Daijiworld Media Network - New Delhi

New Delhi, Nov 8: The Central Drugs Standard Control Organisation (CDSCO) has ordered state drug controllers to conduct thorough inspections of all pharmaceutical manufacturing units to ensure compliance with international good manufacturing practices (GMP) by January 1, 2026.

In a directive issued on November 7, Drug Controller General of India (DCGI) Rajeev Raghuvanshi instructed state and Union Territory regulators to submit monthly reports detailing their inspection findings and follow-up actions. “In case any manufacturing unit is found non-complying with the requirements of revised Schedule M during inspections, strict action shall be initiated,” the letter stated.

The revised Schedule M norms, introduced in 2023, align India’s pharmaceutical manufacturing standards with global benchmarks. Large firms were required to comply by June 2024, while micro, small, and medium enterprises (MSMEs) — with annual turnovers below Rs 250 crore — were granted an extension until December 2025.

The new order signals the end of that grace period, despite repeated requests from smaller firms for more time to meet costly compliance upgrades. The CDSCO move follows growing scrutiny of India’s pharmaceutical industry after toxic cough syrup from a Chennai-based manufacturer was linked to child deaths in Madhya Pradesh in September.

The Health Ministry had earlier instructed all drugmakers to adopt World Health Organisation (WHO)-recommended protocols, including stricter contamination controls and batch testing requirements.

With the latest directive, all state authorities are now required to plan and carry out inspections of units that have applied for the compliance extension, ensuring that every factory meets the upgraded safety and quality standards by the January 2026 deadline.