New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a strict directive to state drug controllers, setting January 1, 2026, as the deadline for all pharmaceutical units to comply with international manufacturing standards. This move ensures that pharma firms meet global norms and aligns India’s pharmaceutical industry with World Health Organisation (WHO) guidelines.
Drug Controller General of India (DCGI) Rajeev Raghuvanshi has asked states and union territories to carry out inspections at all manufacturing facilities and submit monthly reports detailing compliance observations and corrective actions. The directive warns that units failing to adhere to revised Schedule M standards will face stringent action.
The revised Schedule M, updated in 2023, sets India’s good manufacturing practices in line with global standards, including measures to prevent cross-contamination and enable batch testing of medicines. Large pharmaceutical companies met an earlier June 2024 deadline, while micro, small, and medium-sized units received an extension until December 2025. However, the new directive ends the grace period, reinforcing the government’s push for stricter compliance.
The urgency comes in the wake of incidents such as the toxic cough syrup case in Chennai, which resulted in child deaths in Madhya Pradesh, highlighting the critical need for quality assurance. Industry groups had requested further extensions, citing compliance costs, but the regulator emphasized that ensuring safety and global-standard production is non-negotiable.
With this move, the government aims to ensure that Indian medicines are not only safe for domestic consumers but also maintain credibility in the global market. The CDSCO directive underscores the importance of timely action to help pharma firms meet global norms and safeguard public health.
–IANS
