, NAIROBI, Kenya, Jan 27 – The government has rescinded an order for the withdrawal of eleven key drugs from the market.
The Chief Pharmacist Dr Kipkerich Koskei says the issue was sorted out after GlaxoSmithKline (GSK) confirmed that the drugs were from the same company and not counterfeits.
He says there were several letters written between the government and the firm before the matter was eventually sorted out.
A letter in our possession to the Managing Director of GlaxoSmithKline from the Pharmacy and Poisons Board directed the giant manufacturer to immediately stop distribution and order a recall of the 11 medicines, including Septrin and Amoxil which are commonly used antibiotics.
“As a regulatory authority, patients’ safety and the access to high-quality medicines comes high in our mandate,” said a statement signed by Dr Koskei.
The regulator said this was a precautionary approach before counterfeit penetration into the supply chain.
GSK Managing Director John Musunga said the bone of contention was in the labeling of the products which had different manufacturer names.
“GSK is a group of companies and most of these drugs come from our partner companies in Egypt, Europe, France and England but we have confirmed to the board that they are sister companies,” he said.
Another correspondence from the Chief Pharmacist to the GSK Managing Director stated: “We acknowledge your (GSK MD) and regulatory affairs director’s visit to our offices on the same issue and you are hereby directed to provide a list of all your manufacturing sites for all your products marketed in Kenya.”
The manufacturing company was also ordered to provide all the contract manufacturing agreements with other parties and principles including members of the GlaxoSmithKline group of companies, remove ambiguity in both primary and secondary labels by stating clearly who manufactured and where(site address).
The company is also required to apply for manufacturing license (packaging) as this was part of the manufacturing process for products they wanted to produce in Kenya.
The letter stated that the board suspended its order pending investigations into the matter.