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CDSCO DIRECTIVE
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...- CDSCO asks states, port offices to step up screening to curb imports of illegal drugsIndia's drug regulator is intensifying border screenings to block unapproved medicines from entering the country. Authorities are cracking ...
- 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...
- The hidden cost of looking better: What health insurance covers, and what it leaves you to payRising demand for weight-loss drugs, cosmetic procedures and wellness treatments is creating a growing out-of-pocket healthcare expense cat...
- 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...
- Zydus Semaglutide approval: Delhi HC directs CDSCO to decide on patient safety concernsThe Delhi High Court has asked the Central Drugs Standard Control Organisation to review a petition challenging Zydus Lifesciences' approva...
- Zydus Therapeutics' saroglitazar drug granted priority review by US FDAZydus Therapeutics' drug saroglitazar has received priority review from the US FDA. This drug treats primary biliary cholangitis, a liver d...
- Chemists’ strike: CDSCO moves to prevent shortagesThe CDSCO has advised state drug controllers to prevent drug scarcity during the AIOCD's proposed e-pharmacy strike on May 20. Measures inc...
- Drugmakers must report safety data from launch date, not approval date: CDSCOIndia's drug regulator has issued a new directive for pharmaceutical companies. Periodic Safety Update Reports for new drugs must now be su...
- Drug regulator cracks down on delayed safety reporting by pharma companiesIndia's drug regulator CDSCO has issued new rules for drug safety reporting. Companies must now submit safety reports from the actual launc...
- Drug regulator transfers 95 officials in mass reshuffleThe Central Drugs Standard Control Organisation has moved about 95 officials across India. This reshuffle aims to improve compliance and le...
- Weight-loss drug craze for Ozempic, Mounjaro surges in India amid safety concernsIn India, appetite for weight-loss drugs is on the rise, with consumers increasingly turning to injectables such as Mounjaro and Ozempic fo...
- Govt orders safety review of popular weight-loss drugs amid rising demandIndian authorities are increasing vigilance on popular weight loss drugs. Indian Pharmacopoeia Commission will now compile reports on adver...
- CDSCO directs pharmacies to display QR code and toll-free number for reporting adverse drug reactionsThe CDSCO has mandated that all retail and wholesale pharmacies across India must prominently display a QR code and a toll-free number. Thi...
- Drugs regulatory body may waive testing requirement for cough syrups exported to certain countriesCDSCO mulls exempting cough syrups from testing before export to select countries. Quality concerns arose last year prompting mandatory tes...
- CIC issues show-cause notice to CDSCO for denial of info on WHO's suspension on Covaxin procurementUnder Section 20 of the RTI Act, if CIC is convinced that information denial was unjustified and arising out of malafide intention, it may ...
- Dr Reddy's Laboratories to submit a revised protocol for conducting clinical trials of Russian COVID-19 vaccineIn a meeting held on Monday, Subject Expert Committee (SEC) on COVID-19 at the CDSCO, deliberated on the application and asked the firm to ...
- DCGI orders J&J not to use talc raw material for any production till further ordersA CDSCO official said according to the protocol, the manufacturer is "supposed to test for absence of asbestos" for all batches of talc raw...
- 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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