Ministry recalls all ARVs from Kikuyu town manufacturer

The Ministry of Health has recalled all ARVs made by Universal Corporation Limited from the Kenyan market.

The drugs are manufactured in Kikuyu town at UCL’s factory, the only Kenyan factory prequalified by the World Health Organization to make ARVs.  

The government had previously flagged only 14 batches with bottles that had faulty packaging and stained tablets.

However, the ministry now says it is difficult for consumers to identify if their tablets are from these specific batches and to avoid confusion, all ARVs from UCL should be returned.

Head of the National Aids and STIs Control Programme Dr Rose Wafula said patients with drugs from other manufacturers should not return them.

Kenya imports most ARVs from India and UCL supplies less than 10 per cent of the market.

“We are only recalling those from UCL. Kemsa only began distributing these drugs in November and the recall was made on November 8 so there are not many in the market,” she said.

Dr Wafula spoke during the National People Living With HIV Leadership Summit hosted in Nairobi by the National Empowerment Network of People living with HIV-Aids in Kenya (Nephak).

“It is the manufacturer who requested the recall because faulty packaging had stained some tablets. So it is just a normal cautionary move,” she said.

When reached for comment, UCL promised to give a comprehensive response on the development during an interview next week.

The recall notice was first issued by the Pharmacy and Poisons Board on November 8 after it was notified of the defect by the manufacturer.

UCL said it had discovered a discolouration of the induction seals on some bottles, which stained a few tablets with unusual black spots.

The induction seal is the heat-placed silver lining that covers the bottle to ensure the package is airtight and keeps off any contaminants from entering.

PPB chief executive Dr Fred Siyoi said they would also conduct tests on the pills to see if their quality was affected.

Yesterday, head of Nephak Nelson Otwoma accused PPB and the National Quality Control Laboratory of taking too long to release the results of the tests.

“The Ministry of Health cannot recall what is good, they are recalling it back because it is bad. So our question is, what are the health consequences? But the Ministry of Health is not answering that question,” Otwoma said.

“The PPB says they are still doing analysis and investigating, but I am not sure why that analysis and investigation is asking too long. I don’t know what will happen, if it will come to be that these medicines were actually harmful to the health of these people,” he added.

Otwoma said many civil society representatives at the meeting, which ended on Tuesday, say some people living with HIV are unable to return the UCL pills.

“When people are given the drugs, they take it from the tin and throw away the tin. They put the pills in a paper or a kajuala (plastic bag). Now you are coming in and saying take it back and if they will take it back minus the tin, it will not be accepted.

"There are also those who probably may not even get this information or are illiterate and cannot read the UCL imprint. That is the crisis we are dealing with right now,” he said.

Last week, Health director general Patrick Amoth advised patients to return pills back to the health facilities where they picked them.

The facilities are required to counsel all the patients on the need to maintain adherence to treatment as other bands are not affected.

“There are sufficient national stocks of more than six months of TLD (Tenofovir, Lamivudine, and Dolutegravir) drug from other manufacturers other than UCL,” Amoth said.

“Facilities are instructed to quarantine all TLD tablets manufactured by UCL and accept all UCL TLD tablets returned by clients. Details of the reverse logistics, that is how the quarantined stocks at facility level will get back to the manufacturer, are being coordinated by Kemsa and PPB,” he added.

Last week on Friday, PPB issued another statement assuring the public that all medicines supplied to the Kenyan market meet the required quality, safety and efficacy standards.

“The PPB has collected several samples from healthcare facilities and they have been submitted to the Quality Control Laboratory for further analysis,” Dr Siyoi said.

“All healthcare facilities are instructed to quarantine all stocks of the product and accept the products returned by clients,” Siyoi added.

However, some industry players said they suspected rivalry from other potential suppliers of ARVs to the Kenyan market.

Kenya runs one of the world’s biggest HIV treatment markets, with 1.1 million people taking drugs daily.

However, UCL managing director Palu Dhanani has not commented as he is said to be outside the country.

James Kamau, the CEO of Kenya Treatment Access Movement, said the practice of recall of medicines by the manufacturers or the regulatory agency for whatever reason is a normal procedure the world over.

Sometimes, the makers of the drug will discover a problem with their drug and voluntarily recall it. Other times, regulatory authorities will request the medicine be recalled after receiving reports of problems from the public.

"The PPB recall together with UCL is a very good thing as it shows the efficiency of our regulatory systems. PPB are at an advanced stage of testing the particular batch," Kamau said.

"I would also suggest that an impact assessment is undertaken by neutral experts and service players. The government, through the Ministry of Health, needs to assure consumers of the safety of all locally manufactured medicines."