthcare.
Conclusion
Presently PCI and AICTE are the regulatory bodies looking into pharmacy education. AICTE is responsible for its 'birth' and 'nourishment ' while PCI is responsible for evaluating whether the education is of minimum standards of diploma level to ensure that the candidate is fit to work as a registered pharmacist for drug distribution.
To improve the quality of pharma education in India, there must be revolutionary changes in the healthcare system. The syllabus should be periodically reviewed. To shift from industrial base to clinical base it is necessary to make laws for appointing pharmacists at each Primary Health Centre and government hospitals. There should be adequate staff in the state drugs control departments for better control of drug distribution system.
(The author is a specialist in chemicals and pharmaceuticals based in Mumbai)