The stringent regulatory environment in the Gulf Co-Operation Council (GCC) region is having a negative affect on Indian pharmaceutical exporters, according to industry sources.
New GCC norms for product registration are similar to US FDA standards, and as a result, many Indian manufacturers, which had been selling pharmaceuticals without extensive regulatory restrictions, are now finding it difficult to get their products registered in the Gulf.
Previously, the majority of GCC nations were semi-regulated, allowing small and medium-sized Indian drug firms to look to the region for exports. However, the new regulations require that imported drugs be manufactured in US FDA-approved plants.
Furthermore, Indian drugmakers wishing to operate in the region are facing strict scrutiny and growing procedural requirements. Many are now opting to form partnerships with local firms, while a number who were planning to set up manufacturing bases in the Middle East are now reconsidering their options. Producers of Indian traditional medicines have been particularly hit and are now unable to export their products to GCC countries.