Indian eye drop maker halts production after one death, vision loss among some in US

The company initiated a voluntary recall of the product from the US market following the red-flags waved by the FDA

Indian drug regulators on Saturday asked a Tamil Nadu-based pharmaceutical company to stop the production of its eye-care products in the wake of an alert raised by the US pharmaceutical regulator that suspects a link between an eye drop manufactured by the firm and instances of eye infection, vision loss and one death in 12 states in the USA.

Following a joint inspection of the manufacturing plant of Global Healthcare Pvt Ltd in Kancheepuram district by officials from the Central Drug Standards Control Organisation and Director of Drugs Control Tamil Nadu on Friday, the company has been instructed to stop production of all ophthalmic preparations till the investigation is complete.

Quoting the joint inspection report, sources in the Union Health Ministry said the team collected documents and samples of the eye drop and its main ingredient for independent analysis.

The firm exported two consignments of 24 batches of Artificial Tears – the culprit eye-drop – manufactured in 2021 and 2022.

The company initiated a voluntary recall of the product from the US market following the red-flags waved by the US Food and Drug Administration and the Centre for Disease Control.

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For the above-mentioned batches, the firm maintained the control samples that were taken by the inspectors for analysis. The sample of the raw material (Carboxy Methyl Cellulose Sodium) and manufacturing-process related documents were also taken for analysis.

In a statement, the US FDA said it had recommended a recall of the medicine due to the company’s current good manufacturing practice violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging.

The US regulatory step comes days after the CDC issued an alert following identification of 55 cases of infection in 12 states by an extensively drug-resistant strain of Pseudomonas aeruginosa bacteria. Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections.

In the last four months, this is the third instance of poor quality medicines manufactured by Indian firms causing adverse health consequences including deaths outside India. The previous two incidents were related to kids dying allegedly from the consumption of contaminated cough syrups in The Gambia and Uzbekistan.