US FDA alert puts Ranbaxy under scanner of other regulators

UK's Medicines and Healthcare Products Regulatory Agency says an impact assessment is in progress

With the US health watchdog finding serious lapses at Ranbaxy's Mohali plant in Punjab, regulators in Australia and Europe are assessing if any drugs exported by the Indian firm to their regions are affected.

Regulators in Australia and Europe, including the UK, have sought information from the Food and Drug Administration (FDA) about the lapses, which last week led to a US ban on imports of products made at the Mohali facility.

The regulators said action will be taken after assessing the FDA's reply.

Ranbaxy Laboratories, which was acquired by Japanese drug maker Daiichi Sankyo in 2008, commissioned the Mohali plant in 2011 and started exports from there in 2012. It is the third Ranbaxy facility in India to face FDA action, after the Dewas and Paonta Sahib plants.

The US FDA banned import of drugs made at the Mohali unit 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.

The drug maker, which has 16 manufacturing units in eight countries and ground operations in 43 nations, 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) told PTI it will determine whether any action is required when the 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 said.

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) said an impact assessment is in progress.

"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.

"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," MHRA said.

The World Health Organisation did not comment on its action plan, saying only that it had taken note of the US FDA's past actions against Ranbaxy.

Ranbaxy said in May it signed a consent decree with the US FDA and agreed to pay  $500 million to settle charges after a US Department of Justice probe of data integrity and manufacturing processes at certain company units in India.

Ranbaxy clocked over  $1 billion sales in the Americas in 2012, while it garnered over  $420 million in Europe and over  $270 million from Asia and Africa.