Global Pharma Industry Trends: The Challenges of Contract Manufacturing
Global Pharma Industry Trends: Contract Manufacturing Part 2
It is an increasing Pharma Industry trend to move some or all of the manufacturing process overseas, utilising CROs (Contract Research Organisations) to take some of the burden of the high demand for low priced drugs. These moves take advantage of the still emerging pharma market in countries such as Japan and India, keeping costs a great deal lower than could be achieved in the UK.The benefits to the bottom line may be clear, but there are a number of factors to take into consideration when debating taking advantage of developing global markets.
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The most obvious problem with moving production overseas is of course the language barrier. Liaising with non-English speaking companies instantly becomes more complicated, messages often having to be filtered down to a bottleneck of those able to communicate directly with their contracting partner. Problems can also be caused when joining two very different cultures. A practice that may be standard and go without saying on one side might be a completely foreign concept to the other. These issues combined mean that without direct communication and consistent monitoring, intentions can be easily distorted and misunderstandings increasingly likely.
Regulation of drug trials is also a difficulty, there being no regulatory agencies that have the resources or can afford the training to properly monitor overseas practices. The differences in laws between countries mean that extensive research into local allowances would have to be carried out before normal processes could be recreated overseas. Similarly, assurances would have to be made that nothing occurs in the outsourced processes that could jeopardise the legality of the product to be sold in the UK where restrictions may be more stringent.
Due to the lack of full visibility, mistakes and problems become harder to identify, meaning even small issues could develop into something more problematic and possibly costly to rectify. Often the best recourse is to place a company representative within the contracting partner’s organisation to supervise and therefore mitigate the business risks of such an endeavour, but problems continue to occur.
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