The NIAID ClinRegs website provides an online database of country-specific clinical research regulatory information designed to enable users to explore regulations within a country and compare requirements across countries. ClinRegs also provides links to official regulations and other key resources related to international clinical research to facilitate independent analysis. Link… Continue reading
Ramesh Shankar | PharmaBiz.com | Mumbai | 10 November 2014 The Union health ministry’s Apex Committee, headed by Union health secretary, has turned down a proposal by the Drugs Controller General of India (DCGI) to dispose of clinical trial proposals of new drugs already approved in other countries, fixed dose… Continue reading
Zachary Brennan | 10 Nov 2014 The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies. Read full article Also refer to:Free Treatment in Private Hospitals: Myth or Reality?Assessment of the Response of Public Hospitals in…Situational Assessment of Public… Continue reading
Access China Management Consulting Ltd | Region China | July 2014 China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth as well as an aging… Continue reading
Joseph Alexander | PharmaBiz.com | New Delhi | 26 May 2014 With a view to further beef up the process of approvals to clinical trials, the health ministry has begun the process of increasing the number of new drug advisory committees (NDACs) from the current 12 to 50. The Central… Continue reading
The Lawyer | 23 April 2014 Read full article Also refer to:The Myth of Regulation: A critique of the 2008 Draft…Participation in MoHFW meeting on Regulation and…Workshop on ‘Ethics and Regulation of Clinical…Workshop on Ethics and Regulation of Clinical Trials…Regulation of Drug Trials: A National ConsultationNational Consultation on Regulation… Continue reading
Joseph Alexander | PharmaBiz.com | New Delhi | 10 April 2014 As part of the efforts to further streamline the clinical trials sector with more transparency and accountability, the functioning of the New Drug Advisory Committees (NDACs) will also be improved to limit the number of cases to be taken… Continue reading
Ashna Ashesh, Zubin Dash | 5 NUJS L. Rev. 379 (2012) Read full article Also refer to:Trials and Travails: Preceptions and experiences of…Study on Perceptions and Experiences of Clinical…Clinical Trial Related Injury: Note on formula to…Study on ‘Compensation for Clinical Trial…National seminar on Access to Medicines and…Exploratory Study on… Continue reading
Third World Network | Third World Resurgence | No. 259, March 2012, pp 15-19 The free trade agreement which India is negotiating with the European Union threatens to jettison some of the health safeguards in India’s patent legislation which make possible the production of cheap generic medicines. Kajal Bhardwaj identifies the… Continue reading
Indian Council of Medical Research, New Delhi | 2006 The release of revised Ethical guidelines for Biomedical Research on Human subjects by the Council in 2000 was followed by a number of developments in science and technology. These have led to further widening of healthcare between the developed and developing countries … Considering the… Continue reading
Ministry of Health and Family Welfare, Government of India | As amended up to 30 June 2005 This volume also includes The Drugs and Cosmetics Rules 1945, as amended up to 30 June 2005. Read full article Also refer to:Comments on the Drugs and Cosmetics (Amendment) Bill, 2015National Consultation… Continue reading
Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, New Delhi | March 2005 Read full article Also refer to:Research Studies on Access to Medicines: Advisory MeetingsGuidelines not enough, enact surrogacy lawsMeeting with Delhi Govt. on implementation of MoHFW…Trials and… Continue reading
