Misclassifying Drugs as Nutraceuticals: Pharma Firms Booked for Selling Calcium-D3, RedFer-XT, Dawafer-XT Among Others
Pharma Firms Booked
Hyderabad: Telangana's Drugs Control Administration (DCA) has detected multiple instances of pharmaceutical companies misclassifying medicines as nutraceuticals to evade strict drug regulatory requirements. Several firms were found manufacturing and marketing products containing active pharmaceutical ingredients (APIs) under food or nutraceutical licences, a practice that allegedly allows them to bypass the Drugs and Cosmetics Act.
According to a recent media report in The Times of India, during inspections conducted across Hyderabad and other parts of the state, the DCA identified products such as Calcium-D3, Foron-XT, Ribovin, Prokalk-Z, Dawafer-XT, Calgro-D3 and RedFer-XT being sold as nutraceuticals. Investigations revealed that these products contain regulated APIs including ferrous ascorbate, folic acid, zinc sulphate, vitamin D3 and calcium, which are commonly prescribed for conditions like anaemia, nutritional deficiencies and bone disorders.
Officials explained that by labelling these medicines as food products, manufacturers avoided obtaining mandatory drug manufacturing licences and compliance with good manufacturing practices (GMP), quality control testing, safety evaluations and routine inspections. This practice not only reduces regulatory costs for companies but also raises serious concerns about the quality, safety and efficacy of such products reaching consumers.
The DCA carried out raids in areas such as Uppal, Musheerabad, Habsiguda, Malakpet and Mancherial, seizing stocks of tablets and drops that were being sold without valid drug approvals. In one case, a manufacturing unit was found producing tablets with pharmaceutical ingredients under a food licence, while similar violations were detected in parts of Ramagundam in Peddapalli district.
Senior officials warned that mislabelling medicines as nutraceuticals poses a significant public health risk, as products manufactured outside the drug regulatory framework may have incorrect dosages, poor quality standards or inadequate safety checks. The department has initiated action against the firms involved and has intensified surveillance to prevent further violations.
The Times of India reports that the DCA has registered multiple cases so far and plans to continue strict enforcement against companies attempting to exploit regulatory loopholes.
