The Indian Council for Medical Research (ICMR) has approved three other centres, alongside the National Institute of Virology (NIV), as agencies for approving diagnostic kits.
These are the National AIDS Research Institute, Pune; the National Institute of Cholera and Enteric Diseases, Kolkata; and the National Institute of Pathology, New Delhi.
While the rules require that only kits approved by the U.S. Food and Drug Administration (FDA) and European CE be allowed, ICMR said that this was no longer mandatory and Indian diagnostic kit manufacturers were permitted so long as their product was approved by the NIV.
Mylab, a diagnostic kit maker in Pune, was the first such indigenous maker of kits to be validated recently.
Source : The Hindu