GMP picks drug makers out

A number of 18 drug makers out of the total 66 authorised by the Health Ministry will not get GMP certifications and will have to cease operations at the end of 2004, said Daniela Enache, spokesperson for the National Drug Agency. “At present, we have 13 companies that got this certification for all their production flows, two that got certified for certain capacities only and 33 companies that stand all the chances of becoming certified in 2004. Which leaves 18 companies that do not stand a chance and will have to cease operations,” Enache specified. She added the production of the 18 companies to close accounted for some 6% of the Romanian drug market. The Good Manufacturing Practice (GMP) standards became a mandatory requirement as of December 31, 2003, after a series of postponements. The chairman of the Association of Drug Makers in Romania (APMR) Petre Panculescu says the companies that have not received GMP certification yet will no longer be allowed to make drugs, but only sell those in stock for no more than six months. He added none of the companies to cease production was actually that important, except for the vaccine and serum department of the Cantacuzino Institute. ZF