Indian Society for Clinical Research (ISCR) is concerned about stalling of clinical trials which prevents access to novel drugs for juvenile diabetics in the country. On the occasion of both Children’s Day and World Diabetes Day observed annually on November 14, the irony is that there is no permanent cure for juvenile diabetes and at the best, the disease can only be kept under control with drugs.
There have been several global juvenile diabetic trials conducted in India. However for the future these human studies look doubtful going by the current unpredictable regulatory environment in the country which has derailed the clinical research. All efforts to carry out human studies to find safer and better cures for existing diseases including juvenile diabetes are stalled, said Suneela Thatte, president, ISCR told Pharmabiz in a telecon.
Ironically, the International Diabetes Federation evolved this year’s theme for the World Diabetes Day as ‘Protecting our Future’. “India is the diabetes capital of the world and there is a growing incidence of this among children. It is unfortunate that on a day when we celebrate our children day and the future that lies ahead of them, we should also be reminded of so many who suffer from and succumb to a debilitating disorder like diabetes,” she added.
It is estimated that there are over one million children in India who suffer from diabetes, many of whom do not live to see adulthood. Of the 27,000 diabetic children from two to 14 years globally who succumb to the disease annually, 12,000 or 45 per cent die in India alone. There are probably as many who vanish undiagnosed of the disease.
Children have the right to a better and brighter future and we hope that there is a more conducive environment for clinical research in the country so that those suffering from a disease can live in hope of a cure and Children’s Day can be celebrated more meaningfully,” said Thatte.
“We are in a situation in the country where new clinical trials have almost come to a standstill due to regulatory and other external challenges. In this regard the ISCR was distressed on the kind on future or hope of better treatment or cure that could be offered growing diabetic population and when India had already earned the dubious distinction of being termed the 'diabetes capital of the world',” she pointed out.
“The need to develop more effective drugs for diabetes remains an urgent one. It is only through clinical research that we will be able to find cures to our unmet medical needs. Participating in clinical research helps increase our understanding of diabetes and contributes to providing a better quality of life for patients,” pointed out Dr Vyankatesh Shivane, consultant diabetologist and metabolic physician, and joint director Research Health Institute in Diabetes Endocrinology and Metabolism, Mumbai.