Drug regulator begins pan-Indian inspection of cough syrup makers

India’s drug regulator has sought a list of cough syrup manufacturers from all the states and UT as it plans to launch nationwide joint inspections of all such firms as the death toll of children due alleged intake of toxic syrups mounted to 24 on Thursday.

According to sources, the Central Drugs Standard Control Organisation (CDSCO) will conduct testing, inspection and auditing of cough syrup manufacturers.

Meanwhile, a PTI report said that the World Health Organisation (WHO) has received confirmation from the CDSCO on the presence of toxic contaminants in at least three cough syrups, whose intake allegedly led to the deaths of 24 children in Madhya Pradesh’s Chhindwara district.

The contamination

The Union Health Ministry had earlier confirmed that one batch of Coldrif, manufactured by Tamil Nadu-based Sresan Pharma, had 48 per cent Diethylene Glycol (DEG).

The official sources added that two other syrups manufactured in Gujarat, Respifresh TR and Relife, were also found to have DEG levels marginally higher than the prescribed limit.

DEG is a cheap and colourless industrial chemical most commonly used in making products like brake fluids and paints. This can sometimes be mistakenly or illegally used in medicines as a substitute for propylene glycol (a solvent that helps dissolve drugs into liquid form).

Sources suggested that none of the three syrups had been exported from India.

The central drug regulatory body has asked for an explanation from the Tamil Nadu Food and Drug Administration (FDA), as to why product testing and site inspections did not take place at Sresan Pharma’s units.

A recent site inspection audit done after the incident reported 364 observations, of which 38 were very critical in nature.

Sources add that the firm was given a license in 2011, with a renewal awarded by the state FDA in 2016-17, without informing the CDSCO.

“The CDSCO has recommended cancellation of the firm’s license and initiation of criminal investigation against the firm,” people in the know said. TN FDA could not be immediately contacted for a comment.

According to reports, Sresan Pharma’s owner Ranganathan Govindan has been taken into custody by the Madhya Pradesh police in Chennai. On the other hand, a stop production order has been issued against the Gujarat manufacturers.

For Rajasthan, sources said that samples collected in the state were found to be clear and deaths were likely caused by acute respiratory syndrome and encephalitis.

Non-compliance of CAPA norms

Sources said that no state so far has fully complied with Corrective and Preventive Action (CAPA) guidelines which have been introduced for ensuring safety and maintaining standards in pharmaceutical products.

“So far, only 18 state/UT drug control authorities have on-boarded the Online National Drugs Licensing System (ONDLS) which is aimed at streamlining drug licensing and regulatory compliance,” an official in the know said.

ONDLS is a digital, single-window platform for processing various drug-related licenses in India and has been developed by the Centre for Development of Advanced Computing (C-DAC) in collaboration with CDSCO.

The Drugs Controller General of India (DCGI) on Wednesday had urged drug controllers in all states and UT’s to ensure testing of raw materials and finished formulations of pharmaceutical products before releasing them in the market.

In its advisory, the DCGI said that during recent inspections at manufacturing facilities and in the investigations of the drugs declared as not of standard quality, it was found that several manufacturers are not testing each batch of excipients and active ingredients for compliance with prescribed standards before use.

Similarly, the Directorate General of Health Services (DGHS) had directed states to ensure that cough syrups are not prescribed or dispensed to children below 5 years of age.

The incident in MP comes on the back of similar crises that have previously tarnished Indian pharmaceutical firms’ reputation.

In 2022, WHO had issued alerts after Indian-made cough syrups were linked to the deaths of children in Uzbekistan and The Gambia, with tests confirming the presence of lethal contaminants.