By Prof Dora N. Akunyili, Director-General Nat. Agency for Food & Drug Admin. & Control(NAFDAC)
NAFDAC presence in the Ports is focused and purpose-driven, and that is to ensure that only safe and efficacious drugs, as well as wholesome foods, cosmetics, chemicals, medical devices etc, (also known as regulated products) are imported, or exported, through our Airports, Seaports and Land borders.
NAFDAC’s anticorruption efforts have yielded so much in terms of impact on the society because it is a collaborative effort involving all stakeholders, the government, as well as the common man.
Importation and exportation of fake/counterfeit, adulterated and substandard regulated products provide illegal benefits for the perpetrators at the expense of the populace, regulatory authorities, the manufacturing industries whose products are counterfeited and the nation as a whole. Fake/counterfeit drugs in particular pose a growing threat, especially to developing countries, where the most counterfeited medicines are those used to treat life-threatening conditions such as malaria, tuberculosis and HIV/AIDS. We are all aware of the state of the nation in the pre-2001 era when we had ineffective regulation in comparison with what obtains in the present dispensation. Back then, the Ports Reforms Decree No. 61 of 1999 excluded NAFDAC as one of Government Agencies in the Ports. NAFDAC inspectors then relied only upon invitation from the Nigeria Customs Service to carry out their regulatory duties at the Ports. This, coupled with the inadequate number of regulatory officers on ground with very poor motivation and little supervision, opened the way for the unchecked influx of fake, unwholesome and adulterated food, drugs, cosmetics and other products into the country.
Nigeria then became the dumping ground for all sorts of unwanted things and the merchants of death made merchandize of the unsuspecting public for several yeas running. This resulted in, among others:
- High treatment failure rate and death of patients
- Loss of confidence in the quality of Made-in-Nigeria products
- High incidence of food borne diseases.
This situation informed the President directive in October 2001 that NAFDAC be returned to the ports. The fight against the importation, distribution and use of fake and unwholesome regulated products just took on a new dimension, and till today, is far from being over.
It is common knowledge that most of the fake, adulterated and substandard drugs, foods and other regulated products have come and still do come into the country through the ports. We all are aware of the following cases of imports:
(1) Fake drugs falsely manifested as used engines, spare parts, sanitary wares etc
(2) Expired or about-to-expire drugs usually sent as donated items
(3) Placebo compounded and labeled as life-saving, prescription drugs which upon analysis are found to contain little or no active ingredients.
(4) Clones of fast moving goods made in China or India and labeled as “Made in Nigeria’ made in the country whose production site has been certified by NAFDAC
(5) Products defying rules of origin and brought in through the land borders as made in ECOWAS countries
(6) Prohibited or banned goods e.g. frozen poultry in refrigerated containers manifested as used machinery, or sand imported as Corn Starch
(7) Packaging materials, labels etc of foreign finished goods meant for made-in-Nigeria products e.g. packets and empty bottles of designer perfumes imported into Nigeria and filled locally with diluted concentrates; printed packets of imported fast moving drugs imported into Nigeria and used to re-pack expired, fake or substandard drugs.
(8) Drugs concealed in T-shirts, or hidden behind sanitary wares, or household furniture etc.
(9) Regulated products of commercial quantities imported as personal effects,
(10) Expired or unwholesome food having their shelf lives extended and date marking altered to deceive the unsuspecting consumers.
(11) Unregistered products imported with fake NAFDAC Registration numbers, etc.
Faced with these challenges, the Agency was repositioned with the emergence of, among others, the Ports Inspection Directorate saddled with the specific mandate of carrying out the Regulatory functions of the Agency at the Sea Ports, Airports, Land borders, bonded warehouse and inland container terminals.
These functions were streamlined into operational responsibilities at the various ports of entry and include:
(i) Documentation and Endorsement of SGD forms
(ii) Physical/Customs Examination, Release of Regulated products at the ports of entry
(iii) Sampling of products for laboratory analysis
(iv) Export Certification for regulated products and semi-processed food commodities
(v) Surveillance/Monitoring of containers of fake or adulterated products.
The NAFDAC Mandate
The National Agency for Food and Drug Administration and Control (NAFDAC), was established by Decree No 15 of 1993 (as amended), to control and regulate the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, chemicals/detergents, medical devices and packaged water including all drinks (referred to as regulated products). The scope of this mandate puts the responsibility of safeguarding public health on the Agency, and this touches on the life of every Nigerian.
Roles and Functions of NAFDAC
The roles & functions of the Agency are specified in Section five of the establishing Decree, with relevant amendments, as follows;
1. Regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, bottled water, detergents and chemicals (Regulated products)
2. Conduct appropriate tests and ensure compliance with standard specifications designated and approved by the Council for the effective control of the quality of Food Drugs, Cosmetics, Medical Devices, Bottled Water, Detergents and Chemicals and their raw materials as well as their production processes in factories and other establishments
3. Undertake appropriate investigations into the production premises and raw materials for food, drugs, cosmetics, medical devices, bottled water, detergents and chemicals and establish relevant quality assurance systems, including certification of the productions sites and of the regulated products.
4. Undertake inspection of imported food, drugs, cosmetics, medical devices, bottled water, detergents (as well as their raw materials & packaging materials). and chemicals and establish relevant quality assurance systems, including certification of the production sites and of the regulated products.
5. Compile standard specifications and guidelines for the production, importation, exportation, sale and distribution of regulated products
6. Undertake the registration of the regulated products.
7. Control the exportation and issue quality certification of regulated products intended for export.
8. Establish and maintain relevant laboratories or other/institutions in strategic areas of Nigeria as may be necessary for the performance of its functions under this Decree.
9. Pronounce on the quality and safety of regulated products after appropriate analysis
10. Undertake measures to ensure that the use of narcotic drugs and psychotropic substances are limited to medical and scientific purposes.
11. Grant authorization for the import and export of narcotic drugs and psychotropic substances as well as other controller substances.
12. Collaborate with the National Drug Law Enforcement Agency in measures to eradicate drug abuse in Nigeria.
13. Advise Federal, State and Local Governments, the Private Sector and other interested bodies regarding the quality, safety and regulatory provisions of regulated products.
14. Undertake and coordinate research programmes on the storage, adulteration, distribution and rational use of regulated products.
15. Issue guidelines on, approve and monitor the advertisement of regulated products.
16. Compile and publish relevant data resulting from the performance of the functions of the Agency under this Decree or from other sources
17. Sponsor such national and international conferences as it may consider appropriate.
18. Liaise with relevant establishments within or outside Nigeria in pursuance of the functions of the Agency
19. Determine the suitability or otherwise of medicines, drugs, food products, cosmetics, medical devices or chemicals for human and animal use; and
20. Carry out such activities as are necessary or expedient for the performance of its functions under this Decree.
There are several other laws and decrees that give the Agency the legal muscle to effectively carry out its various activities. These include;
1. The Food and Drug Act Chapter 150 of 1976 (as amended by Decree No 21 of 1999), an Act to make provisions for the regulation of the manufacture, sale and Advertisement of food, drugs, cosmetics and medical devices and repeals the existing state laws on those matters.
2. Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous provisions) Decree 25 of 199. This decree prohibits the production, importation, manufacture, sale and distribution of any counterfeit, adulterated, banned or fake, substandard or expired drug or unwholesome processed food, in any form whatsoever. The decree also prohibit, any person from hawking or selling or displaying for the purpose of selling, or aiding and abetting any person to hawk, sell or display for sale any drug or poison in any place not duly licensed or registered by the appropriate authority, including any market, kiosk, motor park, road side stall or in any bus, ferry or any other means of transportation.
3. Drug and Related Products (Registration, Etc) Decree No. 19 of 1993 (as amended by the Food, Drugs and related Products Decree No 20 of 1999) prohibits the manufacture, importation, exportation, advertisement, sale or distribution in Nigeria of any processed food, drug, drug product, cosmetic, medical device or water unless it has been registered in accordance with the provisions of this decree or regulation made under it.
Operations at the Ports
The Agency has well documented Standard Operational Procedures (SOPs) and guidelines for operational – activities at the various sections of the Agency’s Port Operations. These include:
(a) Pre-Importation Requirements
The banks are expected to request for valid NAFDAC product registration certificate for all regulated products from intending importers before opening.
(b) Documentation and Endorsement of SGD Forms
At the port offices, SGD forms for regulated products (i.e. food, drugs, cosmetics, medical devices, detergent, bottled water and chemicals) are vetted before issuance of pre-release stamps. For the pre-release stamps to be issued, the following documents are to be submitted to the vetting officer
i. The SGD form
ii. The clean report of inspection, (now Risk Assessment Report (RAR)
iii. Form M
iv. Bill of Lading
v. Evidence of valid Product Registration with NAFDAC
vi. Certificate of analysis of product (original)
vii. Certificate of Manufacture and free sales issued by the Regulatory Authority in the country of origin
viii. Packing list
For pharmaceutical products, in addition to the list above, the following are also required.
(i) Pre-shipment information-a letter giving full details of the import to the Agency by the importer
(ii) For Pharmaceutical products from India, China and Egypt, NAFDAC Consultants in these countries must issue quality certificates known as Clean Report of Inspection and Analysis (CRIA) giving details of batches of the imports already analyzed
© Physical Examination and Release of Regulated Products
Officers in the field offices participate in the physical inspection of all imports at the ports of entry. Physical examination involves assessing all visible parameters that can attest to the wholesomeness of the product, the integrity of the containers, registration of the product, conformity to labeling requirements – (i.e. are the labels in English, and do they have the basic requirements such as the name of product, manufacturer’s name and address, batch No, date of manufacture and expiry dates? Are the products blown, leaking, soaked, compressed or showing any signs of deterioration?).
If all these are satisfactory the physical examination is adjudged to be satisfactory and a report is forwarded to the port head for further action.
(i) Regulated Products after inspection are sampled for laboratory analysis
The analysis is to ensure conformity with set standards. The products are then recommended for Customs release by the officer in charge of the field office
(ii) The field offices of PID act as the main link between the Agency and other government agencies, such as Customs, NPA, SON, etc
(iii) The field officers monitor the shipping manifests supplied by the shipping companies to checkmate false declaration
(iv) All import violations are sent to the Port offices for sanctions and administrative penalties.
(d) Export Certification
All regulated products for export must be certified by the Agency. The Export Unit of PID is involved in the inspection and certification of products for export.
For registered regulated products with current Good Manufacture Practices (GMP) certificate, the export certificate is issued without further analysis. For semi processed food commodities such as Ogbono, Egusi (melon?) the products are sent to the laboratory to ensure that the level of contaminants such as aflatoxins are within acceptable limits before the products are certified. This is also to ensure that products meet acceptable standards at the country of entry.
Two types of certificates are issued; certificate of manufacture and free sales for food, cosmetics, medical devices and certificate of pharmaceutical product (COPP) for drugs.
The NAFDAC Challenge
The responsibility of safeguarding the health of the nation by ensuring that only safe, efficacious and wholesome food, drugs, cosmetics etc are imported, exported, sold and used in the country is a collective responsibility which must not to be left to NAFDAC alone.
NAFDAC therefore extends the challenge to all stakeholders within and outside the ports community to assist in the fight for our common good. Only through multi-sectoral collaborative efforts of all and sundry will we achieve the synergy needed to eradicate this evil from our land:
(1) FALSE DECLARATION OF MANIFESTS: To date, drugs are still being declared as toys or auto spare parts and with the active participation of officers of some government agencies, these falsely declared goods are cleared at the ports.
(2) IMPORTATION OF SUBSTANDARD REGULATED PRODUCTS
It is amazing that Nigerians still travel abroad to effect the manufacture, importation and clearance of about-to-expire unwholesome, fake and sub standard regulated products/or immediate personal gain, not minding the long term effect of their actions on the common Nigeria. WE CALL ON THE POPULACE TO ALERT NAFDAC about such wicked activities through the various communication channels.
(3) EVASION OF EXPORT CERTIFICATION
Most of the exporters freight their regulated products without proper certification by NAFDAC. In most cases, these products end up being rejected on the grounds of quality by the importing countries at the point of entry and are either destroyed or returned to Nigeria. Apart from the economic loses incurred, these products stand the risk of being blacklisted in international commerce. The Agency has been inundated with Rapid Alert Notices from the European Union and other developed countries over Nigerian food products rejected at the borders on grounds of poor quality, high afflatoxin content, unacceptable percentage of non-permitted substances, additives, colorants, metallic contaminants etc. With appropriate cooperation and a determination to go through due processes, this embarrassment can be reduced significantly.
(4) ILLEGAL TRANSFERS/RELEASE OF REGULATED PRODUCTS VIA BONDED WAREHOUSES
Many importers with the active collaboration of some government agencies are involved in illegal transfers of containers of unregistered regulated products. Such products never end up at the designated bonded warehouses, but end up being smuggled without inspection. The evil effects of these clandestine, get-rich-quick tendencies sometimes get around to the perpetrators and their families long after the immediate gain of a fast business have been forgotten.
In pursuance of its avowed determination to eradicate fake and counterfeit drugs,
NAFDAC has destroyed about N10billion of fake drugs and substandard products in the
last 4 years. The Agency has similarly gotten about 50 fake drugs offenders convicted in
various courts within the same period.
Further, between January and June, 2006 alone, the Ports Inspection Directorate has apprehended and seized unwholesome and substandard drugs and other regulated products worth over N2billion! These are majorly life-saving drugs prescription only (ROM’s) medicines and thermolabile biological whose cold Chain have been broken in transit. Most of these products were either abandoned by the importer on arrival or apprehended at the exit after they may have been released by the authorities. For a full account of these reports, please visit our website: www.nafdacnigeria.org/pressstatements.
RECOMMENDATION AND CONCLUSION:
1. These modest achievements have only been possible because our officers enjoy the goodwill of some government Agencies and the general public in fight to rid the country of fake and unwholesome drugs and other regulated products. NAFDAC therefore solicits the collaboration of the Ports Industry Anti-corruption Committee in this regard. Any case of taking or adulteration should be reported to the agency.