Stop using Lopamidol Inj. USP (K-Scan 370): Govt
Drugs & Food Control team inspects medical stores, diagnostic centres
SRINAGAR, JUNE 09: A team of officers/officials of Drugs & Food Control Organization carried out surprise checks/raids at various Drugs Sale Establishments in and around the vicinity of SMHS Hospital Karan Nagar Srinagar.
The drive was conducted pursuant upon the sale and supply of Lopamidol Inj. USP (K-Scan 370– A diagnostic agent used during the CT Scan procedures) Mfg By: M/s Kiran Medical System, D-117, TTC Industrial Estate Area, Shirwane, Nerul, Navi Mumbai, Distt Thane-400706, Maharashtra State, India bearing different particulars w.r.t Mfg Lic No, Batch No, Mfg Date & Expiry dates as printed on label & QR Scan Code/Barcode respectively. The mismatch label details are as:
|Actual Particulars printed on label||Information revealed from QR Scan Code/ Barcode imprinted on label|
|Mfg. Lic. No : MH/102319A
B. No: GL100218,
Mfg. Dt : 02/2018,
Exp. Dt: 01/2020
|Mfg. Lic. No : ND/44
B. No: GB1316
Mfg. Dt : 03/2016
Exp. Dt: 02/2018
The Department has already initiated investigation in the matter with regard to said batch and matter has been taken with the manufacturer of drug for clarification.
The public in general and the stakeholders, in particular, are informed through the medium of this notice to discontinue usage / stop sale of the above Drug. Further, all the stakeholders who are in possession of any stock of said Drug shall inform the local Drugs Control Authorities along with procurement details to help the Department in effective Product Recall/Seizure.
Furthermore, the Department shall initiate severe punitive actions against the violators who indulge in any sort of unethical trade practices.
A number of Drug Sale Establishments were also inspected regarding the availability of above drug & to ensure that due diligence is secured to the provisions of conditions of Licence/s.
The team took strong notice of violations by certain medical stores. In this regard, the operation of M/s Co-Operative Medical store (I) & (II) SMHS Hospital were disallowed on spot for a period of one week for violating conditions of Licence/s viz- improper storage of medicines, non-maintenance of records and dispensing of drugs without cash memo/invoice.
The operation of M/s Al-Noor Medicate & M/s Darul-Shafa opposite OPD SMHS Hospital Srinagar were also disallowed on spot for one day for conducting the sale in absence of Qualified persons.