As a proactive measure to ensure quality and compliance, the government might inspect the facilities of Wockhardt, which are under US import alert, sources said.
Last month, the US Food and Drugs Administration had placed Wockhardt’s facilities in Waluj near Aurangabad on import alert, barring supply of various products from these facilities to the US.
An email questionnaire to Wockhardt did not elicit any response.
When contacted, the Drugs Controller General of India G N Singh said: “Whenever there are any issues related to quality, our duty is to see that medicines that are available in India are genuine and are good in quality. We will fulfil our responsibility to ensure whatever medicines are moving in the Indian market comply with good manufacturing norms.”
Singh, however, refused to comment on Wockhardt. “I cannot tell you which company we are going to inspect but wherever specific issues are red-flagged, we will not fail to re-confirm,” he added.
Recently, the DCGI had ordered an inspection into Ranbaxy’s Paonta Sahib and Dewas facilities, the two units that continue to be under a US FDA’s import alert since 2008.
The Indian regulator is also studying the recent judgement passed by the US authorities on the company after it pleaded guilty to making fraudulent statements to US FDA to gain drug approvals in the US.
Ranbaxy had also agreed to pay a $500-million
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