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DCGI classifies 80 in-vitro diagnostic medical devices under Medical Devices Rules
The Drugs Controller General (India) has classified around 80 in-vitro diagnostic medical devices including analysers, instruments and softwares, under the Medical Devices Rules, 2017, based on the intended use, risk associated with the device and other parameters
Quality / GMP | 26/07/2021 | By Darshana | 275
CDSCO notifies 10 more medical devices testing laboratories for quality assurance
In a bid to regulate all medical devices under Drugs and Cosmetics (D&C) Act in an effective way, the Central Drugs Standard Control Organisation (CDSCO) has notified ten more medical devices testing laboratories (MDTL) for carrying out evaluation of medical devices under the new Medical Devices (MD) Rules 2017 on behalf of manufacturers in the country
Quality / GMP | 13/07/2021 | By Darshana | 667
NPPA fixes retail prices of 11 formulations under DPCO-2013
The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices of 11 formulations under Drugs Prices Control Order (DPCO) - 2013 based on the decision of 89th authority meeting dated June 28, 2021
Quality / GMP | 12/07/2021 | By Darshana | 211
The Central Drugs Standard Control Organisation (CDSCO) has directed active pharmaceutical ingredient (API) manufacturers to file online applications for issuance of written confirmation certificate (WCC) on the new SUGAM module. For exporting APIs to European Union (EU) countries, a written confirmation certificate is must
Quality / GMP | 09/07/2021 | By Darshana | 1761
Lupin's Nagpur Facility Receives EIR from U.S. FDA
Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) after closure of the U.S. FDA inspection of its Nagpur, India facility. The inspection for the facility was carried out by the U.S. FDA between January 6, 2020 and January 10, 2020
Quality / GMP | 13/04/2020 | By Darshana | 837
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