Month: February 2019

State FDA’s commanded by DCGI on Sugam portals update

The Drugs Controller General of India (DCGI) has instructed state drug regulators to take necessary action and direct all the manufacturers on how to upload their manufacturing sites and formulation data on Sugam portal which will strengthen the drug regulatory system by way of improving the transparency, accountability as well as accessibility of the drugs in the country.

Roles and responsibilities: QMS and the IVDR

One of the new key regions of obligations that should be characterized is the individual or people in charge of regulatory compliance per Article 15. In the event that more than one individual keeps up this job (to enable the maker to meet the openness necessity), the divisions of obligation should be recorded as a hard copy, for example, in sets of expectations, goals,

8 New Medical Devices Notified Under CDSCO

In a bid to regulate medical and diagnostic devices in India, the health ministry has notified eight medical equipment, in order to ensure better quality of medical devices imported into the country, the Union ministry of health and family welfare has added eight more devices to the list of drugs under the Drugs and Cosmetics Act, 1940, and will now require strict regulatory compliance.