Union Health Ministry has advised that cough and cold medications should not be prescribed or dispensed to children below two years.
In an advisory, the Ministry said, these are generally not recommended for children below five years, and above that, any use should follow careful clinical evaluation with close supervision.
The Ministry has written a letter to the Director of Health Services of all States and Union Territories in this regard. The advisory has been issued in view of child deaths in Madhya Pradesh and Rajasthan that were linked to the consumption of cough syrups.
Union Health Ministry has said that the multidisciplinary team is continuing its analysis of samples and other factors to ascertain the cause of deaths reported in Chhindwara in Madhya Pradesh.
Meanwhile, Rajasthan government has suspended Drug Controller Rajaram Sharma and halted the distribution of all 19 medicines supplied by Kayson Pharma.
The action was taken after two children died and several fell ill allegedly due to the consumption of cough syrups distributed under the Chief Minister’s Free Medicine Scheme.
According to Rajasthan Medical Services Corporation Limited, 10 thousand 119 samples of Kayson Pharma’s medicines have been tested since 2012, with 42 found to be substandard. Chief Minister Bhajan Lal Sharma has ordered a detailed investigation into the issue.
Meanwhile, the Madhya Pradesh government has banned the sale of Coldrif syrup following the death of nine children due to suspected kidney infection in Chhindwara district.
In a social media post, Chief Minister Mohan Yadav said, the deaths of children in Chhindwara due to Coldrif syrup are extremely tragic.
The syrup was manufactured at a factory in Kanchipuram. Following the incident, the state government requested that the Tamil Nadu government conduct an inquiry.
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.