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Warning letters, 483s, Recalls, Import Alerts, Audit observations

CDSCO has published list of drugs declared as spurious in the month of September 2024. The list includes popular medicines Deca-Durabolin 25 Injection (Zydus), Shelcal 500 (Torrent), Urimax D (Cipla), Pan D (Alkem). CDSCO routinely samples drugs and medicines from sales and distribution points and test at Central or State Laboratories. The samples picked by CDSCO were failing for multiple quality parameters like Identification, Assay, Dissolution and others. The actual manufacturers of the medicines have informed that the impugned batches are not manufactured by them and the dugs are spurious. CDSCO is investigating the matter.

Spurious or imitation drug products are drug formulations manufactured concealing the true identity of the product and made to resemble other popular brands. Spurious drugs are mostly manufactured by unlicensed anti social elements. Drug inspectors under State Licensing Authorities (SLA), conduct inspections / raids at drug manufacturing establishments and sales outlets, collect samples and test at Central of State Government laboratories to establish drugs are spurious or not. The penalty for manufacture of spurious or adulterated drugs include imprisonment for a term of not less than 10 years and fine of ten lakh rupees or more.

CDSCO Spurious Drug Alert for September 2024

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