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Schedule M Enforcement Reveals Major Quality Gaps in Himachal’s Pharma Sector; Only 11 % Fully GMP Compliant
Inspections carried out after the deadline for compliance ended have shown that out of roughly 90 units assessed, just 10 manufacturers were found to adhere completely to the new system-based GMP standards. The remaining manufacturers received notices citing significant deficiencies that require urgent corrective action.
- By Newsdesk
- New Delhi
- Jan 18, 2026
A rigorous crackdown on pharmaceutical manufacturing in Himachal Pradesh has exposed deep compliance shortfalls in the industry, with only about one in ten units fully meeting the revised Good Manufacturing Practices (GMP) under the updated Schedule M of the Drugs and Cosmetics Rules.
Inspections carried out after the deadline for compliance ended have shown that out of roughly 90 units assessed, just 10 manufacturers were found to adhere completely to the new system-based GMP standards. The remaining manufacturers received notices citing significant deficiencies that require urgent corrective action.
The revised Schedule M, introduced to align domestic drug production with global benchmarks, imposes more stringent expectations on infrastructure, controlled environments, documentation, equipment validation, quality risk management, and assurance systems. These changes mark a shift from the earlier checklist-oriented framework to a more comprehensive quality management regime.
Regulators have warned that units unable to rectify the identified lapses could face severe consequences, including suspension or cancellation of licenses, or forced shutdowns. According to officials, nearly 370 micro, small and medium enterprises (MSMEs) across the state are now under scrutiny amid the compliance drive, but many are struggling with the financial and technical burden of upgrading their operations.
Industry representatives acknowledge the challenges, particularly for smaller players operating on thin margins. Modernizing facilities, strengthening quality systems, and training staff to meet the enhanced regulatory expectations require substantial investment. However, authorities have stressed they will not relax standards, affirming that patient safety and drug quality remain paramount.
Experts note that the enforcement has exposed structural weaknesses in Himachal Pradesh’s pharmaceutical ecosystem, especially among smaller firms that delayed upgradation efforts even after extensions were granted for compliance.
As inspections continue, the state’s drug control administration is intensifying oversight to ensure that medicines manufactured within its borders meet the rigorous quality and safety standards mandated under the revised Schedule M framework.