Major Pharma Companies Recall Medications Due to Manufacturing Issues
In a recent notification by the US Food and Drug Administration (USFDA), two major Indian pharmaceutical companies Cipla and Glenmark have recalled certain medications from the American market owing to manufacturing defects.
As per reports, a New Jersey based subsidiary of Mumbai headquartered drug maker Cipla is recalling over 59 thousand packs of a combination inhalation solution used commonly to treat respiratory illnesses like asthma. The affected products were manufactured at Cipla's Indore facility in Madhya Pradesh. USFDA noted the recall was initiated in March this year due to complaints of under-filled vials and liquid observed outside the sealed pouches, likely causing dosing concerns.
In a separate development, the US arm of Gurgaon based Glenmark Pharmaceuticals recalled over three thousand bottles of an extended-release capsule used for hypertension treatment across the country. The medication recall in mid-April was attributed to failed dissolution specifications during quality tests.
While both recalls were categorized as Class II by the regulator, denoting the defects may result in temporary adverse side effects, timely action was taken by the companies on their own to safeguard patient health. The developments are being viewed with concern by industry observers given India's role as a leading global supplier of affordable generic medicines to regulated markets. Strict compliance to quality standards remains imperative to uphold the ‘Pharmacy of the World' tag.
