2025-10-13

In an exclusive interaction with Pharmacy Industrial India, Arushi Jain, Director of Akums Drugs and Pharmaceuticals, shares how the company is redefining pharmaceutical manufacturing through automation, digitalisation, and sustainable innovation. Jain also highlights the policy measures needed to help India move beyond being just the “pharmacy of the world” to becoming a “healthcare innovation hub.”

Q. What new machines or technologies has Akums recently adopted to enhance efficiency and precision in manufacturing?

Akums has recently embraced advanced technologies and state-of-the-art machinery to enhance efficiency, precision, and consistency in pharmaceutical manufacturing. Aligned with the Pharma 4.0 revolution, automation has been integrated into production processes to reduce human error, improve process control, and ensure higher product quality. This includes digital monitoring systems and Process Analytical Technology (PAT) that allow real-time tracking of critical process parameters, ensuring consistency and enabling early detection of potential issues.

In our quality control laboratories, Akums has upgraded equipment for chemical, microbiological, and stability testing. Advanced instruments such as HPLC, UPLC, GC, LCMS, ICP-MS, FTIR and Laser Diffraction enable precise analysis of raw materials, intermediates, and finished products. Microbiological testing now employs Auto Culture Identifiers and Rapid Sterility Testers to ensure contamination-free sterile and non-sterile products.

Additionally, automation in material handling, packaging, and process monitoring has streamlined manufacturing workflows, improving efficiency and reducing production cycle time. These technological upgrades, coupled with our Quality by Design (QbD) approach, reinforce Akums’ commitment to producing safe, effective, and reliable pharmaceuticals with consistent high quality.

The company has also invested heavily in advanced injectable infrastructure, spanning ampoules, vials, pre-filled syringes, lyophilized products, and infusions, catering to sensitive therapies.

Q. How is automation transforming your production lines, and what benefits have you seen in terms of speed, cost, and quality control?

Automation has significantly transformed our production lines, driving improvements in speed, cost efficiency, and quality control. In manufacturing, we have implemented advanced systems in secondary packaging and shop floor monitoring. Automated pack counts, batch numbering, and verification of printed text have strengthened quality systems and minimised human error.

Our Shipper Label Project has streamlined dispatches by integrating software across 80 packing lines. With online weighing, gross weight recording, and QR code tracking, we have eliminated mix-ups in shipper dispatches, ensuring accuracy and efficiency in warehouse operations.

The implementation of Online OCR and OCV has automated batch coding verification, eliminating manual checks and saving manpower. This supports GMP compliance and prevents errors in labeling or missing details. Similarly, online check weighers in secondary packaging verify each carton for completeness, reducing complaints, enhancing compliance, and cutting manpower costs.

We have also adopted digital pack inserts, replacing physical materials with digital versions, which has reduced packaging costs, eliminated inventory requirements, increased speed, and supported sustainability.

In injectables, camera-based rejection systems for empty or uncapped vials ensure quality at every stage. Collectively, these automations have optimised processes, improved reliability, reduced costs, and reinforced our commitment to delivering safe, high-quality products.

Q. Could you share how Akums ensures compliance with global regulatory standards when introducing new manufacturing technologies?

At Akums, regulatory compliance is central to every new technology adoption, ensuring our facilities align with stringent global standards. For injection dosage forms, we are aligning with EU Annex 1 guidelines, with key activities including ORABS installation, oxygen content monitoring, media fill validation, CCIT, and adherence to ALCOA principles. Most capex elements are in place and nearing completion during scheduled shutdowns, reinforcing compliance readiness.

Our regulatory compliance is validated by global partners such as EQL (Sweden), Olpha (Latvia), Numega (Australia), Viatris (EU), Cooper (EU), Devrimed (Netherlands), LAGAP (Switzerland) and Unicon (UK), reflecting confidence in our systems.

We have also developed advanced digital solutions to enhance traceability and product authenticity. A software-hardware integration generates QR codes for the Top 300 brands on primary and secondary packaging, allowing patients and stakeholders to verify product genuineness and strengthening anti-counterfeiting measures.

In warehousing, centralised and plant-level warehouse management software integrates QR-based tracking from material receipt to dispensing, improving accuracy in managing quarantine, sampling, testing, approval, or rejection. This system has streamlined operations, reducing manpower requirements while improving reliability.

Additionally, our PPIC implementation through the Plan Visage tool enhances production planning and scheduling, ensuring compliance, efficiency, and alignment with global expectations.

Q. How do you maintain the integrity of clean rooms while scaling up operations?

Maintaining the integrity of clean rooms becomes even more critical as operations scale, and at Akums, this is treated as non-negotiable. Our facilities are designed with advanced air-handling systems and HEPA filtration, which tightly control particulates, while strategic zoning and pressure differentials prevent cross-contamination between areas. Complementing these systems, strict protocols, gowning procedures, and continuous environmental monitoring act as additional layers of protection, ensuring every stage of production meets the highest standards of safety and hygiene.

What truly sets Akums apart is our approach to scaling operations. Clean room standards are integrated into the very design of new facilities and expansion plans. This foresight ensures that even as production capacity increases, we consistently maintain global quality benchmarks.

In practice, scalability at Akums is not just about producing more—it’s about producing more responsibly. By combining robust infrastructure, proactive monitoring, and rigorous operational protocols, we guarantee that patient safety, product integrity and regulatory compliance remain at the centre of the focus, even as our manufacturing footprint grows.

Q. Sustainability in pharma manufacturing is gaining importance. What steps has Akums taken to reduce carbon footprint, water usage or energy consumption in its plants?

At Akums, sustainability is central to how we operate and scale our business, ensuring that growth goes hand in hand with environmental responsibility and social progress. Our decarbonisation efforts include the adoption of solar power, transitioning boilers to biomass fuels such as rice husk and briquettes, and implementing piped natural gas across facilities to reduce SOx and particulate emissions. Initiatives like tablet size optimisation and room-temperature-stable dosage forms help reduce packaging waste, lower transportation-related emissions, and minimise cold-chain dependency, making our supply chain more resource-efficient. These measures align with global sustainability benchmarks while strengthening business resilience.

Water and waste management form another critical pillar of our sustainability strategy. Guided by our “4R” philosophy – Reduce, Reuse, Recycle and Recharge, we minimise freshwater use through rainwater harvesting, wastewater treatment, and reuse systems. Waste streams, including biomedical and hazardous materials, are managed responsibly, supporting our target of zero waste to landfill. Beyond our facilities, we extend sustainability to communities through plantation drives, afforestation programs, and clean-up initiatives, improving local ecosystems and generating lasting social impact, demonstrating that responsible growth benefits both people and the planet.

Q. Akums already has a wide product portfolio. Which therapeutic areas or dosage forms are you planning to extend into next?

Akums Drugs & Pharmaceuticals Ltd. boasts a diverse product portfolio encompassing over 4,000 commercialised formulations across more than 60 dosage forms. The company has established a strong presence in various therapeutic areas, including cardiovascular, diabetes , neurology, gastrointestinal, respiratory, gynaecology, pediatrics and more. In recent developments, Akums has expanded its capabilities to include lyophilised injectables and sterile dosage forms, addressing the growing global demand for these advanced pharmaceutical solutions. The company has also secured Good Manufacturing Practice (GMP) certification from the Eurasian Economic Union (EAEU) for its hormonal manufacturing plant, enabling access to regulated international markets. Akums further plans to strengthen its portfolio in rare diseases and lyophilised products. Akums' strategic initiatives reflect its dedication to broadening its therapeutic offerings and enhancing its global manufacturing capabilities.

Q. How do you see the new GST reforms shaping the pharmaceutical manufacturing ecosystem in India?

The recent GST reduction on life-saving and essential medicines is a welcome and patient-centric reform that will make treatments more affordable and accessible for those battling chronic, rare and life-threatening conditions. Even a modest cut in treatment costs can ease the strain on families, encourage better adherence to therapies and help patients seek care without delays. Equally important is the government’s decision to automate the GST refund process, which will speed up reimbursements, strengthen industry cash flows and allow companies to focus more on delivering quality healthcare. At Akums, we view these measures as a meaningful step forward in supporting patients while also reinforcing our mission of providing safe, effective and affordable therapies aligned with the goal of accessible healthcare for all.

Q. What further policy changes would you like to see to support pharmaceutical manufacturing in India?

India has taken big strides in strengthening its pharmaceutical policy framework, but there’s still scope to make it more future-ready. One important change would be the rationalisation of the inverted duty structure, which today puts unnecessary strain on working capital and impacts long-term sustainability for manufacturers. Equally, a simplified single-window clearance system for greenfield projects could cut down delays and help companies respond faster to global and domestic opportunities. We also believe stronger policy incentives for R&D in areas like complex generics, biologics and novel therapies would spark greater innovation from India. Finally, building advanced logistics infrastructure — from modern cold chain systems to sustainability-linked incentives for firms adopting clean energy — would give the sector the resilience it needs. With these measures, India can move beyond being just the pharmacy of the world to becoming a true hub for healthcare innovation.