In the wake of multiple child fatalities linked to contaminated cough syrup, India has refused to extend deadlines for pharmaceutical companies to upgrade their facilities to WHO standards enforcing stricter compliance nationwide.
Glimpse:
Following lab findings that Coldrif syrup contained extremely high levels of diethylene glycol (DEG), the government declined pleas from smaller drug firms for more time to upgrade. Over 10,000 factories face pressure; the implicated manufacturer has had its license revoked and its owner arrested.
In what appears to be a turning point in Indiaโs pharmaceutical oversight, the central government has taken a hardline stance by denying extensions to drug manufacturers to upgrade their production units to meet WHO Good Manufacturing Practice (GMP) norms. The decision comes after investigations tied the Coldrif syrup produced by Sresan Pharma to the deaths of at least 24 children, revealing DEG contamination nearly 500 times the permissible limit.
Smaller manufacturers had petitioned for more time, citing financial burden and logistical constraints. However, regulators emphasized that in matters of public health, safety cannot be postponed. The license of Sresan Pharma has been revoked, and its founder arrested, as authorities inspect supply chains, halt production, and initiate recalls. Indiaโs pharmaceutical sector now faces increased scrutiny, with regulators signaling zero tolerance for violations.
โWhen lives hang in the balance, compliance cannot wait.โ
By
HB Team
