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Telangana DCA initiates action against Tamil Nadu based company for manufacturing drugs under food licence
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Peethaambaran, Chennai
June 26 , 2024
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In the ongoing raids in Telangana, the drugs control administration (DCA) in the state has seized one medicine that was falsely manufactured by a Tamil Nadu based manufacturing company and sold under the guise of food products/neutraceuticals in Bhupalppally district in Telangana state.
The product named ‘Thianova’ (Thiamine Mononitrate tablets 100 mg), was manufactured by Zenomed Healthcare Pvt Ltd in Villupuram District in Tamil Nadu and marketed by Elinova Lifesciences Pvt.Ltd in Hyderabad. The office of the director general of the DCA informed Pharmabiz that the medicine was falsely manufactured and sold as neutraceuticals under food licence (FSSAI Licence Number 12418031000627).
A senior officer of the director general of the DCA said the company was violating the principles of the Good Manufacturing Practices as well as the norms of the Indian Pharmacopoeia. They were manufacturing the drug without a valid licence from the drug control department. Thiamine is used to prevent or treat low levels of vitamin B1 in people who do not get sufficient vitamin from their diets.
“As per the Indian Pharmacopoeia, Thiamine Mononitrate tablets 100 mg is a drug and is used for therapeutic purposes. It cannot be manufactured under a food licence, but should be manufactured under a drug licence adhering to the principles of the GMP outlined in Schedule-M of the Drug Rules. Additionally, it must meet the quality standards prescribed in the 'Indian Pharmacopoeia' (IP) as mandated. Here it was erroneously manufactured and sold in the market. The department has initiated action against the company as per 18C of the Drugs and Cosmetics Act,” he told Pharmabiz.
He said similar cases of 'drugs' being manufactured under 'food licences' were detected previously by the drugs control officials in Telangana in November 2023 and in January 2024. They were declared as 'spurious' by the drugs testing laboratory in Hyderabad as the content of the active ingredient was found to be 'NIL' in the said products. This kind of products poses serious risks to patients' health and has severe implications. Manufacturing and selling 'drugs' without a valid 'drug license' is punishable under the D&C Act with imprisonment up to five years.
In the last week’s raids, apart from Thianova, the DC officials seized two more drugs manufactured without drug licences and were being sold in the market as food products. A drug named, Zyfer-XT (ferrous ascorbate, folic acid tablets), manufactured by Hyderabad based Hindustan Nutraceuticals Inc, and marketed by Matrix–Takeda Pharma in Vikoroli in Mumbai. The drug was also falsely manufactured and sold under a food licence with FSSAI Licence number 10017047000796. This drug was seized by the officials in a raid conducted in Medippalli.
The third incident happened in Malkajgiri where the officials seized, ‘Proferron-XT Haematinic tablets’ (ferrous ascorbate, folic acid & zinc tablets) manufactured falsely by Macsol Lifescience in Gandhinagar in Gujarat.
As per the label claim of the products, Zyfer-XT, Thianova and Proferron-XT Haematinic Tablets are classified as 'drugs' according to the Drugs and Cosmetics Act. They must be manufactured only under valid drug licenses issued under the drugs and cosmetics act, adhering strictly to the 'Good Manufacturing Practices'.
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