…Opposes Weakening Pharmacy Regulations
By Haruna Salami
The Pharmaceutical Society of Nigeria (PSN) has urged the National Assembly to impose tougher penalties on counterfeit drug offenders, proposing fines of up to N125 million, prison terms of up to 20 years and forfeiture of assets linked to their crimes.
The society also cautioned against proposed changes to the Governing Council of the Pharmacy Council of Nigeria (PCN), warning that reducing professional representation without adequate safeguards could weaken regulation and expose Nigerians to public health risks.
The PSN National President, Pharm. Ayuba Ibrahim Tanko, made the recommendations in submissions at a two-day public hearing on proposed amendments to the PCN law and the Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Act.
On the bill seeking to reduce the PCN Governing Council’s membership, identified as SB-1000, the society said the council’s composition must preserve the expertise required for pharmacy education, accreditation, inspection, professional discipline and enforcement of standards.
It argued that effective regulation requires representation from community and hospital pharmacy, pharmaceutical industries, academia, state pharmaceutical authorities and pharmacy technicians.
The PSN proposed a dedicated seat for its national president, noting that the society has more than 50,000 pharmacist members. It also recommended rotational representation of Directors of Pharmaceutical Services from the six geopolitical zones and academic representatives nominated through the Committee of Deans of Pharmacy in Nigerian Universities (CODAPNU).
Other proposed members include representatives of pharmacy technicians, the Federal Ministry of Health and Social Welfare, the National Institute for Pharmaceutical Research and Development (NIPRD), the National Agency for Food and Drug Administration and Control (NAFDAC), and the Nigeria Natural Medicine Development Agency (NNMDA).
The society said the proposed structure should balance professional expertise, public accountability and efficient decision-making.
It also expressed reservations about the proposed six public representatives on the council, recommending minimum competence requirements in areas such as public health, law, finance or consumer protection. It maintained that any reduction in membership should not undermine the council’s technical capacity or federal character.
Although the PSN acknowledged the need to reduce administrative costs, it warned that inadequate regulatory capacity could weaken pharmaceutical inspections, compromise medicine quality and allow illegal operators to thrive.
The society urged lawmakers to assess the PCN’s operational needs, workload, funding and enforcement resources before finalising the proposed changes.
PSN Proposes Tougher Fake Drug Penalties
On SB-951, which seeks to amend the law on counterfeit drugs and unwholesome processed foods, the PSN proposed a fine of at least N125 million, imprisonment of between five and 20 years, or both, for offences under Section 1. It also recommended forfeiture of assets linked to convicted offenders.
For offences under Section 2(1), it proposed a minimum fine of N25 million, imprisonment for at least 15 years, or both, alongside asset forfeiture.
The society said the proposed sanctions would strengthen deterrence against the manufacture, distribution and sale of counterfeit medicines and unsafe processed foods.
It also called for a reorganisation of the federal and state task forces responsible for enforcing the law.
For the Federal Task Force, the PSN proposed the Director-General of NAFDAC as chairman and the head of the PCN’s enforcement department as vice-chairman. Other members would include senior police officers, pharmaceutical inspection officers, NAFDAC food and drug inspectors and a PSN representative who is a pharmaceutical inspection officer designated under the PCN Act 2022.
For the State Task Force, it recommended a registered pharmacist not below the rank of director as chairman, appointed by the minister on the recommendation of the relevant state government. The PCN enforcement chief would serve as vice-chairman, alongside two police officers not below the rank of Chief Superintendent of Police.
The society said the proposed structure would strengthen coordination among regulatory and law enforcement agencies in tackling the production, distribution and sale of fake medicines.
However, effective implementation would require clear responsibilities, adequate funding and coordination between federal and state authorities to avoid overlapping mandates.
Seeks Harmonisation of Health Laws
The PSN further urged lawmakers to harmonise amendments to health regulatory laws to prevent conflicting standards, unclear jurisdictional boundaries and duplication of responsibilities.
It advocated consistent governance standards, clear professional responsibilities and collaboration among regulatory bodies.
The society maintained that reducing the PCN Governing Council’s membership would not automatically weaken regulation, just as a larger council would not necessarily guarantee effective oversight. What matters, it said, is the quality of professional representation, efficient decision-making and adequate enforcement capacity.
Similarly, it argued that tougher penalties would have the desired impact only if offenders could be detected, prosecuted and punished consistently.
The National Assembly, therefore, faces the task of balancing administrative efficiency with professional expertise, effective enforcement and public health protection in considering the proposed amendments.
