Generics approvals questioned
The European Medicines Agency (EMA) is recommending suspending approval of a range of Indian generic medicines after allegations of a flawed testing and approval process.
The medicines gained European Union authorisation largely based on clinical studies conducted at GVK Biosciences in Hyderabad, India.
However an inspection has raised concerns about the GVK process. The EMA Committee for Medicinal Products for Human Use looked at over 1000 pharmaceutical forms and strengths of medicines studied at the GVK site.
“For over 300 of them, sufficient supporting data from other sources were available,” the EMA said in a statement. “These will therefore remain on the market in the EU as EMA is satisfied with the available data”.
“For medicines that lack data from other studies, the CHMP recommended suspension unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs”.
There was no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences, the EMA added.
A TGA spokesperson said they were “considering the implications” of the EMA findings and would take action if required.
Pharmacies to join bowel screen program
Pharmacies around Australia will soon be part of a major new initiative to supply bowel cancer detection kits.
Leading Australian biotechnology company Clinical Genomics is joining forces with Rotary clubs and districts around the nation to support their awareness initiative in May 2015.
The key purpose of the program is bowel cancer awareness and education and to encourage people to do a test.
Kits will be displayed on stalls in pharmacies through May. The total cost of purchasing the kit will go to Rotary to cover cost of program. Rotarians will collect the money from pharmacies at the end of May.
Pharmacies in NSW, QLD and SA will incorporate the Clinical Genomics test into their kits in 2015, with other states to follow in 2016 and beyond.
Pharmacies that would like to get involved can email: Richmond Manyweathers at email@example.com to be connected to their local Rotary group.
TGA warns on a range of products
Customers who have purchased online a number of TGA unapproved products are being advised to take them to pharmacies for safe disposal.
The TGA recently issued safety alerts for the following medications:
Users of each of these products are being advised to “take your remaining tablets to your local pharmacy for safe disposal”.