CDSCOCentral Drugs Standard Control Organization (India)
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There was no immediate official comment from the CDSCO on the report, which named a number of major international pharmaceutical companies.
There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts," the report said.
New CDSCO guidelines on compensating for injuries and deaths during clinical trials
All documentation and communication records are required to be dated, filed and preserved for five years after the completion of the study, or submission of data to CDSCO.
Central Drugs Standard Control Organisation ( CDSCO), under the Directorate of General of Health Services ( DGHS), has put a strict regulatory control over the manufacture, sale and distribution of Oxytocin owing to its misuse ; This week the Jammu drug department seized Oxytocin injections ; States and Union Territories have been directed by the CDSCO to keep a strict vigil on the distribution of this drug
25, 2015 /PRNewswire/ -- BONESUPPORT, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, announced that it has received regulatory approval from the CDSCO (Central Drugs Standards Control Organization) and their MDAC (Medical Device Approval Committee) to market CERAMENT(TM)|BONE VOID FILLER and CERAMENT(TM)|G in India.
Breckenridge Pharmaceutical, Cadila Healthcare (Zydus Cadila), Cadila Pharmaceuticals, CBER (Centre for Biologics Evaluation and Research), CDER (Centre for Drug Evaluation and Research) , CDSCO (Central Drug Standards and Control Organization, India), Cedarburg Pharmaceuticals, Celgene Corporation, Celltrion Group, CFDA (China Food and Drug Administration), Chiesi Farmaceutici, Chugai Pharmaceutical Company, Cipla, Claris Injectables, Claris Lifesciences, Claris Otsuka, Coherus BioSciences, Consort Medical, Covidien, Cubist Pharmaceuticals, Cypress Pharmaceutical, Daiichi Sankyo, Daiichi Sankyo Espha and Company and more.
In a showcause notice issued to GSK India, the CDSCO cited objections raised by experts who said that the advertisements claiming that a vaccine can prevent cervical cancer were inaccurate and misleading.
Biosimilars are biological products that are 'similar' or 'highly similar' to the reference medicinal products (originator products) following the EMA (European Medicines Agency), FDA (Food and Drug Administration, USA) and the CDSCO regulatory guidelines.
1 CDSCO Guidelines Released in 2012: How will they Affect Developers?
Dr Gyanendra Nath Singh commented:The MoU signed between MHRA and CDSCO is going to create a new platform where patients will be given utmost importance.
The researchers investigated CDSCO approvals for and availability of oral Fixed Dose Combination (FDC) drugs in four therapeutic areas: analgesia (non-steroidal antiinflammatory drugs (NSAIDs), diabetes (metformin), depression/anxiety (anti-depressants/ benzodiazepines), and psychosis (antipsychotics).