Rohit Ochaney

Co-Founder & CEO

Standing true to its reputation of being the ‘Pharmacy of the World’, the Indian pharmaceutical industry has grown exponentially in recent times and is strongly emerging as a global pharma manufacturing hub. While easy access to manpower and raw materials has been a major reason for this, government initiatives such as 100 percent FDI, PLI scheme, and Promotion of Research & Innovation in Pharma MedTech Sector (PRIP) have further accelerated pharmaceutical manufacturing & research in the country. However, given the critical & sensitive nature of this line of business, most companies find it extremely difficult to effectively track, manage and collaborate with the numerous vendors or service providers who are part of their daily operations. As a result, they are always on the lookout for vendors or partners who can take care of the entire project lifecycle.

Emerging as the true lifesavers in this regard are firms such as Inotek, who through their deep industry expertise and vast service portfolio, are handholding pharma businesses right from initial commencement of the project to the final delivery. Based in Thane, Inotek was incepted in 2022 by Sunil Lande (Founder & Managing Director) and Rohit Ochaney (Co-Founder & CEO) with a vision to effectively address the existing market gaps by bringing-in a balance between customer needs, evolving regulatory environment and the solutions being offered through a turnkey approach to service delivery.

“The growing emphasis on biosimilars, vaccines and biologics is driving demand for specialized turnkey solutions in high-tech pharmaceutical manufacturing. With increasing investments from international players, coupled with stringent global regulatory frameworks and the integration of Industry 4.0 technologies, turnkey projects are becoming an increasingly attractive choice. As the market moves towards strong global expansion, companies that provide end-to-end services, from design and construction to equipment supply, validation and compliance, are wellpositioned to capitalize on significant opportunities”, says Rohit Ochaney, Co-Founder & CEO, Inotek.

All-encompassing Service Provider

As an expert in delivering comprehensive turnkey solutions, Inotek offers end-to-end services that span from the initial stages of Detailed Engineering to the provision of critical materials such as Clean Room Panels, HVAC Systems, and Water Treatment Plants (WTP), ensuring a robust infrastructure for pharmaceutical manufacturing facilities. The company’s expertise extends to Project Management, enabling seamless execution from concept to commissioning, including Validation and Qualification processes that meet industry standards. Moreover, Inotek offers a unique advantage by assisting clients in obtaining Regulatory Certifications such as USFDA, EU-GMP, WHOGMP, and PIC/S GMP, ensuring global compliance and market readiness adhering to regulatory standards.

To further support its clients, Inotek also provides Technology Transfer Services, enabling immediate product registration and commercialization of the facility posthandover. Owing to such broad spectrum of services being offered under a single umbrella, the company has strongly cemented its position in the industry as a one-stop turnkey solution provider and reliable partner for diverse project requirements of the customers. Some of the major verticals that it caters to include pharmaceuticals, biotechnology, medical devices, nutraceuticals, hospitals and many others. “By providing end-to-end services under one roof, we distinguish ourselves as a reliable partner for timeefficient, cost-effective and tailor-made projects mainly for the pharmaceutical industry. Our bespoke engineering solutions tailored to the unique needs of each client improve operational efficiency and production flow. Further, our integrated and turnkey approach eliminates the need for clients to coordinate with multiple vendors and facilitates seamless & optimized project execution”, adds Rohit.

Quality-driven, Compliant & Customercentric Service Delivery

Always keeping client satisfaction as paramount, Inotek is always ready to go an extra mile to ensure that its customers get nothing short of the best service quality. In light of this, it has an elaborate customer engagement process across the entire project lifecycle wherein it first has a detailed discussion with the client to understand their production goals, budget constraints and regulatory compliance requirements. Based on the gathered inputs, it then creates a scalable facility design comprising of prefabricated cleanroom panels and plug-and-play utilities that enable faster setup and supports both batch-wise and continuous manufacturing. Further, the company also facilitates process-specific customization for various pharma segments such as sterile manufacturing capabilities for injectables, vaccines & biologics, API & high-potency drug production, oral solid dosage & tablet production, and many more.

Compliance has been yet another stronghold of Inotek, wherein every facility designed by the company fully adhere to global regulatory frameworks such as US FDA (21 CFR Part 210 & 211), EU GMP & EudraLex Volume-4, WHO GMP, MHRA, TGA, PIC/S, and ISO 14644. Well aware of the importance of faster regulatory approvals, it also conducts risk assessments and gap analysis right at the initial planning stage itself to spare clients of any compliance issue which in most cases are the primary cause for unnecessary project delays. While automated compliance tracking systems monitor adherence to evolving regulatory requirements, digital validation protocols ensure data integrity & compliance, and Electronic Batch Records (EBR) and Manufacturing Execution Systems (MES) eliminate manual errors and facilitate audit-readiness for clients’ manufacturing setups. Some of a few other noteworthy practices that the company has in place to ensure 100 percent compliance for its client include end-toend quality assurance & risk management, comprehensive documentation for audit-readiness, mock regulatory audits, pre-inspection readiness programs, SOPs as per global compliance requirements, & many more.

Every project that we take-up is tailored to meet regional and international regulatory standards for ensuring seamless approvals. Along with the usual postinstallation support, we monitor clients’ facility in real-time, provide remote assistance when needed and conduct annual compliance audits & periodic facility upgrades to make sure that the clients’ manufacturing plant is fully compliant with all the prescribed regulations and in line with the latest tech advancements. To further ensure value for money of our customers, we also train the client’s team to ensure optimal operation and compliance”, Rohit further explains.

Leveraging Technology for Enhanced Project Outcomes

As a technology-first organization, Inotek has always been at the forefront of cutting-edge technology adoption to provided added value for its customers. While IoT-enabled equipment, AI-driven predictive maintenance and realtime data analytics are a norm for the team, it also uses 3D modelling and simulations to create virtual replicas of the entire manufacturing facility. This enables clients to have a virtual experience of their site, make informed decisions, and save a lot resources through early fault detection even before commencing the actual construction process. Additionally, the company also utilizes Automated Guided Vehicles (AGVs) within the clients’ site to reduce manual handling risks, streamline material transport and facilitate higher levels of precision, safety & efficiency in the production cycle.

Artificial Intelligence and Machine Learning have been at the heart of Inotek’s quality assurance process, wherein it uses AI-powered visual inspection systems to detect even the micro-level defects in drugs and packaging. It also has automated batch release systems and adaptive process control mechanisms in place to analyze deviations, reduce project rejection rates, and dynamically adjust the production parameters to derive optimum yield. Further, the company also utilizes AI-backed airflow and smart energy management systems to automatically adjust air circulation, control temperature & humidity, and make realtime adjustments in these parameters based on occupancy & contamination levels.

Balancing Sustainability & Process Efficiency

Inotek doesn’t fall back in terms of sustainability either. As a socially responsible conglomerate, it has implemented a variety of sustainable practice into its process. This includes energy efficient HVAC & cleanroom solutions, low energy LED lighting integrated with motion sensors, using recycled, non-toxic & low emission construction materials, modular cleanroom panels, ecofriendly floorings & coatings and many more. Further, the company also implements zero liquid discharge systems, rainwater harvesting and advanced filtration & purification systems in each of its projects to reduce water wastage and facilitate safe disposal of pharmaceutical effluents.

Keeping in mind the importance of stable supply of power in pharmaceutical setup, Inotek implements solar power solutions in such a way that they can be used majorly for non-critical plant operations. On the other hand, while hybrid energy systems optimize power distribution between renewable and conventional energy sources, efficient batter energy storage systems ensure constant and stable power supply with reduced grid reliance. As a result, companies are able to not only reduce their carbon footprint in alignment with their corporate sustainability goals, but also significantly cut-down operational costs as well.

“We not only integrate latest manufacturing techniques and automated waste segregation & disposal systems in all our projects, but also use only biodegradable & ecofriendly solvents in all pharma related process. Most importantly, we strive to promote ecofriendly manufacturing by actively participating in various green pharma initiatives and ensuring that all our projects are fully aligned with ISO 14001 standards and LEED certification. This way, we’re able to build a strong corporate sustainability image both for ourself as well as for our customers”, elucidates Rohit.

Exploring Beyond Horizons

With a razor-sharp focus on driving innovation, sustainability, compliance and service excellence in pharma turnkey projects, Inotek already has long-term strategies chalk-out and ready for action. Going forward, the firm envisions enhancing its smart manufacturing capabilities by leveraging AI/ML backed predictive analytics, IoT-enabled manufacturing and blockchain-integrated supply chains for seamless automation, reduced human intervention, faster project completion, forecast future demand, and digitized & regulatory compliant pharmaceuticals production.

Additionally, it is also looking forward to foray into the biopharmaceuticals vertical and commence production of AIdriven personalized medicine for specific patient genomics to support the growing demand for biologics and personalized medicine. Overall, this highly distinguished organization is on a mission to create a globally interconnected pharmaceutical ecosystem that supports innovation, growth and accessibility by forging strategic partnerships, driving joint innovations and helping emerging markets build world-class pharmaceutical infrastructure.