Hooo-Hooo Volume 10, Nr 1 - Page 19

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