The government has extended the deadline for MSME pharma units to comply with revised GMP standards until December 31, 2025, granting them a one-year breather. These companies must submit an upgrade plan within three months, with audits ensuring compliance.

The Union Health Ministry has extended the deadline for small and medium-sized pharmaceutical companies to comply with the revised Schedule M standards, granting them time until December 31, 2025. The extension applies to around 8,500 MSME pharma units with an annual turnover of less than ₹250 crore. 

India, a key medicine exporter to low- and middle-income countries, revised its Good Manufacturing Practices (GMP) in December 2023 to align with WHO standards. Large pharma firms had a six-month compliance window, while MSMEs were initially given a year. 

Industry associations had sought a two-year extension, citing financial and infrastructure challenges. The extension requires MSMEs to submit an upgrade plan within three months, with audits ensuring compliance.

(Source:https://www.business-standard.com/health/small-pharma-companies-get-1-year-breather-to-implement-schedule-m-125021201111_1.html )