At the centre of the controversy is Samkem, a pharmaceutical manufacturer based in Madhya Pradesh, whose products accounted for nearly 80 percent of the reported failures.
Published May 28, 2025 | 5:30 PM ⚊ Updated May 30, 2025 | 10:44 AM
Tablets. Representative Image.
Synopsis: The CDSCO released its Not of Standard Quality list for April 2025, revealing that multiple batches of Albendazole tablets had failed quality checks conducted by the Telangana State Drugs Control Laboratory.
The Union Health Ministry launched National Deworming Day in 2015 — observed every 10 February and 10 August — to provide a single-day fixed-dose deworming treatment to all children between one and 19 years, whether enrolled in school or not.
Telangana joined the effort and intensified efforts to protect children from parasitic worm infections through mass deworming campaigns, but a spate of drug quality failures involving Albendazole — the primary medication used — has raised serious public health concerns.
In late May, the Central Drugs Standard Control Organisation (CDSCO) released its Not of Standard Quality (NSQ) list for April 2025, revealing that multiple batches of Albendazole tablets had failed quality checks conducted by the Telangana State Drugs Control Laboratory.
The issue is not limited to April but also to March. Several batches of Albendazole tablets, intended for children between one and 19 years of age, were found to be substandard. The tablets failed the dissolution test under the Indian Pharmacopoeia standards, a critical parameter that measures a drug’s ability to release its active ingredient in the body.
At the centre of the controversy is Samkem, a pharmaceutical manufacturer based in Madhya Pradesh, whose products accounted for nearly 80 percent of the reported failures. Ironically, the company holds multiple quality certifications, including WHO-GMP, GLP, and ISO 9001:2015, which are generally considered indicators of good manufacturing practices.
Despite this, at least six batches from Samkem failed quality checks in March, and six more were flagged in April.
Another manufacturer, Concept Pharmaceuticals Ltd, based in Uttarakhand, also had multiple Albendazole batches fail the same quality test.
The fallout has had significant public health implications. The failure of these critical batches led the state government to postpone the National Deworming Day(NDD), originally scheduled for February 2025. Officials are now preparing to conduct the campaign in August 2025, after securing fresh supplies from a newly appointed manufacturer.
Soil-Transmitted Helminths (STH), or intestinal worm infections, remain a major health burden in India, affecting an estimated 22 crore children between one and 14. These infections are known to impair nutrient absorption and cause anaemia, malnutrition and developmental delays.
The prevalence of STH, or intestinal worm infections, among school children in Telangana has been found to be high in recent studies. A large-scale school-based survey conducted between November 2015 and January 2016 reported an overall STH prevalence of 60.7 percent among children in government primary schools in Telangana. Ascaris lumbricoides was identified as the most prevalent STH species in the state, and most infections were of light intensity.
In Telangana, the Health Department, in collaboration with the Education and Women & Child Welfare Departments, implements National Deworming Day across government and private schools, Anganwadis, and even degree colleges.
The tablets are administered by medical staff, Anganwadi workers, and school teachers, with mop-up rounds scheduled a week later for children who miss the primary deworming day.
The Telangana State Medical Services and Infrastructure Development Corporation (TGMSIDC) — the agency responsible for procuring medicines for government hospitals and institutions — floated a tender for Albendazole tablets in November 2024, ahead of the National Deworming Day (NDD) scheduled for February 2025.
“The lowest bidder (L1) was Samkem. By January, we began receiving consignments of Albendazole tablets from them,” a TGMSIDC official told South First. “According to our standard procedure, we sent samples from the initial batches to our empanelled laboratory for quality testing. The first few reports came back as NSQ, and we initially assumed it might be an issue with only those early batches.”
However, the problem turned out to be far more widespread.
“Out of 25 batches received, 19 were found to be NSQ in our empanelled lab. Only four batches met quality standards, and one batch is still under analysis,” the official added.
The official noted that the company had supplied a total of 96 lakh Albendazole tablets. “Given the seriousness of the issue — with 19 batches declared Not of Standard Quality — we have blacklisted the company for three years,” the official said.
He added that this was not a loss for the Telangana government as no payment had been made to the company; we only had to postpone the NDD.
“In January, we floated another tender, and a new company was selected. One reason we see here is that the demand for the medicine was quite high, so the manufacturer, in an effort to produce quickly, may not have paid enough attention to the product. Also, only the government buys this product for occasions like this, as nowadays paediatricians don’t prescribe this tablet for children. With improved hygiene, cases have decreased, and it’s not needed outside of these events,” said the official.
He added that the manufacturer only needs to produce for us during that period. The current manufacturer is producing 1.3 lakh tablets per day, “so hopefully, by August, after testing, we will have the drugs available as required,” he said.
According to the TGMSIDC official, the Albendazole tablets failed the dissolution test, which is a critical quality parameter under the Indian Pharmacopoeia (IP) standards. This test determines how effectively a tablet dissolves in the body to release its active ingredient — in this case, Albendazole.
“Albendazole is poorly soluble, its dissolution rate depends heavily on how the tablet is formulated during manufacturing,” the official explained. “One of the key techniques used to ensure proper dissolution is micronisation — a process that reduces the drug particles to a very fine size. Smaller particles mean a larger surface area, which helps the tablet dissolve more efficiently in bodily fluids.”
The official added that manufacturers often use solubilising agents or techniques to enhance dissolution. “If proper micronisation isn’t done, or if the formulation doesn’t include the necessary excipients to aid solubility, then even a soluble drug like Albendazole can fail to dissolve properly — leading to failure in the dissolution test,” the official said.
However, he pointed out that the NSQ wouldn’t have been harmed in the case of Albendazole.
While the testing by TGMSIDC followed its standard procurement protocol, Telangana’s Drugs Control Administration (DCA) also independently identified quality issues with the Albendazole tablets through its routine surveillance.
“We collected random samples of Albendazole tablets from government institutions — including hospitals and distribution centres under TGMSIDC — as part of our regular monitoring process,” Telangana DCA Joint Director G Ramdhan told South First.
He said that 12 samples from Samkem were found to be NSQ across various districts, including Suryapet and Karimnagar. “The Drug Inspectors of the respective districts have issued notices to the manufacturer. We have received multiple replies from the company, while responses to some notices are still pending,” Ramdhan said.
Interestingly, the manufacturer claimed in its responses that the samples were indeed of standard quality. “To resolve the discrepancy, we are now sending the contested samples to the Central Drugs Laboratory (CDL) in Kolkata for further testing,” he added.
If CDL confirms the NSQ status of the samples, the DCA plans to initiate prosecution against the manufacturer, Ramdhan confirmed.
(Edited by Muhammed Fazil.)
