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Time to revamp
Thursday, November 30, 2006, 08:00 Hrs  [IST]

Dr Guru Prasad Mohanta,Dr Prabal Kumar Manna & Dr R Manavalan
The pharmaceutical education in this country is quite old and matured, but still conservative. The three-tier programmes: Diploma in Pharmacy, Degree in Pharmacy and Master of Pharmacy have been in place. Each tier of education is intended for specific purpose. Diploma in Pharmacy is community and hospital pharmacy focussed while Degree in Pharmacy is industry oriented. Masters' programme is specialized in particular field ranging from basic pharmaceutical subjects to industrial pharmacy to pharmacy practice (clinical pharmacy).

The Diploma in Pharmacy (D. Pharm.) programme is centrally controlled and regulated under Pharmacy Act. The Pharmacy Council of India (PCI) is the apex body for making regulation and framing syllabus for this programme and it is uniform through out the country. Under the Pharmacy Act first Education Regulation was framed in 1953 and there after it was amended in 1972 and 1981. The current curriculum is around 15 years old and is under Education Regulation 1991. The syllabus is not revised since then, though some efforts have been made to upgrade the qualification of pharmacists intending to practice profession.

The degree programme (B. Pharm.) is of four years duration basically focussing to cater the needs of pharmaceutical industries. The programme is under the control of two statutory bodies: All India Council for Technical Education and Pharmacy Council of India. The Pharmacy Council of India's approval is necessary if the passed out students intend to register in State Pharmacy Council as registered pharmacists. On the other hand the AICTE permission or approval is necessary to start a degree programme and the institutions offering such programme need to comply with AICTE's requirement, irrespective of whether the students need to register or not after passing out. The pharmaceutical industries do not need the council's registration and what they need is a recognized degree from the university. Similar is the situation in employment in regulatory bodies like Drugs Control Department. The registration of passed out students in the council is essential if they wish to join the profession either in community pharmacy (retail medicine sale) or in hospital pharmacy. The power of AICTE is curtailed with respect to programmes offered directly by the universities. The universities need no approval from AICTE.

There is no uniformity in the B. Pharm. curriculum among the various universities. Often AICTE's syllabus, framed a decade back, is taken as skeleton for designing the course programmes at various universities. The individual university has its autonomy for designing curriculum through the various academic bodies like board of studies, academic council etc. The proposed Education Regulation 2001 of the Pharmacy Council could not see the light of the day.

The Master's programmes (M. Pharm.) are under direct control of individual universities for developing the course curriculum. Like B. Pharm., the institutions need approval from AICTE for offering M. Pharm. Programmes. AICTE's approval for programmes offered by universities is not mandatory. The syllabus is not uniform and the PCI has virtually no role to play. Terminology of the programmes too is different at different universities.

Looking at the need of the future and global scenario in pharmacy profession, seeds of clinical pharmacy have been sown in the country. The few related subjects like pathophysiology, pharmacotherapeutics and clinical pharmacy have been introduced at various levels of programmes. Full-fledged programme at M. Pharm. Level is introduced in Pharmacy Practice. Some institutes even offer postgraduate diploma in clinical pharmacy, though not approved by any university.

The world around us is changing very fast. The new trends have been emerging at high velocity. The industries requirement is fast changing. The new fields or areas become the priorities. The concept of Quality Assurance, Validation, Changed Safety, Health and Environment guidelines are new areas in Pharmaceutical industries. The industries in India are looking forward to export their products to both developed and developing countries. We are very strong in manufacturing. India has largest number of USA FDA approved units (outside USA). International regulatory requirements including complying with ICH guidelines are a necessity for growth and sustainability in globalised era. Expertise in Regulatory affairs has ample scope now in pharmaceutical industries. The country has accepted product patent provision as a part of global commitment. The industries need to develop own drug molecules for survival; simple manufacturing cannot sustain them. The new molecules need to be protected from copying by obtaining national and international patents. The intellectual property rights (IPR) are another emerging area in industrial activity. The industries need to comply with international requirements on safety, health and environments requirements for becoming global players, in addition to satisfying other regulatory conditions. All these areas are of little concern in B. Pharm. Programme at present. However, M. Pharm. Programmes in some universities have some of these areas in their curriculum.

It seems the PCI and AICTE are locking horns over administrative powers of pharmacy colleges in the country. It is very surprising. Pharmacy members of either PCI or AICTE make the regulations for pharmacy programmes. It is not that AICTE makes or PCI makes. The responsibility lies on most of the time with pharmacy teachers. Is not it wise to derive the benefits of both the bodies, as time has not ripened to completely make pharmacy programme health focussed from industry focussed. The present condition requires a balanced approach in pharmacy regulation and curriculum. The pharmaceutical industries are the major employers for pharmacy graduates and postgraduates and their requirements must always be kept in mind. The president of Indian Pharmaceutical Association (IPA) in one of the editorial in Pharma Times writes that 83000 per year pharmacy workforce is required for catering the needs of pharmaceutical industries in next few years. The curriculum must be need based and customer focussed. Lot of clinical organizations are emerging as out sourcing agents for multinational companies. They do need graduates and postgraduates of pharmacy with knowledge and training in clinical pharmacy and related subjects. The medical tourism is inviting lot of foreign patients to our country for medical care. The corporate hospitals are moving for getting accredited. The clinical pharmacy service is a requirement for this. This would provide some opening for clinical pharmacists in hospital sector.

At present only one national institute, National Institute of Pharmaceutical Education and Research (NIPER) is available in the whole country. Fortunately the new Pharmaceutical Policy proposes to establish few more similar institutes in different parts of the country in the line of Indian Institute of Technology.These institutes can lead and provide directions in formulating curriculum at different levels of pharmacy programmes. The establishment of curriculum development cell either at AICTE or NIPER would help updating the programmes across the country. If the statutory bodies fail to provide a direction in this regard, many institutes would come independently to offer need based, customer focussed and market driven programmes. A beginning has already been made by some institutes to offer B. Tech programmes in Pharmaceutical Technology. If B. Pharm. syllabus is not updated periodically, the graduates of such programmes will become irrelevant.

In this globalized era where education has already been included in General Agreement on Trade Services (GATS), the pharmacy programmes at various levels must be upgraded to make them relevant to current need of society for either self-employment or employment globally. Perhaps from the present balanced approach incorporating both the technology and practice aspects in the curriculum at graduation level may shift completely towards practice in times to come in consistence with development of profession around the globe. In developing curriculum a realistic approach is necessary rather than sentimental or emotional attachment to individual subject(s). Pharmacy has been undergoing transformation, with dynamic changes, constantly for the benefit of the mankind, whether in the field of research, industry or community, advances ensuring both quality and length of life should be the factors for deve-loping strategy to face the challenges of tomorrow.
(Dr Guru Prasad Mohanta and Dr Prabal Kumar Manna are professor, and Dr R Manavalanis professor and head, Department of Pharmacy, Annamalai University, Tamil Nadu)

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