–As PMGMAN throws it weight behind NAFDAC
More revelations have begun to emerge about events that led to the closure of the six pharmaceutical companies’ recently shutdown by the National Agency for Food and Drug administration and Control (NAFDAC), as the agency exposed the defaulting companies’ degree of noncompliance to Good Manufacturing Practice (GMP).
In an exclusive interview with the Director General, NAFDAC, Prof. Moji Adeyeye, she explained how the affected companies had been served notice of upgrading of their facilities for almost two years without their acknowledgement of the notice nor submission of action plan for the correction of defects.
She has however warned concerned facility owners to desist from every attempts to reopen the companies without necessary approval, as that will lead to permanent closure, de-registration, blacklisting and prosecution.
In the same vein, the Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMGMAN) has distant itself from the defaulting companies, saying the health of the nation is paramount to the regulatory agency than sentiments.
PMGMAN Chairman, Pharm. Fidelis Ayebae in a telephone interview with Pharmanewsonline, said he has no sympathy for affected companies because pharmaceutical business is not a child’s play to be toyed with.
“NAFDAC has the right to close down any company that fails to comply with GMP guidelines. That is why I may not be sympathetic with pharma companies which failed to go by GMP rules”, he stressed.
The agency via a statement on 28 December, 2020, had announced the temporary closure of six pharmaceutical companies for their failure to comply with Good Manufacturing Practice (GMP).
Adeyeye further disclosed that the initial audit conducted by the agency early 2019 had identified fifteen companies producing drugs in substandard facilities, but after an enlightenment workshop for concerned management, nine of them braced up and commenced action plans to improve, while the conditions of the remaining six deteriorated beyond measures.
“The defaulters were notified in the early 2019 to submit a plan of action within 30 days targeted at addressing non-conformance observed during the nationwide audit of all manufacturers in 2018/2019. There was no response from the companies. Fifteen companies fell into the category.
“In order to understand how to address the non-conformance, NAFDAC conducted a training in mid-2019. The plan of action was to demonstrate their commitment to Good Manufacturing Practice (GMP) corrective and preventive actions (CAPA) on both capital intensive and non-capital-intensive deficiencies.
“The main issue was that the defaulting companies did not acknowledge nor respond to the official notification issued to them despite the fact that all manufacturers were trained on how to address the non-conformances. Recently, in September 2020, the fifteen companies were re-inspected to assess their effort at addressing the previously observed deficiencies only to discover further decline into non-compliance in the six companies, hence the agency was left with no option than to close down the facilities until they are ready to meet extant requirements”, she narrated.
The NAFDAC boss who declined in mentioning the names of defaulting companies until a future date, noted that the agency keeps surveillance on any closed facility through various unannounced and discreet routine visits for compliance monitoring.
More so, she stated that the companies have already signed written agreement with the agency why they must not violate closure order as the consequences outweighs the temporal closure sanction.