…. Says it doesn’t meet required standards; warns against sale of substandard medicines
The government has banned the importation of Para Clear, a children’s paracetamol syrup made by a manufacturer based in Ahmedabad, India, after the product failed local and external laboratory tests.
The LMHRA, the government’s arm that regulates pharmaceutical products in the country, said testing showed that Para Clear contained toxic ethylene glycol, making it harmful to the health of its consumers.
The LMHRA seized and quarantined 256 cartons of the medicine last year after it failed physical inspection at the Quality Control Lab, and according to the agency’s Managing Director, Dr. Keturah C. Smith-Chineh, sample was sent for further testing in Nigeria after the importer challenged the results, she said.
“We want to declare about 256 cartons of Paracetamol Oral Suspension 125 mg/5 ml, known as Para Clear Suspension with batch number L220008 that were confiscated last year,” Smith-Chineh said at a press conference on Monday, June 19. “And this is after multiple tests here and in Nigeria showed that the product did not meet our standards as a regulating agency.”
The Nigeria’s National Agency for Food & Drug Administration and Control identified the tainted drug in a June 12 statement, providing a picture of its packaging in a public alert notice. It also warned that ethylene glycol is “toxic to humans when consumed and can prove fatal,” Bloomberg, a United States based media outlet, quoted the Nigerian agency in its report.
Indian Prime Minister Narendra Modi has marketed his country as a “pharmacy of the world,” thanks to an abundance of generic-drug manufacturers that operate there. But there have been multiple medical scandals in recent years, Bloomberg said.
Contaminated syrups from India were implicated in more than 80 child deaths in Uzbekistan and The Gambia last year. In April, the World Health Organization also found tainted syrup in the Pacific island nations of Marshall Islands and Micronesia produced by an Indian drugmaker.
Smith-Chineh said at Monday's press conference that the decision to ban the product from entering the market was informed by the failed test results from Nigeria.
“Due to the above, the Authority has revoked, with immediate effect, the manufacturer’s license as well as the marketing authorization of all products registered by the company,” she said. “And the toxic medicinal product will be disposed of accordingly.”
“An investigation conducted by the World Health Organization revealed that the Para Clear medical product poses serious threats to the lives of children, similar to the Gambian scenario,” she said.
The decision to take the product to Nigeria for further testing was in line with WHO requirements. A third-party testing of products must be conducted in World Health Organization (WHO) prequalified or ISO/IEC 17025 accredited laboratories.
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.
Smith-Chineh noted that the product also failed the requirement for acute oral toxicity.
She therefore urged the members of the public to report to the Authority if the 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-diabetic) 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 antifreeze formulation.
It is an odorless, colorless, flammable, and viscous liquid. Repeated exposure to ethylene glycol may lead to irritation of the throat, mild headaches, backaches, 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.