Indian Drugmaker Denies Syrup Exported to Liberia Is Toxic
IPNEWS-NEW DELHI: The Managing Director of the Liberia Medicines and Health Products Regulatory Authority (LMHRA), Dr. Keturah C. Smith-Chineh, has disclosed that the Authority has declared “FAIL” about 256 cartons of “Paracetamol Oral Suspension125mg/5ml known as Para Clear Suspension, with batch number L220008.” These 256 cartons were quarantined last year, after a failed physical inspection at Quality Control Lab since October 2022.
Para Clear Paracetamol syrup, was manufactured in India, by a pharmaceutical company known as “Curis Life Sciences PVT. Ltd.
Making the disclosure during an emergency news conference, Managing Director Smith-Chineh said the failed pharmaceutical product was manufactured for the effective relief of headaches, backaches, and fever.
Dr. Smith-Chineh said the samples were taken to National Agency for Food and Drug Administration and Control (NAFDAC) by the LMHRA Quality Control Lab team for confirmatory analytical testing and the quality analysis was paid for. The decision to stop the product from entering the market was followed by another failed test conducted in Nigeria.
Therefore, Managing Director Smith-Chineh disclosed that due to the above, the Authority has revoked, with immediate effect, the manufacturer’s license, as well as marketing authorization of all products registered by the Company. The LMHRA’s Managing Director further intimated that the medicinal product, which is toxic, will be disposed of accordingly.
She further informed the public that an investigation conducted by the World Health Organization (WHO) also revealed that the Para Clear medical product poses threats to the lives of children similar to the Gambian scenario.
“This product came into the country last year September, it was tested in our Quality Control Laboratory and was rendered failed. As part of the procedures we carry on at the LMHRA, if a product is rendered failed, the importer has the right to ask for Third-party testing, to have a transparent process. And this is also in line with international best practice,” Dr. Smith-Chineh noted.
Accordingly, the LMHRA Managing Director, emphasized that third-party testing of failed products must be conducted in World Health Organization (WHO) prequalified or ISO/IEC 17025 accredited Laboratories. Therefore, for the West African region, the Ghana Food and Drugs Authority (FDA) and the National Agency for Food and Drug Administration and Control (NAFDAC), are the two Accredited ISO/IEC 17025 Quality Control labs recommended. Consequently, the samples of the Paracetamol oral suspension were sent to NAFDAC on April 18, 2023.
LMHRA Managing Director Smith-Chineh also disclosed that last week, Friday, June 9, 2023, the results of the failed medicinal (Para Clear Paracetamol Suspension with Batch number L220008) were sent back to Liberia from Nigeria; and it was reported that the product failed due to the fact it has Ethylene Glycol, a substance she said is considered highly toxic and leads to acute renal impairment (kidney failure). The product also failed the requirement for acute oral toxicity.
Therefore, while investigations are ongoing, Dr. Smith-Chineh is encouraging the public to report to the Authority, if the above-mentioned failed medicinal product is seen anywhere on the Liberian market. As part of LMHRA’s policy that all syrups (including anti-malaria, anti-hypertensive, and anti-diabetics) must be quarantined pending analytical results from the laboratory, she assured the public that the 256 cartons of the quarantined product are still intact and will be destroyed (incinerated) subsequently.
Managing Director Smith-Chineh has further warned the public not to consume any of these products because they are not fit for human consumption.
According to scientific researchers, Ethylene glycol is an organic compound with the formula (CH₂OH₂). It is mainly used as a raw material in the manufacture of polyester fibers, paints, and brake fluid as an anti-freeze formulation. It is an odorless, colorless, flammable, viscous liquid. Repeated exposure to ethylene glycol may lead to irritation of the throat, mild headache, and backache, loss of consciousness, acute renal impairment, and death.
Meanwhile, Managing Director Smith-Chineh is calling on the public to report to the regulatory authority all illegal entry and offloading of pharmaceutical products, due to the fact the country has several porous border points and the Authority’s regional staff are constrained.
The public is encouraged to reach the LMHRA on its hotlines at 5054 or 0880140555 or 0770140555.
In related news, an Indian maker of a paracetamol syrup that Nigerian authorities have found toxic told Reuters on Tuesday that tests by a private Indian laboratory found them of “standard quality”, as Indian authorities launch their own investigation.
Nigeria’s National Agency for Food and Drugs Administration and Control (NAFDAC) said in an alert last week that samples of the Indian-made paracetamol suspension, Para Clear, exported to Liberia last year contained the toxin ethylene glycol. It also failed the requirement for “acute oral toxicity with five deaths of the laboratory animals recorded”, the agency said.
Many Indian-made drugs have been found to have contained ethylene glycol and similar toxin diethylene glycol since last year, which the World Health Organization (WHO) have linked to the deaths of dozens of children in Gambia and Uzbekistan. The toxins are commonly used in brake fluid and other products not meant for human consumption.
“There is no possibility at all of finding ethylene glycol or diethylene glycol in our product,” said Jaimik Patel, a director at Curis Lifesciences, based in the western Indian city of Ahmedabad and whose products were sold in Liberia.
“We are challenging the claim that our product was toxic.”
A test of a sample of the medicine conducted by privately run Vaibhav Analytical Services in Ahmedabad on Saturday, and seen by Reuters, said the syrup had less than 0.1% of ethylene glycol and diethylene glycol.
“The sample referred … IS OF standard quality,” the test report from the Ahmedabad-based laboratory said.
Trace amounts of less than 0.1% of ethylene glycol and diethylene glycol in medicines are not considered toxic, according to the WHO.
NAFDAC, in its alert, did not give a toxicity concentration figure but said ethylene glycol was a “toxic substance that is not expected in product formulations”. It did not immediately respond to a request for comment.
Patel said officials from India’s federal drug regulator, the Central Drugs Standard Control Organisation, also picked up the sample for their own investigation. He said Curis had shared the test results and other documents with the regulator and the WHO.
Mumbai-based drug exporter Synercare told Reuters it had shipped two batches of nearly 20,000 Curis-made Para Clear bottles each to Liberia in October. Synercare’s exports manager Dipesh Ajmera and Patel said Liberian authorities have now revoked the permission for the sale of all Curis products, including painkillers paracetamol and ibuprofen and antibiotic medication azithromycin.
Ajmera said Liberian authorities were set to destroy one batch of the paracetamol syrup last year as the drug’s colour did not match that of a comparable product. The paracetamol suspension was supposed to be reddish brown but on physical verification, it was found to be reddish pink, Ajmera said.
Keturah Smith-Chineh, head of the Liberia Medicines and Health Products Regulatory Authority, told Reuters the syrups were to be incinerated because of the colour variation but it was tested in Nigeria at the request of the medicine’s local importer.
“We plan to incinerate all the … stock that came into Liberia,” she said. “There are two other child medications from that manufacturer, and we are working on recalling them.”
