Hyderabad: A government laboratory in Hyderabad flagged Oral Rehydration Salts(ORS) as substandard in March 2026.
The government has now put the product on a national alert list alongside a malaria drug, a cough syrup, and earwax drops, all found wanting in the same monthly sweep by drug regulators.
The Central Drugs Testing Laboratory (CDTL) in Hyderabad and the Drugs Control Laboratory (DCL) in Telangana together identified nine products that failed to meet quality standards, according to the Not of Standard Quality (NSQ) alert published by the Central Drugs Standard Control Organisation (CDSCO) for March 2026.
ORS: the salt that should not fail
The ORS batch in question, bearing batch number S565005 and manufactured in May 2025, came from Goa Antibiotics and Pharmaceuticals Ltd, a subsidiary of HLL Lifecare Ltd, a Government of India enterprise. “The sample received does not conform to the IP 2022 specification with respect to the test for Assay of Potassium content only,” according to CDTL Hyderabad’s findings.
ORS works by replacing fluids and electrolytes the body loses during diarrhoea and vomiting. Its formula, a precise balance of sodium, potassium, glucose, and water, has remained largely unchanged for decades because that balance is everything. A batch that does not deliver the correct Potassium concentration does not just underperform. It potentially misleads a caregiver into believing a sick child has received what they need.
The World Health Organisation lists ORS as an essential medicine. India distributes it through government health programmes, anganwadi centres, and rural pharmacies. The expectation attached to it is absolute.
Earwax drops, a respiratory syrup, and a chronic disease tablet
CDTL Hyderabad flagged four other products in the same month.
Ear Wax Softening Drops manufactured by Vivimed Labs Limited, based in Jeedimetla, Hyderabad, failed the assay for three of its active ingredients, Paradichlorobenzene, Chlorbutol, and Turpentine Oil.
A separate batch of ear drops from Om Sai Pharma Pack in Haridwar, containing the same active ingredients, also failed the assay of Paradichlorobenzene. Two products, same failure category, same month.
A Levosalbutamol Sulphate, Ambroxol Hydrochloride, and Guaiphenesin Syrup from Ipzah Pharmaceuticals Pvt Ltd in Patiala failed on description. This respiratory combination reaches patients managing asthma, bronchitis, and chest congestion. Levosalbutamol opens constricted airways. Ambroxol and Guaiphenesin work to loosen and clear mucus. A product that fails at the description stage raises questions about its basic composition.
Vitamin E Capsules USP 400mg from Renown Pharmaceuticals Pvt Ltd in Vadodara failed the disintegration test. A capsule that does not disintegrate as required cannot release its contents into the body at the right time, rendering the dose unreliable.
State lab findings: pregnancy supplements and an antibiotic
DCL Telangana separately flagged four products through state laboratory testing.
Hydroxychloroquine Sulphate Tablets IP 200mg, manufactured by Lifecare Formulations Pvt Ltd in Puducherry, failed the dissolution test as per IP 2022. Hydroxychloroquine treats malaria but also serves as a long-term medication for patients living with rheumatoid arthritis and lupus, conditions that demand consistent dosing. A tablet that does not dissolve correctly delivers an unpredictable amount of the drug into the bloodstream.
Two entries on the Telangana list carry particular weight because they reach pregnant women and young children. Ferrous Ascorbate, Folic Acid, and Zinc Soft Gelatin Capsules from Capsoft Healthcare Pvt Ltd in Baddi, Himachal Pradesh, failed on assay and identification of Folic Acid and Ferrous content, as well as uniformity of weight and disintegration. Iron and Folic Acid Syrup from Revat Laboratories Pvt Ltd in Ongole, Andhra Pradesh, failed the assay of Iron, Folic Acid, and pH.
Both products enter the supply chain through government maternal and child health programmes. An iron supplement that fails its assay does not correct anaemia. A folic acid formulation that fails identification testing raises the question of whether the nutrient is present at all in the claimed amount.
The fifth DCL Telangana finding, an Amoxycillin, Potassium Clavulanate, and Lactic Acid Bacillus Oral Suspension from JMM Formulation Pvt Ltd in Sirmour, Himachal Pradesh, failed the assay of Clavulanic Acid. Clavulanic Acid is the component that stops bacteria from breaking down amoxicillin and rendering it useless. Without adequate levels of it, the antibiotic loses much of its effectiveness against resistant bacteria.
What the list reveals
The nine products together cover almost every stage of patient care, rehydration, infection, chronic disease, maternal nutrition, and respiratory relief. None sits at the margins of medicine. All carry a direct expectation of reliability from the patient who receives them.
India’s drug regulatory system publishes NSQ alerts monthly. Manufacturers whose products appear on the list face show-cause notices and potential recall action. The CDSCO alert does not by itself establish criminal liability but triggers further investigation by state drug authorities.
What the March 2026 Telangana findings make clear is that substandard drugs do not cluster only around obscure formulations or unregulated markets. They turn up in the products people reach for first, and trust most.
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