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CDSCO INSPECTIONS
Govt tightens drug quality net, initiates 950 actions since 2022: Over 1,100 cough syrup makers are also facing intensive audits amid quality concernsThe government has initiated 950 enforcement actions against pharmaceutical companies since December 2022. These actions aim to improve the...- India takes action against 90% of inspected high-risk pharmaceutical facilities, regulator saysAmid increasing global concerns over Indian pharmaceuticals, India's drug regulator is rigorously addressing high-risk manufacturing sites....
- Death in a vial: Five cases lay bare many uncomfortable truths about Indian healthcareFive young mothers in Kota died after childbirth, with suspicion falling on oxytocin injections. Investigations revealed the vials containe...
- Why CDSCO and BEE have not kept pace with the industries they overseeCDSCO still faces challenges like chronic understaffing, gaps in technical skills, weak lab infra and fragmented approvals. About a decade ...
- Punjab drug body finds critical lapses at Jackson Laboratories' manufacturing facility in AmritsarThe Punjab FDA has taken decisive action by revoking the manufacturing licence of Jackson Laboratories in Amritsar due to severe regulatory...
- WHO seeks details from India over oxytocin-linked deaths; licences of manufacturer cancelledThe World Health Organisation (WHO) has sought details from the Indian government after reports linked oxytocin injections made by Jackson ...
- Plan in the works to let hospitals import med equipment directlyIndia's drug regulator is proposing to allow hospitals to directly import advanced medical equipment like MRI and CT scanners, bypassing cu...
- Banned substance in shrimp: Vet shops under close watchIndia's top drug regulator is cracking down on veterinary shops. This action follows a significant rejection of shrimp exports to major mar...
- Drug companies directed to step up vigil on adverse reactionsIndia's drug regulator, CDSCO, has mandated all drug companies to establish systems for tracking adverse drug reactions. This move comes am...
- Small pharma firms may face closure as regulator tightens quality checksMany small drug makers face closure as regulators inspect facilities for quality standards. Thousands of plants may shut down if upgrades a...
- ED raids seven Chennai sites linked to Sresan Pharma over Coldrif cough syrup deathsThe Enforcement Directorate (ED) conducted searches at seven locations in Chennai concerning the Coldrif cough syrup case. These raids, und...
- Cough syrup deaths: Probe against Coldrif manufacturer exposed lapses by TNFDALapses by the Tamil Nadu Food and Drug Administration in enforcing basic regulatory norms have been exposed following the deaths of childre...
- CDSCO to inspect cough syrup manufacturing unitsIndia's drug regulator is launching nationwide inspections of cough syrup manufacturers following child deaths allegedly linked to toxic sy...
- Cough syrup deaths: CDSCO launches risk-based inspection at manufacturing units of 19 drugsIndia's drug regulator, CDSCO, initiated risk-based inspections at 19 drug manufacturing units, including cough syrups, across six states f...
- UP suspends production licence of Marion Biotech over Uzbekistan deathsTalking to ANI, the Gautam Buddha Nagar drug inspector Vaibhav Babbar said "We have suspended the production license of Marion Biotech comp...
- Noida company stops making cough syrup after Uzbek deaths claim; probe initiatedThe Drugs Controller General of India has initiated a probe in connection with the incident, and Union health minister Mansukh Mandaviya sa...
- CDSCO and state body conducting joint inspection of drug manufacturing unitsA committee of two joint drugs controllers has been constituted at the CDSCO headquarters to monitor the process of inspection, reporting a...
- Regulator weighs inspection of drug-making facilities in USAccording to the proposal, the sites will be inspected if they have made substandard drugs, received quality complaints, or faced action by...
- Norms eased for makers of biologic productsCDSCO has done away with the need for joint inspections to issue licences to allow such companies to make biologic products for testing and...
- Drug regulator maps out new site inspection norms for safer medicinesAccording to some GMP experts, CDSCO’s proposed move may be different from the risk-based inspection system followed by the US Food and Dru...
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