Hyderabad: In a significant enforcement action against the illegal marketing of prescription medicines, the Drugs Control Administration (DCA), Telangana, seized Gabazen Tablets containing Gabapentin 300 mg in Hyderabad’s Malakpet area after detecting that the product was being falsely manufactured and sold under the guise of a food product/nutraceutical. The action highlights a growing regulatory concern over the misuse of food licences to market pharmaceutical products that require strict regulatory oversight.
According to an official press note issued by the Drugs Control Administration on 5 August 2026, officials of the Malakpet unit conducted a raid on 4 August 2026 and found that the product, Gabazen Tablets, was circulating in the market while falsely claiming to be a nutraceutical. The product label indicated it contained Gabapentin 300 mg, a prescription medicine that falls under Schedule H of the Drugs Rules and is therefore classified as a drug under the Drugs and Cosmetics Act, 1940, not as a food or nutraceutical.
The investigation revealed that the product had been manufactured by Gothic Pharmaceuticals Pvt. Ltd., located at Plot No. 68, Cherlapally IDA, Phase-II, Medchal-Malkajgiri District, and marketed by Sifco Ayustar, Hyderabad. The DCA stated that the tablets were manufactured under an FSSAI food licence (Licence No. 10019047001211) and falsely represented as a food product despite containing a pharmaceutical active ingredient that legally requires manufacture under a valid drug licence.
The regulator emphasised that Gabapentin is a prescription-only medicine and cannot legally be manufactured or marketed as a nutraceutical. Drugs containing Gabapentin must be produced only under a valid licence issued under the Drugs and Cosmetics Act and in compliance with Good Manufacturing Practices (GMP) prescribed under Schedule M of the Drugs Rules. Such products are also required to conform to the quality standards laid down in the Indian Pharmacopoeia (IP).
Warning about the public health implications, the Drugs Control Administration stated that medicines manufactured and sold under the cover of food licences are not produced in accordance with mandatory pharmaceutical GMP standards and frequently fail to comply with Indian Pharmacopoeia quality specifications. Such products may expose patients to serious health risks because their quality, safety and efficacy are not assured under the regulatory framework applicable to medicines.
DCA officials collected samples of the seized product for laboratory analysis. The administration said a detailed investigation is underway and legal action will be initiated against all persons found responsible for the violations. The raid was carried out by G. Anil, Drugs Inspector, Malakpet, under the supervision of T. Rajamouli, Assistant Director, Hyderabad.
The DCA further reminded manufacturers and marketers that manufacturing or selling drugs without a valid drug licence is a punishable offence under the Drugs and Cosmetics Act, carrying imprisonment of up to five years. The authority also appealed to the public to report illegal manufacture or sale of medicines, including narcotic drugs and psychotropic substances, through its toll-free helpline 1800-599-6969, available on working days from 10:30 a.m. to 5:00 p.m.
Regulatory Significance: The latest seizure reflects increasing vigilance by state drug regulators against the practice of marketing pharmaceutical formulations as nutraceuticals or food supplements to circumvent licensing and quality-control requirements under the Drugs and Cosmetics Act. Regulatory authorities have repeatedly cautioned that products containing pharmacologically active ingredients cannot be legally sold under food licences and must comply with the stringent manufacturing, quality assurance and prescription requirements applicable to medicines.
Source : Telangana DCA
