| Dr Subhash C Mandal |
The Indian pharmaceutical industry started with a small turnover of Rs 8 crores in the early forties, gradually growing at a fast pace, and reaching a total turnover of Rs 104209 crores in the year of 2009-2010. This industry also exports a huge amount of drugs to the tune of Rs 42154 crores. India is now a leading global player in the pharma manufacturing sector, and has been ranked third in terms of volume and 14th in terms of value of production. Presently, we have about 10563 manufacturing firms providing employment to 3,53,692 personnel, and have 5,50,000 retail outlets. The tremendous development was possible due to necessary protection provided by the Patent Act 1970. Pharma education in India started as a consequence of recommendations of a committee setup by the then British Government under the chairmanship of Col. RN Chopra. This committee made several recommendations for the development of pharma profession in India and starting of pharmacy education in India was one of such recommendations. As a result of it, B.Sc (Pharmacy) course was started at Banaras Hindu University in the year 1932. Thereafter Drugs and Cosmetic Act 1940 and Drugs and Cosmetics Rules 1945 have been enacted to regulate pharma industry. For regulation of pharmacy education and profession, the Pharmacy Act 1948 was framed and enacted. In the mean time, Licentiate in Pharmacy was started in Madras Medical College and in Jalpaiguri, West Bengal. This course has been renamed as Diploma in Pharmacy. Gradually, B Pharm courses started in few universities during the fifties and later on. An upsurge in pharmacy colleges started since early eighties mostly under the private sector.
The pharmacy education is a three-tier system in India, which are:
Two-year Diploma: Diploma in Pharmacy (D Pharm)
Four-year Graduate: Bachelor in Pharmacy (B Pharm)
Two-year Post Graduate: Master in Pharmacy (M Pharm), Ph.D in Pharmacy and the newly introduced Pharm D Course
Diploma in Pharmacy: It is a two-year course with a three-month training in a health care institution approved by the Pharmacy Council of India. D Pharm personnel are generally engaged in community and hospital pharmacy though they also have scope in industry and marketing.
Bachelor in Pharmacy: Graduate pharmacists are mostly engaged in industry in several capacities in manufacturing, quality control, sales and marketing, quality assurance, regulatory affairs and so on.
Master of Pharmacy and Doctor of Pharmacy: These qualified pharmacists may opt for joining industry, research or teaching.
Presently there are about 666 diploma and around 822 degree institutions producing about 26474 D Pharm, 53265 B Pharm, 21996 M Pharm and 38 Ph Ds per year.
Pharmacy education is under dual control of Pharmacy Council of India (PCI) and All India Council for Technical Education (AICTE). Course curriculum of D Pharm is being prescribed by the PCI after approval of the Parliament. Presently D Pharm students are being taught the course curriculum framed in the year of 1991. Course curriculum framed 21 years back has actually lost its relevance in the present context. The need of the society has undergone a sea change due to socio-economic changes and due to the introduction of new drugs and new technologies. In case of B Pharm and M Pharm, AICTE formulated course is generally followed by most of the institutions except by few universities. Hence, B Pharm and M Pharm courses vary from one university to the other. Questions have been raised by experts that the course taught in colleges are more theoretical and not updated, which in general is failing to cater to the needs of the modern pharma industry. Doubts regarding the infrastructure and the quality of faculty members of some of the pharmacy colleges are not beyond questioning. Rationalisation of course curriculum, vigorous industry-institute interaction and regular updating is highly needed to produce skilled technical manpower to compete in the global arena.
Continuing education
Pharmaceutical Sciences & Technology is currently considered as a knowledge-based industry. A drug, which is deemed as life saving today, may be banned tomorrow due to surfacing of serious adverse effects/ toxic effects or it may be outdated due to introduction of a better alternative. Pharmaceutical technology which is considered latest today, gets outdated tomorrow due to development of newer, more sophisticated high-end, effective technology. Even frequent changes in regulations lead to altering of many dimensions in the field of pharmacy. To cope with this situation, a pharmacist requires continuous updating of knowledge.
Teachers
Pharmacists involved in teaching have several scopes for continuous education provided by University Grants Commission (UGC) and AICTE etc. They are also required to go through certain categories of training for promotion. AICTE has established centres for improving the quality of in-service teachers, for upgrading qualification as well as continuing education programmes. It also has some other programmes like- travel grant, seminar grant, career award for young teachers, emeritus professorship, visiting professorship, early induction programme, staff development programme etc. for encouraging teachers. AICTE also has a programme through which they provide financial grant to professional societies/bodies etc. for updating their members. There are also opportunities offered by Dept of Biotechnology (DBT), Indian Council for Medical Research (ICMR), Council for Scientific & Industrial Research (CSIR) etc.
Regulators
Central Drugs Standards Control Organization (CDSCO) organises training for Drugs Control Officers in collaboration with World Health Organization (WHO). Recently, the said training is being conducted by National Institute of Pharmaceutical Education & Research (NIPER) at Mohali, Chandigarh. Homeopathic Pharmacopoeia Laboratory at Gaziabad organises trainings on different aspects of Homeopathic Medicines like, quality control, manufacturing, and GMP etc. Central Research Institute (CRI) conducts training for Drugs Control Officers and personnel engaged in Drug Testing Laboratory. National Aids Control Organization (NACO) organises training for Drugs Control officers on blood safety for effective monitoring of blood banks throughout the country. CDSCO recently launched the National Pharmacovigilance programme involving different health professionals including pharmacists to generate data on ADR and to educate all concerned about its significance.
Industry
Generally the industries have their own training modules and concerted programmes for updating their employees, but sometimes, institutions like, CDSCO, NIPER, Central Research Institute (CRI) arrange trainings for industrial pharmacists. Different professional organisations like Indian Pharmaceutical Association (IPA) and industrial organisations like IDMA, OPPI etc., organise seminars, workshops on different emerging topics to educate and update the large pool of industrial pharmacists. In most cases those trainings are optional, and are not linked with their career advancement. It is suggested that credit earning system for attending seminars, workshops/ trainings like developed countries will be helpful for compulsory and continuous updating.
Hospital and community pharmacists
There are rapid changes in the fields of hospital and community pharmacies with quick obsolescence of medicines. The expectations of patients are also in an upward mode, in tune with global changes.
Pharma education in India was for a long time designed to meet the needs of the industry, but recently changes have been initiated to make it more patient-oriented. Several universities have already started postgraduate courses in Clinical Pharmacy, Pharmacy Practice etc., but the pharmacists need continuing education in the new fields like Pharmacoeconomics, Pharmacovigilance, Clinical Pharmacy, Rational Pharmaceutical Management, Rational Use of Medicines etc. Though such training courses are being arranged by a few professional associations, NGOs, and universities, no formal mechanisms exist for updating the practicing pharmacists. Recently PCI has floated a proposal that a registered pharmacist is required to go through some trainings for renewal of their registration. This may be the first mandatory training in this field.
Ph.Ds: Higher research is generally conducted by the Ph.D Graduates in lifesciences including pharmacy. One recent publication in Nature reported that India produces 8,900 Ph.Ds in science, technology and engineering in 2011 which is quite low in comparison to the number of Ph.Ds produced in China (50,000 in 2009) and US (19,733 in 2009).
Though there exists no definite breakup, it can be said with the help of existing data that India is generating very few number of Ph.Ds in life sciences. It is considered inadequate to match the population explosion and tremendous growth in the Indian economy. India has targeted to produce 20000 Ph.Ds by 2020. The problem is aggravated by an exodus of Ph.Ds to developed countries in search of better facilities and better packages. Research in the emerging fields like – genomics, metabolomics, nanobiotechnology etc require interdisciplinary approach, but unfortunately such culture has yet to be developed in India. Therefore it is envisaged, that a two-pronged approach is needed to produce more quality Ph.Ds and to provide them more conducive environment for conducting research.
Suggestions
The following steps are being suggested for developing quality human resources in pharmacy:
- A comprehensive programme requires to be put into place after judging the present societal need from the pharmacists.
- A well thought out pharmacy course curriculum, to cater to the needs of the industry and the clinical establishment requires to be implemented throughout the country uniformly.
- Industries should frame some sort of evaluation system, may be credit earning points like prevalent in other parts of the world.
- AICTE and PCI need to be more vigilant to ensure required infrastructure and quality manpower of the educational institutions.
- Pharmacy Council should impart training to pharmacists, or they must recognise training imparted by other organizations and allot credit points considering the effectiveness of the course curriculum/ training module.
- PCI should frame suitable legislation to make training mandatory for renewal of registration.
- Pharmacy practice in our country is regulated by two major Acts, which are Drugs & Cosmetics Act and Pharmacy Act, but unfortunately there is no harmonisation between these Acts, resulting in ineffective control over the pharmacy practice. A co-ordination between the two are needed immediately.
- Necessary steps require to be taken for proper utilisation of the potential of pharmacists in pharmacy practice.
- Sufficient quality manpower needs to be created for advanced research in the field of pharmacy.
The author can be contacted at subhash.mandaldr@gmail.com