Circulars on Pharmaceuticals

Last Updated on October 6, 2021 by The Health Master

Download Circulars – DCGI, Govt of India, Health Ministry, 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

DCGI CDSCO

2021

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 dt 30-06-2021 – Medical Devices alert for Ventilator of Philips June 2021

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

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Circulars – ICMR

2020

ICMR 14-08-2020 List-of companies vendors of Rapid antigen test kits for Covid-19 validated or being validated

ICMR on 04-05-2020 shortlisted 21 hospitals for Plasma trial, 90 hospitals are in queue

ICMR Press release 06-04-2020 ICMR scales up its capacity to fight COVID-19

ICMR Press release 23-03-2020 Fast Track Approval for Indian COVID-19 testing kits for commercial use

ICMR Press release 17-03-2020 ICMR enables more laboratories to test for COVID-19 and revises the criteria

2019

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

2018

ICMR 2018 – Guidelines for Management of Type 2 Diabetes

2011

ICMR-DBT – 2011 – Guidelines for evaluation of probiotics in food

FAQs on Cord Blood Banking

ICMR – FAQs on Cord Blood Banking

Circulars – Govt of India / Health Ministry

2021

DoP order dt 25-03-2021 – Public Procurement Policy for Medical devices

DoP dt 03-03-2021 – Gazette Notification of PLI scheme for Pharmaceuticals

DoP dt 16-02-2021 – Revised Guidelines for Public Procurement Policy

2020

Govt of India has issued a mannual on hand made mask 30-03-2020

Ministry of Health has issued a notice on 16-01-2020 for seeking comments / objections / suggestions on the proposal of framing recruitment Rules for Drugs Inspector ( Medical Device). To download the said notice, click below link:

2012

Directions by Health Ministry dated 09-11-2012 under Sec 33(P) of D&C Act for drug formulation in proper or generic name only

Directions by Health Ministry dated 01-10-2012 under Sec 33(P) of D&C Act for drug formulation in proper or generic name only

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

Good Distribution Practice

Samples declared as Spurious / NSQ

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