Latest Circulars, Notices & Guidelines: CDSCO, DCGI

Download Latest Circulars, Notices & Guidelines: CDSCO, DCGI

6589
CDSCO Central Drug Standard Control Organisation
CDSCO
SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
Rakesh Dahiya

Last Updated on June 7, 2024 by The Health Master

Download latest Circulars – CDSCO, DCGI

Download the latest circulars: Govt of India, DCGI, Health Ministry, and ICMR issue notices / circulars time to time for stakeholders, and the same are uploaded on the official websites of the above institutions.

We have provided some of the important notices / circulars relevant to the above-mentioned topic, Click on the links below for more information:

Circulars – CDSCO, DCGI

Source of Circulars / Notices / letters: CDSCO website

DCGI CDSCO Regulator Drugs Controller General India
DCGI

2024

DCGI 30-04-2024 NOC’s for manufacture of Unapproved, Banned, New Drugs Solely for Export Purpose

DCGI Notice dt 16-04-2024 Manufacturing and marketing of unapproved drug Meropenam 1gm + EDTA for Injection

DCGI dt 03-04-2024 Notice to All stakeholders for Strengthening of Private Medical Device Testing Laboratory

CDSCO 28-02-2024 Draft Guidance for Industry – Post Approval Changes in Biological Products

DCGI Notice 12-02-2024 – Online application for Neutral Code for manufacturing of Medical Devices for export purpose

DCGI circular dt 09-02-2024 Regulatory Guidelines for sampling of drugs, Cosmetics and Medical Devices by Drugs Inspectors of Centre and States

DCGI 01-01-2024 Launching of National Single Window System (NSWS) Portal

2023

DCGI 18-12-2023 To update package insert Promotional Literature of FDC of Chlorpheniramine Maleate IP 2mg Phenylephrine HCl IP 5mg drop per ml

DCGI Advisory 05-12-2023 Advisory to all manufacturer of cough syrup, various critical excipients

CDSCO 29-11-2023 updated list of laboratories to conduct Performance evaluation of IVDs dated 29.11.23

DCGI Notice 25-10-2023 Updation of classification in IVD medical devices under the provision of MD Rules 2017

DCGI Circular dt 12-10-2023 Six months relaxation for Regulation of all Class C & D Medical Devices under Licensing regime

DCGI 13-09-2023 Approval of NABL Accredited Private Testing Laboratory for Testing of Cough Syrup to be exported by the Manufacturer or Exporter

DCGI dt 06-09-2023 WHO Alert on falsified DEFITELIO (DEFIBROTIDE) 80 mg per ml concentrate for solution for infusion, B. No. 20G20A, Exp date 08-2024 mfg by Gentium Srl and identified in India

DCGI dt 05-09-2023 Alert on falsified versions of Adcetris Injection Brentuximab Vedotin Manufactured by Takeda Pharmaceuticals Company Ltd

DCGI dt 31-08-2023 Voluntary Recall of Digene Gel, manufactured by Abbott India Limited, Goa-403722

DCGI dt 28-07-2023 Receipt of Cough Syrup of same batch number by two different NABL Accredited Government Laboratories Manufactured by the same Manufacturers or Exporters

DCGI circular dt 19-07-2023 Online Application for the issuance of Form 11 Test License for Veterinary Vaccines or Drugs

DCGI dt 14-07-2023 Alert on Pholcodine containing cough and cold remedies

DCGI dt. 13-06-2023 – Daily Updation of No. of Batches of Cough syrup sample for Export at Different Laboratories for testing

DCGI dt 20-06-2023 Implementation of Pre-Shipment inspection under testing – Ref. Medicines Control Agency, Gambia

DCGI Circular dt. 13-06-2023 – Daily Updation of No. of Batches of Cough syrup sample for Export at Different Laboratories for testing

DCGI circular dt 12-04-2023 Licensing regime of Class C & D Medical Devices

List of 13 Notified Bodies registered with CDSCO under MDR 2017 as on 03-04-2023

List of 13 Notified Bodies registered with CDSCO under MDR 2017 as on 03-04-2023

List of Notified Bodies (13) registered with CDSCO under MDR, 2017 as on 09-03-2023

2022

DCGI Notice 22-12-2022 Registration of Medical Device Testing Laboratory in Form MD-40 as per Medical Devices Rules (MDR) 2017 for Testing of Medical Devices on behalf of the manufacturer

DCGI dt 21-11-2022 28 MDTLs Updated list of medical devices testing laboratory (MDTL) registered with CDSCO under MDR 2017

DCGI-dt-21-11-2022-28-MDTLs-Updated-list-of-medical-devices-testing-laboratory-MDTL-registered-with-CDSCO-under-MDR-2017

DCGI dt 18-11-2022 Procedure to be followed for subsequent in respect of FDCs declared as rational by prof. Kokate Committee

DCGI Notice dt 11-10-2022 Classification of Medical Device pertaining to Oncology under the provisions of Medical Devices Rules, 2017

DCGI Notice dt 10-10-2022 Classification of Medical Device Pertaining to Dental Under the provision of Medical Devices Rules 2017

DCGI circular dt 30-09-2022 Regulation of all Class A & B Medical Devices under Licensing regime, w.e.f 01.10.2022, as per G.S.R. 102(E) dt 11.02.2020

List of Notified Bodies registered with CDSCO under MDR, 2017 as on 25-08-2022

List-of-Notified-Bodies-registered-with-CDSCO-under-MDR-2017-as-on-25-08-2022

Draft Guidance document dated 07-07-2022 on Overview on Performance Evaluation, External Evaluation of In-vitro Diagnostic Medical Device (IVDMD)

Draft Guidance document dated 07-07-2022 on Guidance on Stability Studies of In-Vitro Diagnostic Medical Device (IVDMD)

Draft Guidance document dated 07-07-2022 on Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD)

DCGI Notice dt 11-07-2022 Regarding Licensing of Class A and Class B Medical Devices

DCGI notice dated 06-07-2022 Classification of Medical Devices Pertaining to Rehabilitation under the Provisions of Medical Devices Rules 2017

DCGI-notice-dated-06-07-2022-Classification-of-Medical-Device-Pertaining-to-Rehabilitation-under-the-Provisions-of-Medical-Devices-Rules-2017

DCGI Notice dated 03-06-2022 Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of Medical Devices Rules 2017

DCGI-Notice-dated-03-06-2022-Classification-of-Medical-Device-Pertaining-to-Obstetrical-and-Gynecological-Under-the-provision-of-Medical-Devices-Rules-2017

DCGI Notice dated 03-06-2022 Classification of Medical Device Pertaining to Dental Under the provision of Medical Devices Rules 2017

DCGI-Notice-dated-03-06-2022-Classification-of-Medical-Device-Pertaining-to-Dental-Under-the-provision-of-Medical-Devices-Rules-2017

DCGI Notice dt 03-06-2022 Advisory for registration of Blood Centres on E-rakhtkosh

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 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

2021

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 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

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

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 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 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 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 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 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 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 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 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 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 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 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 Radiotherapy under MDR 2017

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 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 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 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 – 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 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 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 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 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 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

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 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

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

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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 of 3 Categories of MD IVDs – reference SO 648(E) and GSR 102(E) 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 – regarding extension of validity of WHO-GMP / CoPP

DCGI Circular 30-04-2020 – regarding 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 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 07-04-2020 Regarding granting permission to-manufacture Medical gas by Industrial gases plant

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 – 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 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.

DCGI has issued circular on 03-03-2020 regarding disposal applications of WHO-GMP, Certificate of Pharmaceutical Products (CoPP)

DCGI has issued notice on 26-02-2020 regarding submission and processing of application for registration certificate and import license in parallel with new drug application

DCGI has issued notice on 21-02-2020 regarding approval of FDCs containing new drugs

DCGI has issued notice on 21-02-2020 regarding fixing of limit of impurities in the specifications of INDs

DCGI has issued notice on 21-02-2020 regarding permission to conduct BA BE studies and clinical trial

DCGI has issued notice on 21-02-2020 regarding pre-submission meeting for new drugs and clinical trials

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

DCGI has issued notice on 21-02-2020 regarding requirements of stability data for CoPPs

DCGI has issued notice on 21-02-2020 regarding stability data for BA BE study in human for export

DCGI has issued notice on 21-02-2020 regarding sub acute toxicity study report for injectable products for BA BE study in human for export

DCGI has issued notice on 20-02-2020 regarding Considerations-of Honb’le Supreme Court of India in the case of 294 FDCs

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

DCGI has issued a notice 27-01-2020 regarding Processing of post approval to BA BE permission issued in Form CT-07, import license issued in CT-17

DCGI has issued a notice 22-01-2020 regarding – List of Reference Products for Conduct of BE Study. Click below for more information:

2019

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

DCGI has issued a notice 08-11-2019 regarding clarification on exemption of sale license for importer of X Ray, MRI, PET, Ultrasound, CT Scan machine etc. Click below for more information:

DCGI has issued a notice 08-11-2019 regarding clarification on Implantable Medical Devices. Click below for more information:

DCGI has issued a notice 08-11-2019 regarding clarification regarding environmental conditions for equipments. Click below for more information:

CDSCO dt 03-10-2019 – List of 4 Testing Laboratories for Medical Devices (MDTLs)

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 Devices

DCGI dt 27-02-2019 procedure to be followed for regularisation of FDCs declared rational in respect of 294 FDCs by DTAB

2018

DCGI dt 21-05-2018 – Regarding illegal manufacturing of (API, Formulations) and import of Oxytocin in India

CDSCO / DCGI Guidelines

CDSCO Central Drug Standard Control Organisation
CDSCO

We have provided some of the important CDSCO / DCGI Guidelines, Click below links for more information:

Sampling

DCGI circular dt 09-02-2024 Regulatory Guidelines for sampling of drugs, Cosmetics and Medical Devices by Drugs Inspectors of Centre and States

Recall & Rapid Alert System

CDSCO-Guideline-on-Recall-and-Rapid-Alert-System-for-drugs-including-Biologicals-vaccines-version-2017

CDSCO-Guidelines-on-Recall-and-Rapid-Alert-System-for-Drugs

Good Distribution Practice

CDSCO Guidelines on Good Distribution Practices for Pharmaceutical Products

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

CDSCO-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

Clinical Trial

CDSCO dt 10-04-2024 Guidance for Industry on Clinical Trial


Latest Circulars, Notices & Guidelines: CDSCO, DCGI

Latest Circulars by ICMR on Pharmaceuticals

Latest Circulars by the Govt of India, Dept of Pharmaceuticals, Health Ministry

Latest Circulars: (IPC) Indian Pharmacopoeia Commission


Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana


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