Navigation Links
BMJ editorial: India's research participant protection policy

In an editorial published online today in BMJ, Johns Hopkins bioethicist Jeremy Sugarman and other experts warn that action is urgently needed to deal with possible unintended consequences of India's new policy protecting research participants.

Passed earlier this year, the Drugs and Cosmetics Act (First Amendment) Rules, was meant to mitigate ethical concerns with potential serious consequences for public health, as well as India's viability as a continued global leader in clinical research. However, Sugarman and his co-authors highlight specific concerns that could lead to the policy having the opposite effect, including a table of the policy's "Conditions attributable to clinical trial injury or death." One of these is "use of placebo in a placebo controlled trial," to which the authors respond that "placebos are not necessarily harmful. Indeed the use of a placebo is often the only way of truly assessing whether the agent under study is associated with undue risk or significant benefit."

Among the authors other concerns is the policy's call to compensate research participants for injury for "failure of investigational product to provide intended therapeutic benefit," arguing that the purpose of the trial is to determine just that.

The authors give short and anticipated long-term ramifications of the policy, noting that at least 35 collaborative research projects funded by the US National Institutes of Health have been suspended since March 2013, most investigating large scale public health problems. They also note that India is the main supplier of antiretrovirals to donor supported HIV treatment programs in developing countries, and the dramatic fall in clinical trial applications that is already taking place could have a ripple effect on the availability of registered drugs.

"It is essential that the unintended consequences of the new policy are dealt with effectively but rapidly," the authors write. "The relevance, impact, and quality of global health research have been greatly strengthened by engagement of Indian scientists and participation of Indian research volunteers. Advances in health research need India's leadership and participation."


Contact: Leah Ramsay
Johns Hopkins Medicine

Related medicine news :

1. Eighth Annual Bladder Cancer Think Tank Set to Move Research Forward to Improve Treatment Landscape
2. Survey by Dissertation-Texas Reveals Exceptional Rise in Research Projects
3. U.S. Label Market Worth $19 Billion in 2017 Research Reports Now Available at
4. Nanobiotechnology Market - New Industry Research Report is Now Available for Pre-Order at Transparency Market Research
5. New grant empowers young researchers to find a cure for pancreatic cancer
6. HealthCarePoint and ViS Research Streamline Sharing of Qualifications by Medical Researchers
7. Global Markets for Rapid Medical Diagnostic Kits (Mdks) to Surpass $24.2 Billion by 2017: BCC Research
8. Poland Health Insurance Market Analysis and 2015 Forecasts in New Research Report at
9. China Poultry Vaccine Industry Analysis in New Market Research Report at
10. Beaumont Health System Launches Research Trial of Bioresorbable Heart Scaffold
11. Parents dont fully understand biobank research, study finds
Post Your Comments:
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a ... and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is ... to some of the world’s leading providers of cereal and other breakfast foods. Its ...
(Date:6/26/2016)... ... June 26, 2016 , ... ... have been diagnosed with endometriosis. These women need a treatment plan to not ... comprehensive approach that can help for preservation of fertility and ultimately achieving a ...
(Date:6/25/2016)... ... ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize each ... Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into hand ... select a ProHand generator and drag it above media or text in the Final ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary ... Work award to iHire in recognition of their exemplary accomplishments in worksite health promotion. ... Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World Sickle Cell ... pain and the benefits of holistic treatments, Serenity Recovery Center of Marne, ... Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the red blood ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it ... (procalcitonin) assay as a dedicated testing solution for people ... Roche is the first IVD company in the U.S ... assessment and management. PCT is a sepsis-specific ... blood can aid clinicians in assessing the risk of ...
(Date:6/23/2016)... , , , WHEN: ... , , , , LOCATION: , , , Online, with ... , EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice ... Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... industry is witnessing an exceptional era. Several new demand spaces, such ...
(Date:6/23/2016)... 2016 The vast majority of dialysis patients ... Treatments are usually 3 times a week, with treatment ... travel time, equipment preparation and wait time.  This regimen ... for patients who are elderly and frail.  Many elderly ... rehabilitation centers for some duration of time. ...
Breaking Medicine Technology: