Government Mandates CEA Registration for Diagnostic Labs

India Pharma Outlook Team | Monday, 14 April 2025

In a strategic approach to regulating the rapidly growing diagnostic sector, the state health department has made it mandated registration of all diagnostic labs under the Clinical Establishment Act (CEA) 2010. Despite repeated notifications at both central and state levels, a large number of labs continue to operate without proper registration, raising serious concerns over quality and patient safety.

This enforcement creates a turning point in standardizing diagnostic services across the state, providing that laboratories adhere to fundamental protocols, possess proper equipment, and keep skilled human resources.

Dr Narrottam Sharma, Additional Director (Hospital Administration), emphasized, "We will take action against the labs which are not getting registered as per the provisions in the CEA 2010. We have directed all the chief medical health officers to ensure that no lab will function without a valid registration under the Act."

The department has established an extensive identification and inspection drive to locate and evaluate illegal labs. As part of the process, each lab applying for registration will be monitored by a reliable team to ensure compliance with the Act’s provisions, including good infrastructure and skilled personnel. This regulatory effort is anticipated to improve transparency, build public trust, and enhance the overall quality of healthcare diagnostics in the state—showing a new era of compliance and accountability.

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