Back grey_arrow_rt.gif
Ranbaxy Recalling Some Batches Of Three Drugs In Europe
  BANGALORE (May 19, 2010, Dow Jones)--Ranbaxy Laboratories Ltd. (500359.BY) said Wednesday its European operations are recalling some batches of three products, including two anti-depressants, to include mandatory safety warnings.
The development is unlikely to have any significant financial impact, but could add to the regulatory troubles of the Indian generic drug maker, which is facing sanctions in the U.S. for not following some manufacturing practices.
Ranbaxy, a unit of Japan's Daiichi Sankyo Co. (4568.TO), is recalling two products in the U.K. and Denmark and one in Ireland.
"The recall is being carried out as patient information leaflets need to be updated to include safety warnings initiated by the European Medicines Agency," a spokesman said in response to an e-mailed query from Dow Jones Newswires.
"There are no product-quality concerns," he said. "To ensure effective corrective and preventive action, the company is conducting a comprehensive review, in consultation with the authorities."
He didn't provide further details.
Ranbaxy (UK) Ltd. is recalling three batches of anti-depressant mirtazapine tablets available in 15-milligram and 45-mg doses, a notice on the website of the U.K.'s Medicines and Healthcare Products Regulatory Agency said.
The notice, dated May 13, said the company had already recalled all unexpired stock of anti-depressant sertraline tablets of 50-mg and 100-mg strengths.
It couldn't be ascertained which was the third product. Also, details on product recalls in Ireland and Denmark weren't available.
Sriram Rathi, pharmaceuticals analyst at Mumbai-based Centrum Broking, said the development will add to the negative sentiment over Ranbaxy's struggles to resolve regulatory issues in the U.S., the company's biggest market.
Its sales in the U.S. have been suffering since the Food and Drug Administration banned the company in September 2008 from importing more than 30 of its generic drugs because of violations of manufacturing practices at two plants--at Dewas in central India and northern India's Paonta Sahib.
In addition to the import ban, the FDA in February 2009 halted review of drug applications from Paonta Sahib, alleging Ranbaxy had falsified data.
The regulator had also late last year warned Ranbaxy's U.S. unit, Ohm Laboratories Inc., on manufacturing violations at a plant at Gloversville, New York.
The European market contributed about $67 million, or about 12% of the company's consolidated sales, in the three months ended March 31.
Ranbaxy's shares were 1.9% down at INR440.90 on the Bombay Stock Exchange at 0705 GMT, when the benchmark Sensitive Index was down 1.1%.
India's Fake Drugs Are a Real Problem
Global trade in counterfeits is huge and penalties are minimal.
Wall St Jnl May 19 2010
The Food and Drug Administration of the Indian State of Uttar Pradesh recently conducted a series of raids throughout its region to uncover counterfeit drugs. The raids yielded large quantities of substandard medicines and resulted in several arrests.
This evidence of India's fake drug trade jibes with what I've found in several surveys. In 2009, I looked at five important medicines being sold at 52 different pharmacies in Delhi and Chennai, using covert shoppers. In Dehli, 12% of the pills were substandard, as were 5% in Chennai. About 2% of the pills contained no active ingredient. The others did but it had degraded, probably because the pills had expired and been repackaged with new labels; some may have degraded through poor storage.
According to an investigation I just conducted with the Legatum Institute and the International Policy Network, the situation is as bad with at least some of Delhi's wholesalers. We found that 7% of all tested samples were substandard and 3.6% were likely counterfeit. It's probable that the drug supply in poorer areas is even more contaminated.
A strong majority of Indian pharmacists interviewed in our investigation admit that fellow pharmacists knowingly profit from the sale of counterfeit drugs. Nearly all of the pharmacists interviewed claimed to have been propositioned by counterfeiters at one time or another. Last year alone, counterfeit drugs were seized by authorities in Bangalore, Mumbai, Delhi, Jaipur and many other Indian cities. In 2008, about half of the medical products that were confiscated by European Union customs officials originated in India.
Since drugs made in India are sold around the world, the country's substandard drug trade represents a grave public health threat that extends far beyond the subcontinent. Unless serious steps are taken to improve the quality of the Indian drug supply, the global spread of unsafe pharmaceuticals will persist.
It's no wonder the counterfeit drug trade thrives in India. The profits are enormous. The global trade runs into the tens of billions of dollars. Meanwhile, the penalties for making and selling knock-off medicines are minimal. Those fake drug offenses that are prosecuted spend years winding their way through the Indian legal system. According to the Confederation of Indian Industry, "counterfeiting rarely produces dire consequences in terms of incarceration or redress."
By way of comparison, the penalties for selling narcotics such as cocaine and opium are incredibly steep. India has a separate law enforcement agency-the Narcotics Control Bureau-for crimes of this sort.
The public-health consequences of the counterfeit drug trade are serious. These products, often adulterated with road paint and chalk, look identical to the antibiotics they pretend to be. Thousands of people probably die every year either because they're poisoned by bad ingredients in counterfeits or because the counterfeit doesn't treat the victim's malady. Estimates of substandard drugs reach as high as 30% of all medicines sold in parts of Africa, Asia and Latin America. But the truth is we don't really how bad the problem has become.
These bad drugs don't just threaten lives. They undermine the legitimacy of the entire Indian medical system, discourage patients from using life-saving pharmaceuticals, and threaten the economic livelihood of legitimate pharmacists and drug makers.
To counteract the spread of counterfeit drugs around the globe, several steps must be taken. First, Indian officials need to be more honest about the extent to which bad medicines have contaminated their drug supply. In a 2003 report, India's Ministry of Health and Family Welfare stated that between 8% and 10% of India's pharmaceuticals are "substandard." Yet recent media reports quote unpublished government studies claiming the rate is far below 1%. No one I've spoken with believes these figures.
India's leaders must also do more to enforce the anticounterfeit laws already on the books. The penalties for making and distributing bad drugs should be serious and perpetrators should be brought to justice swiftly.
New technologies also have a role to play in ensuring the safety of India's pharmaceuticals. Some drug companies have begun assigning packages-and even individual pills-unique serial numbers. Consumers can check the legitimacy of their medicine by text messaging these serial numbers to a central database and getting a quick and accurate answer.
Other quality control solutions involving bar codes also show promise. But any technology will prove effective only if part of a broader political effort to rid India of substandard medicines. Action is urgently required or thousands of annual avoidable deaths around the globe will continue.
  icon paper stack View Older Articles   Back to Top