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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 9

Madras HC Upholds Centres One-Year Contract Extension of DCGI

DCGI Orders Nationwide GMP Inspection Drive to Enforce Revised Schedule M

Susmita Roy12 Nov 2025 10:43 PM IST
New Delhi: The Drugs Controller General of India (DCGI) has directed all states and Union Territories to immediately launch a nationwide inspection...
Sanofis Tetraxim Vaccine Gets CDSCO Panel Nod for Expanded Indication

Sanofi's Tetraxim Vaccine Gets CDSCO Panel Nod for Expanded Indication

Susmita Roy11 Nov 2025 10:02 PM IST
New Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organization (CDSCO), has approved an additional...
CDSCO Panel Clears MSN Labs Abiraterone Acetate 1000 mg, Mandates Phase IV Trial

CDSCO Panel Clears MSN Labs' Abiraterone Acetate 1000 mg, Mandates Phase IV Trial

Parthika Patel10 Nov 2025 8:38 PM IST
New Delhi: The Subject Expert Committee (SEC) on Oncology, under the Central Drugs Standard Control Organisation (CDSCO), has recommended the grant of...
CDSCO, DoP Told to Find Workable Solution on Revised Schedule M GMP Concerns

Zenvision Pharma Gets CDSCO Panel Nod to Conduct BE Study on Rifaximin Sachets

Susmita Roy9 Nov 2025 12:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to...
Torrent Pharma Slapped with Rs 41.33 Crore GST Penalty for Alleged Erroneous Export Refunds

Torrent Pharma Gets CDSCO Panel Nod to Manufacture, Market Prucalopride Oral Solution

Susmita Roy7 Nov 2025 6:31 PM IST
New Delhi: In a significant regulatory development, Torrent Pharmaceuticals has got the go-ahead from the Subject Expert Committee (SEC) under the...
Dr Reddy

Dr. Reddy's Gets CDSCO Panel Nod for BE Study on Resmetirom Tablets for NASH Treatment

Susmita Roy6 Nov 2025 3:17 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Dr. Reddy's...
Johnson and Johnson Gets USFDA Nod for Oral Psoriasis Drug Icotyde

CDSCO Panel Approves Updated Package Insert for Johnson and Johnson's Stelara

Susmita Roy5 Nov 2025 4:51 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended approval for the updated...
CDSCO Panel Flags Ethnic Variability, Seeks More Data from Takeda for Fruquintinib Hard Capsule Approval

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...
CDSCO Panel Declines to Consider ACME Generics Phase IV Trial Results for Liothyronine Tablets

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...
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