New Delhi: Barely a fortnight after it announced its decision to set up a regional office in China, US drugs regulator Food and Drug Administration, or FDA, says it will next establish its presence in India, Europe, South America and West Asia, to tighten scrutiny of the quality and manufacturing processes in drug plants outside the US.
In a bid to allay quality concerns on drugs and food items increasingly being imported into the US and combat criticism that it is not doing its job of inspecting non-US sites well, the regulator has flagged off its initiative “FDA Beyond Our Borders” with the China office, its first outside the US. And though it is tight-lipped on which country it will enter next, India, with the largest number of FDA-approved drug plants outside the US, is an extremely likely candidate.
The regulator was to expand FDA’s “presence outside of US on a continuous, ongoing basis,” FDA commissioner Andrew C. von Eschenbach had told Mint in a January interview. In a recent address, von Eschenbach reiterated this stance saying FDA could “no longer be simply a gatekeeper assessing benefit and risk before allowing a product to be delivered...or rely solely on inspections to verify quality” but needed to monitor products throughout their life cycle before they reached US borders.
FDA commissioner Andrew C. von Eschenbach had said in January that the regulator wanted to expand its presence outside the US on a continuous, ongoing basis.
That intent has now been backed by action. In a 14 March statement, FDA announced it will create “eight full time permanent FDA positions” in China, after getting an authorization from the government there. The FDA plans to place its personnel in the next 18 months in China, besides hiring five local nationals.
“The permanent overseas offices in China will also allow greater access for inspections and greater interactions with manufacturers to help assure that products that are shipped to the United States meet US standards for safety and manufacturing quality,” stated the release.
With more than 400 FDA-approved manufacturing facilities in India, the country is firmly on the regulator’s radar. “The commissioner has said that he would like “boots on the ground” in China, India, Europe, South America and the Middle East,” Stephanie Kwisnek, an FDA spokeswoman, said in an email. The names of the countries were not in order of expected establishment of the offices, she added.
Exports from the China have been under the scanner recently. Last year, melamine, a prohibited chemical, was found in pet food, leading to largest ever animal food recall in the US. Earlier this month, Baxter International Inc. recalled its entire lot of blood thinning drug Heparin, after severe allergic reactions were traced to an ingredient sourced from China. While no such instances have occurred in the case of Indian suppliers so far, an increasing quantum of medicines being exported by Indian non-patented drug makers has made the FDA wary.
The Indian drug industry is unfazed by the prospect of enhanced and more frequent investigations an India FDA office will entail. Cipla Ltd’s chief executive officer Amar Lulla said a regional office would only enhance the credibility of regulation-compliant drug makers. “The sooner this happens, the better it is. Right now, the whole country is painted with one brush and such steps will separate the good players from the bad,” he said.
The drug regulator came under fire last year when a US government audit pointed out that the existing inspection infrastructure was inadequate and could inspect only 7% of global facilities in a year—a pace that will require up to 13 years to inspect all the plants approved globally.
For the fiscal year to March 2007, FDA could inspect 13 of 714 firms in China and 65 of 410 Indian drug makers, according to the government report.