Even as the extent of Ranbaxy’s transgressions at its Mohali plant became apparent, there is a sense of déjà vu in terms of the deviations found by the US regulatory authority.

Only months ago, industry watchers were horrified by details of the deviations found by the US Food and Drug Administration at one of Wockhardt’s units in Waluj.

In the recent Ranbaxy case, the regulator pointed out in its observations made on the 483 form (the first level of objections raised by regulatory inspectors) that deviations at the Mohali plant included irregular tablet sizes, dirty glass ware and even possible hair from an employee’s arm. A few months ago, the regulator had pointed out to Wockhardt defects including “but not limited to, black particles, fibres, glass particles, sealing defects, and volume variations.”

It further said: “Our investigators found that the washing and toilet facility located approximately twenty (20) feet (approximately six meters) from the entrance/gowning area to the Sterile Formulation (b)(4) manufacturing facility was found to have urinals that lacked drainage piping. The urine was found to fall directly onto the floor, where it was collected in an open drain. Stagnant urine was observed near the open drain.”

Such deviations reflect badly on drug majors. But an industry expert points out that in Ranbaxy’s case there is a “history over-hang”. Since the company is under a microscope following quality concerns at two of its other plants, any deviation now is seen with an electron microscope, the expert said.

As for the glassware and human hair, the expert points out, it is a “cultural over-hang”, and though large companies such as e the ones mentioned do maintain global standards, some element of error cannot be helped. But companies too, he said, need to take extra care to make employees adhere to the highest standards when dealing with medicines.

> jyothi.datta@thehindu.co.in

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