dtab

Union health ministry amends NDCT Rules 2019  to bring clarity in definition of BA and BE study centre

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Union health ministry amends NDCT Rules 2019  to bring clarity in definition of BA and BE study centre

The amendment, named as the NDCT (Amendment) Rules, has brought in a change in the Rule 2, in sub-rule (1) in clause (g) of the Rules 2019. In order to bring clarity in the definition of bioavailability (BA) and bioequivalence (BE) study centre, the union health ministry has amended the New Drugs and Clinical Trial … Read more

DCGI directs manufacturers of FDCs to manufacture, market certain FDCs based on Bombay HC directive

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DCGI directs manufacturers of FDCs to manufacture, market certain FDCs based on Bombay HC directive

With regards to the FDC- Cefadroxil + Clavulanic acid, manufacturers have been directed to submit the protocol for conducting in-vitro study to prove the efficacy of this combination to this office for approval. Drugs Controller General of India (DCGI) has directed all the manufacturers of Fixed Dose Combinations (FDCs) – Cefixime + Cloxacillin, Cefixime + … Read more