Availability and allocations of Medicines for Wildlife
Dear Wildlife Veterinarian
Following a request from the SAVA, after the recent
conference, I would like to bring everyone up to speed
on the above matter.
Initially WPSA imported all Thianil, (Then called
A 3080) as a final product from the USA under a
Section 21 permit. We then bought the molecule and
commenced to manufacture it in RSA. Initially the API
(Active Pharmaceutical Ingredient) was our problem,
but we appointed full time chemists that resolved this.
First understand that if I ask my chemist to make
thiafentanil, etorphine and diprenorphine today
I will receive the material in 7, 4 and 12 months
respectively. That is how long it takes. To order
Etorphine from outside, it has an 18 month lead time.
The MCC is NOT withholding any permits as
suggested. The next challenge was to bottle it.
Until now, we bottle at a Contract Manufacturer in
Johannesburg.
The challenges at the Contract Manufacturer are real
and will be permanent.
• They can manufacture large batches for other
clients instead of our small batches. (We have to
keep them small as a rejected batch has massive
financial and supply implications) They make
their sums.
• They have to have a medical person present
during this manufacturing.
• The testing of the raw material and final product
is dangerous, hence there is resistance.
• There are serious challenges to keep the Water
for Injection within specified limits, leading to
delays as long as 3 months.
• Our products are highly controlled, Medicines
Control Council and International Narcotics
Control Board, to whom we have to constantly
justify every mg, even if spilled!
The end result is that we are forever sucking the
back teat! Why have all this baggage and they can
only charge us for 500 vials where they could charge
another client for 20 000 in the same time with no
baggage?
2016
MARCH
19