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Govt of India

Govt to amend New Drugs and Clinical Trials Rules 2019

The department of health and family welfare has come out with a notification with draft rules for the New Drugs and Clinical...
DCGI CDSCO

DCGI: Already approved drugs is New Drug, if certain changes occur in Active substance

The Drugs Controller General (India) has said that certain changes in the active substance of an approved drug may lead to change...
CDSCO DCGI FDA

CDSCO gives this direction to stakeholders involved in Clinical Trial

The Central Drugs Standard Control Organization (CDSCO) has directed all stakeholders involved in clinical trials (CT) for online submission of serious adverse...
Govt India

Govt to amend New Drugs and Clinical Trial Rules 2019

The Union health ministry has issued draft notification on New Drugs and Clinical Trials (NDCT) Amendment Rules, 2021 for inclusion of provisions...
Medicine Injection Vaccine

Pfizer seeks authorisation for vaccine in India

Pfizer India has become the first pharmaceutical firm to seek from the Drugs Controller General of India (DCGI) an emergency use authorisation...
Document

SII replied to DCGI: Will abide by standard protocol

The Serum Institute of India (SII) has stated that it will follow the instructions and protocols of the Central Drugs Standard Control Organisation (CDSCO)...
Laboratory

Manufacture COVID-19 vaccine before clinical trials end: Govt

Manufacture COVID-19 vaccine before clinical trials end: Govt Two days before World Clinical Trials Day, India’s Ministry of Health...
Laboratory

Testing of new drugs for approval under ND&CT Rules, 2019

The Drugs Controller General of India (DCGI) has mandated testing of all categories of new drugs for their approval under the...
CDSCO DCGI FDA

No separate new drug approval required if… : DCGI

Mumbai, 26 Feb 2020: The Drugs Controller General of India (DCGI) has clarified about fixed dose combination (FDC) approval containing a new molecule.
CDSCO DCGI FDA

SDCs to give BA/BE approvals within 15 Days: CDSCO

The Central Drugs Standard Control Organisation (CDSCO) has asked all state drug controllers to give bioavailability-bioequivalence (BA/BE) study approvals for export within...
Laboratory

Process of post approval changes in Clinical Trial

It has been decided that cases of post approval changes will be processed by CDSCO within 15 working days of receipt of...
Laboratory test chemical

CDSCO urges pharma cos to submit stability studies data

The Central Drugs Standard Control Organisation (CDSCO) has urged the manufacturers to submit stability studies data as per New Drugs and Clinical...
Govt Notification

Drug Rules: Notifications

Download Drug Rules - Notifications Download Latest Notifications of Drug Rules: Govt. of...
WHO

WHO approves the first Malaria Vaccine

The WHO on Wednesday endorsed the first ever vaccine to prevent malaria, debuting a tool that could save the lives of tens of...
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,...
IPC

Safety alert against Hepatitis C drug Sofosbuvir: IPC

The Indian Pharmacopoeia Commission (IPC), which is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) has flagged a drug...
DRDO

Granules India gets license from DRDO for Covid drug 2-DG

Granules India yesterday said it has received licence from Defence Research and Development Organisation (DRDO) to manufacture and market COVID-19 treatment drug,...
PLI Scheme

Pharma Industry urges Govt to include Chile under PLI scheme

Pharma industry has urged the Department of Pharmaceuticals (DoP) to include Chile amongst the countries for Abbreviated New Drug Application (ANDA) /...
Govt of India

Govt to include ICD as depot to import Drugs under Drugs Rules, 1945

Download notification No. GSR 611(E) dt 01-09-2021 The Union health ministry has issued a draft amendment...
Medicine

NLEM: New list of Essential Medicines: 39 new drugs added, 16 dropped

Download the NLEM list for the year, 2003, 2011 and 2015 The government released the revised list of...
DCGI CDSCO

DCGI asks State FDAs to restrict Tolperisone FDC for these usage only

Download DCGI's letter dated 01-09-2021 The Drugs Controller General (India) has asked the State drug controllers to restrict the...
Govt of India

Govt amends New Drugs & Clinical Trial Rules 2019

Download the Notification: The Union ministry of health and family welfare has amended the New Drugs and Clinical Trial Rules 2019, bringing...
Medicine Tablet Capsule

Pfizer Epilepsy Drug Prices were unfairly high: UK review finds

Britain's competition watchdog is sticking with its view that Pfizer and Flynn Pharma broke the law by charging Britain's public health service "unfairly high"...
NPPA Price of drugs

NPPA approves retail prices of these 25 New Drugs: August 2021

Download the notification: The National Pharmaceutical Pricing Authority (NPPA) has approved retail prices of 25 new drugs under the Drug Price Control...

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