USFDA has accused an Indian manufacturer Laxachem Organics, a maker of active pharmaceutical ingredients (API) of causing a bacterial outbreak and banned its products from US markets. The step has been taken as part of the effort to arrest the Burkholderia cepacia or the B Cepacia infection, which is a complex group of bacteria resistant to antibiotics.
Another reason to worry
This issue has been for the first time that because of an adulterated product from an Indian company the US regulator has hinted at possible disease outbreak. US Food and Drug Administration has, till now put Indian drug companies under the scanner for non- compliance of quality standards. The drug regulator has so far banned products of certain companies for quality issues but now Indian pharmaceutical companies have yet another cause to worry about.
Outbreak caused by contaminated API
In fact Centre for Disease Control and USFDA have been jointly investigating multistate outbreak of Burkholderia cepacia or the B Cepacia infection from July this year and during the investigation, they found that the outbreak was caused due to contaminated Docusate Sodium, which is an API supplied by Laxachem.
Laxachem on import alert until it meets US standards
"Laxachem manufactures active pharmaceutical ingredient (API) for repackagers, labelers and wholesale drug distributors, some of which sell API to manufacturing facilities in the United States. According to Laxachem's disclaimer on its website, one of the drugs Laxachem manufactures is Docusate Sodium USP. Companies that received API from Laxachem should not distribute the API or products containing the API to customers," the USFDA wrote in a notification. "Laxachem will remain on import alert until it has been fully inspected by FDA and found to meet US standards," it added.
Process for a voluntary recall initiated
The company had not allowed the USFDA to inspect its site and hence import alert has been placed on the Laxachem's Ahmednagar facility. Drugs, including APIs, made at a facility that denies, limits, or delays an FDA inspection are considered adulterated under the US Federal Food, Drug and Cosmetic Act. The process for a voluntary recall of this product by other distributors has also been initiated.
USFDA has questioned drug manufacturers for quality bar
USFDA has questioned different Indian drug manufacturers in terms of clearing the US drug regulator's quality bar. Last year Indian major pharmaceutical companies like Dr Reddy's, Sun and Zydus came under the FDA's scanner for allegedly violating norms prescribed for good manufacturing. Last month in August Mumbai-based Wockhardt received another import ban. Its two plants have been already barred from exporting to US.