PCN Tightens Regulations, Enforcement against Medicine Vendors

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– Begins proceedings for closure of open drug markets

Registrar, Pharmacy Council of Nigeria (PCN) Pharm. Ahmed Babashehu

Towards curtailing the activities of patent and proprietary medicine vendors who had mostly operated without consideration for the extant laws guiding the practice, the Pharmacy Council of Nigeria (PCN) says it has set machineries in motion to arrest illegal operators, shops, as well as licensed vendors that are operating outside the scope of their licence.

The PCN Registrar, Pharm. Babashehu Ahmed, made the disclosure to Pharmanews in an exclusive interview, saying that the council, in collaboration with the Coordinating Minister of Health and Social Welfare, Prof. Muhammad Ali Pate, had begun proceedings to shut down open drug markets in Lagos, Anambra, and Abia states.

Ahmed noted that, aside from the disturbing operations of illegal medicine dealers, there are many licensed patent medicine stores who are violating the Pharmacy Act of 2022, which stipulates, among other conditions for the storage and dispensing of ethical drugs, that such must be under the supervision of a pharmacist. This, he said, is a major reason why the renewed enforcement drive is necessary, as it will help to further curtail the excesses of the vendors.

Article 59 of the PCN (Establishment) Act, 2022, states that “(i) Ethical drugs shall not be stored, supplied, sold, offered to be sold or dispensed by any person unless under the direct supervision of a licensed pharmacist. (ii) A person shall not store, supply, sell or dispense dangerous drugs unless — (a) he is a licensed pharmacist; (b) the drug is in a container of the prescribed description; and (c) the container bears a label indicating the prescribed particulars of its contents”.

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In reference to the stipulations, the PCN registrar said, “As you may be aware, the PCN is embarking on a reform of the Patent and Proprietary Medicine Vendor License (PPMVL) regulation, as well as enforcement. In this regard, necessary regulatory mechanisms, such as strengthened inspectorate activities, monitoring exercises and well-guided enforcement exercise, have been rolled out to checkmate existence of illegal vendors, shops, as well as licensed vendors that are operating outside the scope of their licence”.

On the efforts of the Council in curbing unethical practices among pharmacists, especially dispensing of prescription drugs without a doctor’s prescription, the registrar revealed that the Council is mulling the development and implementation of a National Prescription Policy, which, he assured, will address the matter headlong.

He said, “The Federal Ministry of Health, in its strategic vision for the health sector renewal, is desirous of development and full implementation of the National Prescription Policy. To this end, the Hon. Minister of State for Health, Dr Tunji Alausa, has directed the Food and Drug Department of the Ministry to coordinate this activity along with all the relevant stakeholders”.

The PCN registrar also informed Pharmanews of the progress achieved by the Council in closing down the Kano open drug market, saying over 90 per cent of the traders have been successfully relocated to the Coordinated Wholesale Centre (CWC). “The centre is now becoming a beehive of activities,” he added.

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Ahmed specifically disclosed that, during the Kano operation, a total of 1,321 shops were sealed, with the development signalling compliance with the National Drug Distribution Guideline. He commended the security agencies for their support throughout the exercise and even beyond.

He added: “I am pleased to inform you and the general public that following the recent success story in Kano, the Hon. Coordinating Minister of Health and Social Welfare has formally forwarded a letter dated 11 March, 2024, to the Executive Governors of Lagos, Anambra and Abia State to support the expeditious establishment of CWCs in their states.

“Following that, the Pharmacy Council of Nigeria has also forwarded letters to the various chairmen of the Special Purpose Vehicle for the establishment of the CWCs in Lagos, Anambra, and Abia States on 2 April, 2024. The PCN, by the letter, requested the chairmen to provide update on the project at the various locations within two weeks, from the date of the letter, to enable the registrar brief the Hon. Coordinating Minister accordingly for further necessary directives.

“Certainly, the health sector renewal agenda of the current administration reinforces the full implementation of the National Drug Distribution Guideline. The broader strategic goal of the Federal Ministry of Health and Social Welfare in this is to significantly diminish the presence of falsified, counterfeit, and poor quality pharmaceutical products and other medical consumables along the healthcare value chain through the establishment of CWCs.”

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Ahmed further revealed that the council is not resting on its oars in tackling sales of fake drugs online, saying the PCN has fully commenced issuance of licence to operators of online platform for sales of medicines. He added that anyone without the licence is not qualified to sell medicines online.

The registrar cited how the Council, through the help of the Interpol, recently arrested the operators of an illegal online platform that was advertising a GSK product.

According to him, “We received a report of an online platform that was advertising the product of GSK. Using the enforcement platform for online registration which is the Interpol, the said online platform operators were invited and handed over to Interpol for further necessary action.

“Let me at this point inform you that PCN has fully commenced issuance of licence to operators of online platform for sales of medicines. The online Pharmacy Regulations of PCN has undergone a review with stakeholders, with support from Salient Advisory, Society for Family Health, PSN Foundation and EPharmacy4FP.”

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