Centre refuses deadline extension for pharma firms after Coldrif deaths

The Central government has turned down requests from drug manufacturers to extend the year-end deadline for upgrading their production facilities to meet international standards, Reuters reported.

The development follows public outrage after at least 24 children died from consuming locally made cough syrup, Coldrif.

Centre mandates compliance with WHO norms

In late 2023, the Centre ordered pharmaceutical companies to ensure that their plants meet standards recommended by the World Health Organization (WHO). The move required companies to opt for stricter safety protocols to stop cross-contamination and conduct batch testing of samples, among other quality-control measures.

The mandate from the Central government came after international scrutiny after Indian-made cough syrups were linked following the deaths of more than 140 children in Africa and Central Asia, severely impacting India's reputation as the "pharmacy of the world".

The report suggests that while major pharmaceutical companies agreed to the mandate and met the June 2024 deadline, smaller companies were granted a reprieve for 12 months to meet their separate December 2024 target. However, some members of the Indian pharmaceutical sector have still been seeking further extensions, warning that the high cost of upgrades could push many of these smaller businesses into bankruptcy.

Centre denies more time to drug manufacturers for upgrading facilities

The report suggests that the Centre's decision to turn down requests from drug manufacturers for more time came after it was highlighted that Sresan Pharmaceutical Manufacturer, the company that produced Coldrif, did not upgrade its facilities based on a government order.

The decision to deny the requests was taken in October after tests revealed a high level of toxicity in some Coldrif syrup. Drugmakers were informed of the decision at a conference on Thursday, the report added, citing sources.

Further, once all the facilities are upgraded, the government aims to phase out an order passed in 2023 for additional testing of cough syrups at government-designated laboratories before export.

Industrial chemical found in Coldrif

Earlier in October, a government laboratory in Madhya Pradesh's Bhopal found that the Coldrif syrup contained 46.28 per cent of diethylene glycol (DEG), an industrial chemical, primarily used in making brake fluids, antifreeze, paints, and plastics. The concentration of DEG in the Coldrif syrup was much higher than the permissible limit, a report in The Economic Times showed.

Coldrif incident

Nearly 24 children have died after being prescribed the Coldrif syrup to treat their cough in Madhya Pradesh. Following the deaths, several states banned the sale of the syrup. A nationwide alert was issued, and on October 3, the health ministry directed all states and union territories to ensure that cough and cold medications are not prescribed to children under two years of age.

On October 7, a plea was filed in the Supreme Court, seeking a judicial inquiry into the deaths and calling for urgent reforms in the nation's drug regulation system, which includes nationwide testing of syrup for toxins.