Technical Committee recommends CDSCO to approve import, marketing of Sanofi TB drug with clinical trial waiver Farhat Nasim28 May 2019 4:21 PM ISTNew Delhi: Apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has been recommended by the Techincal Committee to granted...
CDSCO rejects GSK request to skip Phase III trial for Influenza Vaccine for higher age groups Meghna A Singhania22 May 2019 5:25 PM ISTNew Delhi: One of the oldest pharmaceutical and healthcare companies in India, GlaxoSmithKline recently presented before the Subject Expert Committee...
CDSCO denies approval for Akums Acid reflux FDC in Capsule form Meghna A Singhania8 May 2019 10:15 AM ISTNew Delhi: In order to expand its portfolio, Akum Drugs & Pharmaceuticals Ltd. presented before the Subject Experts Committee (SEC) functional...
CDSCO expert committee suggests ban of yet another 324 FDCs Meghna A Singhania15 April 2019 11:49 AM ISTNew Delhi: Domestic drugmakers are likely to face a blow as 324 Fixed Dose Combination (FDCs) drugs have been recommended to be banned by an expert...
Upload application in SUGAM as per new Rules: CDSCO issues notice Meghna A Singhania13 April 2019 1:39 PM ISTNew Delhi: Through a recent notice, the Central Drugs Standard Control Organization (CDSCO) has informed that uploading of applications through SUGAM...
FDC Rationality: Now 6 months accelerated stability study data to be submitted, directs DCGI Meghna A Singhania27 March 2019 4:48 PM ISTNew Delhi: Manufacturers of Fixed Dose Combinations drugs ( FDC drugs) which have declared rational and approved by Drugs Controller General India...
Manufacturers of SGLT2 inhibitor Drugs to have to INCLUDE safety WARNING in package: CDSCO Farhat Nasim26 March 2019 1:28 PM ISTNew Delhi: Paying heed to the safety updates of Sodium-Glucose Cotransporter-2 (SGLT2) including medicines such as Canagliflozin, Dapagliflozin,...
J&J passes asbestos test, allowed to make baby powder in India Farhat Nasim1 March 2019 2:28 PM ISTNEW DELHI: In a major relief to Johnson & Johnson(J&J), no asbestos was found in the baby powder manufactured in Baddi and Mulund plants. The...
Another trouble for J&J: CDSCO seize samples of baby products for testing Farhat Nasim22 Dec 2018 12:14 PM ISTThe action by CDSCO has come at a time when the company is already embroiled in a controversy over its faulty hip implants. New Delhi: Following...
CDSCO tightens safety and labelling rules for ISOTRETINOIN,prescription of dermatologist mandatory Farhat Nasim21 Dec 2018 1:06 PM ISTIn light of concerns raised regarding Isotretinoin, the matter has been examined by CDSCO in consultation with the Subject Expert Committee...
Asbestos scare: CDSCO draws samples of J&J baby powder from HP plant Medical Dialogues Bureau20 Dec 2018 5:12 PM ISTThe CDSCO, under the Union Health Ministry, said over the next four to five days, drug inspectors will search manufacturing plants and wholesalers of...
Final regulations on e pharmacy likely by December-end, says DCGI Farhat Nasim8 Dec 2018 10:29 AM ISTIn September, the Union health ministry came out with draft rules on the sale of drugs by e pharmacies. Panaji: The union government is expected to...