title: An audit of the approval letters issued by Drugs Controller General of India to Ethics Committees in India.
abstract: OBJECTIVE
  The present study is an audit of the communiqués issued by the Drugs Controller General of India [DCGI] to Ethics Committees [ECs] for content and directives after the mandatory notification of registration of Ethics Committees issued on 8thFebruary 2013.
  
  
  METHODS
  All letters were downloaded from the website of the Central Drugs Standard Control Organization [CDSCO] and evaluated for the date of issue, number of directives, domains covered by the directives [general instructions, administrative requirements and quorum requirements], median time to approval for registration and time elapsed between date of application and issue of the approval letter.
  
  
  RESULTS
  There were a total of 1036 EC letters listed on the website, from which 854 [82.4%] could be downloaded. A working denominator of 841 was arrived at after discarding repeat letters and those that had an incorrect address. The state of Maharashtra had the highest number of ECs registered (209/841, 24.9%) followed by Gujarat [97/841, 11.5%) and Karnataka [96/841, 11.4%]. The number of directives within each letter ranged from 8-22. The overall time to approval was 77.5 [24-919] days and the time to approval between Institutional and Independent Ethics Committees was significantly different.
  
  
  CONCLUSIONS
  The office of the DCGI had a very wide time range for approving registration of Ethics Committees that ranged from less than a month to more than two years. The quality and nature of the directives improved with time. As the country moves towards accreditation, letters issued by the DCGI should have uniformity. The large number of ECs in a single state and lack of even a single one in several others is something that needs to be addressed by policy makers.
authors.affiliation: Department of Pharmacology and Therapeutics, KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Shruti S
authors.initials: SS
authors.lastname: Bhide
authors.affiliation: Institutional Ethics Committee, Mumbai KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Jahnavi V
authors.initials: JV
authors.lastname: Katkar
authors.affiliation: Department of Pharmacology and Therapeutics, KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Mitesh
authors.initials: M
authors.lastname: Maurya
authors.affiliation: Department of Clinical Pharmacology, KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Nithya Jaideep
authors.initials: NJ
authors.lastname: Gogtay
authors.affiliation: Department of Clinical Pharmacology, KEM Hospital, Mumbai, Maharashtra, India.
authors.forename: Urmila M
authors.initials: UM
authors.lastname: Thatte
keywords: Approval; Ethics Committees; audit