Ahmedabad: The United States Food and Drug Administration (USFDA) on Saturday said its quality checks are part of surveillance system and the number of inspections has increased in India in view of rising exports of generic drugs from the country.
“Level of exports of generic drugs has grown up dramatically in recent years and correspondingly we have inspected more. When the exports from here grow up there will be more checks because obviously checks are part of approval process,” Dy. Commissioner for Global Regulatory Operations and Policy USFDA Howard Sklamberg told reporters here.
“They (checks) are part of what we call surveillance system. And when we find something, we take appropriate action,” he said.
In response to a question on action against big Indian generic pharma companies, Sklamberg said, “We apply same standards of inspecting at all levels like between the licensed drug manufacturing companies and generic drug manufacturing companies. The standards are same across all geographies”.
The USFDA had taken action against companies like Sun Pharma last year and earlier Ranbaxy among other Indian drug companies.
“We have introduced a new act called Food Safety Modernisation Act, and under it instead of just working on regulatory aspects, we work at all level with stakeholders like food manufacturers to exporters who export to the US,” he added.
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