Hi all, Why the compensation part of the trial seems to be given more importance but not the process of approval. Normally phase 3 human trials are not normally NOT conducted in west European and USA. For this they recruit Asians and East Europeans (Erstwhile Soviet union countries) because here the Intelligence of the doctors conducting the trial is oon par with the west a nd also documentation etc while the consent for the trial is easily obtained from Union Health Ministry and also the medical professionals. Normally for this a seminar ia arranged in Europe,Geneva or USA for medical professionals and then trials are conducted as in Indore. "Greatness lies not in never falling but in rising everytime we fall" Captain Johann samuhanand, BANGALORE INDIA 91 80 42023252 www.captainjohann.blogspot.com
>________________________________ > From: Admin - InclusiveIndia.Info <[email protected]> >To: [email protected]; [email protected]; >[email protected]; MHA digest ><[email protected]>; "[email protected]" ><[email protected]>; nami india <[email protected]>; >twitter <[email protected]>; MH Policy Committee Secretariat ><[email protected]> >Sent: Friday, 11 May 2012 10:26 PM >Subject: [MhaReformIndia:611] Strengthening the Regulation and Monitoring of >Clinical Trials : Three Member Committee Constituted to Examine Drug Approval >Procedures > > >11-May, 2012 > > >Ministry of Health and Family Welfare > > > > >In order to strengthen the regulation and monitoring of clinical trials in the >country, the following measures have been taken by the Government: > > >i.Twelve New Drug Advisory Committees (NDACs) and Six Medical Device Advisory >Committees (MDACs) have been constituted to evaluate clinical trials >proposals. These committees consist of leading experts from Central and State >Government medical institutions. > > >ii.A draft notification has been issued for incorporation of a new rule in the >Drugs & Cosmetics Rules, 1945, which provides the following: > > >a.Medical treatment and financial compensation to the trial subjects in case >of trial related injury or death; > > >b.Procedure for payment of financial compensation; > > >c.Enhancement of responsibilities of Ethics Committee (EC), Sponsor & >Investigator to ensure that financial compensation as well as medical care is >provided to the trial subjects who suffer trial related injury or deaths and >such information is provided to DCG(I). > > >d.Amendment of the format for obtaining informed consent of trial subjects to >include the details of address, occupation, annual income of the subject so as >to have information regarding socio-economic status of the trial subjects. > > >iii.All clinical trials, the permission for which have been granted by the >office of DCG(I) on or after 15th June 2009, have to be mandatorily registered >on the clinical trial registry at www.ctri.in of Indian Council of Medical >Research (ICMR). > > >iv.CDSCO has issued guidelines for conducting inspection of clinical trial >sites and Sponsor/Clinical Research Organisations (CROs). > > >This information was laid on the floor of the House in Lok Sabha today by the >Union Minister for Health & Family Welfare Shri Ghulam Nabi Azad in response >to a Starred question. > > >SBS/sk >(Release ID :83597) > > > > >Three Member Committee Constituted to Examine Drug Approval Procedures > > >Taking note of the 59th Report of the Parliamentary Standing Committee on the >functioning of the Central Drugs Standard Control Organization (CDSCO), the >Union Minister of Health and Family Welfare Shri Ghulam Nabi Azad has >constituted a committee of three experts comprising Dr. V M Katoch, Secretary >and DG, ICMR, Dr.P.N Tandon, President, National Brain Research Centre, >Department of Biotechnology, Manesar and Dr S S Aggarwal, former Director, >Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow. > > >The Committee has been asked to: > > >(i)examine the validity of the scientific and statutory basis adopted for >approval of new drugs without clinical trials. > > >(ii)outline appropriate measures to bring about systemic improvements in the >processing and grant of statutory approvals. > > >(iii)suggest steps to institutionalise improvements in other procedural >aspects of functioning of the CDSCO. > > >The Committee has been asked to submit its report within a period of two >months. > > >The Parliamentary Standing Committee Report has, inter alia, made >recommendations and observations on various aspects such as organisational >structure and strength of CDSCO, approval of new drugs, banning of drugs, >approval of fixed dose combinations, pharmacovigilance, spurious / >sub-standard drugs, etc. The Report has also pointed out certain >irregularities particularly in the area of approval of new drugs without >clinical trials. > > >SBS >(Release ID :83596) > > >http://www.pib.nic.in/newsite/erelease.aspx?relid=83675 -- >You received this message because you are subscribed to the Google >Groups "Mental Health Advocacy (Reform) India" group. >To post to this group, send email to [email protected] >To unsubscribe from this group, send email to >[email protected] >For more options, visit this group at >http://groups.google.com/group/MhaReformIndia?hl=en >------------- >Affiliated Groups : MENTAL HEALTH ADVOCACY INDIA >[email protected] >Discussions on mental health law / policy / plan monitoring / human rights etc >[email protected] >India-specific news and views related to mental health >[email protected] >Information and support to carers of people with mental health issues >[email protected] >Mutual support and sharing of experiential knowledge, skills and social >learning amongst peers > > > -- You received this message because you are subscribed to the Google Groups "Mental Health Advocacy (News 'N Views) India" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [email protected] For more options, visit this group at http://groups.google.com/group/MhaNewsViewsIndia?hl=en ------------- Affiliated Groups : MENTAL HEALTH ADVOCACY INDIA [email protected] Discussions on mental health law / policy / plan monitoring / human rights etc [email protected] India-specific news and views related to mental health [email protected] Information and support to carers of people with mental health issues [email protected] Mutual support and sharing of experiential knowledge, skills and social learning amongst peers
