Ranbaxy receives regulatory nod for Poanta Sahib plant
NEW DELHI: India's largest drugmaker Ranbaxy Laboratories has received the regulatory nod for its Poanta Sahib plant in Himachal Pradesh from the European and Australian drug regulators.
Although this would not have any revenue implication for Ranbaxy as it continues to export out of this facility to Europe and Australia, the clearance comes as a relief for the drugmaker. Following a ban on some of its drug made at Poanta Sahib by the US Food and Drug Administration (USFDA) in September 2008, regulators of several countries had put on review on import of drugs from this plant.
"The Medicines and Healthcare products Regulatory Agency (MHRA) of UK, and the Therapeutic Goods Administration (TGA), Australia have issued Good Manufacturing Practice (GMP) certificates for Poanta Sahib unit, following a joint audit conducted in November 2008," a Ranbaxy release said on Monday. The MHRA approval covers product filings for the UK and for the entire European Union (EU), the company said.
Both authorities had inspected the facility in 2006 and had found it to be compliant with the GMP requirements. These approvals expired after their two year validity last year. "Subsequent to the routine re-audit in November 2008, conducted by the two authorities, GMP certification has been extended for a further three years by the MHRA and for another two years by the TGA," the Gurgaon-based company said.
The plant has been under scrutiny after the USFDA pointed out deviations from the US drug manufacturing standards in 2006. Last year, the USFDA issued two warning letters to Ranbaxy and banned 30 drugs made at two of the company's plant in India for falsifying data to sell its drugs in the US. On February 25, the USFDA halted approval of all drug applications from the Poanta Sahib plant.
Thereafter, Ranbaxy Canada quarantined all products imported into Canada from the Poanta Sahib plant following a request by the country's drug regulator Health Canada. Similarly, the Australian regulator had said it was reviewing Ranbaxy's products made at the plant to ensure that they are safe to be sold in Australia. But both the USFDA and Australian drugs regulator have clarified that it has so far found no evidence that Ranbaxy's drugs are unsafe for consumers.
April 01, 2009