HC Deb 22 June 1994 vol 245 c206W
Mr. Gareth Wardell

To ask the Secretary of State for Health if she will list the generic drugs prescribed by general medical practitioners which have been tested and found to be qualitatively inferior to the branded products.

Mr. Sackville

Responsibility for this matter has been delegated to the Medicines Control Agency under its chief executive, Dr. K. H. Jones. I have asked him to arrange for a reply to be given.

Letter from Dr. K. Jones to Mr. Gareth Wardell, dated 22 June 1994: The Secretary of State has asked me to reply to your question concerning generic drugs prescribed by general medical practitioners which have been tested and found to be of inferior quality when compared to branded products from innovator companies. The Medicines Control Agency is an Executive Agency of the Department of Health responsible for safeguarding public health by licensing medicines and monitoring adverse reaction to drugs. Generic medicinal products are assessed for safety, quality and efficacy by the Medicines Control Agency (MCA) in the same way as innovator products before being granted a product licence. As part of the assessment the applicant is required to provide data showing that the generic product is equivalent or essentially similar to the innovator product. The MCA has investigated specific complaints about the quality of medicines products by generic companies and found them to be largely unsubstantiated. The Medicines Testing Scheme (MTS) monitors the quality of licensed medicinal products in the UK by obtaining samples of both generic and innovator products and testing them for compliance with their registered specifications. Comparison of results has not found a higher proportion of deficiencies in generic products when compared with innovator products. This finding is supported by reports of defective medicines to the Defective Medicines Report Centre which are no greater for generic than for innovator products. Whilst deficiencies do occasionally occur in both generic and innovator products, there is no evidence from the results of testing carried out by the MTS over the past two years to suggest that generic medicines are of inferior quality compared with the equivalent innovator products.

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