Schedule-M Compliance Deadline For Pharma MSMEs Extended To 31 Dec, 2025

New Delhi, Feb 13 (KNN) The Union Health Ministry has extended the deadline for small and medium-sized pharmaceutical companies to comply with revised Schedule M standards, granting them until December 31, 2025, to meet the new quality and manufacturing requirements. 

This extension applies specifically to pharmaceutical units with annual turnover below Rs 250 crore, affecting approximately 8,500 companies in the MSME category.

The revised Schedule M standards, introduced in December 2023, aim to align Indian pharmaceutical manufacturing practices with global standards, particularly those of the World Health Organisation (WHO). 

While larger pharmaceutical companies with annual turnover exceeding Rs 250 crore were given a six-month compliance window, MSME units initially received a twelve-month period. 

Industry associations, including the Federation of Healthcare Professionals and Laghu Udyog Bharati, had originally requested an extension until December 2026, citing challenges in financing new machinery and training personnel.

The significance of this compliance is particularly relevant given India's position as a major medicine supplier to low and middle-income countries (LMICs), which require WHO Good Manufacturing Practice (GMP) certification. 

Currently, only about 2,000 units in the MSME category possess this certification, highlighting the substantial upgrade requirements facing the sector.

The extension comes with specific conditions, as outlined in the ministry's formal notification amending the Drugs Rules, 1945. 

Small pharmaceutical companies must submit an online application to the Central Licensing Approval Authority within three months of the notification's publication, including a detailed plan for facility upgradation. 

The ministry has emphasised that these facilities will undergo audits after the three-month period, with potential consequences for companies failing to implement their committed upgrades.

Industry experts note that this extension affects the majority of India's pharmaceutical manufacturing sector, as approximately 8,500 of the country's 10,500 pharmaceutical units operate within the MSME category. 

The new timeline establishes January 1, 2026, as the unified date for all pharmaceutical units in India to conform to the revised Schedule M standards, marking a significant milestone in the country's pharmaceutical manufacturing quality standards.

(KNN Bureau)