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Even as MSMEs are struggling to meet and comply with revised Schedule M deadline of December 31, 2025, pharma exporters are planning to strengthen supply chain independence through market diversification and innovation driven growth.
The revised Schedule M aligns India's manufacturing standards with global norms, such as those from the World Health Organisation (WHO), to ensure the quality and safety of pharmaceutical products.
“Exporters may have to look for registration to new sites or re-register new products in the existing sites to keep their supply chains active in the export markets. The need for such diversification is that many domestic manufacturing units may face closure for non-compliance to revised Schedule M deadline. This has further been necessitated amidst global headwinds of geopolitical volatility, shifting trade priorities and the recent US Tariffs on branded generics,” according to an industry expert.
“Indian companies can also adopt localized manufacturing strategies and leverage their expertise in complex drug segments to navigate the disruption,” an expert adds.
The deadline for Pharma MSMEs to comply with the revised Schedule M (Good Manufacturing Practices) is December 31, 2025. This extension was granted by the Union ministry of health, with the condition that small and medium manufacturers applied for the extension with an upgrade plan by May 11, 2025, to the Central Drugs Standard Control Organisation (CDSCO).
Originally mandated in December 2023, the revised guidelines required units with turnovers above Rs. 250 crore to comply within six months, while those below the threshold had a one-year timeline.
The Union ministry of health had extended the deadline through a draft notification on January 4, 2025, enabling small and medium manufacturers with turnovers below Rs. 250 crore to seek timeline extensions. The extension allows smaller manufacturers additional time to upgrade facilities and align with global quality standards.
Manufacturers who met the initial deadline for large companies (June 28, 2024) have already transitioned. This extension provides a one-year grace period for MSMEs to upgrade their facilities, with the understanding that they have submitted an upgrade plan.
Key provisions of revised Schedule M guidelines include modernized facilities to prevent contamination and improve cleanliness, validated equipment towards stringent maintenance of production equipment, environmental controls towards adherence to global standards for air, water, and waste management, Pharmaceutical Quality Systems (PQS): robust systems to guarantee consistent quality, Product Quality Reviews (PQR), which are regular evaluations to ensure ongoing compliance.
“There are challenges to comply with Revised Schedule M guidelines, especially for MSMEs, which have limited resources. Many require financial assistance and technical support to upgrade their operations. Collaborative initiatives by regulators, industry bodies, and the government are crucial to bridge these gaps,” an expert concludes.
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