Laghu Udyog Bharati (LUB), representing micro, small, and medium pharmaceutical enterprises, has appealed to the government to waive risk-based inspections for companies upgrading their manufacturing facilities. The association emphasized that smaller firms require more time and support to comply with the revised Schedule M of the Drugs and Cosmetics Act, which sets stricter Good Manufacturing Practices (GMP) standards.
LUB expressed concerns that current inspections often feel like sudden raids, creating an intimidating environment for smaller manufacturers. They requested a more collaborative and phased approach, especially for companies with an annual turnover below ₹50 crore.
Highlighting the critical role of MSME pharma units during the COVID-19 pandemic, LUB noted their essential contribution in maintaining uninterrupted medicine supplies despite limited resources. The association urged the government to extend the timeline for Schedule M implementation for smaller firms and focus on helping them upgrade facilities rather than penalizing them.
LUB’s appeal reflects the challenge of enforcing quality standards while supporting India’s diverse pharmaceutical sector, where MSMEs form the backbone of affordable medicine supply. The body called for regulatory flexibility, financial aid, and guidance to ensure these manufacturers can meet compliance without jeopardizing their operations.
