Thursday, August 13, 2020
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DCGI nod to Serum Institute for conducting human trials of Oxford...

The Drugs Controller General of India has given the Serum Institute of India a green light to conduct phase 2 and 3 human trials of the Oxford-AstraZeneca COVID-19 vaccine candidate in India..................

Baxter India gets CDSCO nod for Oxiris Filter to treat COVID-19...

Oxiris Blood Purification Filter is intended for use in critically ill COVID-19 patients in need of Blood Purification where excessive Inflammatory Mediators are present i.e. Cytokine Storm release.........................

Bharat Biotech’s COVID-19 vaccine ‘COVAXIN’ gets DCGI nod, human trials to...

Human trials of India’s first indigenous experimental vaccine against COVID-19, COVAXIN, developed by Bharat Biotech is set to begin across India in July........................

CSIR’s anti-pancreatic cancer drug IIIM-290 gets approval for clinical trial

Approval from the New Drugs Division of Central Drugs Standard Control Organization (CDSCO) will pave way for CSIR-Indian Institute of Integrative Medicine (IIIM) Jammu for conducting the clinical trial of this important drug candidate IIIM-290 in pancreatic cancer patients....................

Indian Society for Clinical Research to host 13th annual conference in...

The conference will be focused on ‘Beyond New Regulations- Increasing Participation and Enhancing Patient Safety’. While Dr V G Somani, Drug Controller General India, CDSCO, to be the Chief Guest, Dr Gagandeep Kang, Executive Director, THSTI will deliver late Prof Ranjit Roy Chaudhury Oration........................

CDSCO approves CoSara Diagnostics’ five test kits for TB, Hepatitis B...

CDSCO approval was granted following the completion of the CoSara manufacturing facility and a comprehensive inspection of the location, presentation of the technology, quality system, procedures, product validation data and performance evaluation by an independent NABL & CAP accredited laboratory..........

Cost raising exercise via QCO won’t cover all aspects of patient...

Bureau of Indian Standards (BIS) through the Department of pharmaceuticals (DoP) is in the process of finalizing a quality control mechanism for medical devices...............

CDSCO issues alert on Medtronic’s pacemakers, company says no product recall

The CDSCO has advised patients with specific pacemakers from Medtronic to seek immediate medical assistance if they feel dizzy, light-headed, severe short breath or loss of consciousness. Meanwhile, the company has said it is in talks with the regulator............

Exclusive vertical in CDSCO will check ‘garage manufacturing’, says MTaI

The Drugs Technical Advisory Board (DTAB) has proposed the creation of a vertical in CDSCO specifically for medical devices to enable the latter to regulate all medical devices sold in the country in phases....................

Top govt bodies hold workshop on regulatory compliance to accelerate innovations

The National workshop on regulatory compliance for accelerating innovations held on 9th April, at the Centre for Cellular And Molecular Platforms (C-CAMP), Bengaluru, was one of the six national programs planned across the nation.................