Telangana Drug Control Administration Detects Substandard Drugs in the Market
Hyderabad, October 3, 2024 — The Drugs Control Administration (DCA) of Telangana has identified several substandard drugs circulating in the state using a risk-based sampling approach. This method, implemented through guidelines for Drug Inspectors on risk indicators for sampling, has significantly increased the detection of substandard drugs in the market.
From January to August 2024, the Drugs Control Laboratory in Hyderabad reported 93 drugs as Not of Standard Quality (NSQ). In September 2024, an additional 14 drugs were found to be substandard. The substandard drugs include antibiotics, antiulcer medications, anti-allergic treatments, and haematinics, failing tests for assay, dissolution, and description—critical aspects that ensure the effectiveness of these medicines in treating diseases.
Some of the substandard drugs detected in September 2024 include:
1. Pantlar Tablets (Pantoprazole Gastro-resistant Tablets I.P.)
Manufacturer: Cartel Laboratories, Medchal-Malkajgiri, Telangana
Failure: Dissolution in acid media
2. Parasyp 250 Suspension (Paracetamol Paediatric Oral Suspension IP 250 mg)
Manufacturer: Akums Drugs and Pharmaceuticals Ltd, Uttarakhand
Failures: Assay for Paracetamol and description of the oral suspension, with pink suspension showing sedimentation that could not be re-dispersed
3. Ferrvis-XT Tablets (Ferrous Ascorbate Folic Acid & Zinc Tablets)
Manufacturer: Ridge Formulations Pvt Ltd, Himachal Pradesh
Failures: Dark spots on tablets and incorrect labeling of elemental iron content, classified as a misbranded drug under the Drugs and Cosmetics Act
4. Dixim-O Dry Syrup Suspension (Cefixime & Ofloxacin for Oral Suspension)
Manufacturer: Polestar Power Industries, Himachal Pradesh
Failure: Assay of Ofloxacin
5. Pepsain Syrups (Digestive Enzyme Syrup)
Manufacturer: Sain Medicaments Pvt. Ltd, Hyderabad
Failure: Assay of Fungal Diastase
Other drugs, including Cefixime tablets and suspensions, Pantoprazole tablets, and haematinic capsules, also failed various quality tests, raising concerns about their safety and efficacy.
The DCA has urged the public to report any suspicious drug manufacturing activities or illegal drug operations. Complaints can be made to the DCA via the toll-free number 1800-599-6969, available from 10:30 a.m. to 5:00 p.m. on all working days.
