Hyderabad: Drugs Control Administration (DCA) officials from the Quthbullapur Zone detected and seized ‘THIAMP-100 tablets’ (Thiamine Hydrochloride tablets 100 mg) circulating in the market.
The Thiamine Hydrochloride tablets were falsely manufactured under a ‘food license (FSSAI license)’ and were being marketed as a food product/nutraceutical, said the DCA. The tablets were found to be manufactured at Vatave Healthcare, Punjab.
The Thiamine Hydrochloride tablets were being illegally marketed by Ampira Biotechnics Pvt. Ltd., Chandigarh as a food product/nutraceutical. The label of the product ‘THIAMP-100 tablets’ claims to contain Thiamine Hydrochloride 100 mg, which is classified as a ‘drug’ used to treat ‘Vitamin B1’ deficiency according to the Drugs and Cosmetics Act.
According to the DCA, ‘THIAMP-100 tablets’ (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, said Kamalasan Reddy, director general, DCA.
Drugs that are falsely manufactured and sold under a food license are not produced in accordance with “good manufacturing practices’ (GMPs) often fail to meet the quality standards prescribed in the Indian Pharmacopoeia (IP), said the DCA. Such products pose serious risks to patients’ health and may have severe implications, stated the DCA.
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