The Indian drug exporters have sought the intervention of Union Commerce Ministry to put an end to the entry barrier created by US authorities to disqualify them from participating in government tenders in the US.

The drug exporters want the Central Government to convince their US counterpart of the need for including India among the list of countries approved by the US for import of drugs for its government supplies.

The domestic industry points out that the current federal regulations of the US do not permit Indian companies to bid for drug supply contracts to government establishments like the US military, veterans administration and federal supplies. The companies have raised concern about the lack of uniform regulatory requirements in the various US states which is causing them to prepare separate dossiers for each state of the US.

According to the drug exporters, every US state has its own documentation requirements, registration, fee structure and approval procedures. Terming this as a discriminatory measure, the Indian companies feel that the different norms are posing troubles for them even when they have their manufacturing facilities and products approved by the United States Food and Drug Administration (US FDA).

The exporters are also unhappy with the time taken by the US customs authorities to clear Indian medicine consignments. They say that all goods that originate from countries like India are getting customs clearance after much delay. The exporters wanted Indian government to take up the case with US authorities and make sure that the quality products from India are readily accepted in the US.

The industry alleged that several products, including Ibuprofen are attracting counter veiling duty in the US. They wanted this to be considered as a non-tariff-barrier created by the US.

The comments came after the Union Commerce Ministry called for industry comments before a video conference with their US counterpart to highlight the specific problems faced by pharmaceutical manufacturers who are exporting their drugs to the US. It is known that the Pharmaceutical Export Promotion Council (Pharmexcil) that is actively taking up the cause of Indian drug exporters for a possible solution.

Speaking to Pharmabiz, Dr P V Appaji, executive director, Pharmexcil informed that the Indian exports to US are on the wane due to multiple factors.

"There is severe competition in the US market for generic drugs. This has led to a fall in generic drug prices in that country. While Indian companies are continuing to export their drugs in the same pace, the realisation from such exports has declined," he explained.