Bangalore: No clinical trials in Karnataka


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DHNS

Bangalore, 04 May 2011: The Department of Medical Education will impose a temporary ban on clinical drug trials and research projects in all government and private medical colleges and hospitals in the State from Wednesday.

 

It is estimated that of the 1,500 clinical research trials being carried out in the State presently, 60 to 70 per cent are conducted in Bangalore alone.

 

Medical Education Minister S A Ramdas told mediapersons here on Tuesday that the trend of treating patients like guinea pigs was increasing alarmingly, especially, due to lack of guidelines to regulate drug trials or researches in the country.

 

The department has decided to set up a two-member expert committee to study and frame guidelines to regulate and re-organise clinical drug trials in all medical colleges and hospitals of the State. The panel is expected to submit its report in three months and the ban will be in effect till the Government takes action as per the report.

 

He said: “Doctors in both private and government hospitals were found irregular as they were being lured into signing confidentiality agreements with multi-national pharma companies for carrying out these trials.”

 

“The companies allure doctors by sponsoring their junkets to foreign countries. In one instance, a doctor was found missing six times over several months, as he was away on different junkets to foreign countries.

 

“Until proper guidelines are framed, all clinical trials will be suspended,” he added. Officials at the Department said the Indian Council of Medical Research had made no comments on the protection of patients or the protection of the Intellectual Property rights. The officials also said there was no transparency in the process.

 

The research companies are using the research data, which is confidential, to trade with the international pharma companies and make money, said an official.

 

The $1.3-trillion global pharma business, which is equivalent to India’s GDP, has been exploiting India’s human resources, the officials added.

 

 

Comments on this Article
Rajneesh Singh, Lucknow Fri, July-22-2011, 3:05

Banning clinical trials is not the solution to the problem and when India is emerging as hub of clinical trial and providing employment to many people of medical and pharmaceutical background. Without clinical trial no drug can be launched in the market as this research is meant for the welfare of the society only as preventing any incident which can create much damage to the people. So this issue should be taken very delicately. Loopholes present in implementing the guidelines should be taken into consideration.clinical research professional should be trained well and they should follow ethics as we are dealing with the life of humans not guinea pig.
Satya, Bangalore Thu, May-5-2011, 6:14
I am not sure if the State s Health Ministry is aware of something called ICH GCP guidelines, which is being followed by the trial sites.....and a regulatory (DCGI) body which oversees the conduct in India.....it doesn t make any sense to create more guidelines.....rather they can work on how to regulate the current standards effectively which is in operation. Before taking any decisions....experts should be consulted and proofs should be available for any....already India is not operating to its limit in the clinical trials....given its patient population.....its not fair on the Governments part to say that the patients are treated as Guinea Pig s.....Even if a patients decision in participating in a trial is influenced by their financial status.....Investigators take much effort to clarify about every aspect of the trial.....
Gayathri, Chennai Wed, May-4-2011, 2:26
DCGI must bring stringent regulations in conducting trails in India. Physicians and the concerned clinics who were not conducting the trails as per the norms must be banned for life time.
Pritam, Ahmedabad Wed, May-4-2011, 11:27
This is not fare to ban immediately.First you should know about ICF procedure and what we r doing in that part.We r in the way to develope the drugs safety for the patients.It is not like Govt medicine and treatment.Please run through good decision.
Abodh Kumar, Bangalore Wed, May-4-2011, 8:50

it should not be ban suddenly because clinical trial is essential for human society to improve the patient outcome and quality of care of patients. I am agree that trial should be conducted according to ICH GCP guidelines and i think trial happen according to guideline but due to certain mediacl colleges and hospitals who dont follow guideline and ready to conduct the trial they should punished by goverment. but what about those hospital, medical colleges and pharma company who are following GCP guidleine. if govement has doubt on trial they should make committee for inspection of the trial. Those person who dont know about trial and took decision to ban on the clinical tria. If any doctors or investigators treat a patient with an aim to develope an intervention for the patient of tomorrow. Trial should not be ban. If govermrnt want trial should be conducted according to guideline they should appoint qualified personnnel to inspect the trial. Ban on trial is unethical Abodh Kumar Clinical Research Associates Bangalore
Alpesh Ramani, Ahmedabad Wed, May-4-2011, 8:20
Before laid down such BAN, the regulatory authority i.e., DCGI sholud be first consult.
Dr Dhananjay Lad, Goa University Campus Wed, May-4-2011, 8:19
This statement is not true that we are not following GCP Guidelines. Even subject participation in clinical trials are voluntary, they may cancel their participation without any prior information to PI . In each trial there is one ethics committee. Government may appoint one local drug inspector as a member of this committee and he must attend all meeting of this committee regarding subjects rights, safety human being Another solution is to audit all trials by DCGI that is your job.no need to ban all trials for such a reason.(doctors of many government hospitals treating their patients like Guinea pigs since last 50 years. poor patients also feared for Governments hospitals treatment.). To ban a clinical Trials is not the solution . make a regulations so strong. Make a compulsion to register SMO, CRO to DCGI.is some solutions and not to Ban. Now India is destination for clinical trial.place it always on top otherwise CHINA is waiting for this apportunity. Take a proper action so that we all build our nation economically strong.
Jayasheel, Bangalore Wed, May-4-2011, 7:53
This is the most irresponsible and illogical statement by any government. Government should try to ensure that the drug research subjects are well informed and appropriately protected of their rights but banning trials is not the solution.
Avinash Kadam, Bangalore Wed, May-4-2011, 6:09
It is absolutely not fair to ban the entire clinical research .It is true that the guidelines are violated many a times as well as there are not strong regulations ,but one should not forget the contribution of such research in development of medical science .Such move will hamper new drug development and this will also have a disastrous effect .Instead steps should be taken to make good regulations ,take measures to properly monitor if such guidelines/regulations are followed and more important efforts should be done to educate patients to properly read and understand the informed consent document before enrolling in clinical research.need to empower DCGI office to regulate the industry rather than to ban trials.this move certainly don t have a favorable benefit risk ratio.It will do more bad than good to medical science and patients.
Satya, Orissa Wed, May-4-2011, 4:42
With out knowing the actual misconduct/fraud/violations, it is not the right to ban the trial in a whole State. If something happened at any particular site, then the action should be specific to that particular one. It might be true that, Indian regulation need some improvement, but it can be done with the old regulations and not like to ban the trials for a particular time period and then to do something. This really affects the growth of India in Pharmabusiness and there is no right of Government to take this type of decisions with out a proper justification.
Bharat, Pune Wed, May-4-2011, 2:39
"Due to lack of guidelines to regulate drug trials or researches in the country". Yes this is true, but simultaneoslly we should think on the govenment machinary which is insufficient to enforce the rules and regulations in clinical trials. Government should a hard step from there end to establish a proper machinery within short time. Only banning trials would not solve the issue, ultimately it will halt the drug development process and which should be considered. The government require the trained and sufficient staff. There should be coordination between government, pharma companies and investigators to execute the clinical trial regulations and develop a new required regulations. All three should take joint responsibility to streamline and regulate the clinical trials in India. Hope every stake holder shall understand there responsibilities for the betterment of mankind.
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