Amid US watchdog heat, it is life as usual at Global Pharma'S Chennai unit

The firm ran into trouble after the US FDA informed it of 55 cases of adverse events on the use of its eye drops, some of which caused permanent loss of vision and at least one caused death

The air in and around SIDCO Pharmaceutical Complex at Alathur, some 52 km from Chennai, is filled with odours generated from various organic and inorganic compounds.

With several pharmaceutical plants located in the area, finding the unit of Global Pharma Healthcare was a difficult task, as neither the locals nor Google maps knew where exactly it stood. When Business Standard finally found the plant, it did not appear like a unit surrounded by controversies, facing heat from drug regulators and the United States watchdog. For those in and around the plant, it was work as usual.

One could see a clean factory premises, with a set of courteous employees. After the initial enquiry at the factory gate, two officials who claimed to be in charge of human resources and security teams came down. “For us, it is work as usual. We are not aware of any regulatory issues,” said one of them. According to them, only one unit was shut in the factory and of a total of 250 employees, about 185 were present on Wednesday.

The Chennai-based company ran into trouble after the US Food and Drug Administration informed it of 55 cases of adverse events on the use of its eye drops. The events, recorded between May 2022 and January 2023, included eye infection, permanent loss of vision and one death with a bloodstream infection. Following this, the company had issued an immediate recall of Artificial Tears lubricant eye drops. This was followed by the Tamil Nadu drug controller issuing a notification to the company asking for the recall of all its 14 products.

Interestingly, granting much-needed relief to the troubled company, the director of the Tamil Nadu Drugs Control Department, P V Vijayalakshmi, had reportedly said that ‘no contamination’ was found on the samples manufactured at Global Pharma’s Chennai unit. When Business Standard reached out to the regulator, officials were not available for a comment on the issue. The company has two distributors in the US – Aru Pharma, which has labelled the eye drop as Ezricare Artificial Tears, and Delsam Pharma, which sells it as Delsam Pharma’s Artificial Tears. The US Centers for Disease Control and Prevention (CDC) had also alerted the presence of "a rare strain of extensively drug-resistant" bacteria in some of the samples.

This comes after a shocker for the Indian drug industry last year, when the World Health Organization and other agencies highlighted the presence of toxins in the cough syrups exported from the country, which allegedly led to the deaths of 70 children in Gambia and 19 in Uzbekistan. India had later disputed the findings by the WHO, to ensure that its drug exports were not affected. At present, India contributes to 20 per cent of the generic medicine market globally and its exports more than doubled to $24.6 billion between 2014 and 2022.