New Clinical Trials Rules In India – A Relief For Patients - ACRI India

1. New Clinical Trials Rules In India – A Relief For Patients India has come up with a new set of clinical trials rules for the year 2019 ,which covers lots of aspects about approvals, drugs import systems, orphan drugs, and compensation and monitoring. All these changes have been made only for the betterment of India’s healthcare systems and population health. Thus, these new clinical trials rules are definitely going to help patients too. Here’s how. No compulsory clinical trials for approved drugs As per the new rules, it isn't necessary to conduct clinical trials for drugs that have been approved and marketed already in countries of US, UK, EU, Australia, Canada, and Japan. This will result in the drugs reaching patients faster than ever! Firms introducing a drug in India that is approved in any of the above countries will only have to carry out the Phase-IV trail, which involves the study of long-term effects of the drug. In this way, the newest and most advanced drugs will be available in the Indian market at the earliest. No Phase-III and IV trials for orphan drugs Orphan drugs can be exempted too from the Phase-III and Phase-IV trials. Thus, patients who are suffering from rare conditions that affect less than 5 lakh Indians will also have quick access to the required treatments and medications. However, it is made sure that the rights and safety of patients is ensured. This is possible because it will be taken care that the ethics committees

2. reviewing clinical trials at universities must be registered with the Department of Health Research. Reduced approval time for drugs The new rules also have reduced the time for the Drugs Controller General of India to decide on the clinical trial application to 90 days for drugs developed outside India, and to 30 days for those discovered, researched, and manufactured in India. This number was earlier 180! Also, if the DCGI fails to communicate its decision for drugs approval within the given time period, the permission will be deemed to have been granted. This means that the process for the DCGI to approve a trial will speed up, thus resulting in faster discoveries and faster approvals, thus boosting the image of the Indian healthcare industry, which further will benefit patients. With all of the above mentioned points, it can be clearly seen how the new clinical trials act has proven to be a boon for both the Indian healthcare industries as well as the patients. These new rules will boost the image of the Indian healthcare industry, while also relieving patients of their pain and suffering at the earliest. And, with such benefits, you can benefit too. You can build up a career in the clinical research industry by enrolling yourself with a reputed institute like Avigna Clinical Research Institute, where you can undergo professional training for clinical research diploma courses in Bangalore, and have a bright future ahead. After the required training, you will be trained for your internships, while also attaining 100% guaranteed placement in top CROs, Bio-techs, and pharmaceutical companies.