Mr. Jon Owen JonesTo ask the Secretary of State for Health what sorts of gelatine are used in the manufacture of hard and soft capsules for drugs used in Britain. [143100]
§ Yvette CooperThe measures are laid down in the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy a gents via medicinal products. This guideline has been a force of law by virtue of a Commission Directive 1999/82 and has been incorporated into the United Kingdom domestic law. This guidance note focuses on the cumulative contribution of three factors to the safety of gelatine: the origin of the animals, type of tissue and manufacturing process. It is also recommended that appropriate quality system, such as ISO 9000 certification and Hazard Analysis Critical Control Point, should be put in place for monitoring of the production process and batch delineation. Procedures should also be in place to ensure tractability and to audit suppliers of starting materials.
Mr. Jon Owen JonesTo ask the Secretary of State for Health (1) what steps he has taken to ensure that gelatine used in soft and hard drug capsules is not contaminated with BSE prions; [143098]
(2) what recent tests his Department has (a) carried out and (b) commissioned to ensure that gelatine used in drug capsules does not contain the prion for BSE. [143099]
§ Yvette CooperGelatine used for formulating medicines can be sourced from porcine and bovine hides (skin) and bovine bones. Acid process is applied to bovine bones, hides and porcine skins. An alkaline process is used to produce soft gelatine.
There are no tests designed specifically to detect BSE agent in gelatine.