Drugmaker Ipca Laboratories Ltd has received an “import alert” from the United States Food and Drug Administration banning products from its manufacturing facility in Ratlam, Madhya Pradesh.
The facility had received regulatory observations in July last year, following a USFDA inspection. The preliminary observations on Form 483 resulted in the company voluntarily suspending shipments of active pharmaceutical ingredients (API) from this facility to the US.
But the situation seems to be unresolved, with the company now confirming the import alert to the stock exchange.
Ipca, however, clarified that four APIs manufactured at the said manufacturing facility were excluded from the import alert. They were Hydroxychloroquine Sulfate, Propanolol Hydrochloride, Trimethoprim and Ondansetron.
Details of the violation by the company that elicited the regulatory action were not given. Last July, company management had indicated that the export-related development would have an impact of about Rs 150 crore.
However, later last year, the Canadian health regulator also took similar action, asking Ipca to stop similar shipments to Canada as well.
In its note last September, Health Canada had said that it had taken the precautionary step of asking Ipca Laboratories to voluntarily stop shipment of products to Canada based on a review of a good manufacturing practices (GMP) inspection report by the USFDA where they identified falsification and manipulation of data issues at the company.
“Ipca had not disputed the FDA findings with Health Canada,” the Canadian regulator added. The Health Canada directive covered about 21 APIs.
Clarifying that the USFDA had not issued a recall of any of the affected products, the Canadian regulator had then said that it too was not requesting a recall of products already on the market, as there was no indication of a risk to health.