India Fast-Tracks Clinical Trials

In India, 90% of clinical trials over the past few years have ended abruptly primarily due to contract research organizations (CROs) and drug companies using Indian patients as “guinea pigs”. Despite this dramatic slowdown in clinical trials, the Indian government is taking multiple steps to fast-track the clinical trial approval process while also ensuring that CROs comply with quality standards. Compared to other countries, India has a time consuming multi-tiered review process. One step the government has already taken is reducing processing and approval time for clinical trials. So far, the process has already been halved, which sometimes took up to a year and a half several years ago. Now the process takes 6-8 months, and officials are hoping that taking additional steps will shorten the timeline to 4-6 months. Additionally, CROs must comply with Good Clinical Practice standards and the Indian Council of Medical Research guidelines. Another step the Indian government has taken is waiving phase III trial requirements for drugs already approved in the US, Europe, Australia, Canada, or Japan. Together, these steps ensure timely and safe conducting of clinical trials in India.