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US FDA warning: Drug controller to review Wockhardt, shares hit

Drug Controller General of India (DCGI) G. N. Singh also said medicines sold in India are safe, ruling out any reason for panic.

twitter-logoE Kumar Sharma | July 26, 2013 | Updated 11:58 IST

Emphasising that medicines sold in India are safe and ruling out any reason for panic, G. N. Singh, the Drug Controller General of India (DCGI), also added that regulators in India were vigilant and there had been no failure on their part in detecting any discrepancies in the manufacturing practices of any Indian pharmaceutical companies.

This was a response to Business Today's question as to why the Indian regulator had not noticed the shortcomings the US Food and Drug Administration discovered at the Waluj (Aurangabad) facility of Wockhardt.

However, he said, since the issue had been flagged, the DCGI was reviewing the matter. It was doing the same with Ranbaxy. He said the findings in the case of Ranbaxy would be out soon.

"If regulators abroad are concerned about the safety of their citizens, we in India are equally concerned about the safety of Indians when it comes to the medicines they consume." He said: "I believe in the capability of Indian people, Indian scientists and Indian entrepreneurs. However, wherever there are substandard drugs, we have the mechanisms to filter them out and catch the culprits."

On the observations of the USFDA on the Wockhardt plant, Singh said: "I cannot comment on the other regulatory issues till I get it examined."

Manufacturing practices to some extent come under the purview of state governments, as manufacturing licences are issued by the states. (In certain cases they are jointly covered by state and central regulators.)

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Meanwhile, in a statement, Murtaza Khorakiwala, Managing Director, Wockhardt says: "Wockhardt has already initiated the process of taking corrective measures, including appointment of a leading US based consultant for its Waluj facility in Aurangabad . The consultant has extensive experience and expertise in current good manufacturing practices (CGMP) and will work with the Wockhardt team to address issues raised by the USFDA. Wockhardt is fully committed to achieving full compliance of its Waluj facility at the earliest with the US FDA standards."

In a warning letter issued to the company on July 18, the USFDA had said: "During our March 18, 2013 through March 22, 2013 inspection of your pharmaceutical manufacturing facility located at Waluj, Aurangabad, India, investigators from the US Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals ....(It is) documented that your firm withheld truthful information, and delayed and limited the inspection."

Analysts feel the FDA comments are significant.

For instance, Chunky Shah, research analyst at Credit Suisse, says: "Overall FDA has cited six observations and even suggested Wockhardt hire a third party auditor with experience in detecting data integrity problems. It is not a normal practise of the FDA to suggest hiring of CGMP expert and data integrity consultant in a warning letter."

It lists out the six observations by the FDA, which apart the point about "repeatedly delayed, denied, limited an inspection or refused to permit the FDA inspection" also points to the company failing to "prepare batch production and control records for each batch of drug product that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch."  

Wockhardt's share price continued to take a hit even on the second day. The stock hit a 52 week low on Thursday, July 25, touching Rs 594.85 before recovering to close the day at Rs 638.30. Its 52-week high was Rs 2166.05 on March 12, 2013.

Shares of the company were trading down 10 per cent at Rs 574.50 in early trade at the Bombay Stock Exchange on Friday.

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