In the wake of recent child deaths allegedly linked to contaminated cough syrups, the Central Drugs Standard Control Organisation (CDSCO) has issued an urgent alert to states and Union Territories, emphasizing the critical importance of drug-testing compliance. This directive comes as investigations continue into the deaths of children in Madhya Pradesh and Rajasthan, which have raised serious concerns about the quality and safety of pharmaceutical products.
The CDSCO has stressed the necessity of rigorously testing raw materials, including excipients, before their use in pharmaceutical formulations. This emphasis follows observations made during inspections of manufacturing facilities, which revealed that some manufacturers were not adequately testing each batch of ingredients to ensure compliance with prescribed standards.
Following reports of child deaths, a central team consisting of experts from various organizations, including the National Centre for Disease Control (NCDC), National Institute of Virology (NIV), and CDSCO, visited the affected areas to conduct a thorough analysis of the cases. Nineteen medicine samples that had been administered to children were collected from practitioners and retail stores for analysis. Chemical analysis revealed that one cough syrup, 'Coldrif', contained Diethylene Glycol (DEG) beyond the permissible limit.
In response to these findings, regulatory actions have been taken against the manufacturing unit in Kancheepuram, Tamil Nadu, where the contaminated Coldrif syrup was produced. The CDSCO has recommended the cancellation of the manufacturing license and the initiation of criminal proceedings. Furthermore, states including Kerala, Tamil Nadu, and Madhya Pradesh have banned the sale of Coldrif syrup, while Telangana has issued a public alert advising against its use.
The Union Health Secretary convened a high-level meeting with states and Union Territories to address the concerns surrounding cough syrup quality and promote the rational use of these medications, especially in pediatric populations. During the meeting, states were directed to enhance surveillance of all pharmaceutical manufacturing units within their jurisdiction to ensure compliance with Good Manufacturing Practices (GMP). Strict action against defaulters was also promised.
Adding to these measures, the CDSCO has initiated risk-based inspections of drug manufacturing units in six states: Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh, and Maharashtra. These inspections aim to identify gaps that may have led to drug quality failures and to suggest process improvements to prevent similar incidents in the future.
Despite these efforts, recent reports from the CDSCO indicate that initial tests on cough syrup samples have not found any contamination. However, investigations are still underway to determine the exact cause of the child deaths. The Director General of Health Services (DGHS) has issued an advisory to states and Union Territories on the rational use of cough syrups in the pediatric population.
In light of these events, medical associations are calling for the release of a doctor arrested in connection with the cough syrup deaths, emphasizing the need for a thorough investigation that ensures justice for victims while protecting medical professionals from wrongful blame. The Federation of All India Medical Association (FAIMA) has proposed measures to the health ministry to prevent future incidents, including central oversight and nationwide drug testing.
