Indian pharma steps up efforts on US safety standards

Indian pharmaceutical companies need to step up their efforts to avoid falling foul of regulations in the United States, according to leaders in the sector.

The US is a major export market for Indian pharmaceuticals, for generic medicines, but there have been a series of incidents surrounding the compliance of Indian companies with safety standards set in the US.

“The industry has taken this as a challenge and is working closely with the US FDA [United States Food and Drug Administration] and addressing the issues,” said D G Shah, the secretary general of the Indian Pharmaceutical Alliance, speaking at a conference in Mumbai this week.

He said that in some cases Indian pharma companies had faced issues because of cultural differences and because they had not kept up to date with changing regulations.

Every third pill in the US is manufactured in India and India is the second largest supplier of medicine to the US, after Canada, he said.

“For all of us in India, the US is very important,” said Habil Khorakiwala, the founder chairman of Wockhardt, one of India’s biggest pharma firms. “Irrespective of what are the FDA requirements, we need to create organisation which meets whatever is the requirement of the FDA. I can tell you from our own experience that the standard they expect outside the US is much higher than in the US.

“I think in two, three, four years, you will find state of the art manufacturing facilities in India, so I think it is a blessing in disguise, whatever has happened.”

Mr Shah said that 102 warning letters were issued by the US FDA between August 2013 and August 2016, with 51 letters being issued within the US and 26 letters being sent to Indian companies.

“Considering the volume of medicine that we supply to the US, it’s just natural that some of the warning letters come to Indian companies,” said Mr Shah.

The Indian drugs firm Ranbaxy Laboratories three years ago had to pay a record fine of US$500 million for lying about its methods of testing medicine and for manufacturing substandard drugs in a settlement agreement with the US department of justice.

The FDA in 2013 placed bans on two factories in India operated by Wockhardt, because of concerns over production quality. These were the drugmaker’s main plants for exports to the US.

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