NDA explains how recalled drugs ended up on market

The National Drug Authority (NDA) has explained circumstances under which the 14 drugs that were recalled on December 3 ended up on the market under its watch.

The recalled drugs are mostly injectable antibiotics, painkillers and other medicines used for controlling postpartum haemorrhage (excessive bleeding after child delivery) and those used during surgical procedures.
Dr David Nahamya, the NDA secretary, said the recall is a quality assurance measure that comes as a result of the Good Manufacturing Practices (GMP) audit of manufacturers to check if their products meet the standards.

“We do GMP after every three years. The drugs have to be registered and a dossier reviewed to establish their quality and efficacy. We can also pick samples from the market,” Dr Nahamya told Daily Monitor yesterday in a telephone interview.

Dr Nahamya said while conducting GMP, they travel to the manufacturer’s factory (including those outside the country) to audit the quality standards upon which they clear the drugs that meet the set standards.
However, he was evasive on giving specifics of which kind of set standards the Zhejiang Pharmaceuticals Company Limited deviated from and whether it compromised the drug efficacy rate.

Some reforms
Dr Francis Otim, the Astra Pharma (U) Limited pharmacist, said they have been the official distributor of the recalled drugs in the country for more than eight years and it is only this time that NDA has questioned the manufacturer’s quality standards.

“NDA has been to the factory [premises in China] more than three times and it’s only this time when they found some thing lacking,” Dr Otim said.
He added that the factory has already fixed the defects and invited NDA to go back and audit.
At the moment, Dr Otim said he cannot tell the number of drugs on the market since they are still receiving returns.

In reaction to the recalls, patients’ rights advocates have threatened to take the responsible parties to court for a failure to do their job of quality assurance.
Mr Moses Talibita, the legal officer of Uganda National Health Consumers’ Organisation, a health rights organisation, said they demand that it is enough with the mere recalls but some prosecution success must hold someone culpable.

“The recurrent recalls of health commodities is evidence someone is short-changing the most vulnerable and by the time the recalls happen lives have been irreparably hurt. We may seek for courts interactions in a public interest legal pursuit,” Mr Talibita stated.

Development

JMS asks customers to return drugs. Meanwhile, the Joint Medical Stores in a December 10 letter, also asked its customers to return the same drugs manufactured by Zhejiang Pharmaceuticals Company Limited and another company, Grand Pharmaceuticals Limited.

JMS is a non-governmental organisation mandated to procure, store and distribute human medication and health-related consumable items to health units, owned by the Uganda Catholic Medical Bureau and the Uganda Protestant Medical Bureau, the two entities who own it.
“Check all your stores, patient wards, nurse cabins and many other departments for all medicines manufactured by the two manufacturers,” reads part of the letter.

The drugs. The drugs recalled are Gentamycin injection 80mg/ml, Oxytocin injection 10 IU/ml, Diclofenac Injection 25mg/ml, and Chloramphenicol 250mg Capsules, Tetracycline 250mg capsules, Lidocaine injection 20mg/ml, and Lidocaine injection 20mg/ml,
Other drugs are; Quinine Injection 300mg/ml, Aminophylline 25mg/ml, Atropine injection mg/ml, Metoclopramide injection mg/ml, Chlorpromazine 25mg/ml, Vitamin B complex injection, Indomethacin 25mg capsules and Promethazine Injection 25mg.

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