Latest Circulars, Notices & Guidelines: CDSCO, DCGI

Latest Circulars, Notices & Guidelines: CDSCO, DCGI

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CDSCO FDA

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:

Circulars – CDSCO, DCGI

Source of Circulars / Notices / letters: CDSCO website

DCGI CDSCO

2021

DCGI-dt-16-05-2021-Advisory-regarding-Oxygen-Concentrators-suitable-for-COVID-19-case-management-in-Home-settings

DCGI-Order-18-04-2021-Regulation-of-CT-Scan-equipment-All-Implantable-Devices-MRI-equipment-etc.-as-Drugs-with-effect-from-April-1st-2021

DCGI-Notice-dt-15-04-2021-Regarding-Guidance-for-approval-Covid-19-vaccine-in-India-for-restricted-use-in-emergency-situation-which-are-already-approved-for-restricted-use-by-US-FDA-EMA-UK-HRA-PMDA-Japan-or-which-are-listed-in-WHO-Emergency list

DCGI-Circular-dt-13-04-2021-Special-Condition-under-which-the-permission-for-import-of-drug-with-residual-shelf-life-less-than-60-is-allowed

DCGI-Notice-dt-13-04-2021-Submission-of-notarized-or-apostilled-documents-for-import-and-Registration-of-cosmetics-in-view-of-COVID-19

DCGI-Notice-dt-12-04-2021-Public-notice-hearing-on-irrational-FDCs-which-meeting-to-be-held-from-19.04.2021-to-07.05.2021-by-DTAB-Subcommittee

DCGI-Notice-dt-25-02-2021-Regarding-implementation-of-SUGAM-Online-system-for-reporting-of-SAEs

DCGI-letter-dt-08-02-2021-Supreme-Court-decision-Cr-Appeal-No-200-2020-for-Cognizable-offences

2020

DCGI-Order-dt-28-12-2020-Regulation-of-Blood-Glucose-monitors-Blood-pressure-monitors-Nebulizers-and-Thermometers-as-drugs-with-effect-from-Jan-1st-2021

DCGI-Circular-dt-18-12-2020-Special-Condition-under-which-the-permission-for-import-of-drug-with-residual-shelf-life-less-than-60-is-allowed

DCGI-Letter-dt-04-12-2020-Clarification-regarding-reference-standards

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-be-followed

DCGI-Notice-dt-03-09-2020-Classification-24-categories-of-MD-reference-SO-648E-and-GSR-102E-dated-11-02-2020

DCGI-Notice-dt-03-09-2020-Classification-of-3-Categories-of-MD-IVDs-reference-SO-648E-and-GSR-102E-dated-11-02-2020

DCGI-Notice-dt.-31-08-2020-requirement-of-fees-for-change-in-address-of-authorized-agent-under-MDR-2017

DCGI-Notice-dt-31-08-2020-Submission-of-notarized-documents-for-import-of-medical-devices-and-In-Vitro-kits-in-view-of-Covid-19

DCGI-Circular-dt-10-07-2020-Special-Condition-under-which-the-permission-for-import-of-drug-with-residual-shelf-life-less-than-60-is-allowed

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-of-Covid-19-with-the-condition

DCGI-Notice-dt-17-04-20-Clinical-trial-of-convalescent-plasma-in-COVID-19-Patients

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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-Medical-gas-by-Industrial-gases-plantICMR-Press-release-17-03-2020-ICMR-enables-more-laboratories-to-test-for-COVID-19-and-revises-the-criteria

DCGI-Notice-13-03-20-Guidelines-for-approval-of-synthetically-manufactured-drugs

DCGI-Notice-13-03-20-Requirement-of-CMC-documents-for-approval-of-additional-indication-of-an-already-approved-drug-product

DCGI-Notice-13-03-20-Requirement-of-process-validation-report-for-permission-to-conduct-Clinical-trial-BA-BE-studies

DCGI-Notice-13-03-20-Testing-of-all-categories-of-new-drugs-for-their-approval

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-WHO-GMP-CoPP

DCGI-Notice-26-02-2020-Submission-and-processing-of-application-for-registration-certificate-and-import-license-in-parallel-with-new-drug-application

DCGI-Notice-21-02-2020-regarding-approval-of-FDCs-containing-new-drugs

DCGI-Notice-21-02-2020-regarding-fixing-of-limit-of-impurities-in-the-specifications-of-INDs

DCGI-Notice-21-02-2020-regarding-permission-to-conduct-BA-BE-studies-and-clinical-trial

DCGI-Notice-21-02-2020-regarding-pre-submission-meeting-for-new-drugs-and-clinical-trials

DCGI-Notice-21-02-2020-regarding-Processing-of-application-for-BA-BE-permission-issued-in-Form-CT-07-import-license-issued-in-CT-17

DCGI-Notice-21-02-2020-regarding-requirements-of-stability-data-for-CoPPs

DCGI-Notice-21-02-2020-regarding-stability-data-for-BA-BE-study-in-human-for-export

DCGI-Notice-21-02-2020-regarding-sub-acute-toxicity-study-report-for-injectable-products-for-BA-BE-study-in-human-for-export

DCGI-Notice-20-02-2020-Considerations-of-Honble-Supremen-Court-of-India-in-the-case-of-294-FDCs

DCGI-Notice-07-02-2020-Pathway-for-subsequent-manufacture-of-category-d-FDCs-as-per-Prof.-Kokate-Committee-Report-extension-in-time-limit-for-submission-of-application

DCGI-Notice-27-01-2020-Processing-of-post-approval-to-BA-BE-permission-issued-in-Form-CT-07-import-license-issued-in-CT-17

DCGI-Notice-22-01-2020-List-of-Reference-Products-for-Conduct-of-BE-Study

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2019

DCGI-Notice-dt-15-12-2019-Regarding-warning-of-Schedule-H-H1-and-X-drugs

DCGI-Notice-08-11-2019-Clarification-on-exemption-of-sale-license-for-importer-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-conditions-for-equipments

CDSCO-DBT-and-ICMR-Joint-Guidelines-October-2019-for-Evaluation-of-Nanopharmaceuticals-in-India

DCGI-Circular-05-07-2019-Monitoring-the-end-use-of-drugs-which-are-meant-for-dual-use

DCGI-Notice-dt-15-05-2019-Classification-of-newly-notified-Medical-DevicesFor daily updates on mail, subscribe below

CDSCO / DCGI Guidelines

CDSCO FDA

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-including-Biologicals-vaccines-version-2017CDSCO-Guidelines-on-Recall-and-Rapid-Alert-System-for-Drugs

Good Distribution Practice

DCGI-Notice-25-09-2018-Draft-Guidelines-on-Good-Distribution-Practices-for-Pharmaceutical-ProductsCDSCO-Guidelines-on-Good-Distribution-Practices-for-Biological-Products

Samples declared as Spurious / NSQ

CDSCO-Guidelines-for-taking-action-on-samples-declared-as-Spurious-or-NSQ

Banned Drugs

Blood Bank / Centre

Cosmetics

COTPA

DPCO / NPPA

Drug Rules

Drugs Act

DMROA

EC Act

General

Homoeopathic

Hospital – RMI

Medical Devices

NDPS Act

New Drugs

Testing Laboratories

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