Published Mar 17, 2026 | 9:40 PM ⚊ Updated Mar 17, 2026 | 9:40 PM
Cough syrup (Representational image. Credit: iStock)
Synopsis: A manufacturing unit linked to a toxic cough syrup tragedy that killed children in north India went at least 14 years without the annual inspections mandated under India’s drug regulations, according to a report. The findings are part of a report authored by PB Suresh Babu that examines regulatory gaps which allowed adulterated medicines to enter the supply chain.
A manufacturing unit linked to a toxic cough syrup tragedy that killed children in north India went at least 14 years without the annual inspections mandated under India’s drug regulations, according to a report released in Chennai on Saturday, 14 March.
The report launched by Tamil Nadu Health Development Association (TNHDA) said the Drugs and Cosmetics Rules require manufacturing facilities to be inspected at least once a year, but such checks never took place at the Sresan Pharma unit where the cough syrup Coldrif was produced.
The findings are part of a report authored by PB Suresh Babu that examines regulatory gaps which allowed adulterated medicines to enter the supply chain.
The report was released by former Madras High Court judge D Hariparanthaman at an event organised by TNHDA.
The report pointed to several regulatory lapses that may have contributed to the tragedy.
It notes that Rule 71 of the Drugs and Cosmetics Rules already requires manufacturers to maintain their own drug-testing infrastructure and qualified technical staff to ensure quality control.
However, the report says such provisions appear to have been poorly implemented in practice, raising concerns about whether manufacturers are consistently verifying the safety of raw materials and finished products before distribution.
Experts cited in the report say manufacturers are legally responsible for testing raw materials and maintaining records for inspection. If these checks are bypassed, adulterated substances can enter the production chain undetected.
The report also raises questions about how responsibilities are divided between central and state regulators.
Under India’s regulatory framework, state governments issue licences and conduct routine inspections of pharmaceutical manufacturing facilities, while the national regulator — the Central Drugs Standard Control Organisation — coordinates oversight at the national level and for exported drugs.
The author, Suresh Babu, told South First that transparency about where medicines are manufactured and distributed is crucial in determining accountability when safety failures occur.
“If a medicine is manufactured in one state but incidents are reported elsewhere, there needs to be clarity on whether it was sold locally or transported entirely to other regions,” he said.
The report also notes that certain Good Manufacturing Practice (GMP) compliance requirements introduced in recent regulatory reforms did not apply to smaller companies below a specified turnover threshold, potentially leaving gaps in oversight for some manufacturers.
Public health experts warned that substances such as diethylene glycol, an industrial solvent, should never appear in medicines meant for human consumption.
According to CS Rex Sargunam, paediatrician and president of TNHDA, even small quantities can accumulate in the body and cause serious damage to organs such as the kidneys, particularly in children who may take cough syrups repeatedly over several days.
Sargunam explained to South First that states with large pharmaceutical manufacturing sectors require stronger testing infrastructure and manpower to ensure drug quality is monitored effectively.
“There should be sufficient testing laboratories and staff. Regulatory departments should not economise on these because it directly affects the quality of medicines,” he said.
The report came amid heightened scrutiny of drug quality across India following the cough syrup deaths and subsequent regulatory investigations.
Monthly surveillance reports from the Central Drugs Standard Control Organisation have flagged multiple cough syrups as “not of standard quality” in recent months, including several detected by laboratories in Tamil Nadu.
Earlier surveillance reports documented dozens of respiratory and cough syrup formulations failing content quality tests nationwide, raising concerns about systemic issues in pharmaceutical manufacturing and quality control.
Experts said the repeated detection of substandard medicines highlights the need for stronger inspections, testing systems and coordination between state regulators and the CDSCO to ensure unsafe drugs are identified before reaching patients.
The TNHDA report concluded with several recommendations aimed at strengthening India’s drug safety system.
It called for stricter enforcement of existing rules requiring manufacturers to maintain testing infrastructure, along with greater accountability for states where drugs are manufactured and where they are distributed.
The report also urged stronger oversight by the Central Drugs Standard Control Organisation (CDSCO) for drugs moving across state borders and for those meant for export.
Among its key demands, the report asked the Tamil Nadu government to release a white paper on the operations of the Sresan pharmaceutical unit, publish relevant regulatory notifications online, and consider bringing drug regulation more explicitly under the state list alongside health in the Constitution.
(Edited by Muhammed Fazil.)
