Other drug regulators to review USFDA decision on Ranbaxy

Other drug regulators to review USFDA decision on Ranbaxy
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First Published: Fri, Sep 19 2008. 12 01 AM IST
Updated: Fri, Sep 19 2008. 12 01 AM IST
Hyderabad / New Delhi: Following US drugs regulator Food and Drug Administration’s (FDA) decision on Tuesday to ban the import of 30 drugs made at two Indian plants of Ranbaxy Laboratories Ltd, health regulators in other countries, including those in the European Union (EU), plan to take a close look at the decision before making their own calls.
Shares of Ranbaxy fell 10.06% to Rs340.95 each on the Bombay Stock Exchange on Thursday. A Ranbaxy spokesman declined to discuss the issues related to the FDA fallout even as the company said it hired former New York City mayor Rudy Giuliani and his consulting firm, Giuliani Partners Llc., for advice and to review US compliance issues.
For now, some non-US regulators contacted by Mint gave a clean chit to Ranbaxy and also note that the safety of the drugs wasn’t being questioned even by the US regulator. Still, the ripples from the US decision is being felt in many markets.
“We are aware that there are a number of nationally-approved products manufactured by Ranbaxy on the market in the EU and the various national authorities will need to investigate the impact of the FDA’s findings. We understand that this work is under way,” European Medicines Agency (EMEA) spokesperson Martin Hallworth said in an email.
EMEA, he added, has known of FDA’s ongoing investigation of Ranbaxy’s plants. It was also aware that “no centrally-approved (that is, EU-wide) medicines are implicated in the action taken by the FDA, therefore, no action has been taken by the EMEA”, Hallworth said.
In 2007, Ranbaxy sold $47 million (Rs219 crore today) of its drugs in the UK, while for the entire EU, the revenue was $365 million.
As reported by Mint on 18 September, the UK drug regulator, Medicines and Healthcare Products Regulatory Agency (MHRA), in a response to emailed questions said the agency’s previous inspection of Ranbaxy’s one Indian manufacturing facility in late 2006 had thrown up a few issues of non-compliance with quality standards. That site, whose identity was not disclosed, is up for re-evaluation by the agency’s inspectors in a few weeks, the regulator’s spokeswoman said.
To reassure the UK customers of their safety, MHRA will also initiate lab testing of Ranbaxy products marketed in the country, the MHRA spokeswoman Florence Palmer said.
At a press conference on Thursday in Wellington, New Zealand health ministry chief adviser on public health, Ashley Bloomfield, was quoted on the website of Television New Zealand as saying that the testing of Ranbaxy drugs was under way. “For our own reassurance here in New Zealand, Medsafe is in the process of instituting some testing, batch testing, of the affected medications,” the television channel quoted Bloomfield as saying. The drugs include an antibiotic and a herpes anti-viral treatment medicine.
The New Zealand Herald added the health ministry there would take a final decision on whether to proceed with an import ban on Ranbaxy after considering further information, such as the results of any more recent audits done by other countries’ medicines regulators. According to the newspaper, 12 drugs made in the same two units of Ranbaxy that were at issue with USFDA, are marketed in New Zealand. Mint couldn’t independently verify the New Zealand regulatory moves.
USFDA had said it found inconsistencies in record-keeping and other quality procedures at Ranbaxy’s facilities in Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh.
More problematic for Ranbaxy’s business and image might be a still ongoing US justice department investigation into allegations that Ranbaxy made substandard drugs, including some for AIDS treatment, for exports to Africa, according to The Wall Street Journal. Most of such drugs meant for use in Africa, the worst-affected region by HIV/AIDS, are funded by US agencies, including a government-promoted programme. Mint couldn’t ascertain the status of that US investigation.
Japan’s Daiichi Sankyo Co. Ltd is in the process of taking over controlling interest in India’s largest drug company by revenues.
lison.j@livemint.com
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First Published: Fri, Sep 19 2008. 12 01 AM IST