Question to the Department of Health and Social Care:

To ask His Majesty's Government what assessment they have made of the quality and safety of (1) imported, and (2) home produced generic drugs; and whether they plan to step up testing following the decision of the US military to introduce a new testing programme.

Before a medicine can be placed onto the market in the United Kingdom, it must first receive approval from the Medicines and Healthcare products Regulatory Agency (MHRA) via the granting of a Marketing Authorisation, commonly known as a product licence. Each medicinal product is assessed for its safety, quality, and efficacy. For a generic medicine, an assessment of whether the medicinal product is equivalent to the proprietary medicine will also be performed.

Manufacturers of all medicines, including generics, are required to perform testing for each batch before it is released to market to ensure that it meets the specifications as set out in the product licence. There are currently no plans to amend these testing processes. If the UK product is manufactured in a third country there is an additional requirement for testing after importation i.e., after shipping, but before release to the market. This extra control measure is not a requirement for supply to the market in the United States of America.

It should be noted that medicines, including generics, must comply with the same Good Manufacturing Standards which are applicable for domestic and third country manufacturers. The MHRA’s medicines inspectorate conduct inspections to ensure that those manufacturing medicines meet these stringent Good Manufacturing Practice standards. These standards are also applicable to the testing facilities, which are also the subject of inspections to ensure the appropriate standards are being met.