, NAIROBI, Kenya, Jan 28 – Following media reports about Glaxosmithkline (GSK) and its medicines, GSK would like to clarify the following:
GSK would like to stress the importance that we attach to patient safety. All GSK medicines are manufactured according to good manufacturing practice (GMP) standards and conform to Kenyan and also international quality and regulatory standards.
Furthermore all packaging and labeling of our medicines conform to Kenyan drug registration laws and guideline and have been previously approved by the pharmacy and poisons board.
More specifically we can confirm that all the products are manufactured by companies in the GSK group of companies or in some instances manufactured by third party with the consent of and on behalf of GSK.
In the event that the medicines are manufactured by a third party, they do so in accordance to quality standards required by GSK.
GSK has consistently acted to protect patients from counterfeits of its products and is committed to working with all stakeholders, particularly those government agencies that have responsibility for public welfare.
We have also been actively involved in tackling the threat posed by counterfeit medicines locally through the Kenya Association of Manufacturers (KAM), Kenya Association of the Pharmaceutical Industry (KAPI) and also globally through such organisations as WHO, Impact, Efpia, Pharma and Ifpma.
We are pleased to see Kenya actively addressing the problem of counterfeiting, for example through the formation of the Kenya anti-counterfeit agency.
The Pharmacy and Poisons Board raised concerns about suspected counterfeit GSK medicines in a letter they wrote to us on 14th January 2010.
After responding to their concerns, which centered on product labeling, GSK can confirm that on 21st January 2010, the PPB rescinded its earlier order to withdraw our medicines.
This is after we confirmed that the medicines in question were all genuine GSK products. GSK has since submitted contracts, documentation and registration certificates to the ppb for their review.