Govt allays fears over clinical trials
Mechanism put in place to check violations by institutes
Hyderabad: In the wake of a fresh row over clinical trials in Telangana, the State Health department has given directions to all the Institutional Ethics Committees to check documents of all trials permitted by them within a week and if any trial was found to be in violation of the rules it should be stopped as per the ICMR (Indian Council for Medical Research) rules.
Also, a decision has been taken to instruct all the Ethics Committees to monitor the trials on a regular basis besides setting up of data and safety monitoring boards in each institute.
Director of Medical Education (DME) Dr K Ramesh Reddy in a press note had warned of disciplinary action against the doctors who try to defame the institutes for their personal egos and cause disrepute to the institutes.
He said that in case of any grievance the individual doctor needs to approach the institution head or director as per the specified rules.
This statement comes in the wake of criticism that the Niloufer Hospital's name was dragged unnecessarily into the row involving two doctors working in the same hospital and all the focus was now shifted to allegations on clinical trials being conducted against rules.
Touching upon this, the DME explained that the clinical trials permitted in the Niloufer Hospital by the Institutional Ethics Committee of Osmania Medical College have all the necessary permissions.
The three-member committee, appointed to conduct an inquiry, will check all the documents and consent forms, etc to ascertain whether all safety measures are followed, he stressed.
Further, he said that whenever any complaint comes to the notice of the authorities it is mandatory to conduct enquiry and the same is being done in Niloufer Hospital.
This is a preventive step for the safety of volunteers. Volunteers are enrolled only on basis of coming voluntarily to take part in the clinical trials, the Director said, adding that only healthy individuals who come forward voluntarily are included after taking all precautions and consent.
In an effort to allay fears among the people with question marks raised over clinical trials, the DME said the general public need not panic as none of these drugs is used in OP or IP treatments on regular patients.
Only standard drugs procured after following all safety measures are supplied, he said.