NEW DELHI: In a move to bolster pharmaceutical manufacturing standards across India, the Central Drugs Standard Control Organisation (CDSCO) has instructed state drug regulators to ensure rigorous compliance with the updated Schedule M guidelines, emphasizing prompt inspections and monthly reporting.
The directive, issued yesterday on November 7, comes in the wake of recent incidents highlighting drug quality issues, including the tragic deaths of 20 individuals linked to the contaminated Coldrif syrup. Schedule M, which details Good Manufacturing Practices (GMP) for pharmaceutical products, was revised and notified in January 2022. It includes critical requirements such as establishing efficient product recall systems for defective medicines to safeguard public health.
Under the new mandate, state regulators are required to inspect manufacturing units that have sought extensions for compliance. Large units with annual turnover exceeding Rs 250 crore were originally mandated to comply by July 1, 2023, while micro, small, and medium enterprises (MSMEs) had until January 1, 2024.Following appeals from MSMEs for additional time, the deadline was extended to December 31, 2024.
State authorities must now verify adherence during these inspections and take stringent action against any non-compliant facilities under the Drugs and Cosmetics Act and its rules. Additionally, they are obligated to submit detailed monthly reports to the CDSCO, covering inspections conducted, observations noted, and subsequent actions taken. “This may be treated as top priority and compliance is required to be ensured strictly,” the regulator stated in its notice.
Industry experts view this as a critical step toward enhancing drug safety and quality control in India, especially given the country’s significant role in global pharmaceutical exports. The CDSCO’s emphasis on accountability aims to prevent future lapses and restore confidence in the sector.
