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Small pharma cos struggle with revised Schedule M compliance amid resource & expertise gaps: Harish Jain
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Nandita Vijayasimha, Bengaluru
July 11 , 2025
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Small pharma companies are unprepared for the revised Schedule M even as the deadline for its implementation December 31, 2025 looms large.
From Pharma Quality Systems (PQS) to ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) compliance, environmental monitoring in sterile areas, real time continuous particulate monitoring, annual product quality review and change in control systems, to name a few, are all hanging like a Damocles sword, said Harish K Jai, president Federation of Pharmaceutical Entrepreneurs (FOPE) and director, Embiotic Labs.
For instance, setting up a PQS means changing the entire company works. This needs trained staff, standard operating procedures (SOPs), regular reviews, tools like FMEA (Failure Mode and Effects Analysis) and HACCP. Even the computerised systems with audit trails are tough and nearly impossible as it requires special, expensive GxP compliant software. There is need for validation, secure access and regular backups. The stark reality is that small pharma companies often lack the IT setup or experts, he added.
The December 31, 2025 deadline is absolutely real and non-negotiable. While larger firms have largely adapted, small pharma companies are woefully behind, with only about 15? per cent having submitted upgrade plans. Without immediate, coordinated efforts, a wave of shutdowns looms, threatening not just the small pharma themselves but also drug supply and affordability in India, Jain told Pharmabiz.
From an infrastructure standpoint, the implementation of the revised Schedule M regulations necessitates major changes in facility layout. These include requirement of air quality monitoring tools, microbiology lab, trained staff for annual product quality reviews and digital systems.
These changes, in turn, demand significant investments in HVAC systems, capital expenditure (CAPEX), and comprehensive planning. For many small to mid-sized pharmaceutical manufacturers, this creates a scenario akin to being caught between the devil and the deep sea.
Access to capital remains constrained. The cost of upgrading facilities to meet regulatory expectations often surpasses internal cash reserves, and external funding is not easily accessible—particularly given the reluctance of financial institutions to extend additional collateral-based loans to companies already operating on thin margins, he pointed out.
Even as the revised Schedule M ensures product quality, it will inevitably lead to both CAPEX and OPEX escalation. For smaller players, the question is no longer just about compliance but about survival. The capacity to recover such investments is severely limited, especially in a price-controlled environment, noted Jain.
If the National Pharmaceutical Pricing Authority (NPPA) imposes further price caps or delays justifiable price increases, it could spell existential risk for these enterprises. In such a context, continued operations may no longer be financially viable, accelerating market exits and threatening the very objective of maintaining medicine availability across geographies.
Beyond infrastructure and capital constraints, small pharmaceutical companies often lack the in-house expertise and operational capacity required to implement the revised Schedule M norms. Compliance today is no longer limited to facility upgrades—it demands a holistic transformation in systems, people, and processes, said Jain.
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TOPICS
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