CDSCO definition
Examples of CDSCO in a sentence
Use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration as regulated and approved by Central Drugs Standard Control Organization (CDSCO).
OR TO SUCH OTHER ENTITY AS IS REQUESTED BY AN AUTHORIZED REPRESENTATIVE OF CDS), ANY TRANSFER, PLEDGE OR OTHER USE HEREOF FOR VALUE OR OTHERWISE BY OR TO ANY PERSON IS WRONGFUL SINCE THE REGISTERED OWNER HEREOF, CDS&CO., HAS AN INTEREST HEREIN.
Company will not be liable for any non- compliance by the Franchisee of CDSCO and FDA rules and regulations.
Each test kit should contain material required for conducting the test and the required packing standards and labeling should meet the Good Manufacturing Practices (GMP) standards and kit should be approved by ICMR / CDSCO / US FDA / EU for rapid testing of Sickle cell anemia / disease in India.
The rapid diagnostic kit should be point-of-care, qualitative, ICMR / CDSCO / US FDA / EU approved methodology (immunochromatographic / Lateral Flow Assay (LFA) / any other approved method) assay for the simultaneous detection of Hb S and Hb A as bands in human whole blood capillary sample from finger / heel prick for rapid diagnosis of sickle cell anemia / disease.
In the event such non-compliance of the CDSCO and FDA rules and regulations by the Franchisee is observed by the Company, the Company is entitled to terminate this Agreement forthwith and to take any legal action for recovery for damages, loss, cost or expense incurred by the Company due to such non-compliance.
Type of research ☐ UG/ PG Academic Study ☐ Exempt Academic Study* ☐ Staff Academic Study ☐ Regulatory Clinical Trial *Studies that do not require CDSCO approval Reference Number Date received: Review Date: Outcome: ☐ Approval Applicant Informed ☐ Yes ☐ No ☐ Conditional Approval Date: ☐ Deferral ☐ Approval Declines Version No. Effective Date Page Please complete form and select YES/NO options as appropriate.
This Cue Product is regulated by Central Drugs Standard Control Organisation (CDSCO) as a medical device for use by accredited healthcare providers and operators.
IndiaCo shall recommend to GTC decisions and actions regarding regulatory matters in the Territory relating to or involving GTC-IP, GTC Products, IndiaCo-IP-G, and IndiaCo Products before all Regulatory Authorities in the Territory, including the ICMR, HMSC, CDSCO, DCGI and India state licensing authorities.
Company will not be responsible for any action taken by CDSCO and FDA for non-compliance against the Franchisee owner.