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Thursday, April 25, 2024
TopicCDSCO

Topic: CDSCO

CDSCO expert panel recommends nod to conduct trial of mixing Covaxin, Covishield doses

The study, conducted by Christian Medical College in Vellore, aims to assess whether a person can be given two different Covid vaccine shots to complete the inoculation course.

‘No uniform test for cancer-causing substances in J&J baby products’ — drug regulator summoned

Child rights body issues summons over lack of standard testing methods to screen for presence of formaldehyde and asbestos in Johnson & Johnson’s baby shampoo and talcum powder.

Antidepressant Escitalopram ‘linked to suicidal thoughts’, must carry strongest warning — govt

Citing FDA warning, India's drug regulator starts examining warnings, prescribing information and package inserts given by Indian drugmakers manufacturing Escitalopram.

Strict follow-up, informed consent from recipients — conditions set for cleared Covid vaccines

India has given conditional emergency-use licence to two Covid vaccines — the Oxford-AstraZeneca candidate Covishield, and Bharat Biotech’s Covaxin.

Govt expert panel recommends restricted emergency use of Oxford vaccine Covishield

The panel also asked Bharat Biotech to expedite volunteer recruitment for its ongoing clinical trial of Covaxin and said it may conduct interim efficacy analysis for further consideration.

Cardiac, prostate drugs found to have new side-effects, govt panel wants them listed on packs

The decision is based on recommendations of Signal Review Panel-Pharmacovigilance Programme of India, which is responsible for detection, assessment & prevention of adverse effects from drugs.

Govt panel asks health regulator to dig out details about ‘side-effects’ of HCQ

The Subject Expert Committee has asked Central Drugs Standard Control Organisation to find more about HCQ's 'side-effects', particularly related to taste disorder and urine incontinence.

Bharat Biotech’s Covaxin gets CDSCO nod for phase 3 clinical trials

The recommendation was given after assessing the safety and immunogenicity data of phase 1, 2 clinical trials and have been sent to (DCGI) for final approval.

Govt panel rejects Dr Reddy’s proposal to test Russian vaccine Sputnik V in Phase III trial

Dr Reddy’s had proposed to test Sputnik V in a Phase III clinical trial that generally needs to enroll over 1,000 participants. Govt panel has recommended a smaller trial instead.

Pharma giant Mylan wants hepatitis C drug’s clinical trial for Covid waived, regulator says no

Low-cost hepatitis C drugs sofosbuvir, used in combination with daclatasvir, has shown promise in reducing chance of death among hospitalised Covid patients.

On Camera

Imtiaz Ali obsesses over vulgarity, misses Chamkila’s cultural resistance against purity

Peter Manuel's ‘Cassette Culture’ showed the booming Bhakti music during the '80s and '90s when Anoop Jalota, Gulshan Kumar achieved success by singing the sanitised Bhajans.

Economists vs statisticians — the battle being fought over the soul of India’s GDP data

Economists say there are weaknesses in India’s GDP data. But statisticians claim the accusations are based on flawed understanding, saying while GDP has problems, the economists are looking in the wrong places.

India and Japan hold 10th round of consultations on disarmament, non-proliferation, and export control

The two sides also discussed ways to strengthen cooperation in outer space security, conventional weapons, and export control

These 6 states are key for Modi’s ‘400 paar’ target. They’re also where Opposition can stop him

While this contest looks so predictable in large swathes of our political landscape, it is also more keenly contested than 2019 in some states.