title: Regulatory environment for clinical research: Recent past and expected future.
abstract: In the past few years, there have been numerous updates to policy and guidelines governing the conduct of clinical research in India. These measures were taken by regulators considering safety of Indian patients as the topmost priority although the overall regulatory environment became challenging. However, in the recent past, Indian regulations have evolved positively to favorably support clinical research in India while appropriately balancing patient safety as well. These regulatory changes are expected to bring newer innovative medicines to Indian patients at an earliest.
authors.affiliation: Department of Regulatory Affairs, Global Drug Development, Mumbai, Maharashtra, India.
authors.forename: Amita
authors.initials: A
authors.lastname: Bhave
authors.affiliation: Department of Medical, Novartis India Limited, Mumbai, Maharashtra, India.
authors.forename: Suresh
authors.initials: S
authors.lastname: Menon
keywords: Amendment; Central Drugs Standard Control Organization; circular; gazette; guidelines; regulatory environment