- (1.) Order Dated 8-10-2012 (Before R.M Lodha And Anil R. Dave, Jj.) Writ Petition (Civil) No. 33 Of 2012 This Matter Alleges Malpractices In Clinical Trials By Government And Non-Government As Well As By Independent Investigators.
(2.) Having Regard To The Averments Made In The Writ Petition And Interlocutory Application No. 4 Of 2012, We Are Of The View That For Proper Consideration Of The Matter It Shall Be Appropriate If The Secretary, Ministry Of Health And Family Welfare, Government Of India And/Or Central Drugs Standard Control Organisation Through The Director General Of Health Services, Government Of India, Give Information On The Following Points: (I) The Number Of Experimental New Clinical Entities (Nces) Approved For Clinical Trials By The Drug Controller General Of India (Dcgi) From 1-1-2005 To 30-6-2012, (Ii) Whether Deaths Were Suffered By Subjects Of Clinical Trials. If Yes, The Number Of Deaths, (Iii) Whether Serious Side Effects Were Suffered By The Subjects Of Clinical Trials. If Yes, The Number Of Such Subjects And The Nature Of Side Effects, And (Iv) The Details Of Compensation Paid To The Subjects Who Suffered Side Effects Or Paid To The Family Of The Subjects Who Suffered Death.
(3.) The Above Information Shall Be Supplied Within Four Weeks.;