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Agila Specialties, the usually busy Strides injectibles unit in Bommasandra, on the outskirts of this city, is relatively quiet. Now, the employees here seem to have more time for a cup of tea or a smoke outside the plant.
Though the plant continues to run in three shifts, the work is less. As the company is occupied with a team of inspectors from the US Food and Drug Administration (FDA), currently scrutinising the facility, production has slowed considerably. This has given time to the 2,000-strong workforce to breathe easier.
Recently, the unit had received a warning from FDA for violating manufacturing norms at the sterile-making facility. Earlier, Strides had said US regulatory authorities had inspected the unit in June and had issued Form FDA 483 with observations. It had said it responded to the observations and took corrective action.
The inspection at the plant is crucial, as generic drug major Mylan is close to completing the acquisition of Agila Specialties for $1.8 billion.
Strides said, "As required by the FDA, we have provided a suitable response and explanations. We can't comment further on this at this moment." The company didn't allow these reporters to enter the plant premises.
The vicinity of the Bommasandra facility wasn't comforting. Adjacent to the compound wall is an open drain, where water tends to stagnate. Barely 200 ft from the facility is another open drain.
Next to the open drain is a shack selling tea and cigarettes. For the company's employees, as well as workers from nearby factories, this is the only place for tea during working hours. "We do not have much work these days, as the US FDA team is inspecting the facility. The work is considerably reduced and we have enough time to come out for tea and a smoke," said an employee.
Walk further from the gate and you come across a marble polishing plant, beside which is a waste dump.
