USFDA pulls up Ranbaxy, Strides Arcolab for violating mfg norms

Last Updated 16 September 2013, 17:23 IST

In yet another setback to Ranbaxy Laboratories, the US Food and Drug Administration has issued an import alert on drugs produced by the company at its Mohali plant in Punjab, for violation of current good manufacturing practices.

According to information available on the USFDA website, the import alert, dated September 13, will cover all 'drugs and drug products' produced by the company at the Mohali plant.

While the US health regulator did not specify details for issuing the alert, it said "detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's)".

When contacted, a Ranbaxy spokesperson said: "We have so far not received any communication from the USFDA on this subject. We are seeking information from the USFDA in this regard."

As per the company's website, the Mohali plant produces oral solids in dosage form.
In May this year, Ranbaxy had pleaded guilty to "felony charges" relating to manufacture and distribution of certain 'adulterated' drugs made at two units in India and agreed to pay USD 500 million to US authorities as penalty.

This followed a series of action taken by the USFDA, which in 2008 banned import of 30 generic drugs produced by Ranbaxy at its Dewas (Madhya Pradesh) and Paonta Sahib (Himachal Pradesh) plants for violation of manufacturing norms.

The development had led to a hospital and a pharmacy chain in India to issue advisory against the company's drugs.

The company had admitted to past "shortcomings" but said it has rectified those and insisted that its drugs were safe and efficacious. It had also offered to co-operate fully with any regulator from anywhere in the world wanting to investigate its manufacturing practices.

Ranbaxy Laboratories shares were trading at Rs 332.85 per scrip, in the afternoon trade, down 27.21 per cent from its previous close on BSE.

(Published 16 September 2013, 08:52 IST)

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