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Tag: cdsco

You Searched For "cdsco"
Issuance of Registration Certificate, Import License for Veterinary Vaccines: CDSCO asks SLAs for e-submission of applications

Issuance of Registration Certificate, Import License for Veterinary Vaccines: CDSCO asks SLAs for e-submission of applications

Medical Dialogues Team11 March 2021 1:00 PM IST
New Delhi: In order to streamline the regulatory submission procedure, the Central Drugs Standard Control Organization (CDSCO) (Veterinary Division)...
CDSCO declares 16 drug samples including Clopidogrel, Aspirin  Tablets as Not of Quality Standard

CDSCO declares 16 drug samples including Clopidogrel, Aspirin Tablets as Not of Quality Standard

Medical Dialogues Team10 March 2021 4:55 PM IST
New Delhi: The apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 16 drug samples including Clopidogrel and...
Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension

Etanercept in COVID19 patients: CDSCO Committee tells Lupin to submit revised phase 2 CT protocol

Medical Dialogues Team9 March 2021 5:40 PM IST
New Delhi: The Subject Expert Committee (SEC), functional under Central Drug Standard Organization (CDSCO), has recently suggested drug major Lupin...
Lack of uniform test for carcinogenic substances in JnJ baby products: NCPCR issues summons to CDSCO, DGCI

Lack of uniform test for carcinogenic substances in JnJ baby products: NCPCR issues summons to CDSCO, DGCI

Ruchika Sharma9 March 2021 2:00 PM IST
The NCPCR also asked both the DCGI and the CDSCO as to why the latter has not regulated the standards and ensured uniformity in the testing methods.
CDSCO asks Akums Drugs to revise phase III CT protocol for abortion drug Mifepristone

CDSCO asks Akums Drugs to revise phase III CT protocol for abortion drug Mifepristone

Medical Dialogues Team8 March 2021 6:46 PM IST
New Delhi: Recommending to exclude patients using any contraceptive method other than conventional methods, barrier, male or female sterilization, the...
Lincoln pharma told to revise package insert before launching Sildenafil Citrate Oral Spray in Indian market

Lincoln pharma told to revise package insert before launching Sildenafil Citrate Oral Spray in Indian market

Medical Dialogues Team5 March 2021 12:17 PM IST
New Delhi: Pharma Company, Lincoln Pharmaceuticals has been directed by the Central Drugs Standard Control Organization (CDSCO) Committee to revise...
Include more govt sites for Phase III clinical trial of Ursodeoxycholic Acid Tablets: CDSCO panel to Abbott

Include more govt sites for Phase III clinical trial of Ursodeoxycholic Acid Tablets: CDSCO panel to Abbott

MD Bureau28 Feb 2021 11:15 AM IST
New Delhi: Suggesting to include more government sites in Phase III Clinical trial protocol, the Central Drugs Standard Control Organization (CDSCO)...
CDSCO Panel Asks Dr Reddys to Submit Indian Data for Triptorelin Pediatric Use

Submit more immunogenicity, safety data on Sputnik V vaccine: CDSCO panel to Dr Reddys

Ruchika Sharma25 Feb 2021 12:38 PM IST
Once Dr Reddy's Labs submits the data, its Emergency Use Authorization application will be considered," a source said.
Delhi HC reprimands DCGI after portions of CDSCO drug approval process report found missing

Delhi HC reprimands DCGI after portions of CDSCO drug approval process report found missing

Farhat Nasim22 Feb 2021 6:24 PM IST
The court also directed DCGI to file a status report with regard to the steps taken by it to digitize its records, saying "there is no reason why DCGI...
India imports 80 percent of its medical devices requirement: MoS Health

India imports 80 percent of its medical devices requirement: MoS Health

Ruchika Sharma14 Feb 2021 10:30 AM IST
New Delhi: India currently imports approximately 80 per cent of its requirement of medical devices, with the US, Germany, China, Singapore and...
Serum institute gets CDSCO panel nod for Phase 2, 3 trials for Novavax COVID-19 vaccine

Serum institute gets CDSCO panel nod for Phase 2, 3 trials for Novavax COVID-19 vaccine

MD Bureau7 Feb 2021 12:43 PM IST
New Delhi: The Subject Expert Committee of India's central drug regulatory authority has given a go-ahead to the Serum Institute of India to...
CDSCO Panel asks Aurobindo Pharma to submit revised clinical trial protocol for Covid-19 vaccine candidate

CDSCO Panel asks Aurobindo Pharma to submit revised clinical trial protocol for Covid-19 vaccine candidate

MD Bureau7 Feb 2021 11:00 AM IST
New Delhi: Recommending that the firm should submit Phase II/III Protocol as per the regulatory authority of Brazil, the Central Drugs Standard...
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