Recent concerns over the quality and safety of cough syrups, especially for children, have prompted urgent action by India’s Union Ministry of Health and Family Welfare. Following reports of child deaths linked to contaminated cough syrups in Madhya Pradesh, a high-level meeting was held with officials from all States and Union Territories. The meeting aimed to review drug quality compliance and promote rational use of cough syrups in paediatric care.
Background and Incident Overview
A cluster of child deaths in Chhindwara, Madhya Pradesh raised alarms about cough syrup safety. Investigations by the National Centre for Disease Control and other agencies found one cough syrup brand containing diethylene glycol (DEG) beyond safe limits. This toxic substance is harmful especially to children. The implicated manufacturing unit in Tamil Nadu faced license cancellation and criminal proceedings.
Regulatory Compliance and Manufacturing Standards
Strict adherence to Revised Schedule M and Good Manufacturing Practices (GMP) is essential. The government has initiated risk-based inspections of multiple pharmaceutical units to identify and fix quality lapses. The Department of Pharmaceuticals supports upgrading manufacturing infrastructure through schemes like the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS).
Rational Use of Cough Syrups in Children
Experts emphasise that most childhood coughs are self-limiting and do not require medication. Irrational combinations and unnecessary formulations pose health risks. The Directorate General of Health Services (DGHS) has issued advisories discouraging routine cough syrup use in paediatric populations. Guidelines for doctors, pharmacists, and parents are being prepared to promote safe practices.
Strengthening Surveillance and Reporting Systems
Enhanced surveillance and timely reporting of adverse drug events are critical. States are urged to use the Integrated Disease Surveillance Programme (IDSP) and its community reporting tools effectively. Inter-state coordination is vital for rapid outbreak response and preventive action. Health facilities, both public and private, must ensure prompt communication of unusual health events.
Role of Central and State Authorities
Central agencies including the National Centre for Disease Control, Indian Council of Medical Research, and Central Drugs Standard Control Organisation coordinate investigations and regulatory actions. State health departments conduct local inquiries, implement awareness campaigns, and enforce regulations. Collaborative efforts aim to safeguard drug quality and protect children’s health nationwide.
Public Awareness and Education
Awareness campaigns focus on educating parents about the limited benefits and potential harms of cough syrups in children. Health officials promote rational drug use and caution against self-medication. Pharmacists and healthcare providers receive training to avoid dispensing harmful or unnecessary paediatric formulations.
Ongoing Measures and Future Directions
Investigations continue in affected regions to ensure no further risk remains. Regulatory authorities are intensifying inspections and enforcement. New guidelines and policies will support safer drug manufacturing and usage. The government is committed to preventing recurrence and improving overall drug safety standards.
Questions for UPSC:
- Point out the challenges in enforcing drug quality standards in India’s pharmaceutical sector and suggest measures to overcome them.
- Critically analyse the role of surveillance systems like the Integrated Disease Surveillance Programme (IDSP) in managing public health emergencies with suitable examples.
- Estimate the impact of irrational drug use on paediatric health and underline strategies to promote rational prescription practices.
- What are the key components of Good Manufacturing Practices (GMP) in pharmaceuticals? How do these practices ensure drug safety and efficacy?
