Earlier this month, American drug regulator FDA issued a warning letter to an India-based manufacturer named Lantech Pharmaceuticals over traces of a carcinogen found at one of its facilities.
The FDA said the company failed to "control and monitor" its manufacturing to prevent the chemical from making its way into pharmaceutical shipments.
The warning letter to the Hyderabad-based Lantech was the latest in a series of efforts to police manufacturing plants in India, which the US pharmaceutical industry increasingly relies on. Indian drugmakers have received 34 percent of the FDA warnings this year, according to Down To Earth.
More than 90 percent of the drugs prescribed in the US are generics, and over time, most companies have moved their manufacturing overseas — especially to India and China —
to take advantage of cheaper labour and materials. Today roughly 80 percent of the ingredients used in US medicines are made abroad, according to the Government Accountability Office.
But concerns over of a raft of allergic reactions, side effects and even deaths in the US linked to contaminated drugs made in overseas facilities have grown significantly in recent times. US drugmakers have issued more than 50 recalls since last July linked to low levels of a probable cancer-causing chemical found in generic drugs taken by millions of Americans.
On Wednesday, US health officials tried to reassure patients that they face very low risks from ongoing contamination problems with widely prescribed blood pressure drugs.For decades, the FDA focused its manufacturing inspections on US factories, but has had to change tack and focus abroad because of the reliance on foreign generic drugmakers, including in India.
The FDA is responsible for ensuring that US medicines are produced in safe, sanitary conditions that meet quality standards. But regulators have struggled for years to inspect the supply chain as pharmaceutical production spread globally.The FDA did not open its first permanent offices in China and India until 2008 and 2009, respectively.
That followed dozens of deaths and hundreds of allergic reactions in the US linked to a contaminated blood thinner made at a Chinese facility.The FDA has tried to keep pace with foreign inspections.
But when the GAO's watchdog investigators last examined the issue in 2016, they estimated the FDA had never inspected nearly 1,000 of the 3,000 foreign manufacturing facilities that export drug ingredients to the US.
Earlier this summer, US lawmakers asked the FDA to provide information about its oversight of facilities in China and India linked to the recent recalls.
"We remain concerned about whether FDA has the appropriate resources, policies, management practices, and authorities to oversee adequately foreign drug manufacturing," wrote members of the House Committee on Energy and Commerce, in a June letter to the FDA.
With inputs from AP.