Tag: NAFDAC

  • NAFDAC labs get international accreditation

    NAFDAC labs get international accreditation

    NAFDAC’s Mycotoxin and Pesticides Residues Laboratories in Oshodi, Lagos, have obtained the ISO 17025 accreditation. It was conducted by the American Association of Laboratory Accreditation.

    Director, Special Duties, Abubakar Jimoh, in a statement, described it as a major breakthrough for the agency.

    With the accreditation, the laboratories are recognised internationally.

    NAFDAC Director-General Dr. Paul Orhii said: “With the ISO 17025 accreditation of the two laboratories, agricultural exports tested and certified by the agency will now be accepted worldwide without query. This is a major boost to the country’s image and the agricultural transformation agenda of the Federal Government.

    “Products analysed for export purpose by the two laboratories will now carry a special logo.”

     

    Some other laboratories of the agency are undergoing international accreditation, which would boost current efforts to get some pharmaceutical companies to obtain World Health Organisation (WHO) pre-qualification. I thank the United Nations Industrial Development Organisation (UNIDO) and the American Association of Laboratory Accreditation for their support in attaining this great feat.”

  • NAFDAC, ICPC wage war on corruption in public service

    NAFDAC, ICPC wage war on corruption in public service

    THE National Agency for Foods and Drugs Administrative Control (NAFDAC) in partnership with the Independent Corrupt Practices and other related offences Commission (ICPC) has inaugurated a five-man anti-corruption committee to fight corruption in public service.

    The Anti Corruption and Transparency Unit (AC TU) is expected to assist the agency in the eradication of corrupt practices among staff.

    Speaking during the inauguration, NAFDAC’s Director General, Dr. Paul Orhii, said: “the unit is to assist the agency in the eradication of corrupt practices among staff, clients and other relevant stakeholders.”

    He assured the unit of continuous support.

    Orhii, who was represented by the Acting Director, Special Duties, NAFDAC, Mr. Abubakar Jimoh, said no efforts will be spared to rid the agency of corrupt practices.

    The chairman of ICPC, Ekpo Nta, also assured the committee of full cooperation.

    Nta, who was represented, by Mr. Gaji Barnabas, said: “We are more than ready to partner with you to make Nigeria Public Service the pride of our nation.”

     

  • Customs destroys  1,225  cartons of poultry

    Customs destroys 1,225 cartons of poultry

    The Nigerian Customs Service (NCS), Western Marine Command (WMC), Lagos, yesterday destroyed 1,225 cartons of contaminated poultry foods sized from smugglers.

    The Area Controller (CAC), Comptroller Audu Zaka, assisted by a representative of the National Agency for Food, and Drug Administration NAFDAC, Mr Adamu Isiaku and some other senior officers of the Command, supervised the destruction.

    Zaka said 55 bags of rice and 1,225 cartons of frozen poultry were seized in three days, adding that the total Duty Paid Value (DPV) of the intercepted items was N8, 576,844.50

    The consignments, he said, were smuggled into the country through Benin Republic to Awode Apa on the Nigerian side to Kese where the smugglers wanted to cross the Novo Creek to Ilasa in Ogun State.

    The feat, he said, was made possible because of the synergy with the Central Intelligence Unit (CIU) of the Command and the Comptroller-General’s Task Force.

    “The excellent information sharing between the command and the CIU is helping the command in its anti-smuggling functions. We monitored this consignment right from the border up to the point we intercepted them at Kese”, he said.

    Zaka said on October 31 and November 4, the Command intercepted 950 and 210 cartons of frozen poultry products, adding that the DPV was put at N6.175 million and N1.365 million.

  • Customs, NAFDAC, SON involved in ports corruption, says maritime chief

    All stakeholders, including importers, agents, Customs and other government agencies, such as National Agency for Food, Drugs Administration and Control (NAFDAC), Standards Organisation of Nigeria (SON) and Nigeria Immigration Services (NIS) are involved in corruption at the ports, according to Managing Director, Shibab Services, a freight forwarding firm, Mr Babatunde Shittu.

    When it comes to corruption, he said, agents were at the receiving end as they are seen to be driving graft at the ports.

    He said: “They (stakeholders) are all partners in business because the agents cannot do it alone. The importers cannot do it alone. Also, the agents cannot do it alone because they have to support or consult the Customs who have the power of final release of the consignment from the ports. Looking well at it, it is a joint effort of every one of them; they are in business together.”

    He noted that agents cannot be said to be dubious because the agent is working for someone. He said: “Agents alone cannot be said to be dubious because the agent is working for someone. Most of the importers are more dubious than the agents because the agents dance to the tune of the importer.

    “Some importers bring in consignments, devalue the invoice and want the agent to work with that invoice. The importer already wants to cheat the government in duty and at the end of the da, the agent is only a tool in the hands of the importer. Nobody will see the importer, they only see the middleman that is running around, that is the agent.

    “For instance, an importer gives an agent a job worth N100,000, but says he can only pay N50,000 knowing well that N50,000 cannot cover the job, but some agents jump at it and collect the money, but after sometime, they will come back for more money. “The importer would be forced to give the agent the money because you do not want your cargo to remain there.”

    Shittu pointed out that some importers who have done the valuation already and only want to use the agents to bribe the Customs and to bribe their way to get their consignments out of the ports adding that the agents and importers should be blamed in this case.

    He called on the relevant government agencies to collaborate with all the sectors in the industry to make ongoing port reforms successful. He also charged leaders of the various associations and agenciess to work with the Council for the Regulation of Freight Forwarding in Nigeria (CRFFN) to change the fortune of agents.

  • UI, NAFDAC partner on drug production

    UI, NAFDAC partner on drug production

    The Centre for Drug Discovery Development and Production (CDDDP) at the Faculty of Pharmacy of the University of Ibadan (UI) in collaboration with Reckitt Benckiser, United Kingdom, has organised a three-day international conference on medical regulation with the theme: “Medicine Regulation of claims: from concept to launch.’’

    The conference, which was held at Conference Centre of the university, provided a platform for academic, medical practitioners and regulators to chart a new course in medical regulation in the country.

    In her opening address, Dean of the faculty, Prof Chinedum Babalola, said the conference informed by the need to improve on the relationship between the academia and practitioners. She noted that the faculty has contributed to development of the pharmaceutical industry in the last 30 years.

    The Director General, National Agency for Food and Drug Administration and Control (NAFDAC), Dr Paul Orhii, said NAFDAC is not just a regulator, but a major player in the development of the nation’s pharmaceutical industry. He described the conference as historic.  He said that the regulatory body needed to partner with the academia became to improve the state of pharmaceutical practice in the country.

    He identified the prevalence of substandard drugs as the major challenge facing the agency, saying that the creation of pharmacovigilance and use of post market surveillance were needed to sustain the quality of drugs in Nigeria.

    The agency signed a Memorandum of Understanding (MoU) with the UI He said that Nigeria is producing less than 10 per cent of essential medicine for the growing population. He said the agency has invented Truscan to detect and wipe out fake drugs and other adulterated products in the country.

    Prof Moody, an investigator at Centre for Drug Discovery Development and Production (CDDDP), urged NAFDAC to collaborate with United States Pharmacopeia Centre in Ghana to win the war against fake drugs.

    The Managing Director, Reckitt Benckiser (West Africa), Rahul Murghai, lauded the commitment of practitioners to producing quality drugs and improve the health of the nation.

    The event was attended by Mr Aomesh Bhatt, Managing Director, Directorate of Regulatory and Medical Affairs, Reckitt Benckiser (Europe); Dr Soufia Hanna, Regional Director at Regulatory Afairs and Medical Services.

    Babalola thanked participants for making the event a success.

  • NAFDAC: Need for new legal framework

    Established by Decree No 15 of 1993 (as amended), now Cap NI Laws of the Federation of Nigeria 2004, the National Agency for Food, Drug Administration and Control (NAFDAC), is an appropriate response to a national crisis: the unwholesomeness in the entire gamut of Nigerian pharmaceutical and food production businesses. This explains why the law setting it up comprehensively mandated it to regulate as well as control the manufacture, importation, exportation, distribution, advertisement, sales and use of food, drugs, medical devices, cosmetics, chemicals and packaged water. The agency has since remained focused on, and committed to, meeting the aspirations of the country.

    However, after close to 20 years of its existence, it has become very obvious that a rethink of the law setting up the agency has become imperative if it must meet the expectations of Nigerians or contend with ever changing challenges of the domestic and global drug business. To appreciate the point being made, we need to take a critical look at the dynamics of the Nigerian drug business. Foreign-made pharmaceuticals account for 60 percent of drugs in the market with China and India as top exporters of these drugs. As much as 80 percent of all active ingredients in pharmaceuticals made worldwide come from either China or India, and these two countries are the prime suspects when it comes to bad drugs in the world. Deductively therefore, the bulk of counterfeit and fake drugs consumed by Nigerians come from China and India.

    There are redemptive measures particularly from India, which has a law that imposes life jail on both local exporters of unwholesome products and their foreign collaborators. NAFDAC’s effort at getting a similar law enacted by the National Assembly has not succeeded in getting the federal lawmakers to appreciate the imperative.

    The existing laws such as the Counterfeit, Fake Drugs and Unwholesome Processed Food (Miscellaneous Provisions Act (Cap C3 LFN 2004) and the Government of Nigeria Trade Practices (Miscellaneous Offences) Act No.67, 1992 (Now cap T12 LFN 2004) are too weak to serve the desired purpose. Emphatically, drug adulterators or fakers are serial “murderers” who deserve no less than capital punishment when caught, prosecuted and eventually convicted by the law courts. The existing laws do not have such force.

    Few instances of the inadequacy of the extant laws guiding the operations of NAFDAC will put in sharper perspective the thrust of this write up.

    On March 15, 2010 in Osogbo, the Osun State capital, one Afolabi Nurudeen, a baker, orchestrated an assault on Yedunni Adenuga, an Assistant Director and her team while on inspection of former’s bakery. He did that obviously to prevent the detection of the deadly and cancer-causing flour-enhancer, potassium bromate, outlawed by the agency in accordance with international health practice as part of the measures adopted to protect the mass consumers of bread in the country. Though the culprit was convicted by an Osogbo Federal High Court in the subsequent action filed against him by the agency in May 2011, his sentence, one year imprisonment with an option of N4, 000 fine, was a slap in the wrist. Section 25 (1) of the NAFDAC Act under which he was tried has proved inadequate to address the exigencies thrown up the unwholesome practices of criminally minded Nigerian businessmen and women.

    There is also the celebrated “My Pikin” – the children teething mixture saga of 2008. The agency successfully secured a court judgment against the producers of the deadly product on May, 17, after a protracted trial. Barewa Pharmaceutical Company, the producer of ‘My Pikin’ was directed to wind-up and its assets forfeited to the Federal Government. However, Adeyemo Abiodun, the firm’s production manager, and Egbele Eromosele, the quality assurance manager, bagged seven years imprisonment each for the two counts of conspiracy to sell dangerous drug and selling dangerous drugs. They were discharged and acquitted on the four other counts of adulteration, manufacturing and distribution of the killer drug. Again, in reaching the judgment, the trial judge relied on the provisions of the Miscellaneous Offences Act M17 Law of the Federation of Nigeria (2004).

    The extant laws are weak and inadequate. We reason within the context of the daredevilry of some criminally-minded players in the nation’s food and drug businesses. In their desperation, they can take any risk, especially when the existing laws are not considered serious deterrence against the crimes that would make then instant millionaires. For any meaningful progress to be made in the nation’s drive for the ideal healthcare delivery system and its pharmaceutical component, a total overhaul of NAFDAC Act has become necessary.

    The new legal framework template must take care of institutionalisation of special courts for speedy trial, stiffer penalties such as life sentences without any option of fine for offenders; making drug counterfeiting a non-bailable offence; outright confiscation of counterfeiters’ assets and their use as compensation for victims of the illegal business.

    This proposal might seem draconian, and human rights activists might cry blue murder. We should however understand that only those who fall foul of the law are the targets. More importantly, drug counterfeiting and faking give their victims no choice. They are deadly operators. There was once an attempt on the life of Professor Dora Akunyili in 2003. The suspects were set free after two years of trial on technicalities.

    The soul of the counterfeit drug business in Nigeria is the Bridge Head Market in Onitsha as teams of food and drug control experts move from shop to shop in search of counterfeit and substandard medicines. A successful one month siege on the market carried out by the agency in April 2007 harvested more than 80 truckloads of counterfeit drugs. The question to ask is after the siege, what followed.

    Nigeria must take a cue from the practical responses of India and China, the global capitals of counterfeit and fake drugs. While in China the offence attracts death penalty, it is life jail in India.

    Globally, it is said that a nation’s wealth is determined by the health of the mass of its citizenry. We urge President Goodluck Jonathan to empower NAFDAC, SON and Consumers Protection Council to carry out their statutory functions of protecting Nigerians from the consumption of unwholesome products.

    For NAFDAC, the processes within the strategic execution circle are well aligned to propel success. The only drawback is the legal framework which is too weak to support the current momentum drive by the Dr. Paul Orhii-led management. This should be corrected.

  • NAFDAC cautions against intake of toxic substance

    THE National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians about a toxic substance, Aflatoxins, found in maize, rice, groundnut, among others.

    The drug control agency, which has begun an awareness programme, in collaboration with the International Institute for Tropical Agriculture (IITA), said this became necessary in view of the dangers in the consumption of the fungus.

    The Director- General, NAFDAC, Dr. Paul

    Orhii, who was represented by the agency’s Director, Laboratory Services, Mrs. Stella Denloye, spoke in Ibadan, the Oyo State capital, yesterday at a workshop organised by NAFDAC, IITA and other international organisations.

    He said the toxin could cause liver cancer.

    His words: “Records have shown that there are efforts all over the world, directed at the introduction of preventive strategies to reduce the risks associated with Aflatoxin contamination and toxicity, particularly the incidence of liver cancer.

    “Elimination of Aflatoxins after serious contamination has proved difficult if not impossible. Therefore, prevention and mitigation strategies would need to be the focus for reduction of their presence to acceptable levels.”

    The Deputy Director-General, Partnerships and Capacity, Dr Kenton Dashiell, said Aflatoxin is a major food poison problem in Nigeria, stressing that it cannot be seen or touched and causes liver cancer.

    He went on:” We are meeting here today to sensitise the public and give farmers solution to the fungus, especially people, who process and store grains. With this, it will reduce Aflatoxins in our food.”

  • ‘NAFDAC does not witch hunt traditional healers’

    The decision to observe a Traditional Medicine Day was made by African health ministers in 2000 as part of a strategy to boost the role of traditional medicine in National health system. NAFDAC is using the opportunity of this year’s commemoration to showcase her efforts thus far and the resultant impact in promoting the use of safe and efficacious herbal medicines in Nigeria. I commend the efforts of our respected Traditional Medicine Practitioners towards ensuring that their products are listed with NAFDAC before they are distributed, sold and used in Nigeria.

    The use of Traditional medicines in Nigeria can be traced back to the earliest history of mankind, as in other cultures worldwide. Prior to the coming of orthodox medicines, Nigerians relied solely on traditional medicines for all their ailments, which included the use of herbal, animal and mineral based medicines often followed by spiritual ingredients such as incantations.

    With the level of sophistication, ease of use and effectiveness of orthodox medicines, it was no surprise that the use of traditional medicines enjoyed less acceptance and patronage over time.

    However, in recent times, there has been a reasonable and noticeable swing from the earlier bias in favour of orthodox medicine to greater acceptance of traditional/herbal medicines in many countries including Nigeria.

    The reasons for this trend include but are not limited to: Easy affordability of herbal medicines. Easy Accessibility. The highly publicised but erroneous claims of zero side effects. Global trend towards an increased use of herbal medicines.

    New diseases for which cures are yet to be found in orthodox medicine e.g. HIV/AIDS, Sickle cell disease and many viral diseases like Lassa fever.

    With this new trend, the need to ensure that only good quality, safe and effective herbal medicines are distributed and used became paramount to the Federal Ministry of Health. In furtherance of this, we have a burden of unauthorized advertisement of herbal medicines with unsubstantiated claims on cure of serious diseases with the intention to deceive unsuspecting members of the public.

    The National Agency for Food and Drug Administration and Control (NAFDAC) Decree No.15 of 1993 as amended, now Act Cap N1 Laws of the Federation of Nigeria (LFN) 2004 mandated the Agency to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, medical devices, cosmetics, chemicals and packaged water.

    The Drugs and Related Products (Registration etc.) Decree 19 of 1993, now Cap F33, LFN 2004, in Section 9 defined a drug to, “include any substance of vegetable, animal or mineral origin or any preparation or admixture thereof manufactured, distributed, sold or advertised for diagnosis, treatment, mitigation or prevention of any disease or disorder”.

    For successful implementation of the aspects of the mandate relating to herbal medicines, the Agency in collaboration with relevant stakeholders established:

    • Standards and guidelines for registration of herbal medicinal products in Nigeria.

    • National Advisory Committee on herbal medicinal products.

    • Regulations and guidelines for the regulation of herbal medicinal products.

    NAFDAC is discussing with stakeholders to ensure compliance. The Agency has banned illegal advertisements of herbal medicinal products and bogus claims of cure for disease conditions. Such advertisements contravene Section 2 of the Food and Drug Act. Cap 150 LFN 2004, which regulates and controls advertisement of medicinal products.

    Unpatriotic businessmen who engage in illegal advertisement of their products in the electronic and print media to mislead the unsuspecting members of the public are seriously warned to desist from such malpractice as the Agency will deal decisively with violators. The agency will work closely with National Broadcasting Commission to enforce compliance with the provision of relevant laws.

    Let me seize this opportunity to once again appeal to the Mass media to assist the Agency to address this anomaly. I urge you to insist on seeing an authentic NAFDAC approval before airing any advertisement on herbal medicines.

  • NAFDAC arrests fake importers of drugs

    The National Agency for Food and Drugs Administration and Control (NAFDAC) has arrested importers of counterfeit medicines and other regulated products.

    Briefing reporters in Lagos, NAFDAC Director-General Dr Paul Orhii said the counterfeit medicines and other such regulated products have serious health implications which can lead to death, serious health hazards and security risk to the environment.

    Those arrested  include Ndubuisi of Oke-Arin Market, Lagos, for illegal importation of packaging materials; Anthony in Sabon Gari, Kano for importing fake drugs and Okeke for importing large consignment of packaging materials for Vaseline products.

    Orhii said: “Also, a clearing agent was arrested for attempting to clear 40 packages of fake Tramadol capsules. Chidinnma from Onitsha and one Chioma (surname unknown) were arrested for importing fake Postinor 2 tablets. Aaron was arrested for importing illegal packaging materials for carrot white miracle serum.

    “One Chimezie was arrested for importing two large packages of aluminium caps for wine at the Nigeria Handling Company (NAHCO). Also arrested was Mr Adewale Alaka for illegal importation of packaging materials for bioclaire lightening body cream at NAHCO; One Oke was arrested for importing one large consignment of packaging material for Royal Stallion rice.”

    He said Clifford imported various unregistered pharmaceutical products which were intercepted at NAHCO.

    Orhii said a firm in Okota, Lagos imported fake caustic soda while another importer yet-to-be identified had his consignment from China intercepted at NAHCO.

  • Task force shuts 14 fake medicine stores 

    The Federal Capital Territory, FCT taskforce on counterfeit and fake  drugs has sealed off 14 illegal medicine stores in Karu and Jikwoyi area of the FCT.

    The FCT  Director of Pharmaceutical Services, Murna Kazzah who led the raid team said most of the pharmacies affected were operating illegally.

    She added that some of them were operating with expired license while some were selling drugs to the public without the relevant doctor’s prescription.

    Mrs Kazzah said the committee will not rest until such stores are sent out of the FCT.

    She said  a seven-member task force led by her has been constituted to monitor and stop the distribution of fake drugs in the Abuja  communities.

    Secretary to the Task Force Pharm Halima S.K. Ramon-Yususf said fake drugs include drugs with no active ingredients such as “chalk tablets standing in for paracetamol or Semovita and starch in capsule, drugs with insufficient active ingredients such as 20 percent instead of 95-105 percent, drugs without full name and address of manufacturers, drugs with ingredients different from what is stated on the label, expired drugs re-labeled with the intention of extending their shelf life, drugs not registered by NAFDAC and clone drugs.”

    She added that the effect of fake drugs were worse than the combined scourge of malaria, HIV/ AIDS and armed robbery put together because fake drugs kill en-masse, pointing out that they damage vital organs like liver and kidneys.

    She said in 1991 for example, reported cases from the UCH Ibadan and JUTH Jos shows that fake Paracetamol syrup killed 109 children in one day and advised consumers to protect themselves and their families from the harmful effects of using fake drugs.

    She urged those with expired licenses to come forward and revalidate their licenses after which their pharmacies will be re-opened.