Download Circulars - DCGI, Health Ministry, Department of Pharmaceuticals, ICMR
Download latest circulars: 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 - DCGI / CDSCO
Source of Circulars / Notices / letters: CDSCO website
2022
DCGI Circular dt 06-05-2022 Special Condition under which the permission for import of drug with residual shelf life less than 60% is allowed
DCGI-Circular-dt-06-05-2022-Special-Condition-under-which-the-permission-for-import-of-drug-with-residual-shelf-life-less-than-60-is-allowed
DCGI Dt 05-05-2022 Updated list of laboratories for conducting Performance evaluation of IVD reagents, kit
DCGI-Dt-05-05-2022-Updated-list-of-laboratories-for-conducting-Performance-evaluation-of-IVD-reagents-kit
DCGI dt 28-04-2022 Procedure for regulation of FDCs with respect to 294 FDCs
DCGI-dt-28-04-2022-Procedure-for-regulation-of-FDCs-with-respect-to-294-FDCs
DCGI Dt 11-04-2022 List of the 21 Certified Medical Device Testing Laboratory under MDR 2017
DCGI-Dt-11-04-2022-List-of-the-21-Certified-Medical-Device-Testing-Laboratory-under-MDR-2017
DCGI notice dt 16-03-2022 Classification of Medical Device pertaining to General Hospital Orthopaedic instruments under the provisions of Medical Devices Rules 2017
DCGI-notice-dt-16-03-2022-Classification-of-Medical-Device-pertaining-to-General-Hospital-Orthopaedic-instruments-under-the-provisions-of-Medical-Devices-Rules-2017
DCGI notice dt 23-02-2022 Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017
DCGI-notice-dt-23-02-2022-Classification-of-Medical-Device-pertaining-to-General-Hospital-under-the-provisions-of-Medical-Devices-Rules-2017
2021
DCGI dt 11-11-2021 - List of Notified Bodies registered with CDSCO under MDR-2017
DCGI-dt-11-11-2021-List-of-Notified-Bodies-registered-with-CDSCO-under-MDR-2017
DCGI dt 10-12-2021 - List of the certified Medical Device Testing Laboratory under MDR 2017
DCGI-dt-10-12-2021-List-of-the-certified-Medical-Device-Testing-Laboratory-under-MDR-2017
DCGI Notice dt 03-11-2021 Regulation of CT scan equipment All Implantable Devices MRI equipment etc. as Drugs with effect from April 1st 2021
DCGI-Notice-dt-03-11-2021-Regulation-of-CT-scan-equipment-All-Implantable-Devices-MRI-equipment-etc.-as-Drugs-with-effect-from-April-1st-2021
CDSCO circular dt 27-10-2021 Best Practices for individual users to safeguard against data breaches
CDSCO-circular-dt-27-10-2021-Best-Practices-for-individual-users-to-safeguard-against-data-breaches
DCGI Notice dt 01-10-2021 Module for online processing of applications for registration of BA BE study centres (CT-08)
DCGI-Notice-dt-01-10-2021-Module-for-online-processing-of-applications-for-registration-of-BA-BE-study-centres-CT-08
GCGI dt 28-09-2021 - Registration and labelling requirements of Medical Devices
GCGI-dt-28-09-2021-Registration-and-labelling-requirements-of-Medical-Devices
DCGI dt 21-09-2021 - Guidance Document for Manufacturers, Importers for voluntary mandatory registration of Medical Devices
DCGI-dt-21-09-2021-Guidance-Document-for-Manufacturers-Importers-for-voluntary-mandatory-registration-of-Medical-Devices
DCGI Notice dt 13-09-2021 - Classification of Medical Device pertaining to Software under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Software-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 - Classification of Medical Device pertaining to Personal Protective Equipment under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Personal-Protective-Equipment-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 - Classification of Medical Device pertaining to Pain Management under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Pain-Management-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 - Classification of Medical Device pertaining to Operation Theatre under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Operation-Theatre-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 - Classification of Medical Device pertaining to Nephrology and Renal Care under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-Nephrology-and-Renal-Care-under-the-provisions-of-MDR-2017
DCGI Notice dt 13-09-2021 - Classification of Medical Device pertaining to General Hospital under the provisions of MDR 2017
DCGI-Notice-dt-13-09-2021-Classification-of-Medical-Device-pertaining-to-General-Hospital-under-the-provisions-of-MDR-2017
DCGI Circular 13-09-2021 - Special condition under which the permission for import of drug with residual shelf life less than 60% is allowed
DCGI-Circular-13-09-2021-Special-condition-under-which-the-permission-for-import-of-drug-with-residual-shelf-life-less-than-60-is-allowed
DCGI Notice 10-09-2021 - Timelines for activities requiring minor and major procedures for cargo clearances at port offices of CDSCO
DCGI-Notice-10-09-2021-Timelines-for-activities-requiring-minor-and-major-procedures-for-cargo-clearances-at-port-offices-of-CDSCO
DCGI Notice 09-09-2021 - Online Application for issuance of Written Confirmation Certificate WCC regarding
DCGI-Notice-09-09-2021-Online-Application-for-issuance-of-Written-Confirmation-Certificate-WCC-regarding
DCGI 07-09-2021 - List of standards published under Medical Equipment and Hospital Planning (MHD) of BIS as forwarded by BIS for ready reference
DCGI-07-09-2021-List-of-standards-published-under-Medical-Equipment-and-Hospital-Planning-MHD-of-BIS-as-forwarded-by-BIS-for-ready-reference
DCGI dt 01-09-2021 Manufacturing and marketing of FDC of Tolperisone HCL 150mg + Paracetamol IP 500mg tablet
DCGI-dt-01-09-2021-Manufacturing-and-marketing-of-FDC-of-Tolperisone-HCL-150mg-Paracetamol-IP-500mg-tablet
DCGI Notice dt 27-08-2021 - List of 16 Testing Laboratories for Medical Devices MDTLs
DCGI-Notice-dt-27-08-2021-List-of-16-Testing-Laboratories-for-Medical-Devices-MDTLs
DCGI dt 27-08-2021 Procedure for regulation of FDCs declared as rational in respect to 294 FDCs by DTAB which were licensed to manufacture and market by SLA without approval of DCGI
DCGI-dt-27-08-2021-Procedure-for-regulation-of-FDCs-declared-as-rational-in-respect-to-294-FDCs-by-DTAB-which-were-licensed-to-manufacture-and-market-by-SLA-without-approval-of-DCGI
DCGI dt 27-08-2021 Procedure for regulation of 19 FDCs declared as rational in respect to 294 FDCs by DTAB which were licensed to manufacture and market by SLA without approval of DCGI
DCGI-dt-27-08-2021-Procedure-for-regulation-of-19-FDCs-declared-as-rational-in-respect-to-294-FDCs-by-DTAB-which-were-licensed-to-manufacture-and-market-by-SLA-without-approval-of-DCGI
DCGI dt 27-08-2021 Manufacturing and marketing of certain FDCs as per directions of Honble High Court Maharashtra Nagpur Bench
DCGI-dt-27-08-2021-Manufacturing-and-marketing-of-certain-FDCs-as-per-directions-of-Honble-High-Court-Maharashtra-Nagpur-Bench
DCGI Notice dt 23-08-2021 - Classification of Medical Device Pertaining to Urology Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Urology-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 - Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Obstetrical-and-Gynecological-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 - Classification of Medical Device Pertaining to Dental Under the provision of MDR 2017
DCGI-Notice-dt-23-08-2021-Classification-of-Medical-Device-Pertaining-to-Dental-Under-the-provision-of-MDR-2017
DCGI Notice dt 23-08-2021 – Classification of Medical Devices Pertaining to Pediatrics and Neonatology under MDR 2017
DCGI-Notice-dt-23-08-2021-–-Classification-of-Medical-Devices-Pertaining-to-Pediatrics-and-Neonatology-under-MDR-2017
DCGI Notice dt 19-08-2021 - Certain pre 1988 permitted FDCs de novo manufacturing for sale without approval from CLA
DCGI-Notice-dt-19-08-2021-Certain-pre-1988-permitted-FDCs-de-novo-manufacturing-for-sale-without-approval-from-CLA
DCGI Notice dt 09-08-2021 - Classification of Medical Devices Pertaining to Ophthalmology under MDR 2017
DCGI-Notice-dt-09-08-2021-Classification-of-Medical-Devices-Pertaining-to-Ophthalmology-under-MDR-2017
DCGI Notice dt 06-08-2021 - Classification of Medical Devices Pertaining to ENT under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Devices-Pertaining-to-ENT-under-MDR-2017
DCGI Notice dt 06-08-2021 - Classification of Medical Device Pertaining to Respiratory Under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Respiratory-Under-MDR-2017
DCGI Notice dt 06-08-2021 - Classification of Medical Device Pertaining to Radiotherapy under MDR 2017
DCGI-Notice-dt-06-08-2021-Classification-of-Medical-Device-Pertaining-to-Radiotherapy-under-MDR-2017
FAQs on Cosmetics Rules 2020 by Cosmetic division of CDSCO dt 06-08-2021
FAQs-on-Cosmetics-Rules-2020-by-Cosmetic-division-of-CDSCO-dt-06-08-2021
DCGI dt 02-08-2021 - Updated list of BA-BE Study centre & Bio Analytical Laboratory under New CT RULE 2019
DCGI-dt-02-08-2021-Updated-list-of-BA-BE-Study-centre-Bio-Analytical-Laboratory-under-New-CT-RULE-2019
DCGI dt 26-07-2021 - Inviting Public comments, as steps are being taken by CDSCO to regulate the products like skin patches which are being used as cosmetic
DCGI-dt-26-07-2021-Inviting-Public-comments-as-steps-are-being-taken-by-CDSCO-to-regulate-the-products-like-skin-patches-which-are-being-used-as-cosmetic
DCGI Notice dt 26-07-2021 - Classification of Medical Devices pertaining to Rehabilitation under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Rehabilitation-under-MDR-2017
DCGI Notice dt 26-07-2021 - Classification of Medical Devices pertaining to Physical Support under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Physical-Support-under-MDR-2017
DCGI Notice dt 26-07-2021 - Classification of Medical Devices pertaining to Interventional Radiology under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Interventional-Radiology-under-MDR-2017
DCGI Notice dt 26-07-2021 - Classification of Medical Devices pertaining to Dermatological & Plastic Surgery under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Dermatological-Plastic-Surgery-under-MDR-2017
DCGI Notice dt 26-07-2021 - Classification of Medical Devices pertaining to Cardiovascular under MDR 2017
DCGI-Notice-dt-26-07-2021-Classification-of-Medical-Devices-pertaining-to-Cardiovascular-under-MDR-2017
DCGI Notice dt 26-07-2021 - Evaluation of certain Pre 1988 permitted FDCs - without due approval from CLA
DCGI-Notice-dt-26-07-2021-Evaluation-of-certain-Pre-1988-permitted-FDCs-without-due-approval-from-CLA
DCGI Circular 23-07-2021 Already approved drugs is New Drug, if certain changes occur in Active substance
DCGI-Circular-23-07-2021-Already-approved-drugs-is-New-Drug-if-certain-changes-occur-in-Active-substance
DCGI Notice dt 23-07-2021 - Classification of In Vitro Diagnostic Medical Devices under MDR 2017
DCGI-Notice-dt-23-07-2021-Classification-of-In-Vitro-Diagnostic-Medical-Devices-under-MDR-2017
DCGI Notice dt 12-07-2021 - Classification of Medical Devices pertaining to Anesthesiology under MDR 2017
DCGI-Notice-dt-12-07-2021-Classification-of-Medical-Devices-pertaining-to-Anesthesiology-under-MDR-2017
DCGI Notice dt 07-07-21 to Stakeholders for Module for online processing of applications for issuance of written Confirmation Certificate (WCC)
DCGI-Notice-dt-07-07-21-to-Stakeholders-for-Module-for-online-processing-of-applications-for-issuance-of-written-Confirmation-Certificate-WCC
CDSCO dt 07-07-2021 - List of 14 Testing Laboratories for Medical Devices (MDTLs)
CDSCO-dt-07-07-2021-List-of-14-Testing-Laboratories-for-Medical-Devices-MDTLs
CDSCO dt 30-06-2021 - Medical Devices alert for Ventilator of Philips June 2021
CDSCO-dt-30-06-2021-Medical-Devices-alert-for-Ventilator-of-Philips-June-2021
CDSCO notification 25-06-21 - appointment of 172 Medical Devices officers
CDSCO-notification-25-06-21-appointment-of-172-Medical-Devices-officers
DCGI dt 16-05-2021 Advisory regarding Oxygen Concentrators suitable for COVID-19 case management in Home settings
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, PET equipment, MRI equipment, X-Ray machine, Defibrillators and Bone marrow cell separator as Drugs with effect from April 1st 2021
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-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-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-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-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
CDSCO dt 08-03-2021 - List of 11 Testing Laboratories for Medical Devices (MDTLs)
CDSCO-dt-08-03-2021-List-of-11-Testing-Laboratories-for-Medical-Devices-MDTLs
DCGI Notice dt 25-02-2021 -Regarding implementation of SUGAM Online system for reporting of SAE's
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
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-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-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-Letter-dt-04-12-2020-Clarification-regarding-reference-standards
CDSCO dt 09-10-2020 - List of 10 Testing Laboratories for Medical Devices (MDTLs)
CDSCO-dt-09-10-2020-List-of-10-Testing-Laboratories-for-Medical-Devices-MDTLs
DCGI Notice dt 17-9-2020 - regarding import of drug & related product
DCGI-Notice-dt-17-9-2020-regarding-import-of-drug-related-product
DCGI Circular 08-09-2020 - regarding 294 rational FDCs - procedure to be followed
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 648(E) and GSR 102(E) dated 11-02-2020
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 648(E) and GSR 102(E) 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-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-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-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 - regarding extension of validity of WHO-GMP / CoPP
DCGI-Letter-01-05-2020-Extension-of-validity-of-WHO-GMP-CoPP
DCGI Circular 30-04-2020 - regarding extension of validity of BA/BE study centres
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-approval-17-04-2020-Rapid-CLIA-ELISA-kits-approved-for-testing-of-Covid-19-with-the-condition
DCGI Notice 17-04-20 Clinical trial of convalescent plasma in COVID-19 Patients
DCGI-Notice-dt-17-04-20-Clinical-trial-of-convalescent-plasma-in-COVID-19-Patients
DCGI letter 16-04-20 along with list of 55 critical medicines for Covid-19
DCGI-letter-16-04-20-along-with-list-of-55-critical-medicines-for-Covid-19
DCGI letter 07-04-2020 Regarding granting permission to-manufacture Medical gas by Industrial gases plant
DCGI-letter-07-04-2020-Regarding-granting-permission-to-mafr-Medical-gas-by-Industrial-gases-plant
ICMR-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 which has been previously approved as r-DNA derived drug
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-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-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-Notice-13-03-20-Testing-of-all-categories-of-new-drugs-for-their-approval
DCGI has issued circular on 04-03-2020 Regarding – Disposal of the applications of “Written confirmation” for active substances exported to the EU for medicinal products for human use in accordance with Article 46(2) (b) of Directive No. 2001/83/EC.
https://thehealthmaster.com/circulars-on-pharmaceuticals/
