Note: You must be registered in order to post a reply.
To register, click here. Registration is FREE!
|T O P I C R E V I E W
||Posted - 11 Sep 2022 : 10:07:22
STATEMENT FROM MEDICINES CONTROL AGENCY TO ALL IMPORTERS, WHOLESALERS, DISTRIBUTORS, AND RETAILERS OF PARACETAMOL SYRUP WHICH IS SUSPECTED IN THE CASES OF ACUTE KIDNEY INJURY AND DEATHS IN CHILDREN IN THE GAMBIA.
10th August 2022
The Medicines Control Agency (MCA) is hereby releasing this statement following the reported deaths of children from Acute Kidney Injury by the Ministry of Health (MOH) on the 7th of September 2022.
The information from the Ministry of Health stated that some Paracetamol Syrups have been suspected to be responsible for the AKI in children leading to reported deaths. However, recent data provided to MCA is insufficient to make an informed decision or warrants a general ban, cancelation or suspension, or recall of all the brands of Paracetamol syrups.
Due to the serious nature of the situation, therefore, the MCA urges all the importers, wholesalers, distributors, and retailers of all brands of Paracetamol Syrups to be put under quarantine with immediate effect and to stop their distribution and sale whilst the investigations are ongoing.
The MCA is currently working together with MOH and WHO Officers handling the investigations to get more comprehensive information on the specific products suspected; In addition, MCA has involved the WHO at the higher level for urgent support and facilitation for quality control analysis of the products. Some of the samples have now been sent to accredited laboratories abroad for urgent quality control analysis and we, therefore, await the results after which the appropriate action and feedback will be communicated.
Markieu Janneh Kaira
Medicines Control Agency
|2 L A T E S T R E P L I E S (Newest First)
||Posted - 12 Jul 2023 : 17:52:55
Union Health Minister Mansukh Mandaviya on Tuesday asked small and medium-sized drug manufacturers to be alert to the quality of drugs and ‘expeditiously’ move towards good manufacturing practices through self-regulation.
His remarks came after India-made cough syrups were linked to the deaths of children in The Gambia and Uzbekistan.
He also said that Schedule M of the Drugs and Cosmetics Act of 1940 would be made compulsory for micro, small and medium-sized firms (MSME) in a phased manner.
Schedule M details good manufacturing practices to be followed by drug manufacturing companies.
“There shall be no compromise with the quality of drugs manufactured in India,” he said, adding that stringent action will be taken against companies that make spurious drugs.
Strongly stressing the need for self-regulation in the MSME pharma sector, the health minister underscored its importance for India to maintain the status of ‘pharmacy of the world.’
“Our global position in the pharmaceutical sector is created through the quality of our products. We must undertake all possible steps to ensure that we strengthen this position in terms of value and quality. Hence, the role of self-regulation becomes critical,” he stated.
Mandaviya also directed the Drugs Controller General of India (DCGI) to take stringent action against all pharmaceutical manufacturing companies that make spurious drugs.
“There shall be no compromise with the quality of drugs manufactured in India,” he said.
After India’s image got a knocking, the Union health ministry tightened scrutiny of cough syrup last month. The government has made it mandatory for pharma companies to obtain a certificate of analysis from a government laboratory before exporting products.
Highlighting that the government has zero tolerance towards manufacturers not adhering to quality compliance and making spurious medicines, he stated that special squads have been formed to inspect drug making companies and stringent action has been taken.
In order to ensure the highest quality of pharma products, the regulatory authorities have started a risk-based inspection and audit of plants.
He said that 137 firms were inspected and action has been taken against 105 firms.
Further, production has been stopped at 31 firms and cancellation and suspension of product/section licenses have been issued against 50 firms.
In addition, show cause notices have been issued to 73 firms and warning letters have been issued to 21 firms.
||Posted - 04 Jul 2023 : 15:25:38
Jul 4, 2023, 11:34 AM | Article By: Pap Saine
Presidents of the Gambia Bar Association (GAB), Female Lawyers Association and Loubna Farage – a private legal practitioner have reportedly filed a suit on behalf of 19 plaintiffs representing family members who died from Acute Kidney Injury (AKI) following the consumption of a cough syrup manufactured by Maiden Pharmaceuticals.
According to sources, the suit is against 5 defendants: Maiden Pharmaceutical; Atlantic Pharmaceutical; Medical Controls Agency; Ministry of Health and Attorney General.
The claim is for declaratory reliefs that the deaths of the plaintiffs’ children were caused by the consumption of contaminated medicines manufactured my Maiden Pharmaceutical; damages of 15 million per child for pain and suffering and death and declaration that MCA failed in their statutory duty to regulate the quality & safety of medicines.
|Bantaba in Cyberspace
||© 2005-2023 Nijii