• Pharmacy and Poisons Board ordered a recall of 14 batches containing thousands of tablets after the manufacturer noticed improper packaging had stained a few tablets.
• However, many patients who had been issued with the drugs are still unable to have them replaced at the issuing health facilities.
Image: UCL
Authorities are still conducting tests on the locally-made ARVs that were recalled two weeks ago due to faulty packaging and black spots on some tablets.
The Pharmacy and Poisons Board ordered a recall of 14 batches containing thousands of tablets after the manufacturer noticed that improper packaging had stained a few tablets.
However, many patients who had been issued with the drugs claim they are still unable to have them replaced at the issuing health facilities.
Patients who spoke to the Star said the National Aids and STIs Control Programme, and the National Syndemic Diseases Control Council have not formally written to the facilities directing them to accept returned drugs and issue new ones.
“The nurses say they are also seeing the issue of drugs recall on social media but cannot replace them without receiving a circular from Nascop,” a patient from Kisumu, who did not wish to be identified, said.
However, this was confirmed by patients’ representative Nelson Otuoma, who heads the patients' lobby Nephak.
“Nevertheless, there is a team of volunteers among recipients of care who are willing to work with Nascop to sensitise communities on the matter with the aim of helping mop out the affected drugs out of circulation,” he said.
The Star reached out to Nascop boss Dr Rose Wafula who confirmed facilities have already been informed of the recall and should accept the returned drugs.
"The communication to all counties on the issue was done. There is ongoing follow up and reinforcement to ensure that this is cascaded to the last facility," Dr Wafula said.
Pharmacy and Poisons Board CEO Dr Fred Siyoi said the recall only affects 14 batches of Tenofovir, Lamivudine and Dalutegravir (TLD) made by the Kikuyu town-based Universal Corporation Limited.
“The PPB in collaboration with the manufacturer, Universal Corporation Limited, has initiated investigations into the market complaint to determine the root cause of the deviation,” he said.
Dr Siyoi first ordered the recall on November 8 following complaints of discoloured induction seals on some bottles containing 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.
“In order to protect the safety and health of the public you are required to immediately quarantine batches 5810950, 5810761, 5810973, 5810937, 5810801, 5810612, 5810936, 5810760, 5810906, 5810977, 5810921, 5810830, 5811076 and 5810799 of Tenofovir, Lamivudine and Dalutegravir (300/300/50) manufactured by Universal Corporation pending conclusion of investigations,” Dr Siyoi said in a November 8 letter to Terry Ramadhani, CEO of Kenya Medical Supplies Authority.
James Kamau, the CEO of Kenya Treatment Access Movement (Ketam), 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."
Around the world, misbranding is the most common reason for pharmaceutical recalls accounting for 42 per cent of all recalls, according to regulatory authorities.
The Kikuyu-based UCL is the only WHO-prequalified manufacturer of ARVs in Kenya.
UCL started as a family business in 1996 but is now one of the biggest pharma in Kenya, with more than 100 medications and drugs that it sells to more than 30 countries in Africa.
It is majority-owned by Pharma Strides Shasun of India, who bought a majority stake for Sh1.1 billion in 2016.
The factory supplies ARVs to several countries, through the Global Fund programme.