New Clinical Research Rules To Speed Up Trials Rate In India - ACRI India

1. New Clinical Research Rules To Speed Up Trials Rate In India With India being the second largest populated country in the world, and the first on the list of countries with disease burden, only 1.2% of clinical trials being held here seems to be a very poor number. But, with the new rules that have been set for clinical trials that are likely to come into effect by March 2019, the scenario is expected to change for the better. It has been revealed that the new rules include a regulation wherein if an Indian company does not hear from the drug regulator on their proposal for clinical trials and research in 30 days, the proposal should be considered as approved. This will clearly speed up the approval process to less than a month, where it earlier took somewhere between 3-6 months! (Note: Where the approval period for Indian companies would be 30 days, the same would be 90 days for a multinational company.) This seems to be a very major decision! India has always been considered as a country that is low on innovation and generics, as compared to other advanced countries. But, this new rule will encourage Indian companies to innovate. The new clinical trial rules are said to come into effect by the coming month, which is expected to bring, if not big, then at least a small rise in the number of clinical trials in India. The tightening of clinical trials rules in the past years had lowered the percentage of clinical trials being held in India, which is all set to change now. India is home to a largely ethical and genetically diverse population, suffering from a variety of ailments. Moreover, it is also home to 6 out of 7 genetic varieties of human races that are largely treatment-naive and are looking for a cure. Thus, we need to encourage research on such patients to ensure that we have drugs

2. that work on our population. Taking the example of the drug that is now the gold standard for treatment in heart failure, but came much later to India because of the time it took to have its trial conducted in India, we can see how our population fails to get the best treatment mainly because of the lack of time management. Thus, with the new rule that allows companies to wait only for a month before taking approval as granted, it seems that the Indian population is now set to receive better treatments to ailments that have not yet received a cure yet. With the Indian clinical research industry now moving towards positivity and success, you can also set up your career in the field to have a bright future with the hope of helping your fellow country mates fight diseases like never before! And, for this, you need to get top clinical research training in Bangalore from a reputed institute like Avigna Clinical Research Institute, where you can learn from experienced professionals and also gain 100% placement and internship assistance guaranteed after completing your course.