Cough syrup deaths: Centre to test, inspect, audit all manufacturers

Amid children's deaths due to the consumption of contaminated cough syrups, the Union government’s Central Drugs Standard Control Organisation (CDSCO) has started a pan-India drive to test, inspect, and audit cough syrup manufacturers.

CDSCO comes under the Directorate General of Health Services, Union Ministry of Health & Family Welfare, and is the National Regulatory Authority (NRA) of India.

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It has also asked all states and Union territories to provide a list of cough syrup manufacturing companies for auditing, a PTI report said on Thursday (October 9), citing sources.

No compliance with CAPA guidelines

The sources further said that no state so far has fully complied with Corrective and Preventive Action (CAPA) guidelines, which have been introduced to ensure safety and maintain standards in pharmaceutical products.

So far, 18 state drug control authorities have onboarded the Online National Drugs Licensing System (ONDLS) which is aimed at streamlining drug licensing and regulatory compliance.

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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.

DCGI advisory

The Drugs Controller General of India (DCGI) on Wednesday had urged drug controllers in all states and Union territories to ensure testing of raw materials and finished formulations of pharmaceutical products before releasing in them in the market in the wake of children's deaths allegedly due to consumption of contaminated cough syrup in Madhya Pradesh.

In an 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.

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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 advisory stated.