
Warning letters, 483s, Recalls, Import Alerts, Audit observations
CDSCO has issued spurious drug alert for five medicinal products. The spurious drug alert includes popular brands like Emcure’s Instgra (Dolutegravir tablets), Glenmark’s Telma -AM (Telmisartan & Amlodipine tablets) and Sun Pharma’s Rifagut 400 (Rifaximin tablets). Other drugs in the list are Domperidone and Naproxen Sodium Tablets (Naxdom 500) of Pure and Cure and Cefixime Trihydrate with Lactic Acid Bacillus Tablets (Presef 200LB) of Pragti Remedies. The spurious drugs were found in sales outlets in Delhi, Mumbai, Jaipur, Patna, Guwahati, Kolkata, Ranchi.
As per CDSCO notification, Spurious or imitation drug products are drug formulations manufactured concealing the true identity of the product and made to resemble another drug, especially some popular brand, to deceive the buyer and cash on the popularity of original product. Spurious drugs are mostly manufactured by unlicensed anti social elements and may or may not contain the active ingredients. 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 April 2024
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