Tag: DCGI
DCGI tells unapproved FDC manufacturers to submit phase IV trial protocols
The Drugs Controller General of India (DCGI) has asked the pharmaceutical companies which are manufacturing the Fixed Dose Combinations (FDCs) without its approval to submit phase IV trial protocols with main focus on safety of drugs............
Exclusive: Apex committee on clinical trials takes steps to streamline regulations
The issues related to streamlining of approvals to clinical trials were discussed and appropriate modifications were given green signal by the top health regulatory officials at their 34th apex committee meeting held recently at Delhi.........
“Time ripe for Indian stem cells industry to regenerate its strength”
Mr B N Manohar, Chief Executive Officer, Stempeutics dismisses the claims that Indian stem cells industry hasn’t achieved much and is at the verge of fading out. Read his detailed interview with the Biovoice News.
In a first, ICMR permits Bengaluru’s Milann to perform uterus transplant
The hospital becomes first in India to be given permission by the top regulator, the Indian Council for Medical Research to carry out two transplant surgeries under a study.......Click to read this imp story here.
Bharat Biotech to commence Phase I clinical trial of Zika vaccine...
Bharat Biotech International has announced that the company will initiate the Phase I clinical trial of its Zika virus vaccine..........
Putting spotlight on problems plaguing hemophilia care in India
The conclave held at Delhi highlighted the plights of Hemophilia patients, who lead a painful life with various joint disabilities and the scenario is so worst that most of the patients die due to lack of medicines, or treatments.........
BioVoice eMag April 2017 Issue-11 Volume-1
BioVoice eMag April 2017 Issue-11 Volume-1:
The ‘April 2017’ issue of BioVoice eMagazine includes the COVER STORY on Biorevolution 2.0: India’s quest to become a biotech...
DCGI simplifies regulatory processes for vaccine & r-DNA products
While streamlining the issuance of Form 29 licenses, the Drug Controller General of India has also removed the need for joint inspections of vaccines and r-DNA products....
Govt to reconsider its earlier ban on e-pharmacies?
The health ministry might soon reconsider its earlier decision to temporarily ban the online sale of medicine in India....
Bharat Biotech’s Zikavac to enter phase-I clinical trials
The company's Zika vaccine has completed pre-clinical studies and is now awaiting the regulator's approval to begin phase-1 trials.....