CDSCO Introduces Online Export NOC System on SUGAM Portal Dr. Divya Colin10 March 2025 6:00 PM IST New Delhi: Enhancing the ease of doing business, the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health...
Submit active controlled CT design for moderate to very severe COPD patients: CDSCO Panel tells Zydus Healthcare on Revefenacin inhalation Dr. Divya Colin16 Nov 2024 6:00 PM ISTNew Delhi: Responding to Zydus Healthcare's proposal to manufacture and market Revefenacin Inhalation Solution 175 mcg/3ml, the Subject Expert...
Conduct Phase III clinical trial: CDSCO to Zydus Healthcare over FDC Empagliflozin plus Sitagliptin Dr. Divya Colin12 Nov 2023 4:00 PM ISTNew Delhi: In response to the proposal presented by the drug major Zydus Healthcare, the Subject Expert Committee ( SEC) functional under the Central...
CDSCO Panel approves Novartis proposal to update package insert of Secukinumab Dr. Divya Colin25 Oct 2023 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Center Drug Standard Control Organisation (CDSCO) has granted approval to drug...
No Safety Data On Indian Populations: CDSCO panel tells Alkem over Cefixime Oral Suspension Dr. Divya Colin11 Feb 2023 6:00 PM ISTNew Delhi: Rejecting the drug major Alkem's proposal for manufacturing and marketing the antibiotic drug Cefixime Oral Suspension IP 200mg/ml...
Eris Lifescience gets CDSCO panel nod to study FDC of Metoprolol Succinate, Dapagliflozin Dr. Divya Colin21 Jan 2023 4:30 PM ISTNew Delhi: Directing to present bioequivalence (BE) study results in the Subject Expert Committee (SEC) before initiating the Phase III clinical...
Glenmark gets CDSCO Panel nod to Study FDC Of Bilastine, Dextromethorphan ,Phenylephrine Syrup Dr. Divya Colin12 Dec 2022 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted permission to drug...
Rationale to conduct trial of Tozorakimab is not adequate: CDSCO tells AstraZeneca Dr. Divya Colin11 Dec 2022 6:00 PM ISTNew Delhi: Citing that the rationale for conduct of the proposed trial of COPD (Chronic obstructive pulmonary disease) drug Tozorakimab is not...
Submit Safety Data with Subgroup Analysis of CT: CDSCO Panel Tells Akum Pharma on Tofacitinib Oral Solution Dr. Divya Colin26 Nov 2022 5:45 PM ISTNew Delhi: Regarding the proposal for manufacturing and marketing of anti-rheumatic drug Tofacitinib Oral Solution 1mg/ml, the Subject Expert...
MSN Laboratories gets CDSCO panel nod to manufacture, market Icatibant Injection Dr. Divya Colin18 Nov 2022 6:00 PM ISTNew Delhi: Directing that the drug should be sold by retail under the prescription of the designated medical specialist only, the Subject Expert...
Sanofi gets CDSCO panel nod to market Biphasic Insulin Aspart Injection Dr. Divya Colin8 Nov 2022 6:00 PM ISTNew Delhi: With a condition of conducting a phase IV study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Dr. Reddy proposal to market antidiabetic FDC of Imeglimin and Vildagliptin rejected by CDSCO Panel Dr. Divya Colin2 Nov 2022 6:00 PM ISTNew Delhi: Noting that the clinical experience with the drug Imeglimin is very limited, the Subject Expert Committee (SEC) functional under the...
