The global pharmaceutical Industry takes good effort to improve its productivity by reaching and developing new drugs. Global pharma companies increasingly explore low cost options to outsource contract manufacturing, research (contract & clinical) and drug discovery since they face a slow down in sale of patented drugs with dry R & D pipe lines. Unless the human resource force of the Indian pharma industry is very strong in relevant education and training, it will be tiresome for India to withstand competition from countries like China, which is almost a threat to India in many fields.
The landscape of pharmacy education has undergone a magnificenttransformation during the past couple of decades. Barring a few world renowned medical colleges in India, pharmacy education was essentially offered by the Government-run medical colleges in the past.But today, to meet the fast growing and expanding demand, both in India and abroad, in the areas of production, Quality Control, Research & Development, Regulatory Affairs, Clinical Research, Pre Clinical Studies, Drug Discovery & Development, Computational modeling, Bio Informatics, Data Management, Packaging and labeling, Materials supply, Human Resource Development, Training needs, etc., this program is offered by several private medical colleges and stand-alone pharmacy colleges.
Scope for pharmacy education
In spite of producing an estimated 10,000 pharmacists of all levels, the demand for pharmacists is unmet. Given the expected fast growth and opening of the new avenues including outsourced contract manufacturing and research in the Indian pharmaceutical industry, the demand will only grow further.Several large multi-specialty hospitals have been established in the private sector and many more are in different stages of completion.Large corporations including the Apollo, Reliance, just to mention a few, have either already maintain 24 hours retail pharmacy outlet chains in the country or plans to establish chain stores contributing the demand for pharmacy professionals.Based on these developments, one could safely assume that the future of the pharmacy has an unmet need. The global pharmaceutical Industry is growing at a rate of 10 % per year and India contributes to 2 % of the total turnover.
Courses offered
A student interested in pharmacy education has a number options based on educational aptitude, resource constraints, and future plans.They are:
*A two-year Diploma in pharmacy introduces the student to the world of pharmacy and allows him to understand the basic principles of drug and its action on the humans at the elementary level.This program will allow the student to find a job as a Pharmacy Assistant in a hospital, or set up a medical store either in the urban or rural area (mandatory requirement to get license for opening a pharmacy).
*Four year Pharmacy Degree is the most favored pharmacy program because this opens a wider job opportunity for the students.Several private colleges and selected government medical colleges offer the four year degree programme.This program provides a fairly comprehensive orientation to the human anatomy, physiology, and the action of drug on the human system.Drug chemistry, synthesis, toxicology, drug manufacture, dosage forms, hospital & community pharmacy, clinical pharmacy, government regulations including the Drugs and Cosmetics Act, etc., are covered in four years.The student will also know how the drug acts on the body and how it provides relief.Most institutions started offering an introduction to management which will help students if they start a drug manufacturing venture on their own.Generally, there will be no specialization (like in other under graduate programs) on any particular area.
The student undergoes training program in a Pharmaceutical Industry during the second / third year to get exposure to the realistic pharmaceutical manufacturing / quality control / quality assurance / research & development areas.
This programme opens up a wide array of employment options for the graduate.A pharmaceutical company will employ this graduate either as a professional sales executive to promote its products among the physicians and surgeons.A pharmacy graduate is better placed to respond to some of the focused queries of the doctors than the science graduate because of their pharmacy background.Pharmacy graduate also could be placed in the manufacturing, quality control, quality assurance, regulatory affair, materials supply, pharmacy packaging, retail pharmacy chains, counselor for patients, research & development departments, etc., as degree course in pharmacy covers all the aspects. An enterprising pharmacy graduate could start a pharmaceutical company on her/his own. Of course, starting a medical shop also is an option with patient counseling.
*Two year masters programme (M Pharm): This programme is aimed at B Pharm students, who aspire to specialize in any specific field. Masters programme in pharmacy offers specialization in a particular branches -pharmaceutics, pharmacology, Pharmaceutical Analysis, Quality Assurance, Pharmacognacy, Pharmacy Practice, medicinal chemistry, pharmaceutical biotech-nology, etc. M Sc / M Tech in specialized fields is another good option for the pharma graduate to specialize further
*MBA / PhD Programme:Pharma graduates can register for MBA programme with various specializations, as per interest of the candidate. Post graduates in pharma can register for doctorate programs with specializations in the area of their interest and availability.
*Pharm D Programme: This program is equivalent to The doctorate in pharmacy and is not available in India
Today, the pharmacy graduates are also greatly in needed by the clinical research organizations and site management organizations to coordinate the clinical trials.India is a hot market to conduct clinical trials given the large pool of patient populations and low cost.Clinical trial is the process of validating the safety and efficacy of new drugs and new chemical entities (NCEs).Both foreign and Indian pharmaceutical industry has to conduct clinical trial, establish the safety and efficacy of the products before getting the marketing approvals.Trained pharmacy graduates also find a job opening in the pharmaceutical industry to manage their clinical trials. Courses on clinical research & GCP is being given by Academy of Clinical Excellence (ACE), Catalyst Clinical Services, Institute of Clinical Research India, Kriger Research Institute, Kundani College of Pharmacy, Bioinformatics Centre - University of Pune, Bioinfomratics Institute of India, Synapse in Delhi, Watsalya Institute in Bangalore, Association of Clinical Research Professionals (ACRP), etc. Other diploma / certificate courses available from Institute of Intellectual Property Studies.The state of Andhra Pradesh is setting up India's first pharmaceuticaluniversity to cater to the educational needs of the pharmacists in totality.
Current status
Indian Pharmacy Education Infrastructure consists of
over 200 universities, 1,500 research Institutions, 500 pharmacy colleges, 10,000 pharmacists a year, 15,000 pharmacy diploma holders, 2,000 M Pharms and 50 Ph Ds in pharmacy.Concerns: Though the number is adequate, the quality of pharmacy education is of great concern.
*Lack of accredited Institutions like National Institute of Pharmacy Education and Research (NIPER)
*Lack of patient oriented pharmacy courses
*Faculty strength, especially its quality
*Education system not geared for the post patent era
*Non availability of necessary educational environment with infrastructure facilities
*Partial implementation of national pay scales to the faculty / non availability of experienced faculty
*Difference in syllabus between universities
*Accreditation by Pharmacy Council of India (PCI), All India Council for Technical Education (AICTE)
*Nascent infrastructure facilities for research
*Lack of practical exposure / Internship after B Pharmacy course Changes anticipated and required:
*Shift from Industry to Health in pharmacy education (since 55 % jobs arefor industry sector, 30 % for education and only 3 % for healthcare sector)
*Uniform syllabus through out the country
*Recognition of Indian pharmacy programme across the globe with International registration and licensing
*Strengthening community pharmacy and clinical pharmacy syllabus andcompulsory internship on completion of the course
*Introduction of separate Pharmacy Directorate for substantial growth and Development
*Recognition of a clinical pharmacist in hospitals for prescriptions
*Focus on Industry-oriented research / healthcare & community pharmacy *Introduction of NAPLEX in India for pharmacy practice
*Employment of qualified pharmacists only in pharmacy shops
*Quality Improvement in education, infrastructure facilities, faculty
*Mandatory appointment of pharmacists at PHC and government hospitals
*Training on GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GPP (Good Pharmacy Practice),GPP (Good Packing Practice) for better understanding of the current andfuture quality assurance and regulatory compliance
*Accreditation and grading of the Institutions as per availability ofinfrastructure facilities
*Conduct of awareness workshops, symposiums, conferences, etc
*Involvement of Phar-macy Institutions in natio-nally coordinated projectsand research awards sponsored by AICTE
*Resource sharing and faculty exchange programs
*Employment of diploma holders in pharmacy as pharmacy assistants asin US
Steps taken by PCI & AICTE:
Pharmacy Council of India (PCI) and All India Council for Technical Education (AICTE) are the regulatory bodies overseeing the Indian Pharmacy Education. Birth and nourishment of Pharmacy education is the responsibility of AICTE, whereas PCI apply stringent quality measures for evaluation and up gradation of pharmacy education standards. PCI plans Pharmacy Practice guidelines for hospitals and pharmacy owners, come out with an amendment for cabinet approval on a total revamp to make it more effective as a regulator of pharmacy professionals in the country - acceptance and recognition in the society and code of conduct for pharmacists. PCI is in discussion with the regulatory authorities and government bodies to bring all the activities of Pharmacy education under one umbrella - PCI
Indian Pharmaceutical Association (IPA) is commencing a student forum IPA-SF, a national forum platform exclusively for pharmacy students for their overall development and progress through regional IPAs. This will represent the student's views at all levels of profession - aiding career growth.
PCI and AICTE is conducting several workshops / symposiums / conferences / Industry-Institute contact programs for benefit of pharmacy students in all relative areas, which does not reach out to the relevant authorities at the appropriate time. Appropriate measures are being taken by both the bodies to overcome this and provide opportunity for the students to take relevant training in the respective field.
With India being the one of the top five producers of API, being the most preferred nation for outsourced contract manufacturing, clinical research, data management, Indian pharmaceutical industry is poised for substantial growth for a minimum of next two decades. With shortage in the essential need for pharmacy professionals in the relevant field, the need for the standard pharmacy education has become more relevant for taking India into greater heights in the global pharmaceutical scenario.
(The author is chief clinical project manager,Apollo Hospitals Educational and Research Foundation, Chennai)