The Hindu Business Line : Ranbaxy hires Giuliani as advisor on USFDA move

New Delhi, Sept 18 In a bid to minimise the impact due to the block imposed by US Food and Drug Administration, Ranbaxy Laboratories Ltd has retained the services of former New York City Mayor Mr Rudy Giuliani and Giuliani Partners to provide advice and review compliance issues highlighted by the US drug regulator.

The USFDA has blacklisted about 30 generic drugs being manufactured by the company at its Dewas and Paonta Sahib plants in India. The US drug regulator said that it had taken the decision after the two units owned by Ranbaxy failed to meet the standards specified under the current Good Manufacturing Practice (GMP) requirements of the US Government.

While the FDA has not imposed a ban on the drugs or sought a withdrawal of the medicines from US drugstores, it has issued an Import Alert, under which US officials may detain any products manufactured at these Ranbaxy facilities.

Announcing the appointment of Mr Giuliani, Ranbaxy said, “In announcing the addition of Mr Giuliani, Ranbaxy reiterated its commitment to work cooperatively with the FDA to address the Import Advisory and put into place measures which will allow its products identified on the Advisory to be released into the US marketplace.”

“As the FDA stated, all drugs manufactured by Ranbaxy have repeatedly tested safe and effective with no adverse incidents reported. Ranbaxy is committed to a swift resolution to address these issues and to continuing to supply the global market place with safe and effective pharmaceuticals,” the company added.

While the FDA acknowledged that it has no evidence that Ranbaxy has shipped defective products, it has informed the company that until Ranbaxy resolves the deficiencies at each of the two facilities it will not approve any New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that list the Paonta Sahib or Dewas plants as the manufacturer.

Ranbaxy’s Rs 5 shares closed 9 per cent down on the NSE on Thursday at Rs 341.45.