Spurious Drugs Linked to Sun Pharma, Glenmark, and Macleods: CDSCO Update

CDSCO has published an update on the Spurious and Misbranded drugs in September 2024. Medicinal Products of Pharma Majors Sun Pharma (Pulmosil, Pantocid, Ursocol 300), Glenmark (Telma H) and Macleods (Defcort 6) which were found to be failing for different quality parameters including Assay, Dissolution, Sterility etc. during quality tests by CDSCO laboratories are spurious. As per the CDSCO circular dated 20 September 2024, the Firms have stated that the impugned batches of the above products were not manufactured by them and these are spurious drugs. However the CDSCO circular highlights that this is subject to outcome of ongoing investigations. Telma H is a widely prescribed blood pressure medication, while Macleods’ Defcort 6 tablets are used to treat Duchenne muscular dystrophy (DMD). Sun Pharma’s Ursocol 300 is used for gallstone treatment, and Pantocid is for gastric issues

As per a 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 CDSCO and State Licensing Authorities (SLA), routinely conduct inspections / raids at drug manufacturing establishments and sales outlets, collect samples and test at Central or State Government laboratories to maintain vigilance and surveillance on the quality of drugs. The penalties 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 Alert on Spurious Drugs Linked to Sun Pharma, Glenmark and Macleods (September 2024)