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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 5

CDSCO Panel Approves Updated Package Insert for Takedas Vedolizumab

CDSCO Panel Approves Updated Package Insert for Takeda's Vedolizumab

Susmita Roy5 Nov 2025 4:16 PM IST
New Delhi: In a key regulatory development, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has...
Abbott

Ziller Medical Denied Manufacturing Nod for Cervical Cerclage Pessary Over Inadequate Safety Data

Parthika Patel4 Nov 2025 4:49 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has refused to grant manufacturing...
CDSCO Panel Asks Shilpa Biologicals to Revise Phase III Protocol for Recombinant Human Serum Albumin Study

CDSCO Panel Asks Shilpa Biologicals to Revise Phase III Protocol for Recombinant Human Serum Albumin Study

Susmita Roy4 Nov 2025 4:39 PM IST
New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has sought major revisions in...
Low-Risk Medical Device Makers Get Clarity: CDSCO Publishes Class A Risk Classification List under MDR 2017

Low-Risk Medical Device Makers Get Clarity: CDSCO Publishes Class A Risk Classification List under MDR 2017

Susmita Roy3 Nov 2025 9:07 PM IST
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has released a detailed Risk Classification List of Class A (non-sterile and...
AstraZeneca Gets SEC Nod to Update Lokelma Prescribing Information for Hyperkalemia Treatment

AstraZeneca Gets SEC Nod to Update Lokelma Prescribing Information for Hyperkalemia Treatment

Susmita Roy3 Nov 2025 7:08 PM IST
New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has recommended approval for...
Akums Wins 20-Year Patent for Dual Release PPI, Promises Long-Lasting GERD Relief

Akums Wins 20-Year Patent for Dual Release PPI, Promises Long-Lasting GERD Relief

Farhat Nasim3 Nov 2025 6:02 PM IST
New Delhi: Akums Drugs and Pharmaceuticals Limited has announced that it has been granted a patent for its invention titled 'Dual Release...
MSN Labs Secures SEC Nod for Phase III Trial of Vibegron 75 mg, Excluding Refractory OAB Patients

MSN Labs Secures SEC Nod for Phase III Trial of Vibegron 75 mg, Excluding Refractory OAB Patients

Susmita Roy2 Nov 2025 12:30 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has approved MSN Laboratories to conduct a...
Emcure Pharma Gets CDSCO Panel Nod to Conduct Phase IV Trial on Drospirenone Tablets

Emcure Pharma Gets CDSCO Panel Nod to Conduct Phase IV Trial on Drospirenone Tablets

Parthika Patel2 Nov 2025 11:30 AM IST
New Delhi: Pune-based Emcure Pharmaceuticals Ltd has received a recommendation from the Subject Expert Committee (SEC) under the Central Drugs...
Nearly 50% of Drug Inspector Posts Vacant at CDSCO, Reveals RTI Response

Nearly 50% of Drug Inspector Posts Vacant at CDSCO, Reveals RTI Response

Susmita Roy1 Nov 2025 10:22 PM IST
New Delhi: Nearly 250 Drug Inspector posts remain vacant across the regulatory and medical device divisions of the Central Drugs Standard Control...
Boehringer Ingelheim, CDR-Life enter into new agreement to develop autoimmune disease molecule

Boehringer Ingelheim Told to File Separate Phase IV Trial Plan for Empagliflozin

Susmita Roy1 Nov 2025 5:42 PM IST
New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has directed Boehringer Ingelheim India to...
MSN Labs Secures SEC Nod for Phase III Trial of Vibegron 75 mg, Excluding Refractory OAB Patients

MSN Labs Gets SEC Go-Ahead to Conduct Phase IV Clinical Trial on Elagolix for Endometriosis

Parthika Patel1 Nov 2025 5:25 PM IST
New Delhi: Hyderabad-based MSN Laboratories Pvt Ltd has received a recommendation from the Subject Expert Committee (SEC) under the Central Drugs...
Cipla, Hetero win bid to supply widely prescribed diabetes drug in China

CDSCO Panel Seeks Anesthesiology Expert Review for AIIMS Raipur Trial on Gabapentin, Melatonin, Clonidine FDC

Susmita Roy31 Oct 2025 7:26 PM IST
New Delhi: After reviewing a clinical trial proposal submitted by Dr Pratibha R Mudgal from AIIMS Raipur, involving a fixed-dose combination of...
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Real-World Outcomes of Dydrogesterone ER 20 mg in Recurrent Pregnancy Loss

Real-World Outcomes of Dydrogesterone ER 20 mg in Recurrent Pregnancy Loss

Uncontrolled T2DM in India and Application of Trusted Molecules Empagliflozin, Sitagliptin, and Metformin Coming Together

Uncontrolled T2DM in India and Application of Trusted Molecules Empagliflozin, Sitagliptin, and...

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Participation of the incarcerated in Clinical Trials in India: Need for a road map -Albina Arjuman

Managing GERD in Children with Asthma with H2 receptor antagonists (H2RAs): Indian Paediatricians Perspectives

Managing GERD in Children with Asthma with H2 receptor antagonists (H2RAs): Indian Paediatricians'...

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