Inspections conducted after the end of the compliance deadline revealed that just 10 out of around 90 drug manufacturing units were found fully compliant, while notices were issued to nearly 80 units for deficiencies requiring immediate corrective action.
The revised Schedule M, which came into force after the expiry of the transition period, mandates stricter and more system-driven GMP requirements. These include upgraded infrastructure, controlled manufacturing environments, robust documentation systems, validation of processes and equipment, quality risk management, and enhanced quality assurance mechanisms. The aim of the revised norms is to align Indian pharmaceutical manufacturing practices more closely with global standards and ensure consistent drug quality and patient safety.
Drug control officials have warned that units failing to address the shortcomings highlighted during inspections may face stringent regulatory action, including suspension or cancellation of manufacturing licenses and possible closure. The enforcement drive has brought nearly 370 micro, small and medium pharmaceutical manufacturing units under scrutiny across the state, many of which are struggling to upgrade facilities due to financial and technical constraints.
Industry stakeholders have acknowledged that compliance with the revised Schedule M poses significant challenges, particularly for smaller manufacturers operating on thin margins. Many units require substantial capital investment to modernize infrastructure, improve quality systems, and train personnel to meet the enhanced regulatory expectations. However, regulators have maintained that there will be no dilution of standards, stressing that patient safety and drug quality cannot be compromised.
Officials have also pointed out that the revised Schedule M represents a shift from basic, checklist-based compliance to a comprehensive, system-oriented approach to manufacturing quality. This includes continuous monitoring, lifecycle management of processes, and accountability at multiple levels within manufacturing units.
According to a recent media report in The Tribune, the enforcement of Schedule M in Himachal Pradesh has laid bare long-standing structural weaknesses in the pharma manufacturing ecosystem, particularly among smaller units that have delayed compliance upgrades.
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