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News about Safety
DCGI seeks more data from SII over its application seeking emergency authorisation for Covovax
The Drugs Controller General of India (DCGI) has raised queries and sought more data from Serum Institute of India (SII) over its application seeking emergency authorisation for COVID vaccine Covovax, official sources said yesterday
Safety | 27/12/2021 | By Darshana | 471
Lupin's Goa manufacturing plant receives EIR from US FDA
Global pharma major Lupin Limited announced that it has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (FDA) for its Goa manufacturing facility, after the inspection of the facility in September 2021
Safety | 14/12/2021 | By Darshana | 432
IPC adds 9 new IP impurities standards
The Indian Pharmacopoeia Commission (IPC) has added 9 new IP impurities standards which includes Bromhexine Hydrochloride Impurity C, Cabergoline Impurity A, Cilostazol Impurity B, Citalopram Impurity B, Fosinopril Impurity A, o-toluene sulfonamide, p-toluene sulfonamide, Tributyl o-acetyl citrate/Acetyl Tributyl citrate, Vildagliptin Impurity D
Safety | 07/12/2021 | By Darshana | 641
Innovators need to feel confident, and regulators and innovators should not have any barriers during the process of new drug innovation, stated Drugs Controller General of India (DCGI), Dr V G Somani, during the session on creating regulatory ecosystem to support innovation at the Global Innovation Summit held by the Indian Pharmaceutical Alliance
Safety | 21/11/2021 | By Darshana | 400
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 | 250
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 | 411
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 | 259
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 | 292
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 | 276
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 | 235
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