The Central Drugs Standard Control Organisation (CDSCO), in collaboration with state drug authorities, is scrutinising various drug manufacturing units in New Delhi. They have conducted risk-based inspections on more than twenty-five units located in Baddi, Himachal Pradesh, and Punjab. Following the inspections, show cause notices have been issued to multiple units, some of which have been instructed to cease production. A significant portion of these units falls under the classification of micro, small, and medium enterprises (MSMEs).
Inspections have revealed a troubling trend: the proportion of non-standard quality medicines manufactured by MSMEs is seven times higher than the national average. Out of the 271 samples analysed last year, forty-one were found to be substandard. Moreover, around thirty percent of MSME units inspected until last year were directed to halt production, indicating a clear correlation between non-standard quality and MSMEs.
Recognizing the gravity of the situation, the CDSCO has stressed the importance of reviewing manufacturing practices and quality management systems within pharmaceutical companies. In response, the health ministry has issued a revised Schedule M for pharmaceutical companies aimed at enhancing drug quality.
Companies with a turnover exceeding ₹250 crore must implement the revised Good Manufacturing Practices (GMP) within six months, while those with a turnover below ₹250 crore have been granted a year to comply. As reported by The Economic times, failure to meet these deadlines may result in penalties. Originally included in Schedule M of the Drugs and Cosmetics Rules, 1945, the GMP system was introduced in 1988.
