Indian Clinical Trial Reforms Take Shape as Report Condemns HPV Vaccine Trials | Healthcare in India | Scoop.it

As questions continue to be raised over the policies governing clinical trials in India, new regulations and amendments to the country's pharmaceutical laws are now coming to light.


Specifically, India’s CDSCO (Central Drugs Standards Control Organization) is looking to crack down on unauthorized trials and is now calling for sponsors to reveal payments made to CROs and trial investigators.


A recent announcement by CDSCO says that information in respect of the payments made by the sponsor to the investigator for the conduct [of the] clinical trial should be made available


Formal and legal agreements between sponsors, CROs (contract research organizations) and investigators should be decided prior to the start of the trial and define the relationship in terms of financial support, honorariums, fees and other payments, the order says.


Source and Further reading: http://www.outsourcing-pharma.com/Clinical-Development/Indian-Clinical-Trial-Reforms-Take-Shape-as-Report-Condemns-HPV-Vaccine-Trials