The US Food and Drug Administration (US FDA) is planning to set up a "rapid process" for reviewing fixed dose combinations (FDCs), co-packaged products, and single ingredient antiretrovirals (ARVs) for the treatment of HIV/AIDS, particularly for use in programmes financed by the US President's Emergency Plan for AIDS Relief (PEPFAR).

The US government's move is to make it mandatory for generic companies to get their products cleared by US FDA if they are to be eligible for supply of drugs to anti-AIDS programmes funded by the US. With several of the major anti-AIDS initiatives having the US as a source of funds, the move is expected to create an additional regulatory hurdle before the generic drug makers.

The US move turns more serious in the wake its attempts to undermine the importance and centrality of the pre-qualification system of the World Health Organisation.

The WHO pre-qualification process is based on international standards, guidelines and norms that allow quality and safety assessment of medicines. These standards have been developed and approved by the WHO Expert Committee system involving all WHO member states and WHO governing bodies, and the pre-qualification project has ongoing technical input from regulatory authorities in both developed and developing countries.

Reacting to the US announcement, Medicines Sans Frontiers (MSF) has said that it is the WHO, and not the USFDA, which has the mandate to set international standards for quality, safety, and efficacy. "There is no justification for further delaying the availability of medicines that are already saving lives and that are already certified by the WHO as meeting stringent international standards for quality, safety, and efficacy," it has noted.

According to DG Shah, secretary general Indian Pharmaceutical Alliance, the move is a ploy to discredit the WHO and delay use of generics by funding agencies. "Once the generic companies put in their applications for approval by the US FDA, they would be at their mercy," he said.

"The importing country regulatory agencies in Africa never recognised US FDA approval to import from Indian companies and always insisted on approval by them. Why should now they ask for certification by the US FDA? They will not," he pointed out.

"The WHO, the African countries, the NGOs and the Indian companies should ignore the US move and continue with their good work. We don't need the US FDA certification for safety and efficacy of FDCs that are in use for the last few years and used by more than 11,000 patients!" he said.