title: Regulatory requirements for clinical trials in India: What academicians need to know.
abstract: The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research. Of these, research, though long and difficult, is extremely fulfilling. Academicians often carry out research that is based on observations in practice or in response to their patient's needs. These are called as "Investigator- initiated studies" and these may not have the funding support of the pharmaceutical industry. Hence, the investigator must make sure that he/she complies with the country's regulatory requirements. In the past decade, several changes have dotted the regulatory landscape in the country and have changed the way in which academic research is carried out. The present article outlines regulatory requirements for academic research giving their historical evolution, the key bodies in India that govern or oversee research, along with "must know" and "good to know" facets for the conduct of clinical research in the country.
authors.affiliation: Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Nithya J
authors.initials: NJ
authors.lastname: Gogtay
authors.affiliation: Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Renju
authors.initials: R
authors.lastname: Ravi
authors.affiliation: Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Urmila M
authors.initials: UM
authors.lastname: Thatte
keywords: Academic research; India; clinical trials; compliance; regulations