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CDSCO APPROVAL
Sanofi healthcare receives CDSCO approval for Qftilia therapy for haemophilia patients in IndiaSanofi Healthcare has obtained authorisation from the Central Drugs Standard Control Organisation for Qfitlia. This therapy is designed to ...- National Formulary of India lists drugs not approved by CDSCO, DCGI seeks explanation from IPCThe National Formulary of India released its latest edition amidst concerns regarding unapproved drugs included in it. The Drug Controller ...
- Centre may seek legal view on licensing of sterile drugsThe government is actively exploring a proposal to expand central licensing authority over all sterile drug products following a recent Sup...
- An ECG device in a doctor’s palm: Inside Scanbo’s AI heart-screening pushSurat-based Scanbo has developed an AI-led medical device, D8, that can give a quick interpretation of abnormalities behind the functioning...
- Sun Pharma signs major deal with LIB Therapeutics of US, gains access to $3.7-bn global market for bad cholesterol inhibitor PCSK9Sun Pharma has signed an exclusive agreement with LIB Therapeutics for Lerodalcibep, a cholesterol-lowering medication. This deal covers al...
- CDSCO steps up scrutiny of pharma drugs containing narcotic substancesThe Central Drugs Standard Control Organisation is addressing regulatory gaps related to the illegal diversion of pharmaceutical drugs. Fol...
- Lord’s Mark advances AI breast cancer screening towards clinical trialsIn a groundbreaking collaboration with C-MET, Lord's Mark Industries Limited is making strides in breast cancer screening technology. Utili...
- Takeda partners Dr Reddy's to launch dengue vaccine Qdenga in India from 2027Takeda and Dr. Reddy's Labs will promote the Qdenga dengue vaccine in India. This pioneering vaccine is expected to launch in the first hal...
- Drugs Panel to weigh bringing all sterile drug products under central licensing amid contamination concernsA proposal will soon be considered to centralize licensing for all sterile drug products. This move aims to tighten regulations on medicine...
- QDENGA dengue vaccine to hit India market in 2027; Dr Reddy’s to sell itIndia's first approved dengue vaccine, QDENGA, will launch in the private market by mid-2027. Dr Reddy's Laboratories will distribute and p...
- ETSA winner Theranautilus heads to human trials; JSW One’s IPO plansHappy Friday! Theranautilus is set to begin human trials of its nanorobot-based dental tech soon. This and more in today’s ETtech Morning D...
- Agonisingly slow clinical trial is stopping Indian pharma become global innovator from supplierIndia's regulatory hurdles slow down early-stage drug trials significantly. This complexity causes Indian companies to conduct crucial firs...
- CBIC releases import clearance checklist for cosmetics, drugs, and medical devicesThe CBIC has introduced a new checklist for customs officers reviewing imports. This standardized process aims to streamline clearances for...
- Govt mandates manual verification of imported drugs and medical devices due to SWIFT 2.0 system gapCustoms officers must now manually check import documents for healthcare products. This manual verification applies even to facilitated imp...
- DRL, Emcure get approval to make breakthrough HIV drugIndia's drug regulator has cleared the path for local lenacapavir manufacturing. Two Indian pharmaceutical companies received waivers for l...
- 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...
- 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...
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