Bangalore: Clinical drug trials will continue in hospitals: CM

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  • Bangalore Bio India: Medical Education Minister firm on ban


Bangalore, 05 May 2011: A day after the Medical Education minister announced a ban on clinical drug trials in private and government hospitals in the State, Chief Minister B S Yeddyurappa said on Wednesday that the trials would continue.


“I wish to clarify and set the record straight that no such step will be taken. The Medical Education minister has merely responded to some concerns from certain quarters,” Yeddyurappa said at Bangalore India Bio, billed India’s largest biotech show.


Yeddyurappa said Karanataka is committed to support ethical drug development and the government will ensure that the trials continue without any interruption. However, Ramdas said he was firm on the ban and a two-man committee comprising  medical experts will frame guidelines for all drug trials. He said he will discuss the issue with the Chief Minister on Thursday.


Drug innovation


Reacting to the ban, Biocon Chairman and Managing Director Dr Kiran Mazumdar Shaw said drug trials were being conducted on a strong ethical platform across the country.


“In the internet age, we conform to highest level of transparency and excellence. I hope Karnataka government will ensure that we don’t give up drug trials as they are important in terms of drug innovation,” she said.


Speaking to Deccan Herald, Dr V M Katoch, Secretary, Department of Health Research and Director General, Indian Council of Medical Research (ICMR) said that the ICMR and the Department of Biotechnology have put up the guidelines for clinical research online and it is for the industries to comply with them.


Ethical committee


"People cannot take things for granted. There is no one who can inspect everything as of now. It’s the strength of the ethical committee to check that people follow the guidelines," he said. While the guidelines are recommendatory in nature as of now, the department has plans to make them into a law by the end of the year. 


Dr D C Sundaresh, President, research and laboratory, Ramaiah Institute of Health Sciences termed the ban “really unfair.”  He said medical science cannot advance without clinical researches. “ Our drug trial gets approved by the Drug Control General of India and ethical and scientific committees in the hospital. The patients are made to understand what they will be going through and an ‘informed consent’ is obtained from them. There is no way the patients are treated like guinea pigs,” he said.


Newspaper reports


Dr Sundaresh said the Institute will not ban clinical trials merely on the basis of newspaper reports. The ban will be enforced only if there is a government order, he said. At present, about 12 clinical drug trials are undergoing at the Institute.


However Dr O S Siddappa, Dean and Director of Bangalore Medical College and Research Institute (BMCRI) said that they will discontinue the trials if the government has imposed the ban. 


“Our institute is mainly working on research projects and very few drug trials take place. Government institutes have very stringent procedures unlike the private ones where many pharma companies are entertained,” he added.  At present only two drug trials are going on at the BMCRI.



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Comments on this Article
Dr Pravina Koteshwar, bangalore Thu, May-5-2011, 1:42
Clinical trials shoould not be banned. banning of trials is not teh solution. The approach should be enhancing the quality of study conduct by all stake holders. Physicians partcipating in teh study should ensure teh patient safety. Regulators and ethics committee shouls pay a vital role in ensuring the GCP compliance of the trial to be conducted.
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