There seem to be no respite for troubled Indian drug manufacturers Ranbaxy. Reports say that, after facing U.S. Food and Drug Administration (FDA) action last week for manufacturing lapses, the company, acquired by Japanese drug maker Daiichi Sankyo in 2008, now faces regulators agencies in Australia and Europe which are also assessing if drugs manufactured and exported by the Indian firm to their regions are affected.
Media reports said that regulators in Australia and Europe, including the UK, have sought information from the U.S. FDA about the alleged lapses, which led to a U.S. ban last week on imports of products made at the Ranbaxy's Mohali facility.
Action by these regulators will be taken after assessing response from the FDA, reports said.
The Mohali plant was commissioned by the company in 2011 and had started drug exports in 2012. It is the third Ranbaxy facility in India to face FDA axe after two of its plants in Dewas and Paonta Sahib. The company has 16 manufacturing units in eight countries and ground operations in 43 nations.
The U.S. FDA banned import of drugs made at the Mohali unit last week after it found lapses, including tablets embedded with "black fibre" suspected to be hair from an employee's arm and "black spots" of oil from machines in tablets.
Meanwhile, Ranbaxy said it will continue to fully cooperate with the FDA and take steps to resolve the concerns at the earliest.
A spokesperson for Australia's Therapeutic Goods Administration (TGA), quoted by the media agency, said action will determined after FDA information is assessed.
"The TGA is in communication with the US FDA and is awaiting details to determine whether any Australian medicines may be affected by the FDA findings," the spokesperson was quoted in the report as saying.
The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is also reported to have said that an impact assessment is underway.
"We are currently working with the FDA and other European regulators to assess the impact the FDA's action has on the medicines from the Mohali site that are destined for the UK and European market," the MHRA was quoted as saying.
"There is currently no evidence that medicines on the UK and EU market manufactured at this site are defective, so people should continue to take their medicines," the agency said.
Meanwhile, report said the World Health Organisation did not comment on its action plan, saying only that it had taken note of the U.S. FDA's past actions against Ranbaxy.
In related news, the Indian regulatory authorities, including the Drug Control General of India (DCGI) said they will be looking into complaints against Ranbaxy's Mohali unit.
Ranbaxy clocked sales worth over $1 billion in the Americas in 2012, while it garnered over $420 million in Europe and over $270 million from Asia and Africa, reports said.
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