With the view to ensure patient safety, the drug controller general of India (DCGI) has initiated a surprise inspection drive in the clinical research organisations (CROs) across India for examining various activities undertaken at CROs. Through this initiative, the DCGI plans to gauge on the clinical trial situation in India, to see on whether they are patient centric and conducted as per the rules.
This is the first ever initiative taken by the DCGI's office wherein, he will be personally assisting the officials on random basis to verify CRO's commitment in following the good clinical practices (GCP) and various other regulatory provisions as per Drugs & Cosmetics (D&C) Act and Rules for protecting the rights, safety and well being of the subjects involved in clinical trial.
This is also expected to keep the DCGI personally updated on all the reports of the investigation submitted by the inspectors and other Central Drugs Standard Control Organization (CDSCO) officers about the clinical trial along with verifying information of the investigators, sponsor and CROs about procedures of inspection and follow up of their action.
Dr G N Singh, DCGI who has already inspected couple of CROs in and around Delhi stressed that the centre will henceforth take all the possible measures to ensure and verify the credibility and integrity of clinical trial data generated with in the country. “Our vision is to ensure safety of all our patients and to let them know that we are striving our best towards ensuring their welfare and safety by reaching out to them for that we will be conducting routine surveillance for any specific cause and will make sure that all the laws are properly enforced throughout the country.”
He further added that in the coming years one of the main agenda of the CDSCO will be to ensure effective enforcement of all the relevant rules in the country by frequent monitoring the activities of CROs.
Interestingly, the DCGI along with select officials from the CDSCO has already visited couple of CROs in and around Delhi anonymously to check on compliances and patient conditions. While on the drive, their main focus was to interact with the subjects directly and get information from them on clinical trials. They also investigated on the practices that are followed by the CROs while carrying out clinical trials.