INDIA'S drug regulatory landscape has changed a lot in the last four-five years,thanks to a clutch of legislative changes and new rules and regulations - new good manufacturing practices through amendments to the Schedule M of Drugs & Cosmetics Act, registration norms for imported drugs, amendments to the ScheduleY that lays down the protocols of regulatory assessments and approvals for manufacturing/import of 'new drugs' and clinical trials, and new norms for medical devices,to name a few.But the regulatory machinery and systems have yet to be in sync with these new laws for their meticulous enforcement and effective delivery of regulatory services.
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