The requirement of local trial for a generic or similar biological (Bio- Similar) in other country like USA for its approval in the country, it has been decided that the drugs considered...

  By Jill Hartzler Warner, J.D.   The U.S. Congress and the Food and Drug Administration have long focused on bringing new therapies to patients with rare diseases, including children. Two years...

It has been decided by the Expert Committee constituted by the Ministry of Health & Family Welfare that waiver of Clinical trial in Indian population for approval of new drugs, which have...

As per the decision taken by the Expert Committee constituted by the Ministry of health & Family Welfare, all the Sponsors/ clinical trial applicants should ensure that the number of clinical trials...

NEW DELHI: Multinational pharmaceutical companies keen to conduct clinical trials for new drugs on Indians would have to ensure an early launch of those therapies in India if the trials result in...

It has been decided by the Expert Committee constituted by the Ministry of Health & family Welfare that all the sponsors/ manufacturers/ clinical trial applicants have to provide compensation to the trial...

THE Union Health Ministry is working on a proposal to provide accreditation to clinical trial centres, investigators and ethics committees — all of which will kept be out of the purview of...

Presently there is no specific provision under Drugs and Cosmetics Rules for payment of compensation in case of clinical trial related injury or death of the subject. However, the Good Clinical Practice...