- National Institutes of Health -- India
Link Citation
http://clinregs.niaid.nih.gov/single_country.php?c_id=100
- Ethical guidelines for biomedical research on human subjects
Author
Indian Council for Medical Research
Link Citation
http://icmr.nic.in/ethical_guidelines.pdf
- Drug and Cosmetic Act (1940)
Author
Ministry of Health and Family Welfare
Link Citation
http://www.indianmedicine.nic.in/writereaddata/mainlinkFile/File222.pdf
- Drugs and Cosmetic Rules 1988 (Eight Amendment)
Author
Ministry of Health and Family Welfare
Link Citation
http://dbtbiosafety.nic.in/Files/CD_IBSC/Files/Cosmetic.PDF
- Drugs and Cosmetics (IIND Amendment) Rules, 2005
Author
Ministry of Health and Family Welfare
Link Citation
http://dbtbiosafety.nic.in/act/schedule_y.pdf
- WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
Author
The World Medical Association (WMA)
Link Citation
http://www.wma.net/en/30publications/10policies/b3/index.html.pdf?print-...
- Indian Contract Act (1872). Section 13
Link Citation
http://indiankanoon.org/doc/1463968/
- Regulatory Guidance for Conducting Clinical Trials in India
Author
Clinigene
Link Citation
http://www.clinigeneintl.com/Media/Default/Downloads/Regulations_for_con...
- Apex committee on clinical trials gives approval to 33 proposals of clinical trials
Author
Ramesh Shankar,
Link Citation
http://www.pharmabiz.com/PrintArticle.aspx?aid=85059&sid=1
- Apex Committee turns down DCGI's proposal on trial approval for FDCs, Subsequent new drugs, vaccines
Author
Ramesh Shankar
Link Citation
http://www.pharmabiz.com/NewsDetails.aspx?aid=85021&sid=1
- Guidelines for bioavailability and bioequivalence studies
Link Citation
http://cdsco.nic.in/html/be%20guidelines%20draft%20ver10%20march%2016,%2...
- CDSCO in the process of constituting 38 more new drug advisory committees
Author
Joseph Alexander
Link Citation
http://www.pharmabiz.com/NewsDetails.aspx?aid=82049&sid=1
- CDSCO plans more steps to further streamline clinical trial sector
Author
Joseph Alexander
Link Citation
http://www.pharmabiz.com/NewsDetails.aspx?aid=81342&sid=1
- Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition)
Link Citation
http://www.researchandmarkets.com/reports/2888830/latest-guidebook-for-c...
- China sets new requirements for hospitals running clinical trials
Author
Zachary Brennan
Link Citation
http://www.outsourcing-pharma.com/Clinical-Development/China-sets-new-re...
- International Ethical Guidelines for Biomedical Research Involving Human Subjects
Link Citation
http://www.cioms.ch/publications/layout_guide2002.pdf
- Clinical Trials Regulation: a step in the right direction?
Author
Thomas Hendicott
Link Citation
http://www.thelawyer.com/briefings/clinical-trials-regulation-a-step-in-...
- The EU-India free trade agreement and access to medicines
Author
Kajal Bhardwaj
Link Citation
http://www.twn.my/title2/resurgence/2012/259/cover04.htm
- Inadequacies of clinical trial regulation in India
Author
Ashna Ashesh and Zubin Dash
Link Citation
http://heinonline.org/HOL/LandingPage?handle=hein.journals/nujslr5&div=2...
- Regulatory Guidance For Conducting Clinical Trials In India
Author
Clinigene
Link Citation
http://www.clinigeneintl.com/Media/Default/Downloads/Regulations_for_con...