BRAZIL DELAYS CONTROVERSIAL REPACKAGING REGULATION

A controversial new packaging decree issued by Brazilian regulator Anvisa -- which was due to come into effect in May -- is now likely to be delayed, according to local reports. The measure allows pharmacists to split up and repackage drugs in new packets, according to precise quantities stipulated on prescriptions. The plan's implementation could now be postponed until January 2006.

Industry sources report that most producers have failed to make the necessary costly changes to manufacturing processes in order to comply with the decree. Further, pharmacy groups are still awaiting inspections from regulators. Only two local drugmakers are understood to have applied for re-registration under the regulation.

Meanwhile, Brazilian generics producers' association Pró Genéricos, pharmacy groups and foreign research-based firms have all warned that the measure will encourage copy products. Opponents also claim that there is a lack of suitably trained pharmacists, and that packaging costs to be borne by the manufacturing sector are expected to increase substantially.