• Batch withdrawn as precaution

The National Medicines Regulatory Authority (NMRA) has launched a special investigation following the two incidents reported from Gampaha and Ragama, where a locally-manufactured antibiotic drug has allegedly caused allergic reactions, with a report of one death which may be linked to it, The Sunday Morning learns.

As an immediate response to the incident, the entire batch of the now-questionable drug stock had been withdrawn as per instructions given by the NMRA, it is learnt.

When contacted by The Sunday Morning, Medical Supplies Division (MSD) Director Dr. H.M.K. Wickramanayake said two incidents linked to questionable medicines had been reported, with instructions given for the stock to be withdrawn from State hospitals.

“The relevant batches were withdrawn already. This is a locally-manufactured antibiotic. There are two cases reported. One death was reported and another patient is currently being treated at the ICU. We suspect that these incidents may be linked to hypersensitivity to the antibiotic,” he opined.

Dr. Wickramanayake also said that the case was being handled by the NMRA, with one meeting regarding the incident and stock being held on Friday (30) and another meeting scheduled to be held on Tuesday (4). 

“At the last meeting they decided to withdraw the batches. On Tuesday, we will decide what we should do,” he added.

As confirmed by Dr. Wickramanayake, the medicine is of Sri Lankan origin and has no connection to the Indian line of credit.  

Reports indicate that a 23-year-old woman had allegedly succumbed to complications due to a possible allergic reaction to the said medicine at the Colombo North Teaching Hospital in Ragama. 

The female victim, who had been admitted to the hospital on 27 June due to an infection, had been orally administered the antibiotic, but as she had shown no response, she had been readministered the medicine in the form of a vaccine.

The woman had then developed complications due to an allergic reaction to the medicine, after which she had been admitted to the Intensive Care Unit (ICU) of the hospital, reports said.

With the record of the new incident, a total of three incidents of alleged quality failures have been recorded within the past three months.

Two incidents were reported from the Peradeniya Teaching Hospital and the National Eye Hospital which led to the withdrawal of two pharmaceutical items brought down to Sri Lanka from India under the Indian credit line.

Questions have also been raised over the quality of other drugs imported recently by the State Pharmaceuticals Corporation (SPC).

On 2 April, it was reported that a pregnant woman, who had been admitted to the Peradeniya Teaching Hospital for a caesarean surgery, had allegedly died of complications after being given a certain drug.

Following the incident, the Health Ministry had suspended and withdrawn the drug which had caused complications and a team of experts was sent to Peradeniya Teaching Hospital to investigate the matter. The MSD temporarily withdrew three categories of an anaesthetic drug used for surgeries in Sri Lanka.

Again, on 14 April, the National Eye Hospital suspended surgeries with immediate effect following the report of several incidents of infections in patients who had undergone surgeries.

Primary investigations have revealed that the infections were allegedly related to an eye drop, namely prednisolone, imported from India under the Indian line of credit. The particular batch of drugs has been withdrawn from the hospital sector.

As per health sector sources, investigations into the previous incidents are still underway.

Nevertheless, Academy of Health Professionals (AHP) President Ravi Kumudesh earlier raised concerns regarding the quality of drugs being distributed to the State sector.

Highlighting the recent death reported from Ragama, he alleged that the number of incidents related to low-quality drugs being administered to patients in State hospitals had increased in the recent past and charged that the authorities were trying to cover them up.

Kumudesh urged the Government to appoint an independent committee to investigate these incidents and allow patients to lodge complaints in this regard.