News about Quality / GMP

No price regulation on medical devices other than those under NLEM and TMR: DoP official

No price regulation on medical devices other than those under NLEM and TMR: DoP official

The pricing regulations on medical devices are restricted to a few products and the industry is free to fix the maximum retail price for their products. The listed products should not increase the prices above 10 per cent as per the pricing regulations, said a senior official from the Department of Pharmaceuticals (DoP)

Quality / GMP | 06/09/2021 | By Darshana

Vivera Pharma?s Zicoh receives US patent for its wireless, electronic, dose-controlled medication delivery device

Vivera Pharma?s Zicoh receives US patent for its wireless, electronic, dose-controlled medication delivery device

Vivera Pharmaceuticals, Inc. (Vivera), an innovative, science-driven pharmaceutical company, announced that the US Patent and Trademark Office (USPTO) issued US Patent No. 11,083,850 for Zicoh, the company?s wireless, electronic, dose-controlled medication delivery device.<br />

Quality / GMP | 23/08/2021 | By Darshana

A 10-day quality control programme for pharma industry professionals by PTI

A 10-day quality control programme for pharma industry professionals by PTI

The Pharmacy Training Institute (PTI) has presented a new dimension in quality control as the ongoing pandemic is now increasing its focus on high quality operations across research and manufacturing. The sector is witnessing a shortfall of 25,000 to 30,000 quality control, quality assurance and manufacturing talent pool

Quality / GMP | 13/08/2021 | By Darshana

DCGI classifies 80 in-vitro diagnostic medical devices under Medical Devices Rules

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

CDSCO notifies 10 more medical devices testing laboratories for quality assurance

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

NPPA fixes retail prices of 11 formulations under DPCO-2013

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

CDSCO directs API manufacturers to file online applications for issuance of WC certificate on new SUGAM portal

CDSCO directs API manufacturers to file online applications for issuance of WC certificate on new SUGAM portal

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

Lupin's Nagpur Facility Receives EIR from U.S. FDA

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 296


 

 

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