Don't prescribe cough, cold syrups to children below 2 yrs: K'taka govt to healthcare institutions

Bengaluru, Oct 6 (PTI) The Karnataka Health Department on Monday issued an advisory to healthcare institutions in the state not to prescribe or dispense cough and cold syrups to children below the age of two, following incidents of child deaths due to consumption of syrups in Madhya Pradesh and Rajasthan.

The department has also cautioned all health authorities, medical institutions and centres, stockists, distributors and retailers against the purchase and sale of specified cough syrup that has led to child deaths.

In a circular dated October 5, the Food Safety and Drugs Administration (FSDA) said that in view of recent incidents where deaths have been reported in Madhya Pradesh following the consumption of Coldrif Syrup (Batch No. SR-13), manufactured by a Tamil Nadu-based pharma unit, the Tamil Nadu Drugs Control Department has prohibited the purchase, sale and consumption of the said batch in that state.

Further, a few deaths of children have been reported in Rajasthan due to the consumption of Dextromethorphan Hydrobromide Syrup IP, manufactured by Kaysons Pharma, Jaipur, it stated.

"All District Health Authorities, Medical Institutions, Government Hospitals, Primary Health Centres (PHCs), Community Health Centres (CHCs) and all concerned stockists/distributors/retailers are hereby, cautioned against the purchase and sale of these cough syrups in the state of Karnataka and recall these drugs, if any, under intimation to concerned jurisdictional Assistant Drugs Controller Office for further necessary action," it added.

In view of the child deaths linked to consumption of certain cough syrups in other states, the Karnataka government has also directed all enforcement officers to maintain strict vigil.

Chief Minister Siddaramaiah on Monday instructed the health department to look into the issue.

Following the incident, Health Minister Dinesh Gundu Rao said that an alert had been sounded in the state and urged parents to be cautious while giving any syrup to children below the age of five.

He clarified that the "substandard" cough syrup linked to the deaths of children in other states have not been supplied in Karnataka. Hence, no such incident has occurred here, he said.

"We have already instructed officials to check whether any of these products were sold in Karnataka and so far as per our knowledge, none of this has come to the state," Rao told reporters in Hassan.

According to him, as a precautionary measure, samples of all brands of cough syrup are being collected and tested. The state's drug control department has already taken preventive steps and remains vigilant.

In the advisory, the health department said that cough and cold syrups should not be prescribed or dispensed to children below two years of age. For children between two and five years, such medications should generally be avoided unless clearly indicated and prescribed after proper clinical evaluation.

These instructions have been issued for strict compliance across all government and private healthcare institutions in the state, it said.

According to the advisory, for older children, cough syrups, if required, must be used only after thorough clinical assessment in the lowest effective dose and for the shortest duration possible.

"Also, multi-drug combinations (irrational combinations, oral bronchodilators, cough suppressants) should be avoided," it said.

The advisory further stated that all healthcare providers should adhere to the Standard Treatment Protocols and Therapeutic Guidelines issued by the Ministry of Health and Family Welfare, as well as the Integrated Management of Neonatal and Childhood Illness (IMNCI) guidelines for managing cough and respiratory symptoms in children.

It also suggested that non-pharmacological measures such as adequate hydration, rest, supportive care and a nutritious diet should be encouraged.

All healthcare facilities have been asked to ensure procurement of products only from Good Manufacturing Practice (GMP)-compliant licensed manufacturers.

District and taluk health authorities have been directed to ensure wide dissemination of the advisory among paediatricians, general practitioners, pharmacists, nursing staff and health institutions under their jurisdiction.

The department also warned that random inspections may be conducted to ensure compliance with the issued instructions.

The advisory further stated that any adverse events or suspected cases of cough syrup-related toxicity or death, as well as any unusual or unexplained increase in the incidence of cough among children or within the community, must be promptly investigated and reported on the Integrated Health Information Platform (IHIP) portal under the Integrated Disease Surveillance Programme (IDSP) of the Directorate of Health and Family Welfare.

"Violations of these instructions, including irrational prescriptions, over-the-counter sale, or use of unapproved fixed-dose combinations, will attract statutory action under the Karnataka Private Medical Establishments (KPME) Act, 2007, as well as the Drugs and Cosmetics Act, 1940 and Rules, 1945," it added. PTI AMP KH