The Central Drugs Standard Control Organisation (CDSCO) has ordered state controllers to ensure "strict compliance" with quality norms, stating that some pharmaceutical firms are not testing raw materials, once again highlighting the failure to adhere to regulatory standards.
The directive, which flags a serious but repetitive lapse in quality control, comes as the toll from drinking an allegedly contaminated cough syrup climbed to 22, after two more children died in Madhya Pradesh.
The children, most of whom were from Madhya Pradesh’s Chhindwara district, had consumed Coldrif cough syrup, which, according to reports, contained toxic diethylene glycol nearly 500 times the permissible limit.
“This directorate has time to time emphasised the critical importance of testing of raw materials including the excipients before its use in the manufacturing of pharmaceutical formulations,” Drugs Controller General of India Rajeev Singh Raghuvanshi said in a letter dated October 7, mandating the testing of all raw materials.
Excipients are inactive ingredients used alongside the active pharmaceutical ingredient in drug manufacturing to aid in stability or delivery.
Also read: As cough syrup deaths rise, WHO seeks answers from India on the toxic medication exports
Violations continue
The directive reveals a persistent regulatory failure, as some drugmakers continue to skip essential quality checks, which in the past, too, have proved fatal.
“There have been recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups and concerns related to the quality of these cough syrups,” the letter said.
During the inspections of “manufacturing facilities and in the investigations of the drugs declared as Not of Standard Quality, it was observed in the reports that the manufacturers are not carrying out testing of each batch of the excipients”, it said.
Raghuvanshi asked state controllers to sensitise manufacturers and ensure they implement “robust vendor qualification” systems — the very same recommendations was made after the Gambia and Uzbekistan tragedies.
A probe conducted by the Tamil Nadu government revealed that samples of Coldrif Syrup contained 48.6 percent diethylene glycol, a highly toxic chemical.
Tamil Nadu-based Sresan Pharmaceuticals is the manufacturer of Coldrif. The owner has been arrested and the unit sealed after the deaths of children in Madhya Pradesh and neighbouring Rajasthan.
Madhya Pradesh’s Controller Food & Drug Administration has banned the sale and distribution of the medicine in the state.
CDSCO investigations have shown that manufacturers do not test each batch of active ingredients and even supposedly inert excipients. This oversight is a direct violation of India’s Drugs Rules of 1945, which require comprehensive testing.
Also read: India declares three cough syrups toxic after child deaths
Cutting corners
The regulator’s findings echo past tragedies. In 2022 and 2023, tainted cough syrups exported from India were linked to dozens of child deaths in Gambia and Uzbekistan.
Investigations found the use of industrial-grade solvents such as diethylene glycol in place of pharmaceutical-grade ingredients.
Despite global scrutiny, CDSCO’s latest warning shows that some manufacturers continue to skip mandatory batch testing, possibly to cut costs.
By skipping tests, manufacturers can substitute pharmaceutical-grade propylene glycol with its industrial-grade, and potentially toxic, equivalent.
"India has a complex drug regulatory system; a few exceptions will always exist. The government and the regulator are investigating the matter. We should wait for the outcome of those investigations," a senior industry leader, who coordinates with the government and regulator, said on condition of anonymity.
“The regulator will take serious action and streamline the process to avoid such incidents,” he added.
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