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Banned cancer-causing drugs stay on shelf for two months
Tablets on display. Some medicine is made of chloroform, which increases liver cancer. PHOTO | COURTESY
What you need to know:
- Information from the American Food and Drug Administration indicates that administering chloroform to laboratory animals increased kidney tumours and liver cancer. Chloroform is a colourless chemical substance that makes people unconscious.
The National Drug Authority (NDA) has allowed drug makers who have used chloroform, a substance with cancer-causing effects in their pharmaceutical preparations, to sell the medicines until October 1.
Dr David Nahamya, the secretary of the authority, in a July 25 letter to local manufacturers, without naming the affected medicines and why he allowed sales for another two months, said reputable studies in laboratory animals indicate that prolonged exposure to chloroform “may” cause cancer.
Information from the American Food and Drug Administration indicates that administering chloroform to laboratory animals increased kidney tumours and liver cancer. Chloroform is a colourless chemical substance that makes people unconscious.
The substance has been used by pharmaceutical companies in the manufacturing drug products as a cough suppressant (in cough syrup), counter-irritant, preservative, flavouring agent and solvent, according to information from NDA.
Dr Nahamya said the findings from the research on laboratory animals raise concerns about the “long-term safety of this solvent in finished pharmaceutical products and its potential as a human carcinogen.”
“In light of this information and in a bid to ensure that only safe, quality and efficacious pharmaceutical products are available to the citizens, National Drug Authority hereby bans the use of chloroform in all pharmaceutical preparations,” he said.
The drug regulator said marketing authorisation holders for all finished pharmaceutical products registered with manufacturing processes that involve chloroform should reformulate their products to exclude chloroform and file relevant variations with NDA.
“This ban takes effect on the October 1. No recall will be required for pharmaceutical products manufactured and marketed by existing marketing authorisation before this date. All manufacturers with pharmaceutical products in this category are expected to comply with this directive,” Dr Nahamya warned.
When asked why NDA is giving these manufacturers two months to sell the medicines, which are potentially carcinogenic, Dr Nahamya said: “These are technical issues.”
The use of chloroform in drug manufacturing processes has already been banned in America, the United Kingdom and Europe.
Commenting on the orders, Dr John Collins Kamili, the Company pharmacist and the executive director of Cipla Quality Chemical Industries Ltd, one of the drug manufacturers, said many manufacturers have already complied.
“We have already implemented this directive because it is a good manufacturing practice requirement from the World Health Organisation [for international accreditation],” Dr Kamili said.
Cancer cases
Cancer cases have been on the rise in the country with scientists warning that about 15.8 percent of Uganda’s population is at risk of developing cancer before age of 75 years.
Uganda Cancer Institute said it registered up to 7,000 new cases of cancer in 2021 which more than doubled the 3,000 cases it detected in 2018. The facility attended to more than 65,000 patients last year.
