|Year : 2014 | Volume
| Issue : 4 | Page : 473-476
Restructuring the syllabus for MD Pharmacology: Retrospection of bioassay
Sarita Mulkalwar, Bhalchandra Rane, Lopamudra Behera
Department of Pharmacology, Padmashree Dr. D.Y. Patil Medical College, Hospital and Research Centre, Dr. D.Y. Patil Vidyapeeth, Pimpri, Pune, India
|Date of Web Publication||25-Jun-2014|
CB- 26, Clarion Park, Beside Aundh Tel. Exchange, Aundh, Pune - 411 007, Maharashtra
Source of Support: None, Conflict of Interest: None
Introduction: Career prospects in Pharmacology are witnessing a sea change due to fast and unanticipated development in the field of clinical research. Numerous openings exist now in academia, pharmaceutical industry, Clinical Research Organizations (CRO) or as regulatory consultants, experimental pharmacologists, etc. In short, there are various options to choose from, depending on one's interest. It's high time we ponder now over the training programme for post-graduate students in Pharmacology. It needs to be revised keeping in mind the job prospects & uniqueness of the MD Pharmacology degree. Aim: To take suggestions of experienced pharmacologists on the present syllabus for MD Pharmacology and their opinion on continuation of Bioassay experiment which is currently an important part of it . Materials and Methods: A structured questionnaire was given to 30 experienced pharmacologists to seek their opinion on MD Pharmacology syllabus & continuation of Bioassay as a part of MD practical. Results: Out of 30 participants, 29 (96.6%) did not use their knowledge of Bioassay during their 10 years of post MD career, whether in pharmaceutical industry or in academics. Only 5 of them (16.6%) feel that experiment on bioassay should be continued in the current state. 76.7% of them wish it to be modified to a Dose Response Curve ( DRC) . 6.71% feel that it should be totally scrapped. All the participants feel the need of revising current MD Pharmacology syllabus. Current syllabus is inclined more towards preparing good academicians but it lacks the proper training for creating good clinical research professionals. Medical writing, writing necessary documents for clinical trials including regulatory documents, writing an article for medical journals, marketing communication, product monograph and patient information of a clinical trial could be incorporated. They should be aware of the regulatory requirements for conducting studies on investigational drugs & established drugs as well. Conclusion: Looking at the growing market of clinical research & India being favoured destination for the same, the demand of MD Pharmacologists by pharmaceutical industry is on rising trend. So the revision of the syllabus of MD Pharmacology should be the top priority of experienced Pharmacologists, so as to meet this demand.
Keywords: Bioassay, clinical research, MD pharmacology syllabus, pharmaceutical industry
|How to cite this article:|
Mulkalwar S, Rane B, Behera L. Restructuring the syllabus for MD Pharmacology: Retrospection of bioassay. Med J DY Patil Univ 2014;7:473-6
|How to cite this URL:|
Mulkalwar S, Rane B, Behera L. Restructuring the syllabus for MD Pharmacology: Retrospection of bioassay. Med J DY Patil Univ [serial online] 2014 [cited 2020 May 28];7:473-6. Available from: http://www.mjdrdypu.org/text.asp?2014/7/4/473/135272
| Introduction|| |
The pharmaceutical industry is one of the most powerful and steadily growing industries. One important growth driver for this industry is: innovation and development of new drugs. Initially, new drugs came from the plant world, later on chemistry took over and at present, a large number of drugs in the pipeline are from the field of biotechnology. Irrespective of the source, every new drug has to undergo a series of tests in vitro and in vivo, both in animals and human beings and one needs to have the right educational background to enter this industry. In this context, one important question that crops up for academicians is: Do we provide the adequate knowledge to postgraduate students during their 3 years tenure in the Pharmacology department?
The objectives of the MD Pharmacology course laid down by Maharashtra University of Health Sciences  and most of the other medical universities are:
- To understand Pharmacology in depth with understanding of the rational use of drugs, clinical pharmacology and to prepare good quality teachers.
- Introducing the students to advances in teaching technology, computer-aided learning, patent laws and procedures, etc.
- To orient the students for research and development.
Looking at the above objectives, the existing MD syllabus seems to be deficient in a few important aspects while a few aspects have been unnecessarily overrated, in the authors' opinion. With the current MD syllabus and the evaluation pattern, the first objective of preparing good teachers seems to be achieved, but, looking at the demand of MD pharmacologists in pharmaceutical industry and its expectations from them, we feel that we are lagging behind. This was shown in a survey where 96% respondents felt that Pharmacology curriculum lays emphasis only on becoming good undergraduate teachers & 83% felt that it gives inadequate practical training in research methodology.  Our MD Pharmacology syllabus doesn't seem to be in sync with the industry's demand. , In order to ensure that the pharmacologists ascertain a unique place in the growing pharmaceutical industry and to prepare them to confidently face the different challenges posed by the industry, there is a need for experienced pharmacologists to come together and brainstorm on the idea of reviving the current syllabus.
One important aspect of MD Pharmacology syllabus is Bioassay. Bioassay is the estimation of the potency of an active principle in a unit quantity of the preparation, by comparing its effect with that of a standard preparation, by testing its effect on a suitable test animal or on isolated tissue, under standard conditions. 
Bioassay forms an important part of MD Pharmacology syllabus and it has been given a lot of importance in practical examination.
Bioassay, as compared to other methods of assay, is more time consuming, more laborious, less precise, less reliable and more expensive. Biological variations, difficulty in maintaining uniform experimental conditions and difficulty in assuring the reproducibility of the responses hamper the reliability of the results. With the advent of technology and availability of advanced, sophisticated and more reliable analytical methods, the scenario for Bioassay has changed dramatically.
Pharmacopoeia, the official publication by competent government authorities of various countries, gives recommendations on analytical methods for various drugs. After reviewing the last published pharmacopoeia (Indian Pharmacopoeia, 1996), it has been observed that emphasis on Bioassay is now much less, as compared to that seen in the ones published before 1980. Most of the drugs which were assayed by biological methods are now being recommended to be assayed by chemical methods.
Keeping this in mind, a survey was conducted to assess the opinions of senior pharmacologists from academics as well as the pharmaceutical industry on the current MD curriculum and the need for the 'Bioassay'.
| Materials and Methods|| |
A total of 30 MD pharmacologists having more than 10 years experience were selected for this study. Out of 30, 15 pharmacologists were working on different posts in pharmaceutical industry and 15 were in academics from different medical institutes. A structured questionnaire was given to them personally or was sent by e-mail.
The questionnaire sought information about their views on Bioassay experiment, which is an important part of MD Pharmacology practical examination, and use of their knowledge of Bioassay during their 10 years of post MD career. They were asked to give their opinion on replacement for Bioassay if they wish to scrap it altogether or modify it as a part of practical examination. Most importantly, their suggestions were asked on the current MD curriculum followed by most of the medical institutions in India.
| Results|| |
Views on Bioassay
Of the 30 participants who responded to the survey, 5 participants (16.6%) feel that experiment on the Bioassay should be continued in the current state. Of these five participants, two felt that replacing Bioassay with expensive instruments like HPLC, HPTLC and spectrophotometer & their maintenance will be difficult in government set ups. One of them feels that though Bioassay can be continued as it is, marks allotted to it should be reduced to 50. (At present, the marks allotted to bioassay are 150/400). 
Two participants (6.7%) felt that it should be totally scrapped as it involves unnecessary sacrifice of the animals and should be replaced by computer-simulated experiments.
Rest of the participants (76.7%) felt that it should be modified to a Dose Response Curve, the knowledge of which could be useful for investigating a New Chemical Entity (NCE) in preclinical / phase-1 or proof of concept studies [Figure 1] and [Table 1]. The technique of mounting of tissue & methodology of conducting the experiment can be useful in understanding in vitro Pharmacology experiments carried out for drug development. Same experiment can be used for demonstrating the concept of antagonism. According to many, Bioassay is a crude and outdated method for quantitative estimation. As mentioned above, this application is now superseded by analytical chemistry techniques.
|Table 1: Opinions on continuation of Bioassay as a part of MD pharmacology syllabus (Total no of participants = 30)|
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|Figure 1: Opinion on continuation of Bioassay as a part of MD Pharmacology syllabus|
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Views on Current MD Pharmacology Syllabus
Though the present curriculum for MD students of various medical universities imparts basic training in the areas like experimental, clinical & applied pharmacology, it still remains theoretical and not of much practical utility. It needs to be revised with pragmatic, futuristic and skill-oriented outlook. The student undergoing this course is aware about framing a protocol for a research project, but the desired level of knowledge can be achieved only when it is practically implemented. Hence, conducting at least two research projects (one experimental & one clinical) could be made mandatory for a postgraduate (PG) student. All PG dissertations should be based on clinical/ experimental work & no paper research should be permitted. Paper research like drug utilization studies, prescription audit & Adverse Drug Reaction (ADR) monitoring may only be used for priming of the PG students or as an additional project.
System for evaluation is as important as the syllabus itself. Practical part of Pharmacology carries 400 marks, of which 150 marks are allotted to Bioassay.  In our survey, we found that 29 out of the 30 participants have not used their knowledge of Bioassay during their 10 years of post MD careers, except for guiding PG students, that too, solely because it is the part of the MD curriculum. Only one participant has performed Bioassay for estimation of catecholamines in a patient of pheochromocytoma in a rat blood pressure model, that too almost 40-45 years back. This has become irrelevant today due to the advent of modern techniques [Figure 2] and [Table 1].
| Discussion|| |
Pharmacologists should be aware of the drug development process in greater depth. At present, there is one question on evaluation of a drug from a specific class in MD theory examination, which is mainly focussed on animal models and in vitro testing. In lieu of this, a question on drug development pathway of a compound for a specific disease can be asked. The expected answer should include the current standard treatment for the disease, animal models of the disease, designing of a clinical trial & pharmacokinetic studies to collect pharmacokinetic data etc.
Medical writing in different styles, namely regulatory writing, writing an article for medical journals, marketing communication, product monograph and patient information of a clinical trial could be incorporated.
By modifying Bioassay to DRC, marks on Bioassay can be reduced to 50 and these marks could then be diverted to evaluate the students on practical aspects of clinical pharmacology. Industry posting / clinical research organization posting / laboratory posting which are desirable under MUHS, one should be made compulsory. Students can be evaluated for the same, along with the experimental/clinical project taken up during their tenure. They should be given credit points for these internal projects which could be a prerequisite for the final examination.
| Conclusion|| |
There are various avenues for MD pharmacologists besides being an academician. Students can join the pharmaceutical industry as clinical pharmacologists / medical advisors, open up their own CRO/ BA-BE study units, can be regulatory consultants, can be part of Data Safety Monitoring Board (DSMB) or take up jobs as medical writers. There are quite a few options to choose from & depending on one's interest, he/she could earn certain credit points during the 3 year tenure of the post graduation. This could be made mandatory for taking the final examination.
To summarize, India is fast emerging as a favoured destination for outsourcing of clinical trials. Clinical research industry will greatly flourish globally in coming years. There is a great demand for clinical research professionals today in the global market. Hence, there is an urgent need for experienced pharmacologists to come together & brainstorm on this important issue in order to come up with optimal solution that benefits the prospective students undertaking the MD Pharmacology courses in the future.
In this study, Maharashtra University of Health Sciences syllabus was taken into consideration and hence pharmacologists only from Maharashtra were involved in this survey. We suggest a large scale study involving more pharmacologists from all over the country to obtain useful suggestions so that some concrete steps could be taken.
| References|| |
|1.||Postgraduate curriculum in MD (Pharmacology and Therapeutics), Maharashtra University of Health Sciences. Passed by Academic Council (Resolution No. 365/2006) dtd. 28/06/2006. |
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|3.||Dikshit RK. Postgraduate education in medical pharmacology. Indian J Pharmacol 2007;39:171. |
|4.||Gupta V. Postgraduate education in medical pharmacology. A student's viewpoint. Indian J Pharmacol 2007;39:25. |
|5.|| Satoskar RS, Bhandarkar SD, Rege NN. Drug discovery; New drug development; and Drug Assay 2010;66-76. |
[Figure 1], [Figure 2]