Circulars

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

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

DCGI CDSCO

2021

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

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 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, 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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