New Delhi: India’s drug regulator, the Central Drugs Standard Control Organization (CDSCO), has identified 135 drugs as "not of standard quality" (NSQ) in December 2024 alone. This brings the total tally of NSQ drugs to 336 over the last three months.
Among the flagged drugs is Cefpodoxime Tablets IP 200 mg, an antibiotic commonly distributed through Jan Aushadhi Kendras. Manufactured by Gujarat-based Bharat Parenterals Ltd, this batch (number CT3096) was found substandard by the Jammu & Kashmir drug regulator. The batch has an expiry date of August 2025.
Key medications identified as substandard include:
- Divalproex Extended-Release Tablets IP: Used to prevent seizures in epilepsy.
- Metformin Hydrochloride Tablets IP: A popular anti-diabetic drug.
- Zinc Sulphate Dispersible Tablets IP: Prescribed to address zinc deficiencies.
- Paracetamol Tablets IP 500 mg: A common pain-relief medication.
- Amoxymoon CV-625: An antibiotic for bacterial infections.
These findings highlight the widespread nature of the issue, affecting essential medications used by millions.
Health Ministry's Response
The Ministry of Health has described the detection of NSQ drugs as part of a routine regulatory surveillance activity. According to the ministry, for December 2024:
- 51 samples were identified as NSQ by central drug laboratories.
- 84 samples were flagged by state drug testing labs.
The ministry clarified that NSQ identification is specific to the tested batches and does not imply a blanket concern for all drugs available in the market. “As previous month, this month’s NSQ reporting from states has further increased showing increased participation of States in reporting NSQs to the central database. Increased reporting of NSQs and spurious identifications from states to central databases will further help in improving availability of quality medicines in the country and beyond,” the health ministry said.
Past Trends In NSQ Drug Detection
- In November 2024, 111 drugs were identified as NSQ.
- In October 2024, 90 drugs were flagged.
- From July to September 2024, 195 drugs were detected as NSQ or spurious.
These numbers reflect a persistent issue, demanding stricter quality controls and accountability within the pharmaceutical industry.
Health Experts Raise Alarm
Dr. Tamorish Kole, Chair of the Clinical Practice Committee at the International Federation for Emergency Medicine, called the findings “serious” and stressed the importance of strict regulatory measures. “Drugs like painkillers and antibiotics are common over-the-counter medications in India, making this a significant public health concern,” he said.
Dr. Kole also urged the public to exercise caution:
“People should avoid self-medicating and always consult a doctor before taking unprescribed medications. Proper medical guidance can help mitigate the risks of poor-quality drugs.”
The CDSCO continues to ramp up efforts to identify and remove substandard drugs from the market.
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