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Drug makers dial foreign regulators on quality issues

IPA says it is bringing industry and regulators together to address these concerns

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Aneesh Phadnis Mumbai
Domestic pharmaceutical companies have decided to step up collaboration with foreign drug regulators, with compliance issues at factories here continuing to impact business.

Indian Pharmaceutical Alliance (IPA), the industry body representing research-based companies, has invited regulators from America, Britain and the European Union to address supervisors and mid-level managers at members’ factories in Ahmedabad, Chandigarh, Goa and Hyderabad, on good manufacturing practices and quality culture. The workshops will be in November.

"Quality issues are on ongoing challenge for the Indian pharmaceutical industry. Of the 42 warning letters issued by the US Food and Drug Administration (FDA) last year, nine went