Clinical Establishment Act 2010 Last August, India’s lawmakers enacted the Clinical Establi

Clinical Establishment Act 2010

Last August, India’s lawmakers enacted the Clinical Establishment Act 2010 to overcome quality issues in the country’s private healthcare sector. The Act applies to all public and privately owned medical institutions, including those involved in diagnostic laboratory work.
The law requires all entities that provide medical services to be registered with the Indian government. The legislation also established a national council and state councils for clinical establishments, with the national council responsible for compiling and publishing a national register of clinical establishments, (authorities expect this register to be ready by August 2012) and the state councils responsible for compiling and updating the state register of clinical establishments. The state councils also must set up district authorities for the registration of health units, with the district collector and district health officer as members.

The register will classify clinical establishments by category and determine the minimum standards for healthcare services. This could affect the type of medical devices demanded in India because the standards set for medical institutions might require medical devices and equipment procured to have minimum specifications and quality standards. This should provide good business opportunities for medical device companies already offering high-tech, advanced products.