NAFDAC and the GMP Mandate

pharmacy

The recent decision of the National Agency for Food and Drug Administration and Control (NAFDAC) to shut down six local pharmaceutical companies for non-compliance with its Good Manufacturing Practice (GMP) requirements is a step in the  right direction and deserves the commendation of all stakeholders in the industry.  NAFDAC’s Director General, Professor Mojisola Adeyeye, while announcing the closure in a statement made available to pressmen, said that the agency’s decision was in furtherance of its zero tolerance for circulation of substandard and falsified (SF) medicines in the country.

Adeyeye added, very importantly, that NAFDAC did all within its powers to avoid such a drastic measure by not only issuing appropriate notifications to the affected companies on the need to upgrade their facilities and production processes in line with extant requirements, but also demonstrating its readiness to help them achieve the objective.  Sadly, as the NAFDAC DG revealed, the companies rebuffed the agency’s gestures, with the belief that it was all huff and puff that would sooner or later fizzle out. As they have realised however, NAFDAC seems bent on keeping to its cardinal mandate of ensuring that both locally manufactured and imported pharmaceutical products consistently meet required product specifications for quality, safety and efficacy.

In the first place, it indeed beggars belief that any company manufacturing products as sensitive as medicines and other pharmaceuticals would wait to be hounded by NAFDAC before seeking to comply with its GMP stipulations. For the avoidance of doubt, GMP, as explained by NAFDAC and the World Health Organisation, is that part of quality assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by their marketing authorisations. The essence is to diminish the risks inherent in any pharmaceutical production and ensure that patients and the general populace are not placed at risk.

These laudable objectives of the GMP cannot and must not be compromised for any reason. Otherwise, the Nigerian health sector may relapse to the infamous pre-Akunyili era when fake and substandard drugs flooded the market and took a monstrous toll on the health and lives of many Nigerians.

While some may argue that the clampdown on the defaulting companies negates the nation’s pursuit of self-sufficiency in the production and provision of medicines to the generality of its citizens, it must be emphasised that safeguarding the health of the citizens is much more important than proliferation of local manufacturing companies. Moreover, it is in ensuring that quality standards are established and complied with that the citizens will have more confidence in locally manufactured products and other countries will associate Nigerian pharmaceutical products with quality. Therefore, while NAFDAC and other regulatory agencies are equally expected to be business-facilitators, it should be noted that the best way to facilitate and promote a business or an industry is make it known for consistent commitment to quality.

It is equally worth mentioning that NAFDAC has shown that its ongoing activities towards pharmaceutical manufacturing companies are not driven by sadistic inclinations but the desire to guide them on the path of total transformation, excellence and prestige. Indeed, as the agency disclosed, over 100 inspected facilities were found to be guilty of non-conformance with the GMP requirements. Yet, rather than wielding its sword of Damocles against them, it simply warned and encouraged them to come up with a plan of action, which the majority complied with. Moreover, the agency went ahead to sensitise manufacturers on the availability of Federal Government intervention funds from CBN to assist the health sector especially for local pharmaceutical manufacturers to upgrade their facilities and meet GMP requirements. These are highly progressive and commendable gestures.

We urge NAFDAC not to relent in its renewed campaign to rid the country of unwholesome medicines. It must vigilantly and determinedly continue with its surveillance on the activities of drug manufacturing companies and ensure that only medicines that are safe, efficacious and of good quality are accessible to Nigerians.  The agency must also continue to assist the local manufacturers in becoming paragons of excellence. Especially with Nigeria as the hub of pharmaceutical manufacturing in the West African sub-region, the pharmaceutical market must be thoroughly regulated and quality assurance activities must be consistently carried out to ensure that only the best are allowed to circulate.

We call on pharmaceutical manufacturing companies in the country to cooperate with NAFDAC in its drive to enforce quality compliance; they will be the ultimate beneficiary as Nigerians and foreigners become much more comfortable with buying made-in-Nigeria medicines. With the supportive posture of NAFDAC and the funds available from the CBN, both the six companies that have been temporarily shut down and others still in business can all join hands together with the agency to ensure that the Nigerian pharmaceutical industry is globally reputed for its unflinching commitment to good manufacturing practice.