Indian Journal of Anaesthesia

SPECIAL ARTICLE
Year
: 2017  |  Volume : 61  |  Issue : 3  |  Page : 192--199

Regulatory requirements for clinical trials in India: What academicians need to know


Nithya J Gogtay, Renju Ravi, Urmila M Thatte 
 Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India

Correspondence Address:
Nithya J Gogtay
Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai - 400 012, Maharashtra
India

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.


How to cite this article:
Gogtay NJ, Ravi R, Thatte UM. Regulatory requirements for clinical trials in India: What academicians need to know.Indian J Anaesth 2017;61:192-199


How to cite this URL:
Gogtay NJ, Ravi R, Thatte UM. Regulatory requirements for clinical trials in India: What academicians need to know. Indian J Anaesth [serial online] 2017 [cited 2017 Apr 29 ];61:192-199
Available from: http://www.ijaweb.org/article.asp?issn=0019-5049;year=2017;volume=61;issue=3;spage=192;epage=199;aulast=Gogtay;type=0