NEW DELHI: The Indian Pharmaceutical Alliance on Wednesday asserted that generic drugs manufactured in India meet global regulatory standards and production facilities of the country are subject to far greater scrutiny, as most manufacturers supply in multiple geographies and are inspected additionally and routinely by regulators.
Refuting findings of a study at Ohio State University that stated India-made generic drugs are linked to significantly more “severe adverse events” in patients who use them than equivalent drugs produced in the US, the Indian Pharmaceutical Alliance (IPA) asserted that quality standards are not region-dependent.
“We strongly disagree with the study’s premise that differences in operations and supply chain factors, suppliers, manufacturing and/or distribution practices by different manufacturers, impact the quality and efficacy of Indian generic drugs,” IPA said in a statement. PTI