New Regulatory Regime for 8 Medical Items under Drugs and Cosmetics Act

NEW DELHI: On Sunday, adopting a proactive and sensitive approach to address the needs of the Indian medical Industry, the Union Ministry of Health & Family Welfare has decided to ensure continued access of eight regulated medical devices.

Earlier, the Ministry had notified the following medical items to be regulated under the Drugs and Cosmetics Act which was to come into effect from 1st April 2021, which includes All Implantable Medical Devices; CT Scan, MRIs, Dialysis, X-rays equipment; Defibrillators and bone marrow cell separators.

As per the order the importers and manufacturers are required to take import and manufacturing licence from Central Licencing Authority or State Licencing Authority, as the case may be, for import, manufacture of above devices with effect from April 01st.

Order in this regard has been issued by Drugs Controller General (India) on 18th April 2021 through CDSCO website.