Unease at Wockhardt's Waluj plant

After recovering from issues such as defaults on foreign currency convertible bonds and piling debts, pharmaceutical major Wockhardt has been on the slow lane through the last six months, following warnings from global regulators such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency.

In a letter to Wockhardt founder and chairman Habil Khorakiwala, dated July 18, US FDA compliance officer Maan Abduldayem raised a few concerns related to the company's Waluj facility. "Our investigators found the washing and toilet facility, located about 20 ft from the entrance area to the sterile formulation manufacturing facility, had urinals that lacked drainage piping. The urine fell directly on to the floor, where it was collected in an open drain. Stagnant urine was observed near the open drain. The facilities used to manufacture drugs should be appropriately maintained and repaired and kept in a clean condition," he said.

US FDA observations

• Washing and toilet facility, about 20 ft from the entrance of the sterile formulation-making facility, had urinals that lacked drainage piping
• Urine was found to fall directly onto the floor, where it was collected in an open drain
• When a quality-control analyst was asked to describe the contents of unlabelled and partially labelled vials in the lab glassware washing area, he began dumping the contents into the sink

These issues prompted the US regulator to list 16 observations in Form 483, later given to the company.

Villagers around the company's Chikalthana plant say jobs at the plant haven't been affected. "We are doing business as usual," said the owner of a tea stall near the plant.

Wockhardt didn't allow this reporter to step into the premises. On checking the surrounding areas, it was found garbage had been piled up around the plant and the area had overgrown plants, too. But there was no evidence to show these might have influenced the regulator's opinion.

For Wockhardt, the Chikalthana plant is crucial, as it manufactures the generic version of Toporol XL, a cardiac drug for which the company accounts for 26 per cent of the US market share. In 2012-13, the plant recorded total sales of $283 million (about Rs 1,700 crore). The plant's annual revenue from the UK and European markets is a mere £12 million (about Rs 120 crore).

The Waluj facility-Wockhardt Biotech Park - about 30 km away from Chikalthana, is rather isolated, with new constructions coming up. Unlike Chikalthana, people around the Waluj plant seem to know the goings on. "Khaali tablet plant band hua, baki sab theek hai (Only the tablet plant is shut, everything else is fine)," said a local.

The Wockhardt Biotech Park has two sterile areas housing separate and aseptically filled sterile injectable and ophthalmic capabilities. The company's export-oriented unit (oral solid division) at Waluj makes conventional solid dose forms.

In his letter, Maan Abduldayem had said when a quality control analyst was asked to describe the contents of unlabelled and partially labelled vials found in the laboratory glassware washing area, the analyst immediately began dumping the contents of the vials into the drainage sink. "Because you limited the direct observation by the FDA investigator and prevented any determination of the contents of the unlabelled vials, you limited the inspection," the letter had said.

Wockhardt Managing Director Murtaza Khorakiwala said the management had started "remediation measures". He added, "A baseline assessment of GMP (good manufacturing practices) issues has been conducted by Lachman, our consultant over there.

We have also enrolled Lachman for training in manufacturing and quality functions and that activity has been completed. We have restructured the quality organisation."