India's next leap: From batch dependency to continuous quality leadership

Dr Vinay Rao, Head - Research & Development - STEERLife, highlights the transition to continuous processes is not a distant aspiration; it is a strategic necessity that will define India's competitiveness, credibility, and contribution to global healthcare

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For decades, the Indian pharmaceutical industry has successfully operated as the 'Pharmacy of the World,' built on the backbone of efficient, high-volume batch manufacturing. This traditional process has ensured reliability and scale, supplying nearly 40 per cent of US generics and 25 per cent of UK medicines. But let's be honest, the global game is changing. Increased regulatory precision, intense post-COVID scrutiny, and the demand for absolute supply-chain resilience now require something better. We have to move beyond the inherent limits of batch processing toward the certainty and efficiency of continuous manufacturing.

This isn't a distant, theoretical goal; it's an absolute necessity. If India wants to maintain and strengthen its dominant position, we have to act now. And the most decisive and immediate first step in this modernisation is the widespread adoption of continuous granulation.

The limits of a legacy workhorse

Granulation is arguably the most critical step in making tablets and capsules. It's where raw powders turn into uniform, compressible granules. In our traditional batch operations, this process is sequential and segmented: wet massing, drying, milling, and blending. They often happen across multiple pieces of equipment, with manual transfers and hold points in between.

While it has served us well, this approach introduces some fundamental headaches:

● Variability is inevitable: When you expose a bulk wet mass to short, intense shear cycles or dry a huge bed of material in a fluid-bed dryer, you get inconsistent heat and mass transfer. The result? Inconsistencies between one batch and the next, or even within a single batch. Not every particle gets the same treatment.

● Slow and clunky: All those stop-start cycles, multiple hold points, and reliance on operator judgment create long cycle times. Agility is limited.