Wockhardt, Indian drug major currently facing several import bans and a substantial drop in sales, has completed a revamp of its critical departments of production, quality and drug regulatory affairs. The embattled domestic pharma major has reshuffled senior management and recruited more than 200 fresh hands to strengthen the key departments.
Sirjivan Singh, managing director of Wockhardt UK & Pinewood, has been given additional charge of production and quality back home. Singh, who had been part of Wockhardt family after the acquisition of Merind in 1998 and actively involved in Wockhardt's growth abroad, now shuttles between London and its plants in Maharashtra. Known to be technically sound, Singh is also an expert on injectables.
Udaykumar Rakibe, a fresh hand who heads quality department as senior vice president, reports to Singh. He heads two vital departments of quality assurance and quality control. Govind Shanker Pandey, who joined Wockhardt a few months ago as senior vice president (manufacturing), is also reporting to Singh.
Zoher Sihorwala, who came on board early 2014 from DRL, currently heads drug regulatory affairs (DRA). He reports to managing director directly. Feroz Shaikh, who worked as a senior executive at DRA, has moved to Morton Grove Pharmaceuticals, the US subsidiary of the company, as assistant manager – regulatory affairs.
A senior official confirmed that the HR recruitments were done in various departments of production, quality as well as regulatory affairs. "The focus is to improve the overall performance of the company."
The US Food and Drug Administration has recently raised concerns over the manufacturing practices in the company's Morton Grove unit. The unit accounts for over 50% of the US sales, and an FDA ban, if happens, will compound the company's current woes.
The company's two other units in India, Waluj and Chikalthana, are also facing FDA import ban. Last year in May, its Waluj unit received import alert over non-compliance regarding good manufacturing practices.
The UK drug regulator Medicines and Healthcare product Regulatory Agency (MHRA) also recalled products made at the Waluj plant soon after. In November, the FDA put an import alert on drugs manufactured in the Chikalthana unit. While five products were excluded from the ban, the lucrative Metoprolol has been placed under a ban currently. MHRA, too, had issued a drug recall from this plant. The UK regulator later also took away the good manufacturing practice certificate from the Chikalthana unit. Wockhardt's third facility, Kadaiya in Gujarat, was also issued a "restricted" GMP certificate by MHRA last year. The unit caters to the UK and Europe markets.
Wockhardt officials told dna that the company has brought in a complete change in production and quality departments of two plants in Waluj (cephalosporin plant and Biotech Park) and Chikalthana.
The management has taken a strong view that some of the import bans by foreign drug regulators could have been easily avoided, had the in-house teams acted wisely. "The new teams at quality and regulatory affairs are working hard to win back approvals from foreign regulators as quickly as possible," said an official.
Dr Murtaza Khorakiwala, managing director of Wockhardt, said during an analyst call in February that they have "revamped and strengthened" the leadership team in quality, in manufacturing and regulatory.
"Additionally, there is a significant amount of work that is being done in every facility of ours to review all the compliance-related issues that have been identified by the regulatory agencies as well as the consultants," he had said.