The Central Drugs Standard Control Organisation (CDSCO) is likely to begin auditing of ongoing clinical trial programmes being undertaken in the country within six months from now. The central agency's attempt would be to ensure strict compliance of the Schedule Y norms by all clinical research organisations operating in the country.
The expert inspection team is getting ready to undertake the exercise, Ashwini Kumar, Drugs Controller General of India (DCGI) informed. The auditing of clinical trials would mark the beginning of regulatory intervention in the global and local clinical trial programmes that are going on in the country. The inspections are meant to help boost the confidence of global pharmaceutical companies in the authenticity of the clinical data provided by Indian CROs. It is also aimed at eliminating the apprehensions among the Indian public when it comes to clinical trials on human subjects.
The Schedule Y prescribes world-class norms for conducting clinical trials. All safeguards are inbuilt in the law to ensure conduct of clinical trials in the most scientific and ethical manner. As next step, India will go for regulatory audit of all clinical trial programmes, DCGI said. According to him, the inspections should begin in another six months.
The central authority has already initiated a programme to outsource experts to be part of the inspection team. "The inspection team would consist of medical experts from academia. Their job would be inspection of clinical trial sites and provide us with necessary feedback on Schedule Y compliance. Once we have the report, we can intervene, if necessary, in ongoing clinical trials," DCGI said. "Once we have our own inspection team, we will be able to provide lot of confidence to our policy makers on matters related with clinical trials," he added.
It should be noted that the report of the Mashelkar Committee on Drug Regulatory Issues had recommended that the regulatory agency should develop adequate capacity to undertake routine inspections of the clinical trial sites. It had suggested outsourcing of external expertise for the purpose. It had noted that many stakeholders – sponsors and investigators alike are not fully aware of Good Clinical Practices fundamentals, ethics, written SOPs, documentation, ADR management, internal audits as well as regulatory inspections. The committee had also said that the regulatory officials should be kept up-to-date on the latest global trends in clinical trial data evaluation. The CDSCO attempt is in tune with these recommendations.