Gabapentin Tablets | Hyderabad, August 5 (Maxim News): The Telangana Drugs Control Administration (DCA) has seized Gabazen Tablets containing Gabapentin 300 mg after detecting that the prescription medicine was allegedly being falsely manufactured and marketed as a food product/nutraceutical under an FSSAI licence.
The seizure was made during a raid conducted by DCA officials in Malakpet on August 4. Officials found that the product was circulating in the market despite being labelled as a nutraceutical, although its composition classifies it as a drug under the Drugs and Cosmetics Act, 1940.
The DCA said the product was manufactured by Gothic Pharmaceuticals Pvt. Ltd., located at Cherlapally IDA Phase II, Medchal Malkajgiri district, and marketed by Sifco Ayustar, Hyderabad.
Gabapentin Tablets Can Be Sold Only Under Drug Licence
According to the DCA, the tablets were manufactured using an FSSAI food licence instead of a valid drug manufacturing licence. Officials said the product falsely claimed to be a nutraceutical even though it contains Gabapentin 300 mg, a Schedule H prescription drug that can only be manufactured and sold under a licence issued under the Drugs and Cosmetics Act.
The department stated that drugs manufactured under food licences are not produced in compliance with the Good Manufacturing Practices (GMP) prescribed under Schedule M of the Drugs Rules and may also fail to meet the quality standards laid down in the Indian Pharmacopoeia (IP).
Officials warned that such products pose serious risks to patient safety and public health.
Raids
The raid was carried out by Drugs Inspector G. Anil of Malakpet under the supervision of Assistant Director T. Rajamouli.
DCA officials collected samples of the seized tablets for laboratory analysis. Further investigation is underway, and legal action will be initiated against all those found responsible.
The department noted that manufacturing or selling drugs without a valid drug licence is punishable under the Drugs and Cosmetics Act, with imprisonment of up to five years.
The Drugs Control Administration also appealed to the public to report illegal manufacturing or sale of medicines, including narcotic drugs and psychotropic substances, through its toll-free helpline 1800-599-6969, which operates on working days from 10.30 am to 5 pm. (Maxim News)
