India's Tough Stand on Pharma Standards: No More Time for Compliance

In a decisive move, India's drug regulator has mandated that all pharmaceutical manufacturers adhere to international manufacturing standards by January, rebuffing industry requests for further extensions. This action follows the tragic deaths of children linked to toxic cough syrup since September.

The government initially instructed drug producers to upgrade their facilities to World Health Organization standards late in 2023, a measure aimed at preventing cross-contamination and enabling batch testing. The urgency intensified after India-made cough syrups were associated with the deaths of over 140 children overseas, significantly impacting India's image as the "pharmacy of the world."

While larger pharmaceutical companies met the June 2024 deadline, smaller manufacturers were allowed until December 2025. The Central Drugs Standard Control Organisation emphasized strict enforcement starting January 1, with potential shutdowns for non-compliance, despite warnings from small- and medium-sized drugmakers about job losses and increased medicine prices.