The Structure And Function Of NAFDAC
The national agency for food and drug administration and control (NAFDAC) is a federal government agency under the federal ministry of health (FOH). The agency was formed in 1993 to checkmate illicit and counterfeit products under the country's health and safety law. The reason behind this is that there was infiltration of adulterated and counterfeit drugs in Nigeria. That started after so many deaths were recorded from fake or counterfeit drugs. Couple with the fact that the world health organization assembly in 1988 requested countries to tighten up their fight on fake and counterfeit products.
NAFDAC
In December 1992, NAFDAC governing council was formed. In 1993, supporting legislation was approved as legislative decree No. 15 of 1993. On January 1st, 1994, NAFDAC was officially unveiled as a parastatal of the FOH. This NAFDAC officially replaced the directorate of food and drug administration in the country which was considered ineffective. This was due to partly lack of laws concerning fake drugs.
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NAFDAC is responsible for control of the manufacture, importation, export, advertisement, distribution, sales and use of drugs, foods, cosmetics, medical devices, chemical and packaged water in Nigeria.
Function Of NAFDAC
NAFDAC has various basic functions. According to the requirements of its enabling decree, the agency was authorized to:
a. Regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of drugs, cosmetics, medical devices, packaged water and chemicals
b. Conduct appropriate tests and ensure compliance with standard specifications designated and approved by the council for the effective control of quality of food, drugs, cosmetics, medical devices, packaged water and chemicals.
c. Undertake appropriate investigation into the production premises and raw materials for food, drugs, cosmetics, medical devices, bottled water and chemicals and establish a relevant quality assurance system, including certification of the production sites and of the regulated products
d. Undertake inspection of imported foods, drugs, cosmetics, medical devices, bottled water, and chemicals and establish a relevant quality assurance system, including certification of the production sites and of the regulated products.
e. Compile standard specifications, regulations, and guidelines for the production, importation, exportation, sale and distribution of food, drugs, cosmetics, medical devices, bottled water and chemicals
f. Undertake the registration of food, drugs, medical devices, bottled water and chemicals
g. Control the exportation and issue quality certification of food, drugs, medical devices, bottled water and chemicals intended for export
h. Establish and maintain relevant laboratories or other institutions in strategic areas of Nigeria as may be necessary for the performance of its functions.
NAFDAC envisions that by making these functions known, that its actions will be apparent in all sectors that deal with food, cosmetics, medical devices, bottled water and chemicals to the extent of instilling extra need for caution and compulsion to respect and obey existing regulations both for healthy, living and knowledge of certain sanctions or default. Despite the establishment of NAFDAC, the sale and use of fake drugs did not end.
Function Of The Council
The Council shall-
a. Advise the federal government (FG) generally on the national policies on the control and quality specifications of foods, drugs, cosmetic, medical devices, bottled water and chemicals.
b. Designate, establish and approve quality specifications with respect to food, drugs, cosmetic, medical devices, bottle water and chemicals necessary for their certification.
c. Established the relevant guidelines and measures for quality control of food, drugs, cosmetic, medical devices, bottle water and chemical in conformity with the agency standard specifications.
d. Appoint, promote and discipline employees necessary for the proper discharge of their functions of the agency.
e. Established committee as may be explained which shall be charged with specific function, delegated by the council.
f. Established appropriate programmes for the quality, safety and rational use of food, drugs, cosmetic, medical devices, bottle water and chemical.
g. Encourage and promote activities related to this process, standard, specifications, guidelines on importation, sales and distribution of foods, drugs, cosmetic, etc.
h. Utilize and promote the expansion of research, experiment, surveys, and studies by public or private agencies, institutions and organisations concerning the quality, safety and use of food, drugs, etc and such other matters related to this act as the agency may from time to time determine as necessary or useful.
i. Established, encourage and promote training programme for the employees of the agency and other appropriate persons from public or private organisation and
j. Carry out such activity which are connected with it's other function
Structure Of NAFDAC
Chairman and council
“(NAFDAC) is headed by a chairman who presides over a governing council appointed by the president on the recommendation of the Minister of Health. ”Other council members are:
1. Chairman
2. The Permanent Secretary of the Ministry of Health
3. The Director-General of NAFDAC
4. Standard Organization of Nigeria (SON)
5. National Institute for Pharmaceutical Research and Development (NIPRD)
6. The chairman of the Pharmacists Council of Nigeria (PCN)
7. The chairman of the National Drug Law Enforcement Agency (NDLEA)
8. Representative of the Pharmaceutical Manufacturing Group of Manufacturers Association of Nigeria
9. Representative of the Food and Beverage Group of Manufacturers Association of Nigeria
10. Three Member
Three people from the general public are also represented on the council.
Directorate Of NAFDAC
a. An administration and finance director to be headed by a director who shall serve as the secretary of the agency
b. A planning research and statistics directorate to be headed by a director.
c. A narcotics and controlled substance directorate to be headed by a director
d. A regulatory and registration directorate to be headed by a director.
e. An inspectorate director to be headed by a director.
f. A laboratory service directorate as may be required for the proper performance of the function of the agency.
Several units make up NAFDAC
I. The Legal unit is charged with offering legal advice on “law arising from Employee-Employer relationship and is the custodian of legal documents and all agreements relating to the Agency."
ii. The Public Relations unit is headed by the director-general’s office. Its main function is to inform, sensitize, enlighten and create awareness concerning the role of the Agency. The agency is divided into eight directorates with the last two newly added.
iii. Internal Audit provides a means of measuring the effectiveness of the system of internal control and accounting, and carries out special investigations.
Establishment Of The Governing Council
Staffs Of The Agency
1. There shall be appointed for the agency by the president on the recommendations of the minister a director-general (DG) who shall be a person with good knowledge of pharmacy, food and drugs.
2. The DG shall be-
a. The chief executive of the agency
b. Responsible for the day to day administration of the agency and keep the books and records of the agency and
c. Subject to the supervision and control of the chairman and the council
3. The DG shall hold the office during a period of five years on such terms and conditions as maybe specified in his letter of appointment and be eligible for reappointment for another period of five years.
4. The council may from time to time appoint such other persons as members of staff of the agency as it may seem necessary to assist the agency in the person manxe of it's function under this act.
5. The member of staff if the agency appointed under subsection (4) of this section shall be appointed on such terms and conditions of service as the council may after consultation with the federal civil service commission determine.
6. The member of staff of the agency shall be public officers as defined in the constitution of the federal republic of Nigeria, 1999.
Tenure Of Office
1. A member of the council appointed, otherwise then by office, shall hold office for a term of four years and subject to the provision of subsection
2. Of this section shall be eligible for reappointment for only one further term of four years.
3. The office of a member of the council shall become vacant if-
a. He resigns as a member of the council by notice in writing under his handwriting addressed to the minister or
b. The minister is satisfied that it is not in the interest of the agency for the person appointed to continue in office and notify the member of the council in writing to that effect.
Removal from office of members of the council
1. If it appears to the council that a member of the council, other than an ex-officio member should be removed from office on the ground of misconduct or inability to perform the functions of his office, the council shall make a recommendation to the president
2. If the president after making such enquiries as he considers necessary approved the recommendation, the minister shall in writing declare the office of such a member vacant
3. Notwithstanding the provision of subsection (1) of this section, the president may remove any member of the council if he is satisfied that it is in the public interest to do so.
Removal And Discipline Of Senior Staff
1. If it appears to the council that there are reasons for believing that any person employed as a member of the senior staff of the agency, other than the DG, should be removed from office on grounds of misconduct or inability to perform the functions of his office, the council shall-
a. Give notice of those reasons to the person concerned
b. Afford the person an opportunity of making representation on the matter to the council in person
c. If the person concerned or any three members of the council so request within the period of four months beginning with the date of the notice make arrangements-
i. For a committee of the council to investigate the matter and to report on it to the council and
ii. For the person in question to be afforded an opportunity of appearing before and being held by the investigating committee on the matter.
2. If you council after considering the report of the investigating committee is satisfied that the person in question should be removed as aforesaid, the council may remove the person concerned by an instrument in writing sign on the direction of the council.
3. The DG of the agency may, in a case of misconduct by a member of staff which in the opinion of the DG is prejudicial to the interest of the council, suspend such member of staff and any such suspension shall forthwith be reported to the council.
4. For good cause, any member of staff may be suspended from office or his appointment will be terminated by the council and for the purposes of this subsection "good course" means-
a. Any physical or mental incapacity which the council, after obtaining medical advice, considers to render the person unfit for the discharge of the functions of his or
b. Conduct of a scandalous or other disrespectful nature which the council considers to be such as to render the person concerned unfit to continue to hold his office or
c. Conduct which the council considers to be such as to constitute failure or inability of the person concerned to discharge the functions of his office or to comply with the terms and conditions of his service
5. Any person suspended pursuant to this section shall be placed on half pay and the council shall before the expiration of a period of three months after the date of suspension consider the case against the person and come to a decision as to-
a. Whether to continue such person suspension and if so on what terms (including the portion office emoluments to be paid to him) or
b. Whether to reinstate such a person to his office on which case the council shall restore his full emoluments to him with effect from the date of the suspension
c. Weather to terminate the appointment of the person in question in which case such a person shall not be entitled to the portion of his emoluments withholding the period of the suspension or
d. Whether to take such lesser disciplinary action against such person (including the restoration of search portion of his emoluments that might have been withheld) as the council may determine
6. In any case where the council, pursuant to this section, decide to continue a person in suspension or decides to take further disciplinary action against a person, the council shall, before the expiration of a period of 3 months from such decision come to a final determination in respect of the case concerning that person
7. It shall be the duty of any person who signed the instrument of removal by virtue of this section to serve or cause to be served on the persons concerned, a copy of the instrument
8. Nothing in the foregoing provisions of this section shall prevent the council from making such regulations for the discipline of other categories of staff and workers of the council as it may seem fit.
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Removal And Discipline Of junior staff
1. If any junior member of the staff is accused of misconduct, inefficiency, the DG may suspend him for not more than 3 months and forthwith shall direct the matter to the junior staff appointment and promotion committee to-
a. Consider the case and
b. Recommendation as to the appropriate action to be taken by the DG
2. In all cases under the section, the junior member of the staff shall be informed in writing of the charges against him and be given reasonable opportunity to defend himself
3. DG may, after considering the recommendation made pursuant to subsection (1)(b) of this section, disniss, terminate, retire or downgrade the junior member of the staff concern
4. Any person aggrieved by the DG decision under subsection (3) of this section may, within a period of 21 days from the date of receipt of the letter commencing the decision to him, address a petition to the council to reconsider his case and the council's decision thereon shall be final.
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