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CDSCO Flags 145 Drug Batches for Failing Quality Standards
According to the latest alert, 52 of the identified substandard drug batches were flagged by central drug laboratories, while the remaining 93 were reported by state drug testing labs. These drugs, categorized as Not of Standard Quality (NSQ), failed to comply with national and international regulatory benchmarks.
- By Newsdesk
- New Delhi
- Mar 01, 2025
The Central Drugs Standard Control Organisation (CDSCO) has flagged select batches of 145 pharmaceutical products, including medications for hypertension, allergies, and nausea, as failing to meet quality standards for January 2025.
According to the latest alert, 52 of the identified substandard drug batches were flagged by central drug laboratories, while the remaining 93 were reported by state drug testing labs. These drugs, categorized as Not of Standard Quality (NSQ), failed to comply with national and international regulatory benchmarks.
Among the flagged medications are specific batches of Glenmark Pharma’s widely used hypertension drug, Telma AM, and Alkem Health Sciences’ Ondem-4 tablets, which are prescribed for nausea and vomiting.
A statement issued by the Health Ministry clarified that the quality concerns apply only to the tested batches and do not indicate issues with other versions of the same drugs available in the market.
The list also features batches of fixed-dose combinations (FDCs), including cough syrups and antibiotics used to treat bacterial infections such as tonsillitis, ear infections, throat infections, urinary tract infections (UTIs), and bronchitis. Additionally, certain samples of montelukast sodium and levocetirizine hydrochloride combination tablets, commonly prescribed for allergies, were also found to be substandard.
Many of the flagged drugs were produced in manufacturing units located in key pharmaceutical hubs, including Ahmedabad and Vadodara in Gujarat, Baddi in Himachal Pradesh, Tarapur in Maharashtra, as well as Puducherry, Haridwar, and Roorkee in Uttarakhand.
This latest alert also marks the second consecutive month in which no drugs were classified as spurious, a trend not observed since June of the previous year.
As part of ongoing regulatory monitoring, the CDSCO routinely collects drug samples from sales and distribution points, conducts quality assessments, and publishes monthly lists of substandard and spurious drugs on its portal.
“The primary objective of publishing the spurious drugs list is to raise awareness among stakeholders about compromised drug batches present in the market,” the NSQ alert stated.
The Health Ministry’s note highlighted the increasing involvement of state authorities in reporting NSQ drugs to the central database, emphasizing that such efforts will enhance the availability of high-quality medicines both domestically and internationally.