However, if the increasing competition from global and domestic players, as well as the pressure to enhance profitability were not enough, the impending onset of the product patent regime under World Trade Organization regulations has added to the burden. All of this comes too as drug price controls continue to exist, and costs escalate.
But the industry has risen to these challenges. Automation has been a key enabler in translating this strategy into reality. Due to globalization and competitive market pressures in India, more and more companies are becoming open to automation. Compliance with regulatory requirements, especially for export products, throws up new opportunities and challenges for automation suppliers.
In addition to having well-integrated enterprise applications, the pharma companies are implementing comprehensive applications to optimize operations. Of late, the pharmaceutical industry in India has also begun to take advantage of radio frequency identification (RFID) technology. In addition, some multinational pharma firms are using electronic Case Report Forms (CRFs) for clinical trials being conducted in India. However, these were primarily aimed at supporting clinical trial studies originating from their global research and development (R&D) centers. Domestic pharmaceutical companies have also started taking tentative steps towards experimenting with information technology (IT) solutions in this area.
“The pharmaceutical industry is in rapid transition from a supply-driven market to a demand- and service-driven market, where manufacturing efficiency and responsiveness will play a critical role in future success” according to Asish Ghosh, analyst at ARC Advisory Group Inc., in Dedham, Mass.
Automation is central for Indian labs too. In tune with global trends, Indian labs have transformed themselves from mere testing grounds into efficient specialized businesses focused on quality, accuracy, and continuous improvement of processes. In the process, lab automation and instrumentation have played crucial roles. The current lab automation technology has evolved after an increased volume in tests, which is supported by qualified manpower and investments by companies, states V.R. Kannan, an Indian pharma consultant.
“Lab automation has led to reduction in time-to-market, easing complexities of project time and detecting failure early, thus saving costs,” states Chandresh Jain, product manager, data, Waters (India) Private Ltd. “The spurt of new companies in the biotech space in the areas of contract-clinical research organizations, drug discovery outfits, R&D labs and research institutes has resulted in an increased demand for not just lab equipment, but automation in many of the tasks. The demand is not just for smart technologies but regulatory-complaint solutions,” he adds.
Multinationals are all out to cash in on the situation. Vinod Bambarkar, vertical market manager, sensing and control,
Honeywell Automation India Ltd., says that his firm develops high-end system-critical products for industry applications and will continue to launch such products in India. “Increased demand in the rural healthcare segment in India, which forms the largest segment of the population, will drive the medical and pharma market, which is expected to grow at a compound
annual growth rate of 18 percent as per Government of India data. The market holds strong opportunity for indigenization, R&D hubs for global players and for offering high-end value products,” he added.
He said Honeywell Sensors position and humidity sensors are used in the pharma industry in tablet- capsule- and drug manufacturing machines. Besides this, Honeywell’s environment and combustion control business provides environmental control products to maintain desired temperature. Honeywell sensors are used in critical life saving machines such as ventilators, respiratory equipment, incubators, blood dialysis machines and others.
Indian firms are also trying to tap the market. A “faster and cheaper” blister pack machine was launched by Indian firm Cap Tab for the first time in Europe at this year’s CPhI show in Paris. HCL Technologies has recently launched Equipment Log Manager (ELM), a Microsoft .Net-based application that will enable pharmaceutical companies to comply with the Current Good Manufacturing Practice (cGMP) guidelines of the U.S. Food & Drug Adminstriation (FDA). The ELM is designed specifically for Indian pharma companies looking to get their manufacturing facilities GMP complaint.
Global consultant Ernst & Young says: “India is becoming an integral part of the pharma value chain, as large global pharma companies continue to increase their sourcing of APIs (application programming interfaces), offshoring of clinical development, and partnering with domestic companies for new product development and marketing in India.”
Indian pharma offers a big opportunity for automation firms. Automation is behind schedule in the pharma R&D sector compared to industries such as automotive and aerospace manufacturing. Automation is now being used in many areas of pharmaceutical processes right from drug discovery, manufacturing, formulations and packaging. The Indian pharmaceutical industry is looking for automation suppliers who are familiar not only with their processes and plant technology, but also with regulatory requirements, who can act as automation partners rather than vendors.