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The central government has issued an advisory on the “judicious” use of cough syrups – a development that comes days after the consumption of the medicine allegedly killed children in Madhya Pradesh and Rajasthan.
In its circular, the Directorate General of Health Services (DGHS) said cough syrups were not recommended for children below 5 years of age and that most acute cough illnesses in children “are self-limiting and often resolve without pharmacological intervention”.
“This advisory reiterates the judicious prescribing and dispensing of cough syrups for children,” it said. “Cough and cold medications should not be prescribed or dispensed to children under 2 years. These are generally not recommended for ages below 5 years and above that, any use should follow careful clinical evaluation with close supervision and strict adherence to appropriate dosing, the shortest effective duration and avoiding multiple drugs combinations. Further, the public may also be sensitized regarding adherence to prescription by the doctors,” it said.
It further said that non-pharmacological measures, “including adequate hydration, rest, supportive 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 said.
It goes to say: “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”.
The death of two children — Samrat Jatav, 2, from Bharatpur on September 22 and Nityansh Sharma, 5, from Sikar on September 28 — from allegedly consuming Dextromethorphan Hydrobromide Syrup IP 13.5 mg/5 ml has sparked a row, prompting the government to order a probe.
Dextromethorphan (DXM) is a common over-the-counter cough suppressant whose side effects include drowsiness, dizziness, nausea, vomiting, diarrhoea, stomach pain, agitation and confusion. It is generally not recommended for very young children.
This particular cough syrup — Dextromethorphan Hydrobromide Syrup IP 13.5 mg/5 ml – was manufactured by a Jaipur-based company.
As pressure mounts, the state’s health department refuted allegations of the children’s families that the cough syrup was prescribed at government hospitals. In its statement Thursday, the department said that the medicine is typically not to be prescribed by doctors and isn’t recommended for children under the state’s protocol, and alleged that parents administered the medicine “without consulting doctors”.
The government has also instituted a three-member probe panel and suspended the sale of the medicines, sending samples of the cough medicine for testing. A doctor and a pharmacist have been suspended at a primary health centre in Bharatpur, where one of the deaths was reported.
In Madhya Pradesh, nine children have died after the cough syrups allegedly led to kidney ailments in them.
A joint team comprising representatives from the National Centre for Disease Control (NCDC), National Institute of Virology (NIV), Central Drugs Standard Control Organisation (CDSCO), among others, visited the site in Madhya Pradesh to collect samples of various cough syrups, the health ministry said earlier in the day.
It noted none of the tested syrup samples contained Diethylene Glycol (DEG) or Ethylene Glycol (EG) — contaminants that are known to cause serious kidney injury.
“According to 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 ministry said.
The Madhya Pradesh State Food and Drug Administration (SFDA) also tested three samples and confirmed the absence of DEG/EG, it added.
On reports of the deaths in Rajasthan, the ministry clarified that the cough syrup does not contain Propylene Glycol — a possible source of DEG/EG contamination, it said.
Additionally, the product under reference is a Dextromethorphan-based formulation, which is not recommended for paediatric use, it said.
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