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The Pharmaceuticals Export Promotion Council (Pharmexcil) has sought an explanation from Global Pharma Healthcare on alleged adverse events on the use of its artificial tears (eye drops) in the US and their recall.
The Centre for Disease Control and Prevention (CDC), USA, has issued a Health Alert Network (HAN) Health Advisory about infections with an extensively drug-resistant strain of Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) in 12 States.
As per the information on the USFDA website and portal of the company, Global Pharma Healthcare is voluntarily recalling all lots within the expiry of their Artificial Tears Lubricant eye drops, distributed by EzriCare, LLC and Delsam Pharma, to the consumer level, due to possible contamination.
There are, allegedly, 55 reports of adverse events including eye infections, permanent loss of vision, and one death caused by the eye drops. “It is alleged that the eye drops manufactured and supplied by your company have caused eye infections, permanent loss of vision, and one death, bringing a bad reputation to the Indian pharma industry and is also likely to have an impact on the trust of international agencies on Indian pharma exports,’‘ Pharmexcil said in a communication sent to the company.
The Chennai-based company has been directed to furnish details of the licensees to whom it had supplied the proof of product and manufacturing license and product permissions. “You are further advised to investigate the reasons for the serious adverse events at your end and update us with your findings within two days from the receipt of this email to enable Pharmexcil to inform the Ministry (DoC) and to take necessary further action,’‘ the council said.
When contacted, R Uday Bhaskar, Director-General, Pharmexcil told businessline: “The US is a very important market with 30 percent of our total exports going there. The USFDA is considered to be one of the stringent regulatory agencies and the incident is a big blow our brand image.’‘
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