State drug control officials not empowered to monitor clinical trials: Dr Jagashetty
June 12, 2012, 0800 IST – Source : Pharmabiz News
State drugs control departments have no powers to keep tabs on the clinical trials conducted in their states unless they are empowered as per the Drugs & Cosmetics Act & Rules, according to Dr BR Jagashetty, drugs controller, government of Karnataka.
The department’s team of inspectors has no authority to enter the premises of the clinical trial organizations, said Dr Jagashetty following the recent statement by the Drugs Controller General of India (DCGI), Dr G N Singh who said that the state DCs were required to keep a close vigil on the illegal human studies.
Without empowerment under the D&C Act & Rules, there is no question of inspection and even the clinical trial companies will not permit the inspectorate teams to enter the premises for the inspection, he added.
Further state drugs control departments have no information on clinical trial or clinical research organizations. There is also no mention of human studies in the D&C Act. So far no state drugs control departments have been involved in conducting inspections on clinical trial companies.
A key focus of a clinical trial is to assess the safety of the drug and efficacy. There has been several initiatives to look at pharmacovigilance, a adverse drug monitoring activity, from the government side. “There is definitely need for an audit and a dedicated team of inspectors to be in place to carry out the inspections of all clinical trials,” said Karnataka drugs regulator, said Dr Jagashetty.
India has around 40 clinical research organizations (CROs) including domestic and multinational companies. Out of these, there are around 20 leading companies and Karnataka is home to at least 15 of these CROs. The notable names are Ecron Acunova, Clinigene which is part of Biocon Limited, Lotus Labs. Omnicare, Vaatsalya, Treista Life Sciences which is part of Health Care Global Enterprises (HCG), St. John’s Medical College Clinical Trial Centre, Synchron, D2L, SMO India and Infinitus which are the homegrown companies.
In addition the state also has a presence of global majors include Quintiles, PharmaNet, PharmaOlam and ClinTech International to name a few. Besides this, there are corporate and government hospitals engaged in clinical trials. These cover Manipal Hospital, Fortis, Columbia Asia, Ramaiah Memorial Hospital where international pharma majors identify a principal clinical investigator to carry out the human studies.