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Rule change provides fresh impetus to clinical study: Experts

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Press Trust of India Mumbai
Last Updated : Jan 11 2016 | 8:49 PM IST
Medical experts today welcomed the recent draft amendments to Drugs and Cosmetic Rules, 1945, saying the move would encourage academic research, as they called for undertaking more clinical study in India.
"Clinical research in India provides better, safer and more accessible treatment for patients. There was unanimous agreement that the changing regulations in 2015 had provided a fresh impetus to doing clinical research in India and we welcome the more recent draft amendments to the Drugs and Cosmetic Rules, 1945 to encourage academic research," they said at the 9th annual conference of the Indian Society for Clinical Research (ISCR) here.
"We have a gazette notification of January 6, 2016, which introduces draft amendments in the Drugs & Cosmetics Rules, 1945, that will definitely go a long way in encouraging investigator-initiated research. This is a welcome move," Tata Memorial Hospital Chief, Thoracic Surgery, Department of Surgical Oncology, C S Pramesh said at the conference.
"We have underestimated and undervalued the impact of investigator-initiated research in India and are nowhere close in recognising its worth. We have had regulatory challenges in the past which have been addressed," he said.
Pramesh pointed out that investigator-initiated research in India led to significant outcomes for patients while addressing specific and real needs - accessibility and affordability - of cancer treatment.
"If we have to tackle India's unmet cancer burden, we need to make clinical research work for our country."

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The conference discussed a slew of topics such as clinical operations quality, investigator-initiated and collaborative research and understanding career opportunities in clinical research for students and young professionals.
What we don't see or realise is that these are spectacular
variety of dog products available that can make people jump. The cost of such offerings are astoundingly up to 30% of the payroll cost and some cases even more. Employees are increasingly seeing these offerings as "given" and "new normal". They expect variety and demand more. However are they truly the real engagement initiatives? The answer is in to see what you are trying to address.
A truly engaged employee won't look at too many extrinsic motivators'. (and many of the biscuits' mentioned above are extrinsic in nature.) They dwell for intrinsic motivations. Organisations should start looking at how to brighten those intrinsic motivators to engage individuals, rather than completely focusing on the external factors. External factors are important, but there is no limit to that.
However when people find that alignment and motivation internally, that's when true engagement happens. That's when we see spark of brilliance and the true north.
Keeping employee morale high Like Steve Jobs once said, "It doesn't make sense to hire smart people and tell them what to do, we hire them so that they can tell us what to do." There are life lessons that one can learn from a football game. Getting the team to see the overall organisational purpose and the individual role in the game is very critical.
Though every leader will have their favourites' and a
"core inner circle", advertising that through the leaders conscious and unconscious behaviour can also be a morale dampener. A leader to be conscious of these softer yet important aspects and removing those before it germinates at every leadership level and coaching other people managers on the same lines can help in keeping the morale of the team high and optimum.
On health and well-being of the employees An estimated 350 million people of all ages suffer from depression. The scary part is that in most cases it is not diagnosed due to several socioeconomic reasons. That's one major area to address when we talk about well-being of the people. Having gone through a professional coaching workshop at CFI (Ganesh Chella's), I recognise the importance and relevance of offering trained help for people (employees, family, society ) who needs help.
Further - a) Removing obstacles and controls, b).
Imagine a case where a sole earning member of a family
gets pink slipped, the employee gets into depression, takes extreme step and eventually the family gets ruined and later on his/her children become anti-social. All these in a timeframe in which you and I are not there to experience/see the cause and effect. Though it may sound "Shangri-La" but if you imagine and keep human wellbeing, and future generations at the heart of all decisions, the effort or the thought is worth the walk in the thorny garden.
Technology - Millennials dilemma There was a time when organisations restricted usage of phone only for professional use while at work. Today such archaic thinking will drive away the most talented. Being connected is the new normal; and that's the reality; and gadgets are mere tools to express themselves faster. Millennials or any other demographic cohort that we may nomenclature, will keep those tools to stay connected, and perhaps won't give more importance to these gadgets than what they deserve.
While we all brim with deliberations on what it may tick them, it will be the simpler approach described earlier that will make them stay, say and serve.
Likewise technology does provide us quicker results but
fails to provide the human touch after all it's a machine, Moreover all these are creation of Individuals. It's the effort of individuals that turn coal into diamonds. Here individual's efforts, mind and creativity is coal and its outcome technology is diamond. As rightly said by Carl Gustav Jung -The creation of something new is not accomplished by the intellect but by the play instinct acting of inner necessity.
The creative mind plays with the object it loves. Hence it is very important to keep employees engaged in different ways rather than making them act like machines.
Traditional practices and wisdom never dies; like the mother of the 3 month old baby mentioned; "modern day diapers are convenient for the parent but the child will have to deal with diaper rashes."
To get in touch with the authors please write to: Mr. Vijayaraghavan Pisharody
Email: vijaya.Raghavan@stempeutics.Com
Linkedin: https://in.Linkedin.Com/in/vijayaraghavan1973 Ms. Smita Ranjan
Email: smita.Ranjan@valuelabs.Com
Linkedin: https://in.Linkedin.Com/in/smita (Reference On managing people - HBR)
About Stempeutics:
Stempeutics a Manipal Education and Medical Group Enterprise, is an advanced clinical stage Biotech Company based out of Bangalore.
Media Contact:
Brinda
Brinda@communicateindia.Com
+91-9820491758
Source: Stempeutics Research Pvt. Ltd.

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First Published: Jan 11 2016 | 8:49 PM IST

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