India’s cleanroom sector is entering a pivotal phase, with new and existing players making decisive moves for market share that are reshaping the competitive landscape.
This is also set against the backdrop of a maturing compliance system. India’s Ministry of Health and Family Welfare (MoHFW) notified the world in January this year that it would be revising guidance under Schedule M, which is its Drugs and Cosmetics Rules.
The confluence of these forces, alongside the demand increase across pharma, semiconductors, data centres, and specialised manufacturing, suggests India could evolve from a cleanroom end-user into a hub for cleanroom technology and innovation.
Standards and inspection changes
Schedule M prescribes the good manufacturing practices (GMP) for pharmaceutical products and their production. Some of the major changes introduced in the revised Schedule M include the introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, and computerised storage systems for all drug products.
Following this, in June, the country’s Drugs Consultative Committee (DCC) met and decided it would also change the microbial contamination limits in drug production to be in line with global WHO limits.
Currently, the limits prescribed in Schedule M (specifically Table II, Paragraph B, Part XIID) are less strict than those in WHO TRS 1044 Annex 2. This discrepancy has historically created a regulatory gap. Indian manufacturers targeting regulated markets faced difficulties meeting stricter external standards, and cleanroom validation/monitoring regimes sometimes diverged from the global best practice.
The US FDA’s expansion of unannounced and more frequent inspections of foreign drug‐manufacturing sites in May is also putting Indian generics producers under intensified regulatory pressure.
Indian firms, many of which depend heavily on US exports for income, are seeing higher compliance costs, stricter oversight, and risk of delayed or blocked market access when facilities fail inspections. For example, Sun Pharma announced in September that it’s Halol plant had been classified “Official Action Indicated,” triggering import alerts that restrict US shipments until compliance is restored.
These developments are forcing manufacturers to invest in quality systems, upgrade infrastructure, and maintain continuous audit readiness—raising costs, but also potentially strengthening trust and competitiveness
Both of these developments are causing a shift that could act as a powerful demand accelerator for advanced cleanroom systems. Such as better filtration, monitoring systems, and more precise validation/automation tools. Domestic cleanroom firms, as well as international suppliers, are likely to see increased opportunity as clients seek to upgrade or retrofit existing facilities to meet the new standards.
The competitive landscape
In the shadow of these regulatory developments, there have been a couple of major moves from players in the cleanroom services sector in the last year.
Avanteclad Modular Solutions (ACES spin-out):
In January 2025, Avanteclad Modular Solutions was incorporated. Spun out of cleanroom construction expert Avant Garde Clean Room & Engineering Solutions (ACES), the company aims to
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