The state branch of the Indian Medical Association, has formed a committee to conduct a comprehensive study on the reports of illegal drug trials being conducted in a few hospitals across the state, IMA Kochi chapter president Dr Abraham Varghese has said.
He was speaking at a press conference at the IMA Hall here on Friday.
The committee will have former IMA state president Dr T N Babu Ravindran as chairman, Dr V Mohanan Nair as convener and Dr K Mohanan and Dr A V Jayakrishnan as members.
The committee will submit the report by September 30, after which action will be taken on the issue.
He said that the illegal practices in drug trials should be booked and the accused, if found guilty will be punished.
But the misconception that all the hospitals and doctors are conducting unethical trials should not be spread, which will create a panic situation.
The IMA provided a platform for the representatives of the hospitals, namely Amrita, Lakeshore, Lourde, Lisie and Health and Research Centre, to explain their stand.
Dr Gangadharan of Lakeshore Hospital said that the guidelines of the Indian Council for Medical Research (ICMR) should be followed. But at the same time, an implementing and monitoring agency is required.
He said that the reports have brought to light the research and drug trials in various institutes and must be thrown open for more debate.The trial parameters should be stringent and the detail consent form should leave no room for ambiguities. Drug trials are done at different institutes across the world.All such studies can be done only with the nod from the ethics committee, comprising members from different walks of life and registered under the Drugs Controller General of India.
The health problem of the patient should be reported to the committee.
The progress of the research should be submitted to the committee and the government and a patient safety must be of top priority.
The investigators’ responsibility is high and the total expenses of the trial will be undertaken by the sponsors. The drug trials must be conducted with painstaking attention to detail and each adverse event has to be documented.
They said that no death was caused due to death trials which are done on critical patients. Training is also given for conducting trials.Moreover, only phase three and phase four trials are done in India. Dr Subramanian Iyer of Amrita Hospital said that trial is being done for lapatinib used for cancer treatment in 21 hospitals across 88 countries. Seven patients died over a period of years.
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