HYDERABAD, FEBRUARY 16, 2024: Officials of Telangana Drugs Control Administration have seized fake medicines at Mancherial that were falsely manufactured and sold under the guise of ‘food products/nutraceuticals’.
The product ‘Thiamine Hydrochloride Tablets 100 mg,’ which is a medicine used to treat ‘beriberi’, neuritis associated with pellagra or pregnancy, and to treat and prevent ‘Wernicke-Korsakoff syndrome’, is being falsely manufactured under a food license at Space Healthcare, Kambohpura, Haryana. It is being marketed illegally by Medkline Life Sciences Pvt. Ltd., Haryana, as a food product/nutraceutical.
DCA Director-General VB Kamalasan Reddy said that on intelligence gathered, the officials raided premises of Sri Ram Medical Agencies, Mancherial, on Thursday and detected the product Klinthia 100 mg tablets (Thiamine Hydrochloride Tablets 100 mg), which is manufactured illegally at Space Healthcare, Ansal Road, Kambohpura -132001, Haryana under a ‘food licence (FSSAI licence)’ falsely claiming it as a food product/nutraceutical.
The product ‘Klinthia 100 mg tablets’ containing 100 mg of Thiamine Hydrochloride is a ‘drug’ as per Drugs and Cosmetics Act. Additionally, the composition of this product is listed as a ‘medicine’ under the National List of Essential Medicines (NLEM)-2022. The product ‘Thiamine Hydrochloride Tablets 100 mg’ must be manufactured only under a ‘drug license’ issued under the Drugs and Cosmetics Act, adhering strictly to the ‘Good Manufacturing Practices’ (GMP) outlined in Schedule-M of the Drugs Rules. Additionally, it must meet the quality standards prescribed in the ‘Indian Pharmacopoeia’ (IP) as mandated.
During the raid, the DCA officials seized ‘Klinthia 100 mg tablets’ (Thiamine Hydrochloride Tablets 100 mg), Quantity: 1800 tablets worth Rs 30,000. Samples were lifted for analysis. M. Srinivasulu, Assistant Director, Karimnagar, T. Chandana, Drugs Inspector, Mancherial are among the officers who carried out the raid.
Similar cases of ‘drugs’ being manufactured under a ‘food license’ were previously detected by the Drugs Control Administration, Telangana, in November 2023 and January 2024, which were declared as ‘spurious’ by the Drugs Control Laboratory, Hyderabad, as the content of the active ingredient was found to be ‘NIL’ (i.e., zero drug) in the said products.
The drugs that are falsely manufactured and sold under a food license are not produced in accordance with ‘Good Manufacturing Practices’ (GMPs) and often fail to meet the quality standards prescribed in the Indian Pharmacopoeia (IP). Such products pose serious risks to patients’ health and may have severe implications. Manufacturing and selling ‘drugs’ without a valid ‘drug license’ is punishable under the Drugs and Cosmetics Act, with imprisonment for up to five years.
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