CDSCO Panel Rejects Hetero Lab's Plea for Lenacapavir Approval Without Local Trials Parthika Patel9 Dec 2025 3:12 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has declined the proposal submitted by...
Sun Pharma Told to Revise Delafloxacin Phase III Trial Protocol Parthika Patel8 Dec 2025 7:01 PM ISTNew Delhi: The Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), has directed Sun Pharma Laboratories...
No Ads for High-Risk Medicines: Govt Panel Recommends Major Amendments to Drugs Rules 1945 Susmita Roy8 Dec 2025 12:15 PM ISTNew Delhi: In a significant move aimed at tightening regulatory control over the promotion of high-risk medicines, the Drugs Consultative Committee...
MSD Pharma Gets Conditional SEC Approval to Begin Phase III Trial of Sacituzumab Tirumotecan Susmita Roy7 Dec 2025 11:08 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to MSD...
WHO Alert Spurs India's Probe Into Deadly Cough Syrup, Licence Cancelled, 700 Plus Units Audited, Parliament Informed Susmita Roy6 Dec 2025 11:22 PM ISTNew Delhi: In response to the World Health Organization's alert of 13 October 2025 on contaminated cough syrups linked to child deaths, the Union...
CDSCO Panel Seeks Protocol Revisions in Levim Lifetech's Teriparatide Biosimilar Study Susmita Roy6 Dec 2025 11:02 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has opined that LevimLifetech revise the...
Same Brand Name Used for Multiple Drugs: Govt Panel Calls for Stakeholder Consultation Susmita Roy6 Dec 2025 10:51 PM ISTNew Delhi: In a move aimed at addressing growing concerns over brand name extensions in the pharmaceutical sector, the Drugs Consultative Committee...
Govt Panel Approves Inclusion of Emergency Contraceptive Levonorgestrel Under Schedule K Susmita Roy4 Dec 2025 9:52 PM ISTNew Delhi: In a move aimed at streamlining regulatory clarity and improving access to essential reproductive health products, the Drugs Consultative...
CDSCO Panel Denies Trial Waiver for Atropine, Asks Sun Pharma to Conduct Phase III Study Susmita Roy4 Dec 2025 8:57 PM ISTNew Delhi: Rejecting the proposal for a clinical trial waiver for Atropine Sulphate Ophthalmic Solution IP 0.025% w/v, the Subject Expert Committee...
CDSCO Issues Risk Classification List for 187 Interventional Radiology Devices, Details Susmita Roy3 Dec 2025 5:31 PM ISTNew Delhi: In a move to streamline regulatory oversight of medical devices, the Central Drugs Standard Control Organisation (CDSCO) has released the...
Lupin's Phase IV Report for Glycopyrronium, Vilanterol Inhalation Gets CDSCO Panel Nod Parthika Patel3 Dec 2025 5:02 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has accepted the Phase IV clinical trial...
Alkem Gets CDSCO Panel Nod to Market Synthetic Semaglutide Injection in Multiple Strengths for Type 2 Diabetes Susmita Roy2 Dec 2025 10:22 PM ISTNew Delhi: Alkem Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control...
