Small Pharma Firms Under Threat as Regulator Tightens Quality Norms

India’s pharmaceutical sector is facing a wave of uncertainty as the national regulator intensifies quality inspections across manufacturing plants. Industry experts warn that thousands of small and medium-sized pharmaceutical companies may struggle to survive under the newly strengthened requirements of Schedule M, the country’s framework for good manufacturing practices.

The Central Drugs Standard Control Organisation (CDSCO) has directed state authorities to carry out comprehensive audits of manufacturing facilities, demanding strict compliance with updated standards. For many smaller firms, these upgrades represent a substantial financial burden, threatening their ability to continue operations.

Trade associations fear that widespread closures could lead to serious economic and employment consequences. They argue that regulators should adopt a more supportive approach, including incentives or phased implementation plans to help these firms modernize instead of shutting down.

Larger pharmaceutical companies have already been required to comply, while smaller firms must meet standards by the end of the year. Some are attempting to conduct internal assessments and request more time, but the future remains uncertain for many in this segment.