CDSCO to inspect cough syrup makers nationwide
In the wake of child deaths linked to allegedly contaminated cough syrups, the Central Drugs Standard Control Organisation (CDSCO) has launched a pan-India drive to audit, inspect, and ensure compliance by cough syrup manufacturers, urging states to submit their company lists
New Delhi: Central drug regulator CDSCO has started a pan-India drive to test, inspect and audit cough syrup manufacturers, official sources said on Thursday.
It has also asked all States and Union Territories to provide a list of cough syrup manufacturing companies for auditing.
This comes in the wake of children deaths allegedly due to the consumption of contaminated cough syrups.
The sources further 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, 18 State drug control authorities have onboarded the Online National Drugs Licensing System (ONDLS) which is aimed at streamlining drug licensing and regulatory compliance.
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 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 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.
There have been recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups and concerns related to quality of these cough syrups, the advisory stated.
