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The Union health ministry has said that the samples of cough syrups allegedly caused death of seven children in Madhya Pradesh were tested by the Central and State drug regulators and none of the samples contained contaminants that known to cause serious kidney injury.
Director General of Health Services (DGHS) has issued an advisory to all States and Union Territories on rational use of cough syrups in paediatric population.
The Ministry said that in view of the recent reports suggesting that child deaths in Madhya Pradesh were linked to consumption of cough syrups, a joint team consisting of representatives from National Centre for Disease Control (NCDC), National Institute of Virology (NIV), Central Drugs Standard Control Organisation (CDSCO), etc visited the site.
Various samples were collected in coordination with the State Authorities including samples of various cough syrups.
"As per the test results, none of the samples contained diethylene glycol (DEG) or ethylene glycol (EG), contaminants that are known to cause serious kidney injury. The Madhya Pradesh State Food and Drug Administration (SFDA) also tested three samples and confirmed absence of DEG/EG," said a press statement.
Further blood/CSF samples have been tested by NIV Pune for common pathogens. One case has been found positive for Leptospirosis.
Samples of water, entomological vectors, and respiratory specimens are under further investigation by NEERI, NIV Pune, and other laboratories.
A multi-disciplinary team comprising experts from NCDC, NIV, ICMR, AIIMS Nagpur, and state health authorities is investigating all possible causes behind the reported cases.
Responding to the reports related to two deaths of children in Rajasthan because of contaminated cough syrup consumption, the Ministry clarified that the product in question does not contain propylene glycol, which can be potential source of contaminants, DEG/EG. Additionally, the product under reference is a dextromethorphan-based formulation, which is not recommended for paediatric use, it added.
DGHS has issued an advisory to all States and Union Territories on rational use of cough syrups in paediatric population.
"It is requested that the all state/UT Health Departments, District Health Authorities, and all Clinical Establishments/healthcare facilities under your jurisdiction should implement and disseminate this advisory across government dispensaries, PHCs, CHCs, district hospitals, and medical institutions," said the advisory.
Cough and cold medicines should not be prescribed to children below 2 years and these are not recommended for children below the age of five. For children above this age, any use should follow careful clinical evaluation with close supervision and strict adherence to appropriate dosing, said the Directorate.
Non-pharmacological measures including adequate hydration, rest, support measures should be the first- line approach.
All healthcare facilities and clinical establishments must ensure procurement and dispensing of products manufactured under Good Manufacturing Practices and formulated with pharmaceutical-grade excipients. Sensitisation of prescribers and dispensers across public and private sectors is essential to uphold these standards of care, it added.
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