NATIONAL

4 ICMR labs to become approval hubs for test kits

Mylab was the first to be validated

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, according to a notification issued by the ICMR, signed by Director General Balram Bhargava.

While the rules require that only kits approved by the U.S. Food and Drug Administration (FDA) and European CE be allowed, ICMR chief Balram Bhargava said last week in press briefing 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 on Monday.

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