BRAZIL REGULATOR SUSPENDS DRUGMAKER ON QUALITY FEARS

Brazilian drug regulator Anvisa has indefinitely suspended production at Sao Paulo-based producer Clímax SA, due to the company's alleged failure to meet manufacturing quality requirements. The local drugmaker allegedly infringed basic hygiene regulations. Meanwhile, the agency has also ordered the withdrawal of batches of antibiotic preparation Claritromicina, produced by leading local drugmaker EMS.

The moves follow a series of withdrawal orders issued by the agency in mid-December, which were applied to a number of so-called "similares," or pharmaceutical products with the same active ingredient as branded drugs, albeit in different shapes and dosages. The agency claims that such drugs currently comprise some 70% of the local market, and has pledged to carry out full bioequivalence tests on all copy products by 2009. Nevertheless, the government's efforts to monitor the quality of copy products are unlikely to satisfy the multinational sector's demands for a comprehensive patent and regulatory framework for the sector, where revenue is expected to reach US$8bn by 2007.