India could be a step closer to allowing first-in-man trials on 'foreign' new drugs.
First-in-man trials of 'foreign made' new drugs are not permitted in India and other Phase I studies of drugs developed abroad are only allowed once the drug has completed Phase I and moved to Phase II in other countries.
Drugs Technical Advisory Board (DTAB), India has recommended to the Health Ministry to change the current regulations preventing such studies as India need to participate in the 'global trials' of drugs and drugs discovered in India are safer than those discovered overseas.
The Indian government has not accepted the recommendations. The government has been tightening the regulations of clinical research activities. The Health Ministry has recently proposed a draft bill, under which the Central Drugs Authority (CDA) would have the power to prosecute CROs, investigators and pharma companies who violate rules of clinical trials. India's first official Clinical Trials Registry (CTRI) was launched last month. Any company or CRO conducting a clinical study involving human subjects now has to register the trial before enrolling the first participants.
Source: Drug Researcher.com/01/08/2007 –