More Inspections Due To Rising Drug Imports From India: USFDA


Ahmedabad: The USFDA on Saturday said its quality checks are part of surveillance system and the number of inspections of 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.

The United States Food and Drug Administration (USFDA) members are here to participate in the three-day World Spices Congress held by Spices Board of India.

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.

Speaking about food exports from India to the US, he said that the highest exports is of sea food, then comes spices and the third is rice.

“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.

According to Sklamberg, they are here to explain this to the delegates of World Spices Congress as Indian spices export to the US is substantially.

USFDA team members had also met Gujarat State Food and Drug Administration yesterday to know about how it functions.