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DCGI CDSCO

DCGI approves 3 FDCs containing Cefixime & Cefadroxil as rational

Download DCGI's latest Notices: The Drugs Controller General (India) has allowed three fixed dose combinations (FDCs) as rational with certain conditions.
CDSCO DCGI FDA

CDSCO issues procedure for regulation of 19 FDCs out of 294

Download DCGI's latest Notices: The Central Drugs Standard Control Organisation (CDSCO) has issued a procedure for regulation of 19 fixed dose combinations...
CDSCO DCGI FDA

CDSCO extends deadline to submit details of 19 FDCs permitted before 1988

The Central Drugs Standard Control Organisation (CDSCO) has extended the deadline till September 25, 2021 for the stakeholders to submit details of...
Meeting Committee FDA

Expert Committee on FDCs calls for information from stakeholders

The expert committee, constituted by the Union health ministry for examining the permission of licenses for 19 fixed dose combinations (FDCs) approved...
Medicines

Parameters for evaluating FDCs should be changed: IDMA

The Sub-committee of Drugs Technical and Advisory Board (DTAB) is examining the fixed-dose combinations (FDCs) which are considered irrational by Prof Kokate...
DCGI CDSCO

Sub-committee on irrational FDCs to hear Mfrs from April 19: DCGI

The Drugs Controller General of India (DCGI) has issued notice to sub-committee on irrational fixed dose combinations (FDCs) to hear manufacturers from...
Meeting Committee FDA

Sub-committee of DTAB on FDCs to hear stakeholders from April 19

The sub-committee, constituted for examining the fixed dose combinations (FDCs) considered as irrational by Prof Kokate Committee, has invited concerned stakeholders for...
NPPA Price of drugs

Overmedication: NPPA to conduct Prescription audit of FDCs

The National Pharmaceuticals Pricing Authority (NPPA) has decided to carry out prescription audit to figure out the prescription patterns of fixed dose...
NPPA Price of drugs

NPPA’s remark on approval of FDCs

The National Pharmaceutical Pricing Authority (NPPA)’s remark against approval of fixed dose combination (FDC) drugs has drawn flak from pharmaceutical industry.
CDSCO DCGI FDA

DCGI asks mfrs to get approval for 86 rational FDCs by March 31, 2021

With three more fixed dose combination (FDC) drugs being declared rational, taking the number of FDCs declared rational to 86 under 294...
CDSCO DCGI FDA

DCGI directs drug Cos to submit data on 66 FDCs

The Drugs Controller General of India (DCGI) has directed the drug manufacturers to submit data with reference to 66 Fixed Dose Combinations...
CDSCO DCGI FDA

DCGI extends date to submit application for Cat. ‘D’ FDCs

The Drugs Controller General of India (DCGI) has directed the manufacturers to submit application for category 'd' FDCs as per Prof. Kokate...
CDSCO DCGI FDA

IDMA urges DCGI to continue with Rs.15k registration fee for 83 FDCs

The Indian Drug Manufacturers Association (IDMA) has urged the Drugs Controller General of India (DCGI) asking registration fees of Rs 15,000 to...
Document

Approval procedure of 2,131 FDCs: DCGI

DCGI Directs State SDCs To Ask Cos To Get Product Licenses Of 2,131 FDCs Approved By Kokate Committee
Medicine

New Drugs, FDCs, Clinical trial

Picture: Pixabay What is new drug Rule 122-E Definition of...
Laboratory Diabetes Blood sugar

Glenmark launches unique fixed dose combination drug for Diabetes

Glenmark Pharmaceuticals said it has become the first company in the world to launch a unique fixed dose combination (FDC) drug for diabetes in India.
Laboratory

AstraZeneca launches Clinical Trial Data division in India

Drug firm AstraZeneca on Wednesday said it has launched a clinical data and insights division in India for data-related management of its...
Govt of India

Govt to finalise OTC drug policy soon

India’s over-the-counter drug regulation, which has been in the works for more than four years, is likely to be out soon as...
DCGI CDSCO

Biological E seeks DCGI nod for phase-3 trial for Booster dose

The Hyderabad-based Biological E vaccine manufacturing firm has recently sought the nod of Central drug regulator Drug Controller General of India (DCGI)...
Injection vaccine Medicine

Biological E seeks DCGI nod for Phase-III trial of Corbevax

Biological E has sought permission from India’s drug regulator to conduct the phase-III clinical trial for its C-19 vaccine Corbevax as a...

Bharat Biotech submits Clinical Trial data to CDSCO for Covaxin in children

HYDERABAD: Bharat Biotech, which completed the Phase 2/3 trials of C-19 vaccine Covaxin for use in children under 18 years of age, has submitted the...
CDSCO DCGI FDA

CDSCO to start BA/BE studies registration process online from Oct 15

The national drug regulator will be switching the applications for registration of centres for bioavailability / bioequivalence (BA/BE) studies from the industry,...
DCGI CDSCO

DCGI gives permission to conduct Phase III trial for two-dose C-19 vaccine

India’s drug regulator Drugs Controller General of India (DCGI) has given permission to Zydus Cadila for conducting Phase III trial on the two-dose regimen...
WHO

WHO emergency use authorisation to Covaxin delayed till October 5

New Delhi : World Health Organisation's (WHO) approval for the emergency use authorisation (EUA) to C-19 vaccine Covaxin, developed by the Hyderabad-based Bharat Biotech,...

Latest posts

Govt releases draft policy for R&D, Pharma and Medical Devices

The Department of Pharmaceuticals (DoP) has come out with a draft policy to catalyse research and development (R&D) and innovation in pharmaceutical...

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