The recent recall of all batches of ZAHA Suspension, an essential antibacterial drug manufactured by India’s Ajanta Pharma Ltd, over quality failures is a critical action to protect public health.
While this swift response by the National Drug Authority (NDA) is commendable and vital to catch what slips through the cracks, it should not be our primary line of defence. There is a need to strengthen interventions to prevent importation and the entry of substandard drugs into the market.
According to an October 16 statement by NDA, during routine post-market surveillance, their teams sampled the ZAHA Suspension and found that the bottles were overfilled with no space for shaking the suspension to ensure uniform dosing.
This headspace for shaking the suspension prior to dosing is a critical step to ensure uniform distribution of the active pharmaceutical ingredient.
NDA indicated that the product was creaming, some bottles did not have powder suspended, and the leaflet does not indicate the physical appearance of the product at normal storage conditions.
This is not the first time NDA is recalling a medical product. Between 2020 and 2022, there were about 48 product recalls, with 2020 alone having 27 recalls. Some, if not most, of the recalls are made when many patients are already affected.
These procedures are intended to protect the health of the consumer from harmful effects which may be caused by the use of unsafe, ineffective or poor-quality medicines and other medical products, in line with National Drug Policy 2000 sec.3.6.
The recalls are often made following verified reports of serious adverse reactions not stated in the package insert, unacceptably high frequency of adverse reactions which are mentioned in the package insert, incorrect labelling, and incorrect formulation.
For this ZAHA Suspension, fresh information obtained by Weekend Monitor from NDA, indicates that the recall of all batches was a scaling up of the initial October 16 directive issued by the NDA secretary, Dr David Nahamya, to the local technical representative Abacus Pharma (A) Ltd, which targeted particular batches of the drug.
Mr Abiaz Rwamwiri, the NDA spokesperson, told this newspaper that through deeper investigations, they later discovered the problem was bigger, hence recalling all batches of the drug.
All costs associated with the recall of a product will be for the account of the importer, according to NDA guidelines. Any costs associated with NDA recall-related activities (such as recall announcements, storage, disposal/destruction) will be invoiced to the importer, NDA states further.