COMPENSATION FOR CLINICAL TRIAL IN CASE OF INJURY OR DEATH DISCERNED AT A LATER STAGE
Decided by the Expert Committee, all the sponsors/ manufacturers/ clinical trial applicants have to provide compensation to the trial participant/his/her nominee if any drug- related anomaly is discerned and accepted to be drug related injury or death.
Read MoreKeeping You Informed: An Update on FDA’s Judicious Use Strategy for Antimicrobial Drugs in Food-Producing Animals
Today, “antibiotic resistance” is a widely recognized concern. With the rise of bacteria that are resistant to many, and in some cases, all standard treatments, scientists and medical professionals are not alone in focusing on this problem.
Read MoreFDA Refines Its Thinking on Nanotechnology
FDA finalized three guidance documents that address various aspects of the use of nanotechnology in products regulated by the agency
Read MoreNarendra Modi govt plans to clip wings of drug regulator
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 CDSCO
Read MoreGovernment bans sale and manufacture of pain killer Dextropropoxyphene
As per the notification, Government had suspended the manufacture, sale and distribution of Dextropropoxyphene and formulations containing Dextropropoxyphene for human use.
Read MoreNotification for the Submission of Safety and Efficacy of FDC permitted to manufacture but not approved by DCGI
In respect of FDC Falling under definition of “New Drug” licensed by state licensing Authorities before 1.10.12, without the permission of DCG (I), it has been decided that the DCG (I)
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WAIVER OF CLINICAL TRIAL FOR NEW DRUG APPROVAL IN INDIAN PATIENTS
It has been decided by the Expert Committee that waiver of Clinical trial in Indian population for approval of new drugs, which have already been approved outside India
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LIMITING NUMBER OF CLINICAL TRIALS AN INVESTIGATOR CAN UNDERTAKE
As per decision taken by the Expert Committee the investigator of clinical trial should not be involved in conduct of more than three clinical trials at a time.
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Drug Controller General of India to pharma MNCs: Conduct fruitful clinical trials for Indians
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 commercial production, the drug regulator has said.