News about Safety

DCGI gives nod to phase-I clinical trial of COVID-19 vaccine by Reliance Life Sciences

DCGI gives nod to phase-I clinical trial of COVID-19 vaccine by Reliance Life Sciences

The Drugs Controller General of India (DCGI) recently granted permission to Reliance Life Sciences for conducting phase-I clinical trial of its indigenous COVID-19 vaccine with certain conditions, sources said

Safety | 06/09/2021 | By Darshana

DCGI asks state drug regulators to restrict tolperisone FDC usage only to post stroke spasticity in adults

DCGI asks state drug regulators to restrict tolperisone FDC usage only to post stroke spasticity in adults

The Drugs Controller General (India) has directed the State drug controllers to restrict the fixed dose combination (FDC) tolperisone HCI 150 mg+ paracetamol IP 500 mg tablet only for symptomatic treatment of post-stroke spasticity associated with pain in adults, and direct the manufacturers to submit phase IV clinical trial data on revised indication

Safety | 04/09/2021 | By Darshana

IPC sounds safety alert against hepatitis C drug sofosbuvir

IPC sounds safety alert against hepatitis C drug sofosbuvir

The Indian Pharmacopoeia Commission (IPC), which is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) has flagged a drug safety alert revealing that sofosbuvir which is used in combination with other medicinal products for the treatment of chronic hepatitis C in adults is associated with Stevens-Johnson Syndrome

Safety | 04/09/2021 | By Darshana

NPPA releases draft version of retail price proposals for 11 drugs

NPPA releases draft version of retail price proposals for 11 drugs

The National Pharmaceutical Pricing Authority (NPPA) has released the draft version of the proposed price calculation sheet for retail price of 11 medicines from various players in the country

Safety | 26/08/2021 | By Darshana

Pfizer?s Ticovac vaccine gets US FDA approval for active immunization

Pfizer?s Ticovac vaccine gets US FDA approval for active immunization

Pfizer Inc. announced that the US Food and Drug Administration (FDA) has approved Ticovac (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older

Safety | 16/08/2021 | By Darshana

Govt extends exemption of strict environmental clearance procedures for drug cos till December 31, 2021

Govt extends exemption of strict environmental clearance procedures for drug cos till December 31, 2021

In a bid to ramp up production of various drugs amid the looming threat of the third wave of Covid-19 pandemic, the Central government has extended the exemption of strict environmental clearance procedures for drug manufacturers till December 31, 2021

Safety | 20/07/2021 | By Darshana

DCGI classifies 112 anesthesiology devices under Medical Devices Rules

DCGI classifies 112 anesthesiology devices under Medical Devices Rules

The Drug Controller General (India) has classified 112 medical devices related to anesthesiology, which is used in taking care of a patient before, during and after surgery, under Medical Devices Rules

Safety | 17/07/2021 | By Darshana

NABL releases NABL 126: Specific criteria for calibration of medical devices

NABL releases NABL 126: Specific criteria for calibration of medical devices

The purpose of this document is to specify requirements with which a laboratory has to operate and demonstrate its competency to carry out calibration of medical devices in accordance with ISO/IEC 17025: 2017, ISO 13485, IEC 60601, IEC 62353, Global Harmonization Task Force (GHTF)

Safety | 07/07/2021 | By Darshana

Regeneron Pharma & CCPM enter research collaboration to advance human genetics and precision medicine

Regeneron Pharma & CCPM enter research collaboration to advance human genetics and precision medicine

Regeneron PharmaceuticalsInc and the Colorado Center for Personalized Medicine (CCPM) at the University of ColoradoAnschutz Medical Campus, announced a large-scale research collaboration designed to advance the field of human genetics and precision medicine

Safety | 13/05/2020 | By Darshana 238

Five pharma employees among seven new COVID-19 positive cases in Karnataka

Five pharma employees among seven new COVID-19 positive cases in Karnataka

Five employees of a pharmaceutical company based in Nanjangud were among seven new COVID-19 positive cases reported in Karnataka in the last 48 hours. The five pharma employees were colleagues of P52, a 35-year-old male and resident of Mysuru working in quality assurance department of a well known national pharma company

Safety | 30/03/2020 | By Darshana 236

 
 

 

 

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