Batch variation has implications for developing world

By Nick Taylor

- Last updated on GMT

Related tags Pharmacology Us food and drug administration

Variation between drug batches in developing countries poses “serious clinical implications” and should be tackled by regulators.

Inconsistencies in pharma production, as well as use of counterfeits, cause significant efficacy variation between batches of the same drug. Variation in efficacy can be detrimental to patients and as such it is important that manufacturers and regulators ensure batch quality.

Batch-to-batch variation among antimycotic drugs has “serious clinical and health implications​”, according to research in the Journal of Pharmacy and BioAllied Sciences​. Testing batches of antimycotic drugs in Nigeria the team found variation in virus susceptibility and resistance.

This poses “a threat to public health​” because healthcare professionals prescribe medications based-on assumptions about how they will affect patients. If these assumptions are false, due to batch variation, patient care is likely to suffer.

To address the issue the researchers call on regulators to consistently screen drug batches to ensure quality. Furthermore, there should be documented investigations, looking into the manufacturing process and other areas, when drug batches fail to meet quality requirements.

Regulatory challenges

Stoppage and reconfiguration of equipment between batches can, unless properly managed, lead to variation. Strong regulators and the policies to support them are needed to ensure consistent quality but the researchers acknowledge this is a challenge.

In spite of the massive activities by the National Agency for Food, Drugs Administration and Control (NAFDAC) against production and importation of adulterated and substandard drugs into the country, fake drugs are still reported on regular basis​”, say the researchers.

Efforts by NAFDAC to control counterfeiting were praised earlier this month by Margret Hamburg, commissioner of the US Food and Drug Administration (FDA), according to The Nation​. Also, the World Bank is to support NAFDAC drug quality initiatives, reported the Nigerian Tribune​.

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