In the light of recent guidelines issued by the Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare, and reports of child fatalities linked to inappropriate medication, the Indian Academy of Pediatrics (IAP), Nagaland State Branch, has issued a public advisory urging parents and caregivers to exercise extreme caution in the use of cough syrups for children.
According to IAP Nagaland, most cough and cold illnesses in young children are mild, self-limiting, and typically resolve without the need for medication. The advisory highlights several key points for public awareness:
Avoid cough syrups in young children: Combination cough and cold syrups should not be used in children below two years of age. Such medications must only be prescribed after proper clinical evaluation and with strict adherence to dosage guidelines. Parents are advised not to administer these medicines without consulting a paediatrician.
Use bronchodilators and mucolytics judiciously: For children experiencing cough due to bronchospasm, asthma, or wheezing disorders, bronchodilators such as salbutamol or levosalbutamol may be used—preferably through inhalation and under medical supervision. Mucolytics or expectorants like ambroxol, bromhexine, or acetylcysteine may be considered in selected cases with thick sputum, but only under paediatric guidance. Routine or unsupervised use is discouraged, especially in infants and toddlers.
Limited role of antihistamines: Antihistamines may be considered for children above six months of age in cases of allergic rhinitis. However, they should not be used routinely for simple coughs or colds.
Non-drug measures first: Adequate hydration, rest, saline nasal drops, and steam inhalation remain the safest and most effective first-line approaches for managing respiratory symptoms in children.
Avoid self-medication: Parents are strongly advised against giving over-the-counter cough syrups without medical consultation. Seeking proper paediatric advice is essential for safe and effective treatment.
IAP Nagaland urged all healthcare providers and parents to adopt rational, evidence-based practices to safeguard the health and wellbeing of children.
Centre warns States on pediatric cough syrup misuse & quality
PTI: Amid concerns over the quality of cough syrups, the Union Health Ministry on Sunday stressed that all drug manufacturers must comply with the Revised Schedule M and warned that strict action will be taken against violators.
A high-level meeting, chaired by Union Health Secretary Punya Salila Srivastava with representatives from all states and Union territories, reviewed compliance with drug quality norms and measures to promote the rational use of cough syrups, particularly in pediatric populations. The meeting follows reports of child deaths in Chhindwara, Madhya Pradesh, and Rajasthan allegedly linked to contaminated cough syrups.
States were advised that most coughs are self-limiting and do not require pharmacological treatment. The advisory issued by the Directorate General of Health Services (DGHS) on rational use of pediatric cough syrups was discussed, along with measures to strengthen regulatory oversight of retail pharmacies and prevent irrational or unsafe formulations.
Rajasthan’s principal secretary (Health) said investigations so far indicate the four reported deaths were not linked to cough syrup quality. Awareness campaigns on rational use of pediatric formulations are underway, and further investigations continue.
Discussions focused on three key areas: compliance with Schedule M and other quality standards in drug manufacturing, rational pediatric use of cough syrups, and stricter regulation of retail pharmacies.
A central expert team from NCDC, NIV, and CDSCO visited Chhindwara and Nagpur, collecting clinical, environmental, entomological, and drug samples for analysis. Preliminary results ruled out common infectious diseases except for one leptospirosis case. Of 19 medicine samples collected, nine of 10 analyzed met quality standards, while one, Coldrif cough syrup, contained DEG above permissible limits. Regulatory action by Tamil Nadu FDA has been taken, with CDSCO recommending cancellation of the manufacturing license and initiating criminal proceedings.
Risk-Based Inspections are underway across 19 manufacturing units in six states to identify systemic gaps. States were also urged to enhance surveillance, report promptly, and strengthen coordination for early detection of unusual health events.
ICMR Director General Dr Rajiv Bahl advised against prescribing cough syrups to children and highlighted the functioning of the National Joint Outbreak Response Team. DGHS Sunita Sharma and DCGI Dr Rajeev Raghuvanshi stressed rational use, GMP compliance, and timely inspection to ensure safety in pediatric drug administration.