Trials and errors

The problem with clinical trials is not weak rules,but the inability to enforce them.

The problem with clinical trials is not weak rules,but the inability to enforce them.

Clinical research in India has been in limbo since January 3,when the Supreme Court held back the Central Drug Standard Control Organisation CDSCO from granting permissions,after irregularities in the process were brought to its notice. While the health ministry had set up a committee to suggest improvements in the process,and the government had established a three-tier system with a new drugs advisory committee,a technical committee and an apex committee,it had also granted approvals to 162 trials in the interim. The Supreme Court,having learnt on Monday that only five of these had been vetted by the health secretary,has demanded that the subjects consent be video-recorded,and that the 157 other trials be re-evaluated by the technical committee and apex committee,which must factor in a risk-benefit analysis,innovation value and the medical need in this context.

Clinical trials are essential for pharmaceutical development and more evolved patient care. After it introduced patent protection laws in 2005,India has been of great interest to drug companies and clinical research organisations because of diverse genetic material,and also because Ramp;D costs can be nearly 60 per cent lower in phase II and III trials,according to CII estimates. The 500 million-and-growing clinical research industry,despite its huge potential and clear utility,has been hampered by regulatory uncertainty. Clinical trials have often been conducted in deceptive,even immoral,ways without informed consent,and with misrepresented data,and the resulting reputational damage has tripped up this entirely necessary business. Now,because of the Supreme Courts intervention,the government has modified Schedule Y of the Drugs and Cosmetics Act,to tighten norms on clinical trials,but the regulatory stress should be on minimising the vulnerability of subjects,not stretching out timelines or making it unnecessarily oppressive for sponsors.

The real issue,though,is not the lack of clear rules as much as the inability to enforce them. A parliamentary standing committee report in May last year harshly exposed the CDSCOs internal workings. Though its workload is growing by 20 per cent every year,it lacks the staff and infrastructure,advisors and independent testing labs to do its job merely nine deputy and assistant drug controllers handle 20,000 applications of various types. State authorities often act on their own,and do not have the technical capacity or manpower to check abuse of research protocols,or collusion between doctors and sponsors. These gaps need urgent attention,if

clinical trials are to be conducted ethically,which would benefit Indian patients as well as advance drug development.