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Revised Schedule M pushes Indian pharma cos to align with international standards: Expert
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Nandita Vijayasimha, Bengaluru
February 21 , 2026
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The revised Schedule M pushes Indian pharmaceutical companies to align with international standards. The updated GMP (good manufacturing practice) requirements demand high accuracy, hygienic and validated measurement instruments, said Gaurav Bawa, senior vice president, WIKA India.
Leading pharma manufacturers have been upgrading to more reliable temperature and flow measurement systems to ensure the expected level of sterility, consistency and traceability across all processes. This shift is especially evident in areas such as fermentation, filtration, utilities, and CIP/SIP, where precise monitoring directly influences product quality, he added.
It is not just the Indian norms but global regulations like the US FDA and EMA also influence the purchase of measuring instruments. US FDA and EMA regulations mandate tighter control over process parameters, process parameters, traceability, and documentation. As a result, instruments must meet global standards such as FDA, 3 A, EHEDG, and material safety norms. This drives the industry to adopt validated, audit ready instrumentation. Consequently, pharma companies prefer equipment with hygienic design, certified materials and proven long term accuracy, Bawa told Pharmabiz in an email.
To this end, there are several key trends which are reshaping the industry. These are smart sensors where real time monitoring, wireless connectivity and cloud integration enable continuous data collection and improved traceability. Also, instruments operating without physical contact minimize contamination risks, maintain sterility in critical environments, and reduce mechanical wear. Moreover, miniaturization is the preference. Smaller, compact sensors offer high precision in advanced drug manufacturing and help achieve tighter control over sensitive process parameters, he noted.
High precision measurement supports micro batch and specialized therapies by reducing variability and strengthening compliance with stringent quality standards. Collectively, these trends reflect the pharma industry’s shift toward greater automation, operational flexibility, and data driven decision making, said Bawa.
On whether there were challenges for WIKA in a market dominated by MSME pharma manufacturers, he said, “MSMEs make up a large portion of India’s pharmaceutical landscape. While many of them aspire to upgrade, challenges such as budget limitations, low levels of automation, and limited technical expertise slow the adoption of advanced instruments.”
WIKA addresses these challenges by offering cost efficient, scalable solutions, strong local service support and NABL certified calibration facilities, helping MSMEs achieve compliance without disproportionate investment, he said.
Looking ahead, measurement technologies for pharmaceuticals will continue to evolve rapidly to support higher expectations for sterility, accuracy, and operational efficiency. Key advancements are likely to include IIoT (industrial internet of things) enabled sensors which analyse real-time process data, detect early signs of drift or failure, and automatically schedule maintenance. This will help prevent unplanned downtime and maintain consistent product quality, he said.
As sustainability becomes integral to pharma operations, instrumentation will be engineered to reduce power consumption, minimize heat generation and lower water or steam usage during CIP/SIP cycles. Advances in sensor materials and microelectronics will deliver probes with quicker responses to temperature and pressure changes, enabling tighter control, particularly important for micro batch and continuous manufacturing, he said.
A move toward circular manufacturing will drive the use of recyclable metals, low impact polymers, and environmentally responsible coatings, supporting greener production environments. Collectively, these innovations will enhance operational efficiency, reduce downtime, improve product consistency and align the pharmaceutical industry with global sustainability goals, said Bawa.
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