French regulators have identified another Indian API maker they say lacks just about every kind of good manufacturing practice needed to produce acceptable drugs, sanitation, data integrity and sample control. As a result, they have recommended the European Medicines Agency recall all of its products and not allow them to be used in any new drugs.
The recommendations come after an August inspection of the Nandu Chemicals Industries in Hubli. Inspectors were there primarily to look over Nandu’s manufacturing of zinc sulphate but said the company makes many other APIs.
The report, published on the EudraGMP site said, “Significant deficiencies were observed in the vast majority of inspected areas.” In particular, it found “falsification practices...and inadequate control systems” across the site.
On top of that, inspectors reported the facility lacked basic hygiene practices in the packing area and inadequate standards for retaining samples for stability studies. Cleaning was subpar and the facility was not carefully monitoring the quality of the purified water.
The French agency suggested that the EMA order the recall of all of Nandu’s products from the European market and require drugmakers to drop it as an API supplier.
Nandu joins a long list of Indian and Chinese API makers against which the EMA has taken actions. Following an inspection earlier this year by Italian regulators, the EMA recommended recalls of all of the products produced at a JP Laboratories unit in Maharashtra and a Krebs Biochemicals & Industries plant in Andhra Pradesh.
- access the report here
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