Latest Circulars, Notices & Guidelines: CDSCO, DCGI thehealthmaster.com/2021/04/18/latest-circulars-notices-guidelines-cdsco-dcgi Rakesh Dahiya
Articles Latest Circulars, Notices & Guidelines: CDSCO, DCGI By Rakesh Dahiya April 18, 2021 1408
Last Updated on July 11, 2021 by The Health Master
Circulars – CDSCO, DCGI Govt of India, DCGI, Health Ministry, ICMR issues notices / circulars time to time for stake holders and the same are uploaded on official websites of above institutions. We have provided some of the important notices / circulars relevant to the above said topic, Click below links for more information:
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Circulars – CDSCO, DCGI Source of Circulars / Notices / letters: CDSCO website
2021 CDSCO-dt-07-07-2021-List-of-14-Testing-Laboratories-for-Medical-DevicesMDTLs CDSCO-dt-30-06-2021-Medical-Devices-alert-for-Ventilator-of-Philips-June2021 CDSCO-notification-25-06-21-appointment-of-172-Medical-Devices-officers DCGI-dt-16-05-2021-Advisory-regarding-Oxygen-Concentrators-suitable-forCOVID-19-case-management-in-Home-settings DCGI-Order-18-04-2021-Regulation-of-CT-Scan-equipment-All-ImplantableDevices-MRI-equipment-etc.-as-Drugs-with-effect-from-April-1st-2021 DCGI-Notice-dt-15-04-2021-Regarding-Guidance-for-approval-Covid-19vaccine-in-India-for-restricted-use-in-emergency-situation-which-arealready-approved-for-restricted-use-by-US-FDA-EMA-UK-HRA-PMDAJapan-or-which-are-listed-in-WHO-Emergency list DCGI-Circular-dt-13-04-2021-Special-Condition-under-which-thepermission-for-import-of-drug-with-residual-shelf-life-less-than-60-isallowed DCGI-Notice-dt-13-04-2021-Submission-of-notarized-or-apostilleddocuments-for-import-and-Registration-of-cosmetics-in-view-of-COVID-19 DCGI-Notice-dt-12-04-2021-Public-notice-hearing-on-irrational-FDCs-whichmeeting-to-be-held-from-19.04.2021-to-07.05.2021-by-DTAB-Subcommittee CDSCO-dt-08-03-2021-List-of-11-Testing-Laboratories-for-Medical-DevicesMDTLs
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DCGI-Notice-dt-25-02-2021-Regarding-implementation-of-SUGAM-Onlinesystem-for-reporting-of-SAEs DCGI-letter-dt-08-02-2021-Supreme-Court-decision-Cr-Appeal-No-2002020-for-Cognizable-offences
2020 DCGI-Order-dt-28-12-2020-Regulation-of-Blood-Glucose-monitors-Bloodpressure-monitors-Nebulizers-and-Thermometers-as-drugs-with-effectfrom-Jan-1st-2021 DCGI-Circular-dt-18-12-2020-Special-Condition-under-which-thepermission-for-import-of-drug-with-residual-shelf-life-less-than-60-isallowed DCGI-Letter-dt-04-12-2020-Clarification-regarding-reference-standards CDSCO-dt-09-10-2020-List-of-10-Testing-Laboratories-for-Medical-DevicesMDTLs DCGI-Notice-dt-17-9-2020-regarding-import-of-drug-related-productFor daily updates on mail, subscribe below DCGI-Circular-08-09-2020-regarding-294-rational-FDCs-procedure-to-befollowed DCGI-Notice-dt-03-09-2020-Classification-24-categories-of-MD-referenceSO-648E-and-GSR-102E-dated-11-02-2020 DCGI-Notice-dt-03-09-2020-Classification-of-3-Categories-of-MD-IVDsreference-SO-648E-and-GSR-102E-dated-11-02-2020 DCGI-Notice-dt.-31-08-2020-requirement-of-fees-for-change-in-address-ofauthorized-agent-under-MDR-2017 DCGI-Notice-dt-31-08-2020-Submission-of-notarized-documents-forimport-of-medical-devices-and-In-Vitro-kits-in-view-of-Covid-19 DCGI-Circular-dt-10-07-2020-Special-Condition-under-which-thepermission-for-import-of-drug-with-residual-shelf-life-less-than-60-isallowed DCGI-Letter-01-05-2020-Extension-of-validity-of-WHO-GMP-CoPP DCGI-Circular-30-04-2020-Extension-of-validity-of-BA-BE-study-centres DCGI-approval-17-04-2020-Rapid-CLIA-ELISA-kits-approved-for-testing-ofCovid-19-with-the-condition
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DCGI-Notice-dt-17-04-20-Clinical-trial-of-convalescent-plasma-in-COVID-19Patients Subscribe below for daily updates on mail Enter your email address: Delivered by FeedBurner DCGI-letter-16-04-20-along-with-list-of-55-critical-medicines-for-Covid-19 DCGI-letter-07-04-2020-Regarding-granting-permission-to-mafr-Medicalgas-by-Industrial-gases-plantICMR-Press-release-17-03-2020-ICMR-enablesmore-laboratories-to-test-for-COVID-19-and-revises-the-criteria DCGI-Notice-13-03-20-Guidelines-for-approval-of-syntheticallymanufactured-drugs DCGI-Notice-13-03-20-Requirement-of-CMC-documents-for-approval-ofadditional-indication-of-an-already-approved-drug-product DCGI-Notice-13-03-20-Requirement-of-process-validation-report-forpermission-to-conduct-Clinical-trial-BA-BE-studies DCGI-Notice-13-03-20-Testing-of-all-categories-of-new-drugs-for-theirapproval DCGI Circular 04-03-2020 – Regarding – Disposal of the applications of “Written confirmation” for active substances exported to the EU DCGI-Circular-03-03-2020-Regarding-Disposal-of-applications-of-WHOGMP-CoPP DCGI-Notice-26-02-2020-Submission-and-processing-of-application-forregistration-certificate-and-import-license-in-parallel-with-new-drugapplication DCGI-Notice-21-02-2020-regarding-approval-of-FDCs-containing-new-drugs DCGI-Notice-21-02-2020-regarding-fixing-of-limit-of-impurities-in-thespecifications-of-INDs DCGI-Notice-21-02-2020-regarding-permission-to-conduct-BA-BE-studiesand-clinical-trial DCGI-Notice-21-02-2020-regarding-pre-submission-meeting-for-new-drugsand-clinical-trials DCGI-Notice-21-02-2020-regarding-Processing-of-application-for-BA-BEpermission-issued-in-Form-CT-07-import-license-issued-in-CT-17
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DCGI-Notice-21-02-2020-regarding-requirements-of-stability-data-forCoPPs DCGI-Notice-21-02-2020-regarding-stability-data-for-BA-BE-study-inhuman-for-export DCGI-Notice-21-02-2020-regarding-sub-acute-toxicity-study-report-forinjectable-products-for-BA-BE-study-in-human-for-export DCGI-Notice-20-02-2020-Considerations-of-Honble-Supremen-Court-ofIndia-in-the-case-of-294-FDCs DCGI-Notice-07-02-2020-Pathway-for-subsequent-manufacture-of-categoryd-FDCs-as-per-Prof.-Kokate-Committee-Report-extension-in-time-limit-forsubmission-of-application DCGI-Notice-27-01-2020-Processing-of-post-approval-to-BA-BE-permissionissued-in-Form-CT-07-import-license-issued-in-CT-17 DCGI-Notice-22-01-2020-List-of-Reference-Products-for-Conduct-of-BEStudy Subscribe below for daily updates on mail Enter your email address: Delivered by FeedBurner
2019 DCGI-Notice-dt-15-12-2019-Regarding-warning-of-Schedule-H-H1-and-Xdrugs DCGI-Notice-08-11-2019-Clarification-on-exemption-of-sale-license-forimporter-of-X-Ray-MRI-PET-Ultrasound-CT-Scan-machine-etc. DCGI-Notice-08-11-2019-Clarification-on-Implantable-Medical-Devices DCGI-Notice-08-11-2019-Clarification-regarding-environmental-conditionsfor-equipments CDSCO-dt-03-10-2019-List-of-4-Testing-Laboratories-for-Medical-DevicesMDTLs CDSCO-DBT-and-ICMR-Joint-Guidelines-October-2019-for-Evaluation-ofNanopharmaceuticals-in-India DCGI-Circular-05-07-2019-Monitoring-the-end-use-of-drugs-which-aremeant-for-dual-use
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DCGI-Notice-dt-15-05-2019-Classification-of-newly-notified-MedicalDevicesFor daily updates on mail, subscribe below
CDSCO / DCGI Guidelines
We have provided some of the important CDSCO / DCGI Guidelines, Click below links for more information:
Recall & Rapid Alert System CDSCO-Guideline-on-Recall-and-Rapid-Alert-System-for-drugs-includingBiologicals-vaccines-version-2017CDSCO-Guidelines-on-Recall-and-RapidAlert-System-for-Drugs
Good Distribution Practice DCGI-Notice-25-09-2018-Draft-Guidelines-on-Good-Distribution-Practicesfor-Pharmaceutical-ProductsCDSCO-Guidelines-on-Good-DistributionPractices-for-Biological-Products
Samples declared as Spurious / NSQ CDSCO-Guidelines-for-taking-action-on-samples-declared-as-Spurious-orNSQ Compiled by: Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana Also read latest notifications on: Banned Drugs Blood Bank / Centre Cosmetics COTPA DPCO / NPPA Drug Rules 6/15
Drugs Act DMROA EC Act General Homoeopathic Hospital – RMI Medical Devices NDPS Act New Drugs Testing Laboratories Other trending news
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