17 September 2014 | News | By BioSpectrum Bureau
CDSCO hands new commandments for pharma cos and CROs
According to a new order issued by the Central Drugs Standard Control Organization, pharma companies and clinical research organizations (CROs) now need to explain and justify their research while conducting clinical trials in India.
Companies now are mandatorily expected to lay out all the parameters during the application filing process.
The parameters include assessment of risks versus benefits to patients, innovation details and existing therapeutic treatments, and information on unmet medical needs.