- Negligence by Tamil Nadu authorities caused the cough syrup tragedy, alleged CDSCO
- At least 23 children died after consuming syrup made by Tamil Nadu-based Sresan Pharmaceuticals
- Sresan Pharma lacked WHO-GMP certification and was never audited or registered on central portals
The central drug regulator has blamed the negligence of Tamil Nadu authorities for the cough syrup tragedy. At least 23 children had died in Madhya Pradesh after consuming an adulterated cough syrup made by a Tamil Nadu-based company over the last few weeks. An investigation by the Central Drugs Standard Control Organisation (CDSCO) has now found that lapses by the state drug controller led to the tragedy, said sources.
The state drug regulator ignored regulations and failed to act on the centre's recommendations, they said, adding that they neither took timely action against the syrup manufacturer nor maintained proper oversight. This led to the poisonous syrup reaching the market and resulted in the children's deaths, the sources said, citing CDSCO findings.
The CDSCO investigation revealed that Sresan Pharmaceuticals, which manufactured the poisonous Coldrif syrup, was never audited by any agency. Neither had it registered on the central portal for the drug manufacturers, sources added. Ranganathan Govindan, owner of the company, was arrested two days ago after evading the police for several days.
The central regulator has also blamed Tamil Nadu authorities for allowing the company to operate for decades without a WHO-Good Manufacturing Practice (GMP) certification. It also alleged that the state government didn't cooperate with the central team and that the drug controller did not share with them the required information, sources said.
State authorities did not properly monitor the activities of the pharmaceutical company that was granted production permission, they added.
Sresan was granted a license in 2011 and renewed in 2016. The Coldrif cough syrup manufactured by the company was declared adulterated by the state authorities earlier this month after samples showed the presence of diethylene glycol (DEG), a poisonous substance that could cause severe kidney, liver, and nervous system damage in humans.
The company's factory was also found to be in a very poor condition. An inspection at the factory in Kancheepuram recently found unbilled containers of DEG, and that the company was adding 46-48% of DEG to Coldrif against the permitted limit of only 0.1%.
The Tamil Nadu drug controller never provided information about it to the central government, said sources citing the CDSCO findings.
The centre had implemented a national data portal to better monitor pharmaceuticals, but Sresan never registered on it despite it being mandatory, said sources. In October 2023, a Google form was shared with all the states, asking them to provide information on pharmaceuticals. This directive was flagged at monthly review meetings and state FDA (food and drug administration) meetings. But Sresan ignored it. The company also did not register on the SUGAM portal, which is mandatory under the law.
State regulators are responsible for registering pharma companies on central portals, but the CDSCO found that the Tamil Nadu Drug Control Department failed to ensure it, according to the sources.
Sresan Pharma was also not included in any CDSCO audits. The state regulator is responsible for auditing all pharmaceutical companies in its jurisdiction.
The Tamil Nadu government conducted an audit of Sresan Pharma earlier this month at the request of Madhya Pradesh authorities, but did not inform the centre, sources said. On October 3, when a central team arrived in Kancheepuram to inspect their factory, the state drug officer did not appear before them despite repeated calls, they said.
The same night, the state authorities declared that 48% DEG was found in the syrup and sealed the factory.
