India’s revised Schedule M regulations are gradually reshaping the country’s pharmaceutical manufacturing ecosystem. Industry officials caution that while the reforms are expected to improve quality standards and global credibility, they could also lead to consolidation among thousands of small- and medium-sized drug manufacturers that may find it challenging to comply with the new requirements.
The common concern across the industry is that compliance is no longer limited to installing new equipment or upgrading facilities. It now requires sustained investment in quality systems, documentation, data integrity, skilled manpower, and continuous audits, significantly increasing the cost of doing business.
