|
Indian pharma manufacturing has entered a new era as digitalization drives a quantum leap across the sector. The adoption of advanced technologies such as automation, data analytics, artificial intelligence (AI), and smart quality systems is transforming traditional production models into highly efficient, agile, and compliant operations.
This shift is not only enhancing productivity and reducing costs but also strengthening regulatory compliance and product quality, positioning India’s pharmaceutical industry as a globally competitive, future-ready manufacturing hub, said Harish K Jain president, Federation of Pharma Manufacturers Association and director Embiotic Labs.
Kaushik Desai, executive committee member, industrial pharmacy section, International Pharmaceutical Federation (FIP) and pharma consultant, said that by 2030, the pharmaceutical industry would undergo a radical transformation, driven by advancements in smart manufacturing and the development of next-generation therapies.
Automation, AI and continuous production methods would streamline drug manufacturing, making it more efficient and cost-effective. At the same time, breakthroughs in gene therapies, biologics, and personalized medicine will redefine treatment possibilities, offering more targeted, effective solutions for patients. Together, these innovations would not only enhance production capabilities but also revolutionize how medicines are developed, delivered, and tailored to individual needs, shaping the future of healthcare, Desai added.
Three key strengths underpinning manufacturing
First, India has the highest number of USFDA-approved manufacturing plants pegged around 750 outside the United States, reflecting its strong compliance culture and global quality standards. Second, Indian companies have earned a reputation as dependable contract manufacturers, offering cost-effective, scalable, and reliable production for global pharma players. Third, the Government of India’s Production Linked Incentive (PLI) scheme has provided a major boost to domestic manufacturing by encouraging investments in advanced facilities, critical APIs, and high-value products, further strengthening India’s position as a global pharma manufacturing powerhouse.
In fact, it is the Union government’s PLI scheme announced in April 2020 during the Covid pandemic that has played a pivotal role in accelerating investments across the Indian pharmaceutical manufacturing landscape.
By offering financial incentives linked to incremental production, the scheme has encouraged companies to invest in new Greenfield plants, expand existing facilities, and adopt advanced manufacturing technologies. This influx of capital has strengthened domestic capabilities in APIs (active pharmaceutical ingredients), key starting materials, and high-value formulations, reducing import dependence and enhancing supply security. As a result, the PLI scheme has not only stimulated capacity creation but also supported the development of a more self-reliant, innovation-driven pharma manufacturing ecosystem in India.
When announced by the Union government for pharmaceuticals, its aim was to boost domestic manufacturing of APIs, KSMs, DIs, and high-value drugs like biosimilars, complex generics, etc with total outlays of Rs 15,000 crore and Rs 6,940 crore for different schemes, running through FY 2028-29/2029-30, supporting selected companies to reduce import reliance, enhance self-reliance as part of the Atmanirbhar Bharat, and increase global competitiveness. Selected firms receive financial incentives based on sales of identified products, driving investment in critical areas like anti-cancer, autoimmune drugs, and key raw materials.
Digital technologies impact manufacturing
Digitalization is an important component of Pharma 4.0 following Industry 4.0. It helps to connect everything, creating new levels of transparency and adaptivity for a ‘smart’ plant floor. It accelerates the pact of decision-making, and provide in-line and on-time control over business, operations, quality, and regulatory compliance. Notably, this new connectedness will require higher levels of security, since linked systems heighten vulnerability, said Jatish N Sheth, president, Karnataka Drugs and Pharmaceutical Manufacturers Association and director Srushti Pharma.
The universal curve ball, Covid-19, acted as a powerful catalyst for this transformation, compelling pharmaceutical companies to rapidly adopt digital technologies to ensure business continuity and supply chain resilience. Disruptions caused by lockdowns, workforce limitations, and sudden spikes in demand highlighted the need for remote monitoring, digital quality management systems, and data-driven decision-making. As a result, many Indian pharma manufacturers accelerated investments in digital tools, embedding technology deeper into their operations and laying the foundation for a more resilient, responsive, and technology-driven industry.
The key technologies implemented in pharma are automation of systems to improve precision, speed, and consistency in production. Robotics helped to provide real-time views and reduce manual errors. AI & Machine Learning (ML) helped in predictive maintenance, process optimization, and faster root-cause analysis. Internet of Things (IoT) also helped to provide data in real-time in monitoring of equipment, environmental conditions, and production parameters.
Advanced analytics and big data supported in decision-making to improve processes and enable regulatory compliance. The Manufacturing Execution Systems (MES) helped to integrating shop-floor operations with quality, inventory, and production planning. Then there was Digital Quality Management Systems (eQMS) to streamlining documentation, audits, and regulatory reporting. Cloud Computing facilitated remote access, scalability, and collaboration across sites. Together, these technologies are reshaping Indian pharma manufacturing into a smarter, more efficient, and globally competitive industry.
|