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Tag: FDA

  • FDA approves 327 hand sanitizers for COVID-19 fight [Full list]

    The Food and Drugs Authority (FDA) has approved 327 hand sanitizers to aid in the fight against the novel coronavirus in Ghana.

    “Following the safety measures put in place by His Excellency the President of the Republic of Ghana, the Food and Drugs Authority has fast-tracked the registration of hand sanitizers to ensure availability of quality, safe and effective hand sanitizers on the market to protect the public against the spread of the Coronavirus,” a statement from the FDA noted.

    The FDA in the statement signed by its Chief Executive Officer, Delese A. A. Darko, also noted that the hand sanitizers were quickly screened, approved and registered to enable the public to “avoid patronizing unregistered or sub-standard hand sanitizers. This would help promote the use of effective hand sanitizers, which would help fight against the spread of COVID-19 in the country.”

    The FDA however warned persons selling unregistered hand sanitizers to desist from such practices else have themselves to blame if they are caught.

    “It is important to note that, it is a criminal offence to offer for sale unregistered or substandard hand sanitizers to consumers,” the Authority added.

    Find below the full list of hand sanitizers registered and approved by the FDA: 

     

    Source: citinewsroom 

  • No medical product approved as cure for coronavirus FDA warns public

    The Food and Drugs Authority (FDA) has called on the public to disregard any medical products including in-vitro diagnostic purported to prevent, detect, treat or cure Covid-19.

    The Authority warned all actors in the medical product supply chain to conduct due diligence on all products intended for the diagnosis or treatment of Covid-19.

    This was contained in a statement signed by Mrs Delese A.Darko, the Chief Executive Officer, FDA and copied to the Ghana News Agency in Accra.

    The statement said the Authority received a notification through the World Health Organisation Rapid Alert system on falsified medical products including the in-vitro diagnostics.

    The statement urged all actors in the medical product supply chain to clarify with the Authority any suspicious product intended for diagnosis or treatment of Covid-19.

    It said medicinal products should be registered with the FDA before usage and imported only through Tema Habour and Kotoka International Airport.

    “We wish to assure the public that our officers in the regions are working to ensure that the products do not get into our supply chain”, it said.

     

    Source: myjoyonline

  • FDA advises public to stay away from self-testing kits on COVID-19

    The Food and Drugs Authority (FDA) says it has neither registered nor recognised any rapid diagnoses test (RDT) kits for self-testing in the country.

    It said not even the World Health Organisation (WHO) had approved any RDT for use and, therefore, cautioned the public to be wary of any RDT kits.

    Speaking in an interview in Accra today, the Head of Medical Devices Department of the FDA, Mr Joseph Yaw-Bernie Bennie, said for now, only the Polymerase Chain Reaction (PCR) test was the recommended one and that was what the Noguchi Memorial Institute for Medical Research in Accra and the Kumasi Centre for Collaborative Research in Kumasi were using.

    Request for registration

    He said currently, over 100 companies and institutions had approached the FDA to allow them to bring in RDTs from China, South Korea and other places with one of them requesting to be allowed for local mass production of the RDT kits in partnership with a foreign partner.

    “Since the outbreak of the pandemic in the country, a lot of people have made enquiries and the possibility of bringing in the RDT kits for testing on the COVID-19. Ordinarily, it is a good thing because the WHO is recommending that we should do mass testing.

    “But we do not want to do test and give false positives and false negatives. So, there is the need to make sure that the tool you are using for testing is correct,” Mr Bennie explained.

    He added that the COVID-19 was a novel virus which the scientist community was not very conversant with, “and almost everybody relies on good test cases.”

    Mr Bennie expressed concern that there was a lot of information being churned out, most of which was not correct, adding that Ghana was doing a lot of international collaboration to ensure that whatever the Ghanaian scientists were doing was good.

    “Let me tell you that as of now that we are talking, WHO has not come out with any pre-qualified RDT that we can run with because it is not available as of now,” he said giving the assurance that if there was any RDT, Ghana would have been the first to go for them.

    Mr Bennie said the RDT kits were available, but explained that they had limitations and that it was not advisable to patronise them because even after using it, “you still have to go for a confirmation test using the PCR, which gives precise results as to whether the person has it or not.”

    He said while the PCR gave accurate information of the presence of the virus in a person, the current RDT kits available gave an indication and, therefore, required a confirmation test as to whether the person had it or not.

    No registration

    “So the Ministry of Health says for now, it is only PCR and so now, the ministry says we should not register any RDT for now,” he stated, adding that things could change in the course of time.

    Mr Bennie, therefore, asked Ghanaians to tread cautiously and remain calm while those mandated to find solutions too play their part, adding that when it becomes necessary for the use of the RDT based on the recommendations from the WHO, it would be done.

    He stated that the current state of the RDT would create anxiety and fear since the kits could not give full confirmation of the virus in people.

    Mr Bennie said the use of RDT could be counterproductive since it could indicate negative when in actual fact the person would be positive and the vice versa.

    Observation of protocols

    He mentioned that for now, the testing was restricted to only suspected cases and not mass testing as an option and advised Ghanaians to rather concentrate more on the frequent hand washing under running water and the observation of all the protocols.

    Additionally, he recommended that people should observe the social distance the President announced and when it was not pressing, people should limit movement, “since we are told that the virus does not move, people move it. We stop moving, the virus stops moving, the virus dies.”

    Source: www.graphic.com.gh

  • FDA engages pharmaceutical industry players over essential drugs

    The Food and Drugs Authority (FDA) has met with stakeholders of the Pharmaceutical Industry and assured them of fast tracking the approval for the production of essential drugs, including chloroquine, which are needed for the case management of COVID-19.

    The stakeholders, however, gave the assurance that the industry had the capacity to produce the selected drugs and that the current stocks of locally manufactured and imported medicines were adequate to cater for the COVID-19 pandemic for the next three months.

    In an interview with the Ghana News Agency on Thursday, Mr James Lartey, the Head of Communications Department, said the Authority would, however, not compromise the quality, safety and efficacy of any drug, as seen in the approval for hand sanitisers.

    The proposed drugs for treatment for COVID-19 include hydroxychloroquine and chloroquine; and Remdesivir.

    Hydroxychloroquine and chloroquine are oral prescription drugs that have been used for treatment of malaria and certain inflammatory conditions.

    Chloroquine has also been used for malaria treatment and chemoprophylaxis; while hydroxychloroquine is used for treatment of rheumatoid arthritis, systemic lupus erythematosus and porphyria cutanea tarda.

    “Remdesivir is an investigational intravenous drug with broad antiviral activity that inhibits viral replication through the premature termination of RNA transcription and has in-vitro activity against SARS-CoV-2 and in-vitro and in-vivo activity against related beta coronaviruses,” the FDA explained.

    “It is necessary to establish the current stocks of essential medicines, both finished products and raw materials, the capacity of the local manufacturers to meet the needs of the country to help the Ministry of Health in planning to avert any shortages and stock outs.

    The meeting was also used to solicit support from the industry to fight the pandemic.

    Mrs Delese Darko, the Chief Executive Officer (CEO), led a team of FDA Officers during the engagement.

    The stakeholders included the Chamber of Pharmacy, Pharmaceutical Manufacturers Association of Ghana (PMAG), Pharmaceutical Importers and Wholesalers Association (PIWA), Community Practice Pharmacists Association (CPPA), and Small Scale Pharmaceuticals Manufacturers Association.

    Part of the FDA’s function is to advise the Minister of Health on measures for the protection of consumer wellbeing.

    The industry players, however, urged the Government to supply the requisite guarantees to enable them to secure financial support from the banks to produce the needed essentials drugs.

    It should also consider making provision for Personal Protective Equipment (PPE) to Community Pharmacists and Over-the-Counter Medicine Sellers who were the first-line of call for most consumers.

    source: GNA

  • FDA has not registered RDTs for screening and diagnosis for coronavirus

    The Food and Drugs Authority (FDA) says it has not registered any Rapid Diagnostic Test Kits (RDTs) for screening and diagnosis of Corona Virus (SARS-Cov-2) in Ghana.

    A statement signed Mrs Delese A. A. Darko, Chief Executive Officer, said the current tests for screening and diagnosis of the Coronavirus in the country, approved by the Ministry of Health is the Polymerase Chain Reaction (PCR) tests.

    The statement said: “The FDA, guided by current global practices and advice from Eminent Ghanaian Scientists, is also not registering any such RDTs (Based on serology; antigen-antibody reaction) for self-test.

    This process will be guided by independently evaluated diagnostics as an assurance of quality. As evidence accumulates based on rigorous data, the FDA will update and/or amend this guidance as appropriate and necessary in the interest of public health and patient protection.”

    It said the FDA entreats all prospective applicants to be guided appropriately.

    It appealed to the public to direct all concerns regarding the use of Rapid Test Kits for Coronavirus and other FDA regulated products to 0299802932, www.fdaghana.gov.gh, fdaghana among others.

    It urged the public to comply with safety measures such as handwashing, sanitizing, social distance, avoiding handshake and touching of the face.

    Source: GNA

  • Rapid diagnostic test kits for coronavirus not registered FDA warns

    The Food and Drugs Authority (FDA) has cautioned the general public that it has not registered any Rapid Diagnostic Test Kits (RDTs) for screening and diagnosis of Coronavirus (SARS-CoV-2) in Ghana.

    “The current tests for screening and diagnosis of the Coronavirus in Ghana, approved by the Ministry of Health is the Polymerase Chain Reaction (PCR) tests,” the FDA said in a statement.

    The statement said the FDA, guided by current global practices and advise from eminent Ghanaian scientists, is also not registering any such RDTs (based on serology; antigen-antibody reaction) for self-test.

    “This process will be guided by independently evaluated diagnostics as an assurance of quality. As evidence accumulates based on rigorous data, the FDA will update and/or amend this guidance as appropriate and necessary in the interest of public health and patient protection,” it pointed out.

    It asked that all concerns regarding the use of rapid test kits for coronavirus and any other FDA regulated products should be directed to the following contacts: 0299802932, WhatsApp 0206973065, www.fdaghana.gov.gh, Instagram: fdaghana_, Facebook: fdaghana or twitter: fdaghana .

    “To ensure your safety and protection against Covid-19, you are all reminded to strictly comply with the safety measures put out by His Excellency the President of the Republic of Ghana (including handwashing, sanitizing, social distance, avoiding handshake and touching of face)”, it advised.

     

    Source: 3news.com

  • Why I cursed FDA officials Afia Schwarzenegger

    Television personality and Comedienne, Afia Schwarzenegger has finally opened up on why she cursed all officials of the Food and Drugs Authority (FDA)

    Afia Schwarzenegger in a video last week rained curses on all workers of the Food and Drugs Authority with blindness and failure in all their endeavours.

    Speaking on Accra-based Neat FM monitored by MyNewsGh.com, Afia mentioned that she cursed the authority because they took away food from her mouth.

    “I cursed the FDA because they told a client I work with that if he stops working with me, they will cancel the GHC25,000 fine he’s supposed to pay”.

    She indicated that when the individual told the FDA that he had stopped working with her, the authority truly cancelled the fine; an indication that they want to deprive her a source of livelihood.

    Source: mynewsgh.com

  • FDA, Police and Customs Division seize smuggled goods at Achimota

    The Police in collaboration with the Food and Drugs Authority (FDA) and Customs Division of the Ghana Revenue Authority (GRA) have intercepted a 40-feet truck full of contraband goods.

    The goods, according to the organisations, were smuggled into the country last Tuesday.

    The goods, believed to have been smuggled from Nigeria and included sexual enhancement drugs, pirated wax prints and other pharmaceutical products, were seized at Achimota.

    Deputy Superintendent of Police (DSP) Effia Tenge, Head of the Public Affairs Unit of the Accra Regional Police Command, told the media that police had a tip-off that the truck with the registration number AE 960 JEG was loaded with goods believed to be contraband had arrived from Kano in Nigeria.

    She explained that the goods were about to be offloaded within Accra and its environs, thus, police rushed to the scene and arrested Sani Mohammed, the driver of the vehicle, together with the goods.

    DSP Tenge said the vehicle was impounded at the Regional Police Headquarters for investigations and a search in it revealed a quantity of the pirated wax prints and the pharmaceutical products.

    The police then invited the FDA and the Customs for the necessary action to be taken, she said.

    James Lartey, Public Relations Officer of the FDA in an interview said the medicines were supposed to be imported to Ghana via two approved routes.

    He named the two legal routes as the Kotoka International Airport and the Tema Habour, adding that anywhere else was illegal.

    Mr Lartey said one could not import any drug unless it was approved, noting that there were drugs that had to be stored under certain temperatures whilst they were being imported, else, they would go bad before their original expiry date.

    The Public Relations officer said drugs which have been approved would be kept under the right temperature.

    The collaboration between FDA and the security agencies would ensure the safe disposal of the unapproved drugs as well as protect the lives, innocent citizens.

    He cautioned the public against the importation of counterfeit drugs, explaining that when found culpable, one would spend between 15 and 25 years in prison.

    Unapproved importation of drugs would also lead to a fine of not less than 7,500 penalty units, equivalent ¢90,000.00, he added.

    Source: GNA

  • Stop usage of Bupivacaine FDA

    The Food and Drugs Authority (FDA), on Wednesday ordered hospitals and all concerned parties in the pharmaceutical supply chain to stop usage, importation, and distribution of unregistered heavy Marcaine 0.5 per cent injection (Bupivacaine).

    This is to protect public health and safety; FDA statement signed by Mrs Delese A. A. Darko, the Chief Executive Officer and copied to the Ghana News Agency in Accra stated.

    The statement said the product was unauthorized and unregistered, it has no English language as part of the label and Patient Information Leaflet.

    According to the statement, the FDA had received a number of complaints for investigation on therapeutic ineffectiveness of Heavy Marcaine 0.5% injection (Bupivacaine) manufactured by Astra Zeneca/ Aspen which was being used in major health facilities in the Central and Greater-Accra Regions.

    The statement said FDA has initiated investigations and yet to conclude on who was the importer of the product into the country.

    Source: GNA

  • Edem fires FDA again for banning Ghanaian celebs from advertising for alcoholic beverages

    Ghanaian rapper Edem was in the news November last year with a call on the Food and Drugs Authority and other relevant bodies to reverse the decision of banning Ghanaian celebrities from endorsing alcoholic beverages.

    Even though that call failed to get the attention of anybody that mattered, he is back again with some more jabs.

    In a tweet sighted by zionfelix.net, Edem expressed shock that the FDA will be claiming that they have ban celebs from endorsing alcoholic beverages when people are doing so.

    He stated that some musicians have been advertising foreign drink like Ciroc in their music videos and wondered if the FDA had not seen them.

    The VGMG boss also described Ghana as a f*ck!ng cow boy town that has bodies like the FDA functioning.

    Check out his tweet below…

    Source: Zionfelix.net

  • Ghanaian musicians only think about awards and not business; always behaving like kids Shatta Wale

    Dancehall act, Shatta Wale has reacted to Adonko Bitters going to Nigeria to sign on Naija Celebs just because FDA has banned Celebs from advertising Alcoholic beverages.

    According to him, Ghanaian musicians always behave like kids, and no wonder FDA thinks they have negative influence on Kids. Shatta Wale added that GH musicians always think about awards and not business.

    Shatta Wale took to his Twitter page and tweets.

    ” Ghanaian musicians only think about awards and not business and more over they behave like children no wonder FDA sees us a great influence to minors !!! Poor industry poor mentality !!!!! “

    Shatta Wale continued,

    “Congrats to all my naija brothers and celebs on their Adonko deal ..Infact Adonko pls come and sign me cuz am also a nigerian ,my name is shatta Ike chwuku wale ..Thank you . Small time dem go Ban alcohol for parties and then after they will Ban water too then we wil drink Urine and our sweat !!!! Nonsense !!!!

    The Food and Drugs Authority (FDA) in 2015, banned celebrities from advertising alcoholic beverages as an adherence to a World Health Organization (WHO) policy.

    Source: Ghgossip.com

  • Wendy Shay and Bullet meet up with FDA Board over celebrities alcohol endorsement ban

    The Food and Drugs Authority (FDA) in 2015, banned celebrities from advertising alcoholic beverages as an adherence to a World Health Organization (WHO) policy.

    According to the Authority, the ban was part of efforts to ensure that minors are protected from being lured into alcoholism.

    Well, musician Wendy Shay  and her manager, Bullet has decided to take it upon themselves to meet up with the FDA board so as to determine the way forward.

    The excited Wendy Shay took to her Twitter page and tweets,

    ” Now Gh companies are paying Naija celebs big money for endorsement I told Gh celebs to wake up but nobody mind me. If Gh no go wake up I wake up with FDA ..Great meeting,very educative..something big is coming Ghana wake up !!!! “

    Source: www.ghgossip.com

  • Cindy and Lele Tomato paste recalled from market after detection of anomaly

    Rabaj Company Limited has announced a recall of all Cindy and Lele Tomato paste from the market after it identified “an anomaly in a particular batch”.

    Rabaj in a public notice directed all its key distributors and retailers to return stock in their possession to their depots nationwide.

    Read: FDA trains University of Energy students on its regulations

    The notice further advised individuals in possession of the two brands to return them to the retail outlets where they were purchased.

    Rabaj said recalling all batches of the brands will enable it to clear the particular defective batch from the market.

    Read the entire public notice below;

     

    Source: Graphic.com.gh

  • FDA educates Mallam market women on food safety

    he Food and Drugs Authority (FDA), as part of its mandate to ensure public health and safety and the overall wellbeing of the public, has organised the 9th edition of its monthly market durbar at Mallam Market.

    This was done in association with Environmental Health Officers from the Ablekuma North Municipal Assembly. The objective of the sensitisation is to educate market women and consumers on the dangers associated with unhygienic handling of food and the abuse of drugs and other substances.

    The officers from the Food Safety Management Department of the FDA said the Authority has received reports that some market women add yeast to corn dough and cassava dough while others also add kola nuts to powder pepper.

    Read:FDA trains staff on food risk profiling and ranking

    Mr. Benjamine Osei Tutu, an officer with the FDA, stressed on the need for the market women to desist from adulteration of food items since it may be deadly for human when consumed. He pleaded with them to always put the wellbeing of the public first before thinking of hefty gains.

    Mr Francis Fiifi Essuman from the Agro Products and Biosafety Department of the FDA advised sellers to keep agro produce under the right condition to ensure its safety.

    Read:25 cartons of adulterated cosmetic products destroyed by FDA

    The market folks were also educated on the harmful effects of cigarette and tobacco, public smoking, abuse of tramadol and the dangers associated with buying medicines from peddlers.

    The Environmental Health Officers from the Ablekuma North Municipal Assembly also indicated the need to maintain environmental hygiene in the market to prevent breeding of rodents and other pests from contaminating their food items.

    Source: laudbusiness.com

  • FDA takes sample of alleged pig feed bread for testing

    The Eastern Regional branch of Food and Drug Authority (FDA) has begun investigation into allegation leveled against a 52-year-old woman for allegedly baking wheat bread with pig feed at Obomeng in the Kwahu South District.

    According to the District Environmental Officer, Welbeck Didza, the FDA on Wednesday took a sample of the said dough for forensic testing.

    Read:FDA detains 802 cartons of Lucozade, 2 arrested for changing expiry dates

    Information gathered by Agoo Fm news indicates that, the FDA after taken sample from the police also visited the wholesaler implicated in the matter at Nkawkaw where the suspect usually buys her goods from.

    Akosua Dwamena was arrested on Saturday 21st September 2019, for allegedly using Pig feed to bake wheat bread. The suspect has been supplying bread to some schools and other communities in the enclave for about 25 years.

    Read:FDA trains staff on food risk profiling and ranking

    Meanwhile, Madam Dwamena has denied all the allegations leveled against her insisting she deals in wholesome bread.

    According to her, this is a ploy by some neighbours just to bring her down after they allegedly threatened her following some misunderstanding. She was however confident the investigation will prove her innocence.

    Source: kasapafmonline.com

  • FDA issues directives on water labelling

    The Food and Drugs Authority (FDA) has issued new labeling guidelines to all commercial water producers in the country.

    From October 1, 2019, all bottled and sachet water producers are to ensure that all labelling information on both primary and secondary packaging should be the same.

    Read: FDA detains 802 cartons of Lucozade, 2 arrested for changing expiry dates

    Additionally, the name and contact details of the franchisee(s), where applicable, should be on the front of the pack or the principal display panel of the secondary and the primary package.

    The font size on the product label should be at least half the size of the largest font on the label.

    Read: FDA trains agro produce importers and facility operators

    The Chief Executive Officer of the FDA, Mrs Delese A.A. Darko, outlined the guidelines at a stakeholder engagement at the FDA head office in Accra last Monday.

    The engagement was for the FDA to interact with the stakeholders and discuss the way forward on the new directives.

     

    Source: Graphic.com.gh