Friday, April 20, 2012
Wednesday, April 18, 2012
Interview of Ghooi sir
Posted on March 1, 2012 by Author & Editor in Expert Interviews
Dr. Ravindra Bhaskar Ghooi, experienced in Preclinical Industry, Pharma Industry, Clinical Research and Drug Discovery.
Dr. Bhaskar Ghooi
Q. Can you share about your career journey?
A. I have done my BSc. Chemistry, MSc. Pharmacology and PhD in Medicine. I started my career in Preclinical Industry worked for 11 years then I worked for few Pharma industries as Medical Advisor, then I was into teaching Clinical Research and Drug Discovery in ICRI for 6years, then I was vice president for CliniRx CRO, Gurgaon. At present am working as Professor in Symbiosis International, Pune.
Q. What are the challenges you faced in Preclinical Industry and clinical Research?
A. The first important challenge in Preclinical Industry is shortage of jobs. Honestly, there are few jobs and it’s not easy to get. After I left and when I enter in to medical department in Industry, the first challenge I faced is “no industry allows a non-medical person to become medical advisor”. So, there is a lot of unfair competition where non-medicals suffer very badly. So far, I haven’t seen any medical advisor who is a non-medical degree holder. The job of Medical advisor is not looking for this structure, it involves in more teaching activities, delivering the matter, interacting with regulatory authority, in which none of these doesn’t require a medical degree. But which is essential in terms of medical then it should have a medical degree. This has become a major rude block and major block. These are my challenges.
Q. As you said, it is difficult for a non-medical person to enter as Medical Advisor. How did you get opportunity for Medical Advisor?
A. I don know what opportunity I got but it was decided to take as Medical Advisor. The company looks for good and efficient person and it didn’t bother about the qualification. If every where the companies look for such kind of good and efficient people there would be less unemployment.
Q. why there are less opportunities in Pharma Industry?
A. since, last 1970, they changes the Patent law in India, since that time the drug discovery has not been done in great fashion except for few companies who are doing basic drug research and no body were doing preclinical research. Obviously when nobody was doing preclinical research then there are no opportunities. After that they have started doing research during 1990, the number of companies involved in doing basic drug research and Preclinical research Is handful and majority of the companies are working on chiral compounds or either combination products and still bringing the molecules from abroad and they are doing co marketing and there is greater amount going on clinical research rather than preclinical research in India. Then that’s all the opportunities in preclinical research.
Q. Now a days every one from life science back ground are entering in to Clinical research. Post graduate degree holder of Clinical Research and M.Pharm degree of some specialization, both want to enter into Clinical research and still M.Pharm degree holders are in imagination that there are more jobs in clinical Research though they can go for Pharma industry where Post graduate degree holder in Clinical Research cant enter into a Pharma Industry nor Preclinical Industry. Even though he has adequate knowledge on Clinical research he is less weighed than other degree holders. In such condition what is the use of holding a degree?
A. Clinical Research course is implemented to teach, to create awareness and to train the students who want to enter in to Clinical Research. It is not the problem with the course. Course is giving you the knowledge and the institutions are more starting clinical research without approval from government. There are few institutes with government approval and running the course. Now it is over supply. Because of job scarcity, if every one is choosing clinical Research and when jobs are very less, it gets polluted. That every one should understand. Ultimately, who is having efficient knowledge on clinical research, he will be absorbed, no matter of qualification. If a company has one post two hundred applications will be there, then the company look for people who work for very low salary. So, there shouldn’t be too many people for any course. Most of the institutes just doing business by starting the courses without government, there are no good teachers in Clinical Research and they are trying to cheat students and companies by highlighting placement assurance. This is an unfair requirement. It’s because of many institutes clinical Research has become more famous and fashion.
Q. Based on your experience is Clinical Research is benefit to the society or not?
A. Absolutely beneficial. There is no doubt about it.
Q. Do Investigators are really dedicating their roles and responsibilities to Clinical Trials?
A. Most of the Investigator’s are dedicating to the best of their ability and capabilities. If the Investigator is not dedicating it mean that he hasn’t been trained further properly. In such condition no matter of blaming him.
Q. Is Investigator is getting benefits and challenges in Clinical Trial?
A. Obviously, Investigator is benefiting. He is getting advantages and there are no disadvantages. He is benefiting with funding but still he will not spend any amount on patient serious adverse event (SAE). He needs to collect amount from his birth rate. Conventionally in India, the doctors are not ready to spend anything and they expect their requirements to be done free by some one else. This is due to pamper by Pharma Companies because they want their trial to be done and they want their product to be marketed. The Pharma Companies are bribing the Investigators. The challenges of Investigator should understand properly about clinical trial and he should conduct the trial according to the compliance of rules and regulations. Untrained people shouldn’t be encouraged. The truth today in India, the common people and media, every body against Clinical Research and more connectivity media has played an unfair role in pointing only the negative aspects rather than positive aspects, making very foolish comments without understanding the issues. As a result, the common man doesn’t have a good opinion on Clinical Research and the Clinical Research Professionals done nothing to correct the opinions. They are discussing among themselves and forgot to interact with public. So, because of that people are looking us suspiciously and no one is interested to take part in Clinical Research industry. Most of the clinicians are not recording the documents properly. So, these are major challenges to Investigator.
Q. The Government is involved in giving approval to a new drug why not the Government involves in bribing Investigator from Pharma Company?
A. Approval of the drug is later issue. Before that the drug is to be experimented. So that the Pharma Companies are pampering the Investigators. Government can’t be expected to do this thing because Government itself can’t do its job properly. How can we expect it to involve…!
Q. If the trial is delegated to Investigator. How many hours is he dedicating to the Clinical Trial?
A. He dedicate hardly TEN minutes. The entire work is done by Clinical Research Coordinator and the doctor is spending minimum of ten minutes. If he is popular investigator, he look after 10 or 15 trials but he is supposed to look for only 5 trials. Here every thing is overlooked and he is not ready to pay anything to Clinical Research Coordinator and he want the work to be done free. Because of this, lot of fraud is take place.
Q. How to increase employment rate in Clinical Research?
A. This is difficult question. We can’t expect increase in employment rate but there can be decrease in outcome of students. There should be smart choice of selecting course and institute. No institute can stop their false claims on their advertisement and no company guarantee’s to hire lot of students from institutes. Honestly, if institutes stop their false claims then nothing can be happened and outcome of students will not be more.
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