Regulatory Changes in India

Bio-IT World reports that in an attempt to broaden examination of the clinical research process within its borders, “India’s drug regulator may consider changing the rules and regulations governing first-in-man studies of molecules discovered in other nations, according to Shirish D. Sherlekar, head of the life science practice at Mumbai-based Tata Consultancy Services (TCS).”

The Indian Council of Medical Research has been regularly working towards establishment of a mandatory clinical trials registry to improve the reliability of data. The growth in clinical research in India continues, and so the importance of clinical monitors and research associates increases. India will have to play close mind to regulations over the next years since CRO growth is expected to increase in rapid numbers.