The Indian drug-maker Lupin Limited is recalling 5,720 tubes of a skin medicine over quality issues, according to US Food and Drug Administration (FDA).
The Lupin's US arm Lupin Pharmaceuticals Inc is recalling the tubes of Clobetasol propionate Cream from the US market. The medicine is being recalled after the US FDA found it to be of poor quality. The cream is used in the treatment of various skin conditions, such as dermatitis, eczema, and psoriasis.
The tubes being recalled were manufactured at Lupin's Pithampur plant in Madhya Pradesh. The formal reason for the recall is the following finding by the FDA: "subpotent Drug: Low assay result observed during long-term stability testing".
Lupin initiated the Class III nationwide (US) recall of the affected lot on January 23 this year. As per the FDA, a class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".
The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products. Indian medicines have a long history of quality issues, either not having enough drugs or having impurities that can cause adverse conditions.
Lupin's latest run-in with FDA
This is not the first time that Lupin has come on FDA's radar. The company has recalled products at least four times over the past year over quality issues and failing regulatory tests.
In January 2023, Lupin recalled 16,056 bottles of Rifampin Capsules used in the treatment of all forms of tuberculosis. The recall was observed after impurities were detected and the drug failed stability test.
In December 2022, Lupin recalled blood pressure medicine Quinapril over impurities in the tablets. The prolonged use of the impurity detected can cause cancer, WebMD quoted FDA as saying.
The Hill reported, "The tablets were contaminated by substances known as nitrosamines, which the FDA reports are commonly found in food and water.These impurities are found in meats, dairy products and vegetables, and can increase a person’s risk of developing cancer when faced with prolonged exposure, according to the FDA."
In September 2022, Lupin recalled 7,872 bottles of same Rifampin Capsules which were also recalled last month. The recall was for manufacturing lapses.
In January 2022, Lupin recalled 50,832 bottles of anti-bacterial medicine Gatifloxacin Ophthalmic Solution. It's used in eye treatment. The recall was ordered after failing stability tests.
In January 2022, it was also reported that Lupin was recalling 23,965 bottles of Oxycodone Hydrochloride tablets. The tablets are used for the treatment of moderate to severe pain.
Indian pharma scandals recently
The Lupin recall is the latest scandal to hit Indian pharma industry in recent weeks, which is prone to quality tests. Here are some of the recent instances where Indian medicines have made headlines over the world for wrong reasons.
US eye drops: Earlier this week, the US Centers for Disease Control and Prevention (US CDC) alerted that EzriCare Artificial Tears eye drops, manufactured by Chennai-based Global Pharma Healthcare, has been linked to one death, some blindings, and a range of other complaints in the United States.
The Global Pharma suspended the supply in the US following the US CDC alert. At least 50 people have been infected across the United States.
The Washington Times reported, "Fifty people have been infected in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah and Washington. Some patients have been blinded by their infections, and one patient died when the germ entered the bloodstream, according to a Jan. 20 CDC report."
Uzbekistan cough syrup: The Uzbek authorities in December said that 18 children died from an India-manufactured cough syrup. The syrup was made and sold by Uttar Pradesh's Noida-based Marion Biotech.
Reuters reported the Uzbek authorities as saying that they found ethylene glycol in the syrup. Ethylene glycol is a toxic substance and can cause death, according to US Centers for Disease Control and Prevention (US CDC).
Gambia cough syrup: Indian cough syrups made by Maiden Pharmaceuticals was linked to the death of at least 70 children in Gambia last year. The authorities found that the syrups were contaminated with diethylene glycol and ethylene glycol, according to the BBC. The ethylene glycol was also found to in the medicines by Uzbek authorities.
(With PTI inputs)
