| Topic : Clinical Trials and Research Process Outsourcing |
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Posted in Community :
Moving up the Biotechnology value chain |
Clinical Research - outsourced |
Indian Business Academy
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last activity : 07 06 2010 20:18:04 +0000
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PUNE: The proposed Central Drug Authority (CDA) bill — that envisages imprisonment of five years and a fine of Rs 20 lakh for those found violating norms of clinical trials — will be tabled during the upcoming monsoon session of the Parliament.
Drugs controller general of India Dr M. Venkateswarulu, who was in the city on Saturday, said the CDA bill has been framed with an aim to check the increasing clinical trials being conducted in the country.
“As of today, there’s no act or law to monitor the clinical research and drug trials in the country,” he said at a panel discussion on ‘Clinical research harmonisation: scope and challenges’. The discussion was held after the launch of Association of Clinical Research Professionals(ACRP) India.
“There cannot be any compromise in clinical research and the trials that are being done in the country,” he said. “There is need for more transparency and knowing about the associated risk factors.”
He further said the draft CDA bill is ready, and the Parliament will take a decision on the final quantum of punishment.
Expressing concern over the growing tendency of pharma industry to outsource work, he said there should be a limit to outsourcing of work. “The people who undergo clinical trials of drugs should not be exploited. They should be well informed about the risks. Their safety should be ensured. There should be proper communication with people while conducting trials.”
Admitting that India had emerged as a favourite destination for conducting clinical trials, he said, “Our top priority is to ensure safety. There is a need to enhance capacity building to handle trials in a more scientific and rational way.”
Earlier, president and chief executive officer of ACRP, Thomas Adam, said clinical trials will begin to ‘migrate’ to India in large numbers.
“Young talent will be the driving force in attracting this to India,” he said, adding that the first phase of the ACRP-Bilcare partnership will focus on programmes in India and Singapore, followed by Thailand, Korea, Malaysia, Bangladesh and Sri Lanka.
Drugs controller general of India Dr M. Venkateswarulu, who was in the city on Saturday, said the CDA bill has been framed with an aim to check the increasing clinical trials being conducted in the country.
“As of today, there’s no act or law to monitor the clinical research and drug trials in the country,” he said at a panel discussion on ‘Clinical research harmonisation: scope and challenges’. The discussion was held after the launch of Association of Clinical Research Professionals(ACRP) India.
“There cannot be any compromise in clinical research and the trials that are being done in the country,” he said. “There is need for more transparency and knowing about the associated risk factors.”
He further said the draft CDA bill is ready, and the Parliament will take a decision on the final quantum of punishment.
Expressing concern over the growing tendency of pharma industry to outsource work, he said there should be a limit to outsourcing of work. “The people who undergo clinical trials of drugs should not be exploited. They should be well informed about the risks. Their safety should be ensured. There should be proper communication with people while conducting trials.”
Admitting that India had emerged as a favourite destination for conducting clinical trials, he said, “Our top priority is to ensure safety. There is a need to enhance capacity building to handle trials in a more scientific and rational way.”
Earlier, president and chief executive officer of ACRP, Thomas Adam, said clinical trials will begin to ‘migrate’ to India in large numbers.
“Young talent will be the driving force in attracting this to India,” he said, adding that the first phase of the ACRP-Bilcare partnership will focus on programmes in India and Singapore, followed by Thailand, Korea, Malaysia, Bangladesh and Sri Lanka.
So after all this is a good initiative in this regard and helping in every manner.
2 comments on "Clinical trial bill to be labeled"
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varsha mishra, technical Manager(QMS), rfrac
| 10 08 2008 19:37:16 +0000
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Hardik Patel, Team Lead (Staffing and Recruitment), Rishabh Softwares Pvt. Ltd. / Rishi Infotech Pvt. Ltd
| 07 24 2008 14:12:29 +0000
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PUNE: The proposed Central Drug Authority (CDA) bill — that envisages imprisonment of five years and a fine of Rs 20 lakh for those found violating norms of clinical trials — will be tabled during the upcoming monsoon session of the Parliament.... |