The National Agency for Food, Drug Administration and Control (NAFDAC) has shut down six local manufacturers of finished pharmaceutical products (FPPs) for promoting fake drugs by failing to meet minimum Good Manufacturing Practice standards in line with extant requirements
Director-general of NAFADC, Prof Mojisola Adeyeye, who gave the hint, said the agency’s decision to shut down the pharmaceutical companies was in furtherance of its zero tolerance for circulation of Substandard and Falsified (SF) medicines in the country.
She noted with dismay that these local manufacturers, in spite of appropriate notification, failed to meet minimum Good Manufacturing Practice (GMP) standards in line with extant requirements, which are required to ensure the quality, safety and efficacy of pharmaceutical products.
Adeyeye, however, maintained that the companies would remain shut until the respective GMP compliances are met.
According to her, the actions are to serve as deterrent to all local and foreign manufacturers who may not want to comply with basic GMP requirements.
She stated: “NAFDAC in its current effort and relentless drive to address the challenges of Substandard and Falsified (SF) medicines in Nigeria recently blacklisted a foreign manufacturer of finished pharmaceutical products (FPPs) and delisted its local representative for gross violation of NAFDAC extant laws and regulations.
“NAFDAC owes the nation the responsibility of safeguarding public health and will not back track in ensuring that only medicines that are safe, efficacious and of good quality are accessible to the Nigerians”.
There had been growing concerns over circulation of fake and substandard drugs in the market.
Last month the Pharmacists Council of Nigeria (PCN), had threatened to shut down open drug markets in Onitsha, Aba and others across the country for non-compliance to the National Drug Distribution Guidelines (NDDG) policy.
PCN Registrar, Dr Elijah Mohammed, had said the closure of the drug markets became necessary following violations of drug distribution policy.
He explained that the policy provided for the relocation of the open drug markets to a Coordinated Wholesale Centres (CWCs).
The PCN boss said that a lot of emphasis was placed on operators of open drug markets being the biggest players in the NDDG framework.
He said so far, PCN has registered several Mega Wholesale centres and they have also fully commenced operations.
Mohammed identified the markets as a major of source of fake and falsified medicines and other health related products.
“Open Drug Markets are unregulated open markets where professionalism have no place as medicines are sold in shops and stores not duly registered.
“The conditions and the environment are not in tandem with approved guidelines for drug distribution. There are no pharmacists to oversee the operations and ethical practices,” he said.
Mohamed noted that the operations have major negative impact on the health of the citizens.
“Existence of the markets also has its impact on the pharmaceutical sector as it contributes to the chaotic drug distribution with negative impacts on the economy.
“It is a common fact that where faking and falsification exists, the growth and development of the local pharmaceutical industry will be severely affected,” he said.
The registrar explained that CWCs are facilities registered by the PCN for purposes of drug distribution within the framework of the NDDG.
“It will operate under the direction of a Superintendent Pharmacist and with a designated number of subsidiaries to be manned by distribution managers.
“The PCN and NAFDAC being the regulators will have offices in the facilities to ensure compliance with regulations,” he said.