Small Pharma Faces Hurdles in Meeting Revised Schedule M Compliance

Indian small pharma firms are struggling with the complex requirements of the new Schedule M rules, with December 31, 2025, looming near. Harish K Jain, director at Embiotic Labs and president of the Federation of Pharmaceutical Entrepreneurs (FOPE), mentioned the serious problems of the small firms, threatening drug manufacturing closure and loss of affordability.

The revised norms involve comprehensive changes like Pharma Quality Systems (PQS), ALCOA compliance, ongoing inspection of the environment in sterile areas, annual review of product quality, and current control systems. 

Implementation of PQS is done through trained personnel, complex standard operating procedures (SOPs), and advanced machinery like Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP). Apart from that, the implementation of computerized systems with audit trails requires expensive GxP-compliant software that most small firms cannot manage or maintain because of weak IT infrastructure and expertise.

Also Read: Indian Pharma Charts Clear Path to Meet Revised Schedule M Rules

Whereas the larger pharmaceutical firms have tended to make the change, less than 15% of small firms have submitted upgrade plans. The common facility modifications involve the addition of high-technology HVAC systems, microbiology laboratories, and computerized monitoring equipment, involving high CAPEX and OPEX. Lack of capital also stifles these problems, with banks unwilling to extend loans to already slim-margin-operating small firms.

Jain warned that additional price controls by the National Pharmaceutical Pricing Authority (NPPA) would put such companies' survival at risk and drive most of them out of business. Apart from infrastructure, the new regulations entail end-to-end change in systems, processes, and skill sets of people, which would not only render compliance a regulatory necessity but a matter of survival for small pharma firms.