South African regulator eases API oversight rules in face of shortages

South Africa, facing a growing number of drug shortages, particularly of penicillin, is changing its inspection requirements in a move that will make it easier for drugmakers to switch suppliers of active pharmaceutical ingredients (APIs).

The Medicines Control Council (MCC) of South Africa announced on Wednesday that it will now allow drugmakers to rely on a World Health Organization (WHO) prequalification to shorten the time needed to approve API suppliers, BDLive reports. The move had been urged by the industry, which has been facing delays for government inspections of API makers of up to 15 months, the newspaper said. It comes as the country has shortages of about 70 drugs.

MCC registrar Joey Gouws told the publication that the MCC has been "swamped" by API applications in the past two years and didn't have the manpower to keep up. Previously, the MCC inspected the API manufacturing facility, evaluated the end product and reviewed data on a drug's safety and efficacy supplied by drugmakers. Now, if the API maker is WHO-precertified, it will only review the furnished data from drugmakers.

The move is welcomed by one of South Africa's largest drugmakers, Aspen Pharma. Stavros Nicolaou, Aspen's head of strategic trade, said it "will make an impact, particularly for high-volume products where limited numbers of active pharmaceutical ingredient suppliers have been registered with the MCC."

Drug shortages affect countries worldwide, and regulators often play a part in deepening them as well as dealing with them. Last fall, India experienced shortages of some HIV meds as producers waited for the government to sign contracts for the drug. Then they found themselves having to ramp up production to keep product available. The FDA was accused by Congress several years ago of exacerbating drug shortages in the U.S. when its regulatory steps resulted in plant closings. The agency now tries to find alternate suppliers where regulatory steps indicate a shortage will occur and has even allowed some companies with serious issues to keep producing essential drugs to mitigate shortages.

- read the BDLive story