The Directorate General of Health Services on Wednesday issued a directive to states and Union Territories, urging stricter testing of pharmaceutical products following the deaths of more than 20 children linked to the consumption of contaminated cough syrup, India Today reported.

The department, which reports to the Union health ministry, said that manufacturers must comply with the drug control rules, which require thorough batch testing of raw materials and finished products, and sourcing ingredients only from approved vendors.

The health authority also asked drug controllers to ensure they inspect pharmaceutical manufacturing facilities and verify compliance to norms, India Today reported.

The Supreme Court on Friday agreed to hear a public interest litigation seeking an inquiry and systemic reform in drug safety mechanisms following the deaths caused by the consumption of contaminated cough syrups, PTI reported.

The plea also seeks that all pending first information reports and investigations in the matter be transferred to the Central Bureau of Investigation.

At least 20 children have died in Madhya Pradesh over the past month allegedly after consuming contaminated cough syrup. After suffering from fever and cold, the children had consumed Coldrif syrup, resulting in vomiting and difficulty in urinating. The first death was reported on September 2. Deaths have also been reported in Rajasthan.

The syrup is manufactured by Sresan Pharmaceuticals, a pharmaceutical company in Tamil Nadu’s Kancheepuram district.

The formulation has now been banned in eight states and Union Territories – Himachal Pradesh, Karnataka, Kerala, Madhya Pradesh, Puducherry, Punjab, Tamil Nadu and Uttar Pradesh.

The Tamil Nadu director of drug control found on October 2 that Coldrif samples were not of standard quality. Three days later, Madhya Pradesh also reported that one sample of Coldrif had 48.6% of diethylene glycol in it.

The permissible limit of diethylene glycol as an impurity is 0.1%. However, drug officials Scroll spoke to said that the chemical is unsafe even in trace amounts and should ideally be completely absent from an ingestible syrup. Its presence is a serious quality compliance issue, the officials said.

On Monday, the Madhya Pradesh drug controller found two more cough and cold syrups – Relife syrup and Respifresh TR – contaminated with diethylene glycol, and labelled them as “not of standard quality”.

On October 3, the Directorate General of Health Services had issued an advisory to all states and Union Territories, reiterating the “judicious prescribing and dispensing” of cough syrups for children.

The department had said that most “acute cough illnesses in children are self-limiting and resolve without pharmacological intervention”, adding that cough and cold medications should not be prescribed for children under two years.

WHO flags ‘regulatory gap’

The World Health Organization said it was concerned about India’s “regulatory gap” in screening syrup medicines, Reuters reported on Thursday.

“WHO expresses deep concern over these developments and emphasises…the regulatory gap in DEG/EG [diethylene glycol/ethylene glycol] screening for domestically marketed medicines in India,” a WHO spokesperson told Reuters.

The WHO has said that the need to issue a Global Medical Products Alert on the Coldrif syrup will be investigated after receiving a reply from Indian health authorities.

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