CDSCO

In a move aimed at speeding up approvals for new drugs, the government has changed the way testing permissions are granted, allowing companies to begin laboratory testing immediately after filing applications instead of waiting for detailed scrutiny. In an official circular, the country's apex drug regulatory authority, Central Drugs Standard Control Organization (CDSCO), said it has decided that "No Objection Certificate (NOC) for testing of drug samples at the designated laboratories (IPC, Ghaziabad; CDTL, Mumbai; CDL at CRI, Kasauli; or NIB, Noida) shall be issued immediately upon receipt of applications in the concerned division." Earlier, the regulator examined detailed specifications submitted by applicants before issuing permission for testing. These included "Type of formulation, dosage form, Critical Quality Attributes (CQAs), and general characteristics of the product," along with "Product development reports, forced degradation studies, and other relevant data, in ...

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CDSCO had earlier informed the global health body that none of the syrups were exported to other countries

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The investigation against the Kanchipuram-based manufacturer of Coldrif cough syrup, linked to the deaths of children in Madhya Pradesh, has brought to light lapses by the Tamil Nadu Food and Drug Administration in enforcing basic regulatory norms, CDSCO sources said. Licensed in 2011 by the Tamil Nadu Food and Drug Administration (TNFDA), Sresan Pharma continued operations unchecked for over a decade despite its dismal infrastructure and multiple violations of national drug safety rules, they said. A recent inspection by the Central Drugs Standard Control Organisation (CDSCO) exposed the unit's appalling conditions and total non-compliance with Good Manufacturing Practices (GMP), the sources said. "The CDSCO has not been involved in any of the audits at Sresan Pharma. Since the CDSCO was not involved and the state FDA did not inform the CDSCO about this company in any way, this company was not part of any of the CDSCO databases," a source said. TNFDA officials could not be reached

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CDSCO flagged three spurious drugs, including Pan D, Pan 40 and diazepam injection, and listed 94 medicines as not of standard quality in its August 2025 surveillance update