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News about Safety
The decision comes as the latest in the drug regulator?s efforts to classify the medical devices sold in the country based on the perceived risk of the product type and its use in patients. The measure is to help the authority to bring in all the medical devices under the regulatory control, according to experts
Safety | 28/02/2022 | By Darshana | 757
Stempeutics gets DCGI nod for phase-III clinical trial on its product for treating COVID patients
Stempeutics yesterday said it has received DCGI clearance to conduct phase-III clinical trial on its product for treating COVID-19 patients suffering from Acute Respiratory Distress Syndrome (ARDS). The company will be using its stem cell product, Stempeucel, for conducting the label extension phase-III clinical trial
Safety | 20/01/2022 | By Darshana | 544
DGFT imposes restriction on export of anticoagulant enoxaparin & intra-venous immunoglobulin
Amid the rising cases of Covid-19 and Omicron variant in the country, the Directorate General of Foreign Trade (DGFT) has imposed restriction on export of anticoagulant enoxaparin and intravenous immunoglobulin (IVIG) active pharmaceutical ingredients and their formulations to ensure their adequate supply in the domestic market
Safety | 11/01/2022 | By Darshana | 602
Dr Reddy's Labs gets DCGI nod to launch molnupiravir in India
Dr. Reddy's Laboratories Ltd announced that it has received Emergency Use Authorization from the Drugs Controller General of India (DCGI) to manufacture and market the oral anti-viral drug molnupiravir capsules 200 mg for the treatment of adult patients with Covid-19, with SpO2 >93% and who have high risk of progression of the disease including hospital
Safety | 29/12/2021 | By Darshana | 530
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 | 499
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 | 626
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 | 1004
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 | 501
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 | 276
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 | 509
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