CDSCO Flags 60 Substandard Drugs, Including Critical Injectables

India’s top drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has identified 60 medicines as “not of standard quality” in its April 2025 alert. These include eye drops and IV fluids that have previously been linked to serious health events such as blindness in the US and maternal deaths in Karnataka.

The drugs were found to be of poor quality in tests for sterility, contamination, pH levels, and wrong dose, thus having serious implications for patient safety, especially in emergencies and long-term care.

Eye drops and IV fluids fail key quality testing.

Among others, carboxymethylcellulose sodium eye drops, which are used to treat dry eyes, have been highlighted. Three batches manufactured by Martin & Brown Biosciences from Himachal Pradesh failed the tests for sterility, pH, and levels of active ingredient in the drug. These drops evoke a scenario quite similar to US recalls in 2023 concerning vision loss and infection.

Compound sodium lactate injection (Ringer’s lactate) was again flagged in 2024 after multiple maternal deaths from Karnataka were linked.. The most recent failed batch was manufactured by Ecolife Healthcare, while the previous batch came from Paschim Banga Pharmaceuticals.

Sodium chloride IV fluid linked to maternal deaths and illness in 47 other patients in West Bengal also failed recent tests. The product, manufactured by Captab Biotec, contains bacterial endotoxins, which can trigger life-threatening septic shock.

Important injectable drugs don’t make the cut.

The latest findings from CDSCO call for better quality control, especially for medications used in emergency rooms, surgeries, and for chronic care. Patients and healthcare workers should be on alert and report any side effects they notice. With worries about counterfeit drugs on the rise, keeping a close eye on regulations is more crucial than ever. Recently, a few life-saving injections didn't meet CDSCO quality standards:

•  Bupivacaine Hydrochloride, a local anesthetic, had harmful particles in it.

•  Iron Sucrose Injection, which is given for anemia, had the wrong pH and alkalinity.

•  A mix of Ceftriaxone and Sulbactam antibiotics was found to be contaminated with bacterial endotoxin.

•  Other antibiotics, like Amikacin Sulfate and Gentamicin, also showed contamination, which could lessen their effectiveness or lead to serious complications.

Chronic Illness Medications Also Affected

Chronic disease patients, as well, were not spared:

• Antiepileptics like Phenytoin Sodium and Levetiracetam failed dissolution tests and dosing tests, constituting a risk for controlling seizures.

• Diabetes drugs, including Teneligliptin-Metformin and Glimepiride, showed assay failures.

• Telmisartan, a blood pressure medication, also failed the quality test.

• A fixed-dose tuberculosis drug (Rifampicin-Isoniazid-Pyrazinamide) failed assay standards, potentially encouraging drug resistance, a major public health concern.

Counterfeit drugs in circulation raise alarm bells.

The CDSCO alert also revealed counterfeit and counterfeit drugs that mimic genuine brands:

• A batch of Nandrolone Decanoate Injection (sold as Deca-Durabolin 50) failed both identity and dosage tests. The listed manufacturer denied making the product.

• Similarly, D’mex Colecalciferol (Vitamin D3) tablets failed to meet standards for cholecalciferol content. The named manufacturer again denied responsibility, suggesting the presence of counterfeit products on the market.

What This Means for Public Health

Recent findings from CDSCO stress that we need better quality checks, especially for drugs used in emergency rooms, surgeries, and for long-term treatment. Patients and healthcare workers should keep an eye out for any bad reactions and let the authorities know. With the rise of fake medicines, it's crucial to have strong regulations in place.

(Input from various sources)

(Rehash/Muhammad Faisal Arshad/MSM)