Among the 10 drugs, three were antibiotics—a particularly concerning trend given India's ongoing battle with antimicrobial resistance.
Published Oct 29, 2025 | 11:00 AM ⚊ Updated Oct 29, 2025 | 11:00 AM
Representational image.
Synopsis: Telangana’s Drug Control Lab flagged 10 NSQ drugs in September 2025, including two TGMSIDC-supplied for govt hospitals. Sunrise Labs’ Rabeprazole had less than 50% active ingredient, leading to blacklist and recall. Nationwide, CDSCO reported 112 NSQ, 2 spurious; Himachal dominated failures. Antibiotic, cardiac, and injectable meds raised resistance and safety alarms.
The Telangana Drug Control Laboratory has identified 10 Not of Standard Quality (NSQ) pharmaceutical products in its September 2025 testing report, according to the Central Drugs Standard Control Organisation (CDSCO) latest NSQ release.
These drugs include two drugs procured by the Telangana Medical Services and Infrastructure Development Corporation (TGMSIDC) for government hospitals.
Among the failures, a locally manufactured acid reflux medication has been blacklisted after tests revealed it contained less than 50 percent of the labeled active ingredient.
The 10 drugs found substandard by Telangana’s lab include critical medications such as antibiotics, acid reducers, pain relievers, and an anti-nausea drug used in chemotherapy patients.
The nationwide report for September 2025, compiled from state and Central Drugs Standard Control Organization (CDSCO) laboratories, flagged a total of 112 pharmaceutical products as NSQ, with only two identified as spurious or counterfeit drugs.
The discovery involves Rabeprazole Gastro-Resistant Tablets IP 20mg, manufactured by Sunrise International Labs Ltd. in Hyderabad’s Cherlapally industrial area. The product, supplied to government hospitals through TGMSIDC, failed both assay and dissolution tests, with the assay revealing less than half the required active pharmaceutical ingredient.
“The product manufactured by Sunrise International Labs Ltd. in Hyderabad has been blacklisted because it failed the assay test with less than 50 percent of the labeled content,” a government official told South First.
The official explained that batches of Rabeprazole from this manufacturer have been recalled from government hospitals.
“The total amount paid for the said item will be deducted from their dues. Additionally, 25 percent of the payment for all other products supplied by Sunrise International Labs shall be withheld for a period of four months to closely monitor the performance and quality of their other products,” he added.
The second drug procured by TGMSIDC that failed quality tests was Calcium Carbonate Tablets I.P., manufactured by Revat Laboratories Pvt. Ltd. from Andhra Pradesh. This batch failed description specifications.
“No punitive action has been proposed against the manufacturer for the Calcium Carbonate batch that failed due to description defects,” the official explained.
“However, the concerned batch RCBT-003 has been immediately recalled from all government hospitals and distribution channels to prevent further use. The complete cost of the defective batch will be deducted from the pending payments due to Revat Laboratories.”
As a precautionary measure, 25 percent of payments for all other products supplied by Revat Laboratories will also be withheld for four months to monitor overall product quality and performance.
When asked whether this withholding of 25 percent payment is a standard norm for companies whose products are declared NSQ, the official confirmed, “Yes, this is the established protocol. Whenever a product comes as NSQ, 25 percent of payments for all other products from that manufacturer are withheld for a monitoring period of four months. This serves both as a penalty and as a quality assurance mechanism to ensure the company addresses its manufacturing deficiencies.”
Among the 10 drugs identified by Telangana’s lab, three were antibiotics—a particularly concerning trend given India’s ongoing battle with antimicrobial resistance. Amoxycillin & Potassium Clavulanate Tablets, manufactured by Dr. Edwin Medilabs in Punjab, failed both assay and dissolution tests. This widely prescribed antibiotic combination, equivalent to the brand name Augmentin, is used to treat respiratory infections, urinary tract infections, and dental infections.
Another pediatric antibiotic formulation, Cefpodoxime Proxetil & Potassium Clavulanate Oral Suspension manufactured by Upkar Pharmaceuticals in Himachal Pradesh, failed assay tests. The oral suspension format is specifically designed for children, making the assay failure particularly dangerous as pediatric dosing is calculated by weight.
Two batches of Aceclofenac & Paracetamol Tablets from Mahys Pharmaceuticals in Andhra Pradesh were found to be misbranded—both manufactured in January 2025. This combination is one of the most commonly prescribed pain medications in India, used for arthritis, back pain, and post-operative pain management.
The fact that both batches from the same manufacturer in the same month were misbranded indicates a systematic quality control breakdown at the facility, raising red flags about the company’s manufacturing practices.
Across India, the September 2025 testing report identified 112 NSQ pharmaceutical products, though only two were confirmed as spurious or counterfeit—Amoxycillin & Potassium Clavulanate Tablets from Medicef Pharma in Himachal Pradesh and Tramadol Hydrochloride Sustained Release Tablets from Medicross Laboratories, also in Himachal Pradesh.
The majority of failures came from manufacturers in northern states, particularly Himachal Pradesh, which hosts a major pharmaceutical manufacturing hub in Baddi and Solan districts. The state accounted for approximately 85-90 percent of the NSQ drugs in the report, while southern states represented only 7-8 percent of substandard products.
CDSCO’s Central Drug Laboratory in Kolkata reported the highest number of NSQ findings with over 30 entries, followed by testing laboratories in Himachal Pradesh, Chhattisgarh, and Chandigarh.
Critical medications that failed quality tests nationwide included:
Cardiovascular drugs: Multiple batches of Telmisartan (blood pressure medication) from various manufacturers showed description and dissolution failures. Clopidogrel & Aspirin combinations, critical for preventing heart attacks and strokes in cardiac patients, also failed dissolution tests.
Injectable medications: Iron Sucrose Injection from SAI Parenterals in Hyderabad failed sterility tests—an extremely serious finding as contaminated injectable drugs can cause life-threatening bloodstream infections. The same manufacturer’s Amikacin Sulphate Injection also failed sterility, particulate matter, and description tests.
Acid reducers: Pantoprazole and Rabeprazole tablets from multiple manufacturers showed dissolution failures. These proton pump inhibitors are among the most prescribed medications globally for treating acid reflux and ulcers.
Public health program drugs: Diethylcarbamazine Citrate Tablets, part of India’s National Programme to Eliminate Lymphatic Filariasis, failed description tests. This drug is distributed through mass drug administration campaigns, making quality failures particularly concerning for public health objectives.
The report also revealed several repeat offenders. Gidsha Pharmaceuticals in Gujarat had eleven batches of Calcium Carbonate with Vitamin D3 tablets fail dissolution tests. Affy Parenterals from Himachal Pradesh had multiple batches of Telmisartan and Albendazole fail quality specifications. R.P. Biotech from Punjab had seven different products flagged for various failures.
(Edited by Amit Vasudev)
