India’s small pharma firms warn of GMP deadline fallout

India’s micro, small and medium-sized drugmakers are pushing back against tougher manufacturing rules, warning they could drive closures and shortages. The revised Schedule M good manufacturing practice standards and new bioequivalence requirements, due January 2026, are seen as too costly for smaller operators.

Industry groups have appealed for an extension to April 2027, noting that compliance costs for bioequivalence studies alone can reach $3,000–6,000 per product. Additional mandates - QR codes for cancer medicines, updated gene therapy rules, and harsher penalties - are piling on financial stress, particularly for firms already running on thin margins.

Reviewing the changes, industry analyst GlobalData notes the potential for consolidation and supply gaps in critical generics, including oncology and cardiovascular medicines. The concerns come as India’s pharmaceutical market, worth $50 billion in 2024, depends heavily on small-scale manufacturers for affordable treatments both at home and abroad.