Published Apr 24, 2026 | 1:23 PM ⚊ Updated Apr 24, 2026 | 1:24 PM
Across the 141 entries, dissolution failures represented the most common reason for rejection.
Synopsis: ORS, one of the world’s simplest and most trusted solutions, has found a place on a national quality alert list that included 141 drugs, ranging from basic rehydration sachets to anti-epileptics, pregnancy supplements and a pain-relief injection used in intensive care.
Dehydration is common in summer, and oral rehydration salts (ORS) are the go-to solution in acute cases. But what if the ORS you buy to meet emergencies is of substandard quality?
It is true. The Central Drugs Testing Laboratory (CDTL) in Hyderabad has flagged substandard ORS in its March 2026 report as falling short of prescribed standards.
ORS is one of the world’s simplest and most trusted solutions. It has found a place on a national quality alert list that included 141 drugs, ranging from basic rehydration sachets to anti-epileptics, pregnancy supplements and a pain-relief injection used in intensive care.
The monthly Not of Standard Quality (NSQ) alert, published by the Central Drugs Standard Control Organisation (CDSCO), covered drugs tested across its affiliate state and central laboratories in March 2026.
The substandard ORS, 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.
Tests conducted at the CDTL found the sample not conforming to IP 2022 specifications with respect to the assay of Potassium content.
“The sample received does not conform to the IP 2022 specification with respect to the test for Assay of Potassium content only,” CDTL Hyderabad noted its finding.
ORS works by restoring the precise electrolyte balance lost during diarrhoea and vomiting. An incorrect potassium level does not just reduce efficacy. It potentially misleads a caregiver into believing a patient has received adequate treatment.
Also Read: How to identify if your medications are safe
A pattern emerged when the 141 entries were mapped by manufacturer location.
Himachal Pradesh, home to a dense cluster of pharmaceutical units located in Baddi, Nalagarh, Kala Amb, Paonta Sahib and Sirmour, accounted for the largest share of manufacturers flagged on the list.
Uttarakhand’s Haridwar and Roorkee corridor followed. Together, these two Himalayan states produced a disproportionate volume of India’s generic drugs and appeared repeatedly across the alert.
Companies from Baddi alone appeared across at least a dozen entries. They included Shiva Biogenetic Laboratories, Capsoft Healthcare, Solitaire Pharmacia, Spanker Biotech, Martin and Brown Bio-Sciences and others.
The concentration reflected both the density of pharma manufacturing in the region and the reach of national drug surveillance.
Also Read: 71 medicines, including PAN-D fail quality tests
Across the 141 entries, dissolution failures represented the most common reason for rejection.
Dissolution tests measure whether a tablet or capsule releases its active ingredient at the right speed inside the body. A tablet that dissolves too slowly or too quickly delivers an unpredictable dose; too little offers no therapeutic effect; too much risks toxicity.
Products that failed dissolution included Telmisartan tablets used for hypertension, Metronidazole tablets for infections, Folic Acid tablets dispensed through government maternal health programmes, Prednisolone tablets for inflammation, Glimepiride tablets for diabetes, Azithromycin tablets for bacterial infections, and Tacrolimus capsules used to prevent organ rejection after transplants, a medicine where dosing precision is non-negotiable.
Three separate batches of Tacrolimus capsules, at 0.5mg, 1mg and 2mg doses, from Spen Formulations Pvt Ltd in Una, Himachal Pradesh, appeared on the list, all flagged by CDL Kolkata for failing both dissolution and assay.
Tacrolimus suppresses the immune system after organ transplants. Patients who receive substandard doses risk rejection episodes.
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Several entries on the list were of particular concern because they targeted vulnerable populations.
Kerala State Drugs and Pharmaceuticals Ltd, a government manufacturer based in Alappuzha, appears twice on the list: once for Folic Acid Tablets IP 5mg and then for Diclofenac Sodium Tablets IP 50mg, both flagged for failing dissolution tests by state labs in Thiruvananthapuram and Thrissur, respectively.
Ferrous Ascorbate and Folic Acid capsules from Capsoft Healthcare and Iron and Folic Acid Syrup from Revat Laboratories in Ongole, Andhra Pradesh, appeared on the DCL Telangana list.
These formulations reach pregnant women through public health supply chains. A substandard iron or folic acid preparation does not correct anaemia or support foetal neural development, the two core reasons for which they are prescribed.
Paracetamol, India’s most widely consumed pain and fever drug, appeared in multiple entries across different states and manufacturers. Batches from Ipca Laboratories, Healer’s Lab and York’s Pharma failed dissolution tests. Paracetamol Tablets IP 650mg from Ipca, flagged by CDTL Mumbai, came from a manufacturer considered to be one of India’s larger generics companies.
Two batches of Dextromethorphan, Phenylephrine and Chlorpheniramine Syrup from KNM Pharma Pvt Ltd in Ahmedabad — different batch numbers, same product — failed for microbial contamination, specifically Total Aerobic Viable Count.
Microbial contamination in an oral syrup, particularly one given to children for cough and cold, raises immediate safety concerns beyond mere substandard quality.
Sterile Water for Injection IP from Bioiv Labs in Nalagarh failed the sterility test. An injectable water product that fails sterility does not just underperform; it actively endangers the patient.
Fentanyl Citrate Injection from Maan Pharmaceuticals in Mehsana failed bacterial endotoxin and sterility tests. Fentanyl is a high-potency opioid used in surgery and critical care.
Lactulose Solution IP from Unicure India Ltd appeared twice, two separate batches, both flagged by CDL Kolkata for failing microbial contamination and assay of Lactulose content. Lactulose treats constipation and hepatic encephalopathy, a condition that affects brain function in patients with liver disease.
Separate from the NSQ list, the March 2026 alert carried one entry under the spurious category.
Buprenorphine Injection IP 2ml, batch number LM1889, manufactured December 2023, surfaced with a striking note: the manufacturer listed on the label stated that it had never produced that batch. CDL Kolkata flagged the product as purported spurious. The case is being investigated.
Buprenorphine is a Schedule H1 controlled opioid used in pain management and opioid dependence treatment. A counterfeit batch circulating in the supply chain, with no traceable manufacturer and no verifiable composition, represents a category of risk that sits beyond substandard.
(Edited by Majnu Babu).
