Vanta Bioscience’s Chennai Preclinical
Research Facility Gets GLP Accreditation
Vanta Bioscience, a US-owned and operated preclinical
Contract Research Organization (CRO), has received Good Laboratory Practice (GLP)
accreditation for its toxicology facility in Chennai from the National GLP
Compliance Monitoring Authority (NGCMA), a branch within the Government of
India, after successfully clearing preliminary and final audits.
NGCMA administers the GLP programme in India as a member
state and participant in the principles of GLP charter of the Organization for
Economic Co-operation and Development (OECD). As a result, data generated at
Vanta Bioscience is now recognized by member countries around the world,
including: Canada, Germany, Japan, and the US. This certification covers the
areas of acute toxicology, genotoxicology, subacute toxicology, subchronic
toxicology, chronic toxicology (carcinogenicity), and reproductive toxicology.
GLP refers to a uniform worldwide quality system of
management controls for research labs to ensure the consistency, reliability,
reproducibility, quality and integrity of the tests performed under the OECD
principles of GLP.
Vanta Bioscience is a full service lifescience R&D
outsourcing company with research laboratories in Chennai, India, and offices in
Brussels, Belgium and West Des Moines, Iowa, US. Complying with OECD GLP, ISO,
AAALAC & US FDA GLP (21 CFR Part 58) guidelines, Vanta Bioscience provides a
broad and integrated portfolio of services covering pharmacology, safety
assessment, chemistry and CMC/clinical consulting and project management.
Pharmexcil Asks Govt To Hike
Reimbursement For Product Registration
Pharmaceutical Export Promotion Council of India (Pharmexcil)
has demanded the union Ministry of Commerce and Industry to increase the
reimbursement fees provided to the Indian companies for product registration in
the US by 50 percent. Through this proposal, the Council aims to safeguard the
interest of the Indian companies against the burden of huge user fee that the
USFDA is planning to levy from all the companies exporting to the US through its
proposed Generic Drug User Fee Act (GDUFA).
Dr. P. V. Appaji, director general (DG), Pharmexcil stressed,
“By increasing reimbursement , we hope to provide some kind of relief to all the
exporters in the backdrop of this proposed Act. We have initiated to take up
this export friendly decision to ensure that no matter what the circumstances
the exports are not affected drastically due to this issue.”
He further informed that Pharmexcil is soon planning to
take-up this issue with the US government as well so that they can urge them to
re-consider their proposal on the fee structure.
( Ref : Chronicle Pharmabiz, July 5, 2012 )