Cdsco

CDSCO seeks views on single ethics review model for multicentre trials

The consultations, scheduled for August 28, follow new ICMR guidelines proposing that a single Ethics Committee review all participating sites in multicentre research

Eisai launches Alzheimer's drug Leqembi in India after CDSCO approval

The disease-modifying therapy for early Alzheimer's disease will cost ₹21,682 per vial, with treatment expenses varying according to patients' weight and dosage

Delhi High Court seeks Centre's response on PIL over HPV vaccine rollout

The court sought replies from the Centre, ICMR and CDSCO on a PIL seeking disclosure of adverse event data and raising concerns over the HPV vaccination programme

Emcure broadens Poviztra's use for MASH after CDSCO nod for semaglutide

The drugmaker will market Poviztra for treating MASH after CDSCO approved the new indication for innovator semaglutide, expanding the medicine's approved uses in India

Novo Nordisk's Wegovy gets CDSCO nod for fatty liver disease indication

The approval makes Wegovy the first GLP-1 therapy cleared in India for treating adults with non-cirrhotic MASH and moderate-to-advanced liver fibrosis

Novo Nordisk's Wegovy gets CDSCO nod for treatment of fatty liver in India

Novo Nordisk India on Friday said it has received approval from the Central Drugs Standard Control Organisation for indication of its Wegovy injection for the treatment of fatty liver disease in India. The Central Drugs Standard Control Organisation (CDSCO) has approved a new indication for Wegovy (semaglutide injection 2.4 mg), Novo Nordisk India said in a statement. It makes Wegovy the first and only GLP-1 RA to be approved both globally and in India for the treatment of noncirrhotic Metabolic Dysfunction Associated Steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis along with a reduced calorie diet and increased physical activity, it added. MASH is a liver disease that develops due to excess fat buildup in the liver, causing chronic inflammation and liver damage. Novo Nordisk India MD Vikrant Shrotriya said the burden of MASH continues to rise in India, but treatment options are still severely limited. People with MASH face a higher risk of serious liver .

CDSCO tightens IVF reagent sale norms, restricts supplies to ART clinics

The drug regulator has directed manufacturers and distributors to supply IVF media and reagents only to registered ART clinics, strengthening oversight of assisted reproductive technologies

Govt plans easing licence timelines for moderate, high-risk medical devices

Draft amendments to the Medical Device Rules seek to reduce manufacturing licence timelines for Class B, C and D devices to improve regulatory efficiency and ease of doing business

Eli Lilly launches its first solid tumour RET-gene therapy in India

The US drugmaker has launched Tanstrive, a RET-targeted oral therapy for advanced or metastatic solid tumours, following marketing authorisation from the CDSCO

Government bans 16 fixed drug combinations over health safety concerns

Health Ministry prohibits 16 fixed drug combinations, including antibiotic and cosmetic formulations, after an expert review found they lacked therapeutic justification and posed potential health risk

CDSCO prohibits clinical trials at KKR-backed HCG cancer hospital

Drug regulator alleges irregularities in reporting adverse events and conflict-of-interest disclosures by the unit's ethics committee during human clinical trials

CDSCO flags banned antibiotics in shrimp exports amid rising rejections

Regulator seeks state-wise enforcement data as EU, US and Japan reject consignments linked to over 40 farms

CDSCO directs drugmakers to maintain pharmacovigilance systems

The drug regulator has asked central and state authorities to verify compliance with pharmacovigilance requirements during routine inspections and regulatory reviews

CDSCO flags spurious liver drug, 169 others fail quality tests in April

CDSCO flags one batch of a liver drug as spurious and identifies 169 drugs and formulations as not of standard quality during April surveillance

Dr Reddy's unveils oral diabetes drug Obeda for type 2 patients in India

The once-daily prescription tablet for type 2 diabetes received CDSCO approval after a Phase III trial showed comparable efficacy and safety to the innovator drug

CDSCO asks states, UTs to monitor surrogate promotion for GLP-1 drugs

CDSCO has directed states and UTs to curb surrogate advertising of GLP-1 obesity drugs amid rising sales and aggressive awareness campaigns

India's next pharma leap will be built on smarter global regulations

A risk-based system allows regulators to pay attention where it matters most, while providing industry with predictability

CDSCO asks firms to file safety reports from launch date of new drugs

India's drug regulator has directed manufacturers and importers to submit Periodic Safety Update Reports (PSURs) for new drugs from the date of actual marketing of the product rather than from the date of regulatory approval, in a move aimed at strengthening post-marketing safety surveillance. In an advisory issued by the Central Drugs Standard Control Organisation (CDSCO) on April 21, the regulator said it has observed instances where companies obtained approval for a new drug but launched the product in the market much later while submitting PSUR data from the approval date instead of the launch date. The CDSCO said such a practice results in the loss of "valuable safety insights" that are critical for monitoring adverse effects and ensuring patient safety after commercial roll out of medicines. Under the Fifth Schedule of the New Drugs and Clinical Trials Rules, 2019, manufacturers and importers are required to submit PSURs as part of post-marketing drug safety monitoring. "In v

Medtech backs India-NZ FTA, flags CDSCO exclusion as key regulatory gap

Medical device makers welcome India-NZ FTA for easing market access and exports, but flag absence of CDSCO in regulatory recognition framework as a key gap

Centre revises DCGI recruitment rules, raises age limit to widen pool

The Centre has raised the age limit and broadened eligibility norms for appointing the Drug Controller General of India to address a shortage of qualified candidates