Generic drug manufacturers to get new labelling abilities

19th November 2013 - Fine Cut

Producers of generic pharmaceuticals are to be given the power to independently update labelling used on their products when new safety data becomes available without having to rely on other bodies.

The US Food and Drug Administration is planning to implement the change, which would give generic manufacturers the same powers as producers of branded pharmaceuticals.

Firms that manufacture goods for sale in the US are likely to welcome the change, as it will speed up the process of adding new safety advice to labelling. Currently, generic producers have to notify the FDA of the information they want to add or update, and wait for the body - along with the manufacturer of the branded equivalent - to decide on the updates.

According to the Press Trust of India, the FDA is making the move to give generic producers more input and encourage them to "actively participate with the FDA to ensure that product safety information is accurate and up-to-date". According to data from the government body, over 80 per cent of prescriptions in the US are for generic drugs, which have the same medical effects of branded equivalents but are produced and sold, under licence, at a cheaper cost.

Around 40 per cent of all generic and over-the-counter drugs are produced in India, but the move will affect any company that manufacturers generic drugs for the US market - which is estimated to be worth around $300 billion (£186 billion) annually.

While the new process will streamline the changing of pharmaceutical labelling, the generic producer will still have to notify the brand name manufacturer when they intend to make a change to the information contained on the product's packaging.

Keeping safety information up-to-date on pharmaceutical packaging is crucial to ensuring it is not misused by consumers. Producers should also make the information as visible as possible, as according to research by The Co-operative Pharmacy, nearly 50 per cent of UK men do not read the information printed on over-the-counter medicine before consumption.

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