Regulator flags unauthorised mfg & sale of male infertility drugIndia’s drug regulator has directed states to crack down on the unauthorised manufacture and sale of Enclomiphene products. CDSCO said the ...
Regulator mandates full review of globally unapproved drugsIndia’s drug regulator has clarified that new drugs not approved anywhere globally must undergo the full domestic regulatory process, even ...
IPA seeks to regularise 'legacy' drugsThe Indian Pharmaceutical Alliance seeks to regularize many drugs. These drugs have been marketed for years without central approval. Examp...
Government tightens surveillance on GLP-1 weight-loss drug promotion amidst surrogate advertising concernsCentral government directs state regulators to enhance surveillance over GLP-1 drug promotion. Approved GLP-1 drugs are only for Type 2 dia...
NHRC seeks action from Rajasthan over Kota maternal deaths linked to faulty oxytocinThe National Human Rights Commission has directed Rajasthan officials to act on maternal deaths. Substandard oxytocin injections in Kota ar...
India takes action against 90% of inspected high-risk pharmaceutical facilities, regulator saysAmid increasing global concerns over Indian pharmaceuticals, India's drug regulator is rigorously addressing high-risk manufacturing sites....
US FDA approves world's first oral cholesterol-lowering pill: What it means for patientsThe FDA has approved Lipfendra, an oral PCSK9 inhibitor, for high cholesterol. This new once-daily pill offers an alternative to injectable...
Emcure Pharma gets CDSCO nod to market Poviztra for fatty liver treatmentEmcure Pharmaceuticals announced its brand Poviztra is now available for fatty liver treatment. This follows regulatory approval for treati...
Novo Nordisk's obesity drug Wegovy wins India approval to fight silent fatty liver killerIndia's drug regulator approved Novo Nordisk's Wegovy for MASH treatment. This drug targets a serious progressive form of fatty liver disea...
Schedule H1 explained: Why did India tighten its prescription rules for high-alcohol medicines?Schedule H1 Explained: High-alcohol oral medicines now require a doctor's prescription under Schedule H1. This stricter classification mand...
India-UK FTA: Pharma industry flags regulatory priorities ahead of July 15 rolloutIndustry stakeholders expect stronger trade, investment, and research partnerships but say implementation clarity will determine the pact’s...
Govt to plug regulatory gaps in drug dealsAuthorities discovered drugmakers hid licence cancellations to obtain supply orders. The government now mandates states display this inform...
Govt steps up efforts to curb 'irrational' drugs with crackdown on FDCs not part of official databaseThe government plans to act against drugmakers with unlisted products. This move aims to stop the sale of irrational fixed-dose combination...
AI profiling of traffickers at airports, screening of students in varsities part of India's maiden drug control visionIndia will deploy AI passenger profiling and drug screening in educational institutions. This national roadmap aims to combat drug traffick...
Regulator seeks views to curb similar sounding drug brandsThe Central Drugs Standard Control Organisation in India is inviting public contributions concerning new regulations aimed at curbing the s...
Death in a vial: Five cases lay bare many uncomfortable truths about Indian healthcareFive young mothers in Kota died after childbirth, with suspicion falling on oxytocin injections. Investigations revealed the vials containe...
Why CDSCO and BEE have not kept pace with the industries they overseeCDSCO still faces challenges like chronic understaffing, gaps in technical skills, weak lab infra and fragmented approvals. About a decade ...