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Tag: Paracetamol

  • NAFDAC insists report of under-dosed Paracetamol fake

    NAFDAC insists report of under-dosed Paracetamol fake

    The National Agency for Food and Drug Administration and Control (NAFDAC) says the recent publication claiming that paracetamol drugs in Nigeria are under-dosed is fake.

    Prof. Mojisola Adeyeye, Director-General of NAFDAC, stated this in an interview on Thursday in Abuja.

    Adeyeye said that the publication was a disservice to Nigeria, adding that academic publications need to be more responsive to issues of public health.

    A 2023 study with samples from five paracetamol brands claiming to contain 500mg paracetamol as its active ingredient, were said to have been tested and analysed using the spectrophotometric method.

    But the paracetamol concentrations were reportedly found to range from 185mg to 358mg, which is less than the recommended 500mg.

    The study’s researchers raised concerns about the possibility of treatment failure due to under-dosed paracetamol tablets.

    Adeyeye, however, said that findings have shown that the said publication has been retracted.

    Adeyeye, who cautioned against playing on the intelligence of the 250 million Nigerians, enjoined all Nigerians to use paracetamol.

    “There is nothing wrong with our paracetamol. The publication is fake and I’m speaking from the perspective of a professor.

    The NAFDAC boss said as a scientist she proved the publication wrong and immediately the agency instructed its staff to do sampling.

    “And when you are doing sampling, you don’t do sampling in one place. We used 36 made RS2 software of mathematical package to know where to go, to know how many samples to take.

    “So that statistically when the results come out it can be validated. So they went and took samples from Abuja and Lagos.

    “But as a scientists we did the test using international standard not a Nigerian university standard, not a Nigerian standard, not a West African standard.”

    She argued that there is no single lab in Nigeria that is better than that of NAFDAC, adding that the agency had been judicious in its financial management.

    “That lab were these products were tested this week is a WHO pre-qualified laboratory and we have been working on that for about six years.

    “We got that in September 2023, WHO pre-qualified laboratory, only few countries have such attainment or laboratory have such attainment in Africa.”

    The NAFDAC boss said that the agency was building quality culture in the industry and encouraging local production of food and drugs to allow for more jobs and save foreign exchange.

  • NAFDAC releases findings on paracetamol tablets in Nigeria

    NAFDAC releases findings on paracetamol tablets in Nigeria

    The National Agency for Food and Drug Administration and Control (NAFDAC), based on its scientific findings, has faulted claims that nearly all paracetamol drugs in the country are under the recommended doses.

    Prof. Mojisola Adeyeye, the Director-General of NAFDAC, made this known on Monday while briefing newsmen on findings carried out by the agency due to a publication’s claim of under dose paracetamol tablets in the country.

    Adeyeye said that based on a scientific response to recent reports suggesting widespread under-dosing of paracetamol tablets in Nigeria, NAFDAC conducted a comprehensive testing of tablets, sampled from different pharmacy outlets to investigate these claims.

    “As a Scientist and Professor of Pharmaceutical Manufacturing and Drug Evaluation for 30 years, the publication gave me a great concern on the lack of responsibility regarding the impact of the unscientific release on the Nigerian society.

    “The results of the laboratory testing are ready after paracetamol tablets from 13 different local manufacturers were sampled from Lagos and Abuja pharmacy outlets.

    “We assured the public that we will publish the result of our own investigation of the paracetamol tablets in Nigeria immediately after we conclude testing in the agency’s WHO pre-qualified laboratory.

    “A minimum of 20 tablets from each manufacturer were used for the assay analysis by regulatory officers with verifiable analytical skills and competencies using the British Pharmacopoeia monograph 2023 edition Volume 3.

    “The result of our test clearly showed that all the 20 tablets from each manufacturer met the stipulated dosage standards and specification.

    “This includes adherence to both national and international regulatory requirements”.

    She said: “This is a 100 per cent pass rate for the full compendia tests result for the 20 samples of paracetamol tablets tested.

    “While the assay was validated using British Pharmacopoeia testing methodologies for precise and reliable assessments of the dosage levels in the sampled paracetamol tablets.

    “The assay results clearly contradict the results of the published report circulated on social media and we fault this grim publication in totality,” she said.

    She added that parameters including uniformity of mass, average weight, friability, hardness, identification and disintegration time that were not part of the subject in question were also tested.

    They were found to have met the BP specifications, she said.

    “Basic scientific facts such as the range of the concentrations of the standard curve solutions (0.01 to 0.05) being lower than the solution test samples (0.1) further invalidates all the analysis because the anticipated test solution concentration should fall within the calibration concentration range.

    “These are basic laboratory testing and scientific facts that those competent in pharmaceutical and regulatory science should know.

    “These are the simplest of many rigorous tests that earned the NAFDAC Central Drug Control Laboratory the coveted Pre-qualification by World Health Organisation (WHO),” she said.

    According to Adeyeye, the pharmaceutical manufacturing sector in the country strives to maintain and enhance the quality of pharmaceutical products to align with NAFDAC’s quality culture.

    “This publication that has now been retracted is a disservice to the pharmaceutical industry and the nation.

    “The mischief of placing the article in the social media on the background of World Health Organisation logo is highly distasteful and illegal.

    “NAFDAC emphasises the importance of evidence-based information to guide public discourse and urges stakeholders to rely on and check for accurate and comprehensive data”.

    The Director-General reassured Nigerians of the agency’s commitment to public health and safety.

  • Anambra man sentenced to 7 years in prison for falsifying Emzor paracetamol

    Anambra man sentenced to 7 years in prison for falsifying Emzor paracetamol

    An Anambra State based man named Ogbodo Friday has been sentenced to 7 years in prison for falsifying Emzor paracetamol.

    TheNewsGuru.com (TNG) reports Friday was sentenced to 7 years in prison without an option of fine for endangering the lives of innocent consumers through circulation of fake drugs.

    He was sentenced on Tuesday by a Federal High Court in Awka, Anambra State in what the National Agency for Food and Drug Administration and Control (NAFDAC) has described as a boost to ongoing war against the circulation of substandard and falsified medicines in Nigeria.

    Friday, a middle-aged man, was arrested by the investigation and enforcement officers of NAFDAC in his residence at 18, Abagana street, Fegge, Onitsha, Anambra State where falsified Maldox (Sulfadoxine and Pyrimethamine), a brand of anti-malaria tablet manufactured by a registered Nigerian Pharmaceutical Company was recovered from him.

    Operatives of the Agency acting on intelligence swooped on his residence in Onitsha and when apprehended, Friday confessed that he cut Emzor Paracetamol tablets and repackaged them as Maldox (Sulfadoxine & Pyrimethamine), which he then supplied to undisclosed dealers in falsified medical products at the head bridge market, Onitsha.

    In a statement signed by the Resident Media Consultant to NAFDAC, Sayo Akintola, in Abuja on Wednesday, the convict claimed that he had been in the business of adulterating and falsifying medicines for more than a year, making huge returns.

    Following the overwhelming evidence, the Agency charged him to court in Charge No: FHC/AWK/C/57/2021- between FRN V. OGBODO FRIDAY.

    On 26th January 2022, he was arraigned at the Federal High Awka, Anambra State before Justice H.A. Nganjiwa on a two-count charge bordering on possession of Fake Maldox (Sulfadoxine and Pyrimethamine) and packaging of Emzor paracetamol in a manner that is misleading.

    After Ogbodo Friday pleaded guilty to the offence, the Prosecution reviewed the facts thereafter and the Court convicted the Defendant on the two-count charge and sentenced him to five years in prison on count 1 and two years in prison on count 2 without an option of fine.

    In his judgment, Justice Nganjiwa condemned the action of the convict, noting with dismay that many people could have died from ingestion of the fake maldox. He emphasized the need for the Court to send the right message to other merchants of death who are still in the dangerous line of business.

    Speaking in the same vein, the Director General of NAFDAC, Prof Mojisola Adeyeye, in palpable elation, commended the judiciary for rising to the occasion when it was needed. She said the Agency would not rest on its oars until all still in the dangerous business of falsifying medicines to make money at the expense of the lives of fellow Nigerians are brought to book or abandon the trade for clean jobs.

    Prof. Adeyeye however, vowed that other similar cases in court would be pursued to a logical conclusion by her Agency with a view to safeguarding the lives of the citizenry.

    She admonished members of the public to always assist NAFDAC in its quest to rid the nation of fake drugs and other unwholesome food products by providing useful information that would lead to the arrest of those who perpetrate the criminal act of falsifying medicines to make money.

    “I urge you and I also encourage you that when you see something, say something. This is the only way we can collectively fight and win the battle against these merchants of death who profiteer in circulating falsified and substandard medicines at the detriment of the wellbeing of their fellow human beings”, she said.