European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) are planning to begin an initiative to share work on inspections of manufacturing sites in each other's territories from January 2012.
India, a major hub for drug manufacturing, can take a cue from the two global regulators to initiate similar exercise at least with neighbouring countries of Asia and Africa, stated Kaushik Desai, chairman, Industrial Pharmacy Division of IPA.
The EMA and US FDA efforts will enable the two authorities to rely on each other's inspection outcomes rather than carrying out separate inspections in duplicate. The move is expected to enable better use of the two authorities' inspection resources. It will reduce the burden of inspections for medicines manufacturers and shift the authorities' inspection capacity to other regions, according to the two global regulators.
The initiative came about after a pilot plant was constructed and necessary combined inspections were carried out. The outcome of the inspections were positive, said Desai.
While pharma industry heads contented that the Schedule M is way behind US FDA and EMA regulations. At least with the global regulators of the developing world, we could share site inspections.
Both US FDA and EMA took a decision to apply for inspections of manufacturing sites of human or veterinary medicines in the European Economic Area or United States of America. It will focus on sites that are already known to the two authorities and have a history of compliance with good manufacturing practice (GMP) following previous inspections. The move is also the latest step in increased collaboration between European authorities and the FDA. In August this year, the authorities announced the successful completion of two pilot projects involving the sharing of information on inspections. The outcomes of the initiative will be reviewed after three years.
The key reason for this to come through is the fact that both EMA and US FDA have similar stringent regulations and in an era of cost cuts, it would make more sense to combine and share the sites, said Desai.
India accounts for the highest number of US FDA certified plants estimated at 161 and a number of EMA audited centres. While Indian GMP needs to be revised to include global standards to be cleared during international audits stands. To begin with, it must at least commence the initiative with the regulators in the emerging market representing countries of Africa like Nigeria, Uganda, Tanzania and Ethiopia and Asian countries like Malaysia and Singapore. Later it could discuss with the US FDA and EMA and recommend review of plants based on past records as it would improve efficiency and economies- of-scale Desai stated.